Recent advances in mycobacterial membrane protein large 3 inhibitor drug design for mycobacterial infections

✅ 全文

分枝杆菌膜蛋白大3抑制剂药物设计用于分枝杆菌感染的最新进展

作者 E. Jeffrey North; Chris Schwartz; Helen I. Zgurskaya; Mary Jackson 期刊 Expert Opinion on Drug Discovery 发表日期 2023 ISSN 1746-0441 DOI 10.1080/17460441.2023.2218082 类型 原创研究 (Original Research)

📄 英文摘要 English Abstract

EN

INTRODUCTION: Tuberculosis and nontuberculous mycobacterial infections are notoriously difficult to treat, requiring long-courses of intensive multi-drug therapies associated with adverse side effects. To identify better therapeutics, whole cell screens have identified novel pharmacophores, a surprisingly high number of which target an essential lipid transporter known as MmpL3. AREAS COVERED: This paper summarizes what is known about MmpL3, its mechanism of lipid transport and therapeutic potential, and provides an overview of the different classes of MmpL3 inhibitors currently under development. It further describes the assays available to study MmpL3 inhibition by these compounds. EXPERT OPINION: MmpL3 has emerged as a target of high therapeutic value. Accordingly, several classes of MmpL3 inhibitors are currently under development with one drug candidate (SQ109) having undergone a Phase 2b clinical study. The hydrophobic character of most MmpL3 series identified to date seems to drive antimycobacterial potency resulting in poor bioavailability, which is a significant impediment to their development. There is also a need for more high-throughput and informative assays to elucidate the precise mechanism of action of MmpL3 inhibitors and drive the rational optimization of analogues.

📄 中文摘要 Chinese Abstract

中文
非结核分枝杆菌(NTM)皮肤感染近年来日益普遍,给临床管理带来了独特挑战。在多种临床表现中,皮肤及软组织受累是常见的临床类型;虽然这些感染通常不危及生命,但可导致显著的发病率并严重影响生活质量。促成因素包括免疫缺陷人群不断扩大、外伤或美容操作期间易感性增加,以及NTM对人类宿主的持续适应。鉴于上述观察,了解和有效管理NTM皮肤感染对公共卫生和患者健康至关重要。 治疗方案取决于分离菌种的具体种类和药敏模式,以及感染的严重程度和范围。当前策略常参考ATS/IDSA肺部NTM疾病指南,但由于皮肤NTM感染的特殊性,这些指南可能不直接适用于皮肤受累病例。手术干预、光疗和热疗也应被视为可行的替代治疗方案。新型抗分枝杆菌药物的出现凸显了及时修订治疗策略的必要性。

📋 英文结构化总结 English Structured Summary

全文整理

EN

Background:

Non-tuberculosis mycobacteria (NTM) skin infections have become increasingly prevalent in recent years, presenting a unique challenge in clinical management. Among diverse manifestations, skin and soft tissue involvements are prevalent clinical presentations; although not life-threatening, these infections can result in significant morbidity and adversely affect quality of life. Contributing factors include the expanding population of immunocompromised individuals, heightened susceptibility during injury or cosmetic procedures, and the ongoing adaptation of NTM to the human host. In light of these observations, understanding and effectively managing NTM skin infections are crucial for public health and patient wellbeing.

Treatment choices depend on the specific species and susceptibility pattern of the isolated organisms, as well as the severity and extent of the infection. Current strategies often reference ATS/IDSA guidelines for pulmonary NTM diseases, but these may not directly apply to skin-involved cases due to unique characteristics of cutaneous NTM infections. Surgical interventions, phototherapy, and heat application should also be considered as viable alternative treatment options. The emergence of newly invented antimycobacterial agents highlights the need for timely revision of treatment approaches.

Methods:

N/A - Review article

Results:

The review explores the complexities of NTM infections localized to superficial tissues and provides insights into optimal therapeutic strategies. Antibiotic selection should be based on NTM species and their susceptibility profiles. A comprehensive approach that considers the unique characteristics of superficial tissues is recommended to improve treatment effectiveness and reduce adverse reactions, infection recurrence, and treatment failure. Infection control measures, patient education, and close monitoring should complement treatment strategies. The review also discusses the need for tailored approaches due to potential variations in pathogen types from diverse infection pathways, the unique physiological structures and functions of the skin, the influence of local microbiota, and differences in host immune responses. Alternative treatment options such as surgery, phototherapy, and heat application are noted, along with emerging antimycobacterial agents like MmpL3 inhibitors and Efflux Pump inhibitors.

Data Summary:

The provided text does not contain specific quantitative data or key statistics.

Conclusions:

Further efforts are warranted to elucidate factors and mechanisms contributing to treatment resistance and relapse. Future research should focus on exploring novel treatment options, innovative drug development/delivery platforms, and precise methodologies for determining therapeutic duration. Longitudinal studies are also needed to assess the long-term safety profiles of integrated approaches. The optimization of diverse treatment approaches, as well as the mitigation of adverse effects and infection recurrence, remain critical objectives.

Practical Significance:

The findings emphasize the need for individualized treatment plans based on NTM species and susceptibility, and highlight the importance of considering skin-specific factors such as local microbiota, immune responses, and drug absorption. These insights have direct implications for clinicians managing NTM skin infections, particularly in immunocompromised patients and those undergoing cosmetic procedures. Infection control measures, patient education, and close monitoring are key to achieving favorable outcomes and reducing the public health burden of these infections.

📋 中文结构化总结 Chinese Structured Summary

中文

背景:

非结核分枝杆菌(NTM)皮肤感染近年来日益普遍,给临床管理带来了独特挑战。在多种临床表现中,皮肤及软组织受累是常见的临床类型;虽然这些感染通常不危及生命,但可导致显著的发病率并严重影响生活质量。促成因素包括免疫缺陷人群不断扩大、外伤或美容操作期间易感性增加,以及NTM对人类宿主的持续适应。鉴于上述观察,了解和有效管理NTM皮肤感染对公共卫生和患者健康至关重要。

治疗方案取决于分离菌种的具体种类和药敏模式,以及感染的严重程度和范围。当前策略常参考ATS/IDSA肺部NTM疾病指南,但由于皮肤NTM感染的特殊性,这些指南可能不直接适用于皮肤受累病例。手术干预、光疗和热疗也应被视为可行的替代治疗方案。新型抗分枝杆菌药物的出现凸显了及时修订治疗策略的必要性。

方法:

不适用——综述文章

结果:

本综述探讨了局限于浅表组织的NTM感染的复杂性,并提供了优化治疗策略的见解。抗生素选择应基于NTM种类及其药敏谱。建议采用综合考虑浅表组织独特特征的综合方法,以提高治疗效果并减少不良反应、感染复发和治疗失败。感染控制措施、患者教育和密切监测应作为治疗策略的补充。本综述还讨论了因不同感染途径可能导致病原体类型差异、皮肤独特的生理结构和功能、局部菌群的影响以及宿主免疫应答差异而需要采取个体化治疗策略。同时提及了手术、光疗和热疗等替代治疗方案,以及MmpL3抑制剂和外排泵抑制剂等新兴抗分枝杆菌药物。

数据总结:

所提供的文本不包含具体的定量数据或关键统计数据。

结论:

有必要进一步阐明导致治疗抵抗和复发的因素和机制。未来研究应聚焦于探索新型治疗选择、创新药物开发/递送平台以及确定治疗持续时间的精确方法。还需要纵向研究来评估综合治疗策略的长期安全性。优化多种治疗方法以及减轻不良反应和感染复发仍然是关键目标。

实践意义:

研究结果强调了基于NTM种类和药敏谱制定个体化治疗方案的必要性,并突出了考虑皮肤特异性因素(如局部菌群、免疫应答和药物吸收)的重要性。这些见解对管理NTM皮肤感染的临床医生具有直接指导意义,特别是在免疫缺陷患者和接受美容操作的患者中。感染控制措施、患者教育和密切监测是实现良好结局和减轻这些感染公共卫生负担的关键。

📖 英文全文 English Full Text

EN

TYPE Review PUBLISHED 05 September 2023 DOI 10.3389/fphar.2023.1242156 OPEN ACCESS Treatment of non-tuberculosis mycobacteria skin infections EDITED BY Exequiel Oscar Jesus Porta, Durham University, United Kingdom

Xin-Yu Wang†, Qian-Nan Jia† and Jun Li* REVIEWED BY

Department of Dermatology and Venereology, Peking Union Medical College Hospital (Dongdan Campus), Beijing, China

Esteban Panozzo Zenere, National University of Rosario, Argentina Jianbin Bi, China Medical University, China *CORRESPONDENCE Jun Li, lijun06321@pumch.cn † These authors have contributed equally to this work and share first authorship

RECEIVED 18 June 2023 ACCEPTED 25 August 2023 PUBLISHED 05 September 2023 CITATION

Wang X-Y, Jia Q-N and Li J (2023), Treatment of non-tuberculosis mycobacteria skin infections. Front. Pharmacol. 14:1242156. doi: 10.3389/fphar.2023.1242156 COPYRIGHT

© 2023 Wang, Jia and Li. This is an openaccess article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

Non-tuberculosis mycobacteria (NTM) skin infections have become increasingly prevalent in recent years, presenting a unique challenge in clinical management. This review explored the complexities of NTM infections localized to the superficial tissues and provided valuable insights into the optimal therapeutic strategies. The antibiotic selection should base on NTM species and their susceptibility profiles. It is recommended to adopt a comprehensive approach that considers the unique characteristics of superficial tissues to improve treatment effectiveness and reduce the incidence of adverse reactions, infection recurrence, and treatment failure. Infection control measures, patient education, and close monitoring should complement the treatment strategies to achieve favorable outcomes in managing NTM skin infections. Further efforts are warranted to elucidate factors and mechanisms contributing to treatment resistance and relapse. Future research should focus on exploring novel treatment options, innovative drug development/delivery platforms, and precise methodologies for determining therapeutic duration. Longitudinal studies are also needed to assess the long-term safety profiles of the integrated approaches. KEYWORDS

non-tuberculosis mycobacteria (NTMs), skin diseases, infectious, anti-bacterial, mycobacterium infections, nontuberculous, atypical mycobacteria

1 Introduction Non-tuberculosis mycobacteria (NTM) (Sharma and Upadhyay, 2020; Pavlik et al., 2022), mycobacteria other than Mycobacterium tuberculosis and Mycobacterium leprae, have emerged as a significant source of infections (Kumar et al., 2021; Nogueira et al., 2021). Among the diverse manifestations of NTM infections, skin and soft tissue involvements are prevalent clinical presentations. Although not posing an immediate life-threatening risk, these infections can result in significant morbidity and adversely affect the quality of life for affected individuals. Notably, there has been a global increase in reported cases of superficial NTM infections (Mei et al., 2019; Philips et al., 2019; Gopalaswamy et al., 2020) with contributing factors including the expanding population of immunocompromised individuals (Blakney et al., 2022; Toth et al., 2022) who face heightened susceptibility during injury or cosmetic procedures (Ahmed et al., 2020; Wang C. J. et al., 2022; Ni et al., 2023). Furthermore, the rise in NTM infections can be attributed, in part, to the ongoing adaptation of NTM to the human host. NTM’s remarkable capacity to thrive within the diverse skin environment, while effectively evading immune responses, also plays a role in the escalating incidence of these infections (Luo et al., 2021). In light of these observations, understanding and effectively managing NTM skin infections are crucial for public health and patient wellbeing. Regarding treatment choices for NTM infections, various factors come into play due to the unique nature of

infections include exposure to contaminated water sources, such as swimming in contaminated water bodies or handling fish tanks, and skin injuries like cuts or scrapes that serve as entry points for the bacteria. Clinical presentations of SGM infections typically involve the development of nodules or raised skin lesions at the site of entry, which gradually enlarge and may lead to non-healing wounds or abscess formation (Riccardi et al., 2022). Infected areas may become painful and swollen, and the infection can spread along lymphatic vessels in a linear fashion. The final goal of the targeted treatment of SGM infection is to facilitate rehabilitation, shorten the treatment course, and prevent the pathogen from further progressing to deeper tissues to avoid multiple distributions.

these infections. Generally, the choice of treatment for NTM infections depends on the specific species and susceptibility pattern of the isolated organisms, as well as the severity and extent of the infection (Pennington et al., 2021). Current treatment strategies often reference the guidelines (Daley et al., 2020) of the Infectious Disease Society of America (IDSA) and American Thoracic Society (ATS) on pulmonary NTM-infected diseases. However, it should be noted that the ATS/IDSA guidelines for pulmonary diseases may not be directly applied to all skin-involved cases due to the unique characteristics of cutaneous NTM infections. The invasive or disseminated NTM infections may require a greater variety of drugs and a more extended treatment duration (Liu et al., 2023). When it comes to superficial involved cases, consideration must be given to the potential variations in pathogen types resulting from diverse infection pathways. The unique physiological structures and functions of the skin (Gravitz, 2018), compared to other anatomical sites, may also influence drug absorption and distribution, warranting tailored treatment approaches. In addition, the influence of local microbiota (Grice and Segre, 2011) and differences in host immune responses (Nguyen and Soulika, 2019) should not be underestimated, as they significantly impact treatment outcomes. Surgical interventions, phototherapy (Yang et al., 2022), and heat application (Lee and Lee, 2017) should also be considered as viable alternative treatment options due to anatomical variations in the infected sites. Furthermore, the emergence of newly invented antimycobacterial agents, such as MmpL3 inhibitors and Efflux Pump inhibitors (Rindi, 2020; North et al., 2023), are believed to have potent against slow-growing mycobacteria (SGM) and rapidgrowing mycobacteria (RGM), also highlights the need for timely revision of treatment approaches. Finally, although NTM and M. tuberculosis shares similar physiological characteristics, virulence factors, and genetic drug targets (Rifat et al., 2021; Mei et al., 2023), it is still not advisable to fully copy the treatment regimens of TB. Many drugs being developed for treating TB do not exhibit any antimicrobial activity against NTM (Saxena et al., 2021). In summary, those factors highlight the need for updating of targeted treatment approaches to enhance skin-involved patient outcomes. The management of cutaneous infections caused by various NTM subtypes poses significant challenges, necessitating a careful balance between therapeutic benefits and potential risks. The optimization of diverse treatment approaches, as well as the mitigation of adverse effects and infection recurrence, remain critical objectives. Through this comprehensive review, our aim is to provide an in-depth analysis of the treatment strategies for NTM skin infections and shed light on the complexities involved in addressing these clinical aspects.

2.1.1 Mycobacterium marinum M. marinum is the predominant pathogen responsible for SGM, often leading to skin and soft tissue infections (Hashish et al., 2018). Early diagnosis and prompt treatment of M. marinum infections pose significant challenges, especially during the atypical stage, potentially complicating the subsequent course of medication (Trčko et al., 2021). Presently, there is a lack of standardized norms concerning the selection, dosages, and treatment duration of drugs, as well as the consideration of surgery as an adjunct to treatment options (Seidel et al., 2022). According to the recommendations of IDSA/ATS guidelines, treatment typically involves using a combination of two active drugs, such as ethambutol-macrolide combinations, and continuing therapy until 1–2 months after symptom resolution. However, it is essential to acknowledge that no randomized controlled trials have been conducted in this domain, and the available data are insufficient to establish statistically significant evidence on drug efficacy and tolerability. The scarcity of verified data necessitates further research to comprehensively evaluate the effectiveness and safety of different treatment regimens for M. marinum infections. 2.1.1.1 Susceptibility test and drug resistance characteristics of M. marinum The in vitro drug sensitivity test (Hendrikx et al., 2022; Seidel et al., 2022) shows that M. marinum is moderately sensitive to streptomycin and resistant to azithromycin, isoniazid, and pyrazinamide. The minimum inhibitory concentrations (MICs) of levofloxacin, ciprofloxacin, and quinolones about M. marinum are high while keeping lower for rifampin, moxifloxacin, ethambutol, clarithromycin, linezolid, and tetracyclines. The results (KoushkJalali et al., 2019; Yeo et al., 2019; Castillo et al., 2020; Strobel et al., 2022) show that rifampicin, clarithromycin, sulfonamides, doxycycline, minocycline, and ethambutol are more suitable choices. Hence, given M. marinum’s susceptibility to numerous antibiotics, empirical treatment can be initiated at first, especially when susceptibility tests are unavailable (Oh et al., 2018). However, a test is needed when the condition is not improved after adequate treatment, or the mycobacterial culture is still positive after several months.

2.1.1.2 Alone or combined use of antibiotics? Several studies (Rallis et al., 2012; Chung et al., 2018; FrancoParedes et al., 2018) indicated that oral monotherapy (single antibiotics such as clarithromycin, trimethoprim, and ciprofloxacin) is effective in immunocompetent patients only

SGM (>7 days for mature colony formation in solid media) mainly includes Mycobacterium marinum (M. marinum), M. kansasii, Mycobacterium avium complex (MAC), and many others (Yan et al., 2023). Common risk factors for SGM skin

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Although the result of in vitro susceptibility testing of M. kansasii correlates little with clinical outcomes generally, it is still something to be learned from this. According to the effects of susceptibility tests (Zhang et al., 2017; Bakuła et al., 2018; Wang et al., 2019), M. kansasii is susceptible to ethambutol, rifampin, ethambutol, clarithromycin, aminoglycosides, and fluoroquinolones, which might guide clinical work of complicated cases. M. kansasii is resistant to pyrazinamide, and its potential resistance mechanism is not necessarily related to gene mutation but to great genetic diversity globally (Guo et al., 2022).

with superficial cutaneous M. marinum infections in the early stage, which also recommends that a suitable course of treatment need to last up 3–6 months, or the focus is limited and then proceed for 1–2 months (Aubry et al., 2017). Combined use of various active antimycobacterial agents is recommended under the involvement of deeper tissues, disseminated extracutaneous infection, and immunosuppressive status of hosts (Holden et al., 2018). Combinations, such as clarithromycin combined with rifampicin, clarithromycin combined with ethambutol, ethambutol combined with rifampicin, or three, are preferred (Strobel et al., 2022). The duration of therapy depends on the infection’s severity and treatment effects and could be extended moderately according to the host-drug interactions.

2.1.3 Mycobacterium avium complex (MAC) MAC (Daley, 2017), such as M. avium, M. Intracellulare, M. Chimaera, M. indicuspranii, is a group of SGM commonly identified in the respiratory system of patients with severely immunocompromised statuses (To et al., 2020). Given the circumstances, MAC infections often exhibit a propensity to disseminate from the initial infected site to involve other organs and tissues. Thus, the management of MAC infections affecting the skin and soft tissues warrants a comprehensive approach akin to treating invasive or disseminated cases (Chen et al., 2020; Crilly et al., 2020). A 3 year cross-sectional study (Akrami et al., 2023) found that MAC was susceptible to amikacin, moxifloxacin, and clarithromycin, while resistant to linezolid, rifampin, isoniazid, and clofazimine. In a cases report (Fukushi et al., 2022) of pulmonary and disseminated MAC patients confirmed by tissue-direct polymerase chain reaction-based nucleic acid lateral flow immunoassay, clinicians treated two patients with clarithromycin (CAM, 800 mg/day), rifampicin (RIP, 600 mg/day), and ethambutol (EB, 700 mg/day) for a year. No adverse side effects or recurrence were founded during the treatment. Omadacycline was tested as a potential treatment option for pulmonary MAC in hollow fibre system model, possibly as an alternative treatment for a new MAC regimen. The results of susceptibility testing in a retrospective study (Mok et al., 2019) of 88 isolates showed that M. chimaera is susceptible to clarithromycin, amikacin, rifabutin, and streptomycin while resistant to moxifloxacin and linezolid with a high probability, which might influence the overall therapeutic strategy. Several studies (Maurer et al., 2019; Li et al., 2022; Schulthess et al., 2023) on susceptibility testing found that M. chimaera and other members of the MAC generally have similar susceptibility (clarithromycin, amikacin, and rifabutin). In summary, for MAC infections that are susceptible to macrolides, a regimen of at least three drugs, including a macrolide and ethambutol, is preferred over a monotherapy of just a macrolide or ethambutol.

2.1.1.3 Other treatments? Surgeries (incision and drainage) are needed when the M. marinum goes deeper or poor curative effect for a long time. This may involve drainage of abscesses, removal of infected tissue, or excision of nodules or lesions that are unresponsive to antimicrobial therapy. Keeping the affected area clean and dry, avoiding activities that may traumatize the skin, and using appropriate dressings or bandages to protect the affected skin from further irritation or contamination are necessary. It is also recommended that amputation (Hendrikx et al., 2022) might be considered in case of severe cutaneous infections caused by multidrug-resistant isolates. Other than that, hot compress therapy (Strobel et al., 2022) might be a choice due to its hightemperature intolerance. (The optimal temperature is 30 Degrees Celsius).

2.1.2 Mycobacterium kansasii Cutaneous infections caused by M. kansasii predominantly affect immunocompromised hosts, including individuals with conditions such as diabetes or those who have undergone renal transplantation (Zhang et al., 2017; Okuno et al., 2020). Often, these cutaneous infections are concomitant with pulmonary involvement. As a result, when managing M. kansasii infections in superficial tissues, it is reasonable to refer to the guidelines established for the treatment of pulmonary NTM infections. According to the official ATS/ERS/ESCMID/IDSA clinical practice guidelines, for patients with rifampin-susceptible M. kansasii, a treatment course lasting over 12 months, comprising rifampicin, ethambutol, and either isoniazid or a macrolide, is advised. There are a few differences between the guidelines of ATS/IDSA and the consensus of the British Thoracic Society (BTS) (Haworth et al., 2017). Rifampin and ethambutol are the same, while the part combined with isoniazid or clarithromycin differs. Both regimes mentioned above need years of treatment duration. A recent study (Chapagain et al., 2020) indicated that the regime of BTS and a novel one (rifapentine + tedizolid + minocycline) show better efficacy on M. kansasii of pulmonary diseases. Another study (Moon et al., 2019) found that the macrolide-containing regimen is as effective as the isoniazid-containing regimen, which might reduce the cumulative side effects of long-term use of anti-tuberculosis drugs. Clofazimine only shows a modest to poor impact on M. kansasii in a clinic in an observational study (Srivastava and Gumbo, 2018) on the antimicrobial effect of clofazimine monotherapy in the intracellular-infection hollow fiber model of M. kansasii.

2.1.4 Other less common SGM Less common organisms include M. xenopi, M. malmoense, M. simiae, and M. szulgai. Despite the close phylogenetic relationship among these organisms, they exhibit discrete epidemiological characteristics and pathogenic behaviors. Therefore, the management of these SGM demand a nuanced approach that meticulously considers the distinctive attributes of each individual species. According to the established consensus, the recommended treatment approach involves a combination of two to three types of antibiotics, administered for a duration of at least 12 months beyond the point of culture conversion (Yan et al., 2023).

recurrence; the other four patients were treated with combined antibiotics, clarithromycin-minocycline, clarithromycinciprofloxacin, clarithromycin-TMP-SMX, and ciprofloxacin-TMP/ SMX. Treatment courses range from 10 weeks to 40 weeks. While only three complicated infection patients with a prolonged period of the same therapy showed satisfactory clinical consequences, which meant immunosuppressed hosts were at higher risk of having persistent SGM infection than the immunocompetent population. Moreover, the findings from an in vitro and in vivo experiments (Ahmad et al., 2022) have demonstrated that gepotidacin, a first-inclass triazaacenapthylene topoisomerase inhibitor, exhibits a promising and potentially novel mechanism of action, allowing it to evade prevailing resistance mechanisms. These results underscore the potential of gepotidacin as a valuable therapeutic candidate with the ability to overcome resistance challenges commonly encountered with existing antimicrobial agents.

For example, in the case of M. xenopi infections, a daily regimen that consists of at least three drugs: rifampicin, ethambutol, and either a macrolide or a fluoroquinolone (e.g., moxifloxacin) is recommended according to the official ATS/ERS/ESCMID/IDSA clinical practice guidelines. Nevertheless, the consensus regarding treatment recommendations (such as azithromycin, clarithromycin, rifampicin, ethambutol, amikacin, and moxifloxacin) for less common NTM species is largely based on low-quality evidence derived from published scientific literature.

2.2 Rapid-growing bacteria (RGM) Similar to SGM infections, direct inoculation of RGM can occur through various routines, including trauma, surgical procedures, injections, tattoos, and other operations that involve the disruption of the skin barrier. In such instances, RGM can potentially spread to deeper tissues and cause infections beyond the initial site of entry. Clinical presentations of RGM skin infections often involve the development of nodules, abscesses, or ulcers at the site of entry. These skin lesions can be painful, red, and may contain pus. In immunocompromised individuals or those with underlying medical conditions, RGM skin infections can be more severe. Treatment of RGM infections includes various regimens with different response rates (Kasperbauer and De Groote, 2015). The selection of antibiotics is mainly based on the results of drug susceptibility tests. According to the results (Chang and Whipps, 2015; Dumic and Lutwick, 2021), RGM is more sensitive to tigecycline, tobramycin, clarithromycin, and amikacin. However, the susceptibility profile varies from species to species. Drug resistance (Forbes et al., 2018; Shrivastava et al., 2020) still poses a significant challenge to a successful outcome due to the presence of the erm41 gene, which could lead to inducible resistance to macrolide, prolong the therapy, and increase the incidence of drug-induced toxicity. Below are details of the most common RGM species.

2.2.2 Mycobacterium chelonae The results of susceptibility testing (Franco-Paredes et al., 2018; Uslu et al., 2019; Watanabe et al., 2022) indicated that M. chelonae is often susceptible to macrolides, cefoxitin, fluoroquinolones, and tobramycin. The monotherapy (clarithromycin) can be sufficient for localized or superficial infections but not enough for patients who develop potential resistance. At least two antibiotic agents (oral macrolide combined with cefoxitin, amikacin, or imipenem) and 4–6 months of systemic treatment are recommended for these complicated cases. A biologics side-effects induced case (Frizzell et al., 2020) showed that omadacycline monotherapy at a dose of 300 mg orally daily for 4 months was efficient against M. chelonae skin and skin structure infections without recurrence in a 1-year follow-up. Surgical debridement, incising, draining, and source control are recommended in treatment if there is extensive involvement of extra-pulmonary M. chelonae infection (Dumic and Lutwick, 2021). Like M. marinum, thermal therapy was efficacious due to its thermal sensitivity. In addition, routine treatment (antimicrobial and surgical therapies) added a single bacteriophage (Little et al., 2022) showed stable disease improvement with no evidence of bacterial resistance to the phage. Bacteriophage therapy involves using viruses to infect and target specific bacteria, leading to the destruction and elimination of the bacterial population. Given the current challenges posed by antimicrobial resistance, bacteriophage therapy has emerged as a promising and attractive therapeutic option.

2.2.1 Mycobacterium fortuitum complex Mycobacterium fortuitum complex consists of M. peregrinum, M. porcinum, M. fortuitum and many others. Combined antibiotics treatment is often required, and surgical therapy may be needed optionally (Philips et al., 2019). After reviewing several in vitro antimicrobial susceptibility research (Forbes et al., 2018; Yeo et al., 2019; Da et al., 2020; Kumar et al., 2021; Das et al., 2022), we found that M. fortuitum strains were susceptible to many antibiotics. The isolates are susceptible to amikacin (intermediate to highly sensitive), ciprofloxacin (highly susceptible), doxycycline (intermediate susceptible), clofazimine, trimethoprimsulfamethoxazole (TMP-SMX) and linezolid, resistance to all the antituberculosis agents, while different to macrolides (decreased sensitivity due to inducible susceptibility) and imipenem. A study (Chew et al., 2021) of 86 isolates showed that M. fortuitum is resistant to clarithromycin and tobramycin but susceptible to tetracyclines and quinolones. Similarly, a retrospective case series (Wang J. et al., 2022) of 18 patients with cutaneous M. fortuitum complex infections found that five uncomplicated infection cases showed an excellent response to the treatments. One patient received monotherapy of doxycycline for 8 weeks with no

2.2.3 Mycobacterium abscessus group The M. abscessus group (M. abscessus, M. massiliense, and M. bolletii) is the primary source of cutaneous involvement of RGM (Jeong et al., 2017; Franco-Paredes et al., 2018). M. abscessus has an irregular resistance pattern to numerous anti-NTM agents (Lee et al., 2015; To et al., 2020; Kumar et al., 2021). Compared to M. massiliense, some M. abscessus and M. bolletii isolates (not all) have inducible macrolide resistance due to the functional erm41 gene, which could lead to inadequate response to a macrolides-dominant therapeutic schedule. Hence, antimicrobial susceptibility testing on all clinically significant isolates is strongly recommended before starting the therapy. The susceptibility list should include at least amikacin, cefoxitin, imipenem, clarithromycin, linezolid, doxycycline, tigecycline, ciprofloxacin, and moxifloxacin. Per the

referred to, a safer, more effective, higher adherent, a broader spectrum of anti-NTM activities, and more cutaneous-specific treatment strategy is needed. Thus, we reviewed the treatment of NTM infections involving skin or soft tissues in recent years to give some suggestions on this topic. NTM skin involvements exhibit distinctive therapeutic disparities compared to other NTM-infected manifestations, owing to the unique structural characteristics of the skin, variations in drug distribution patterns, diverse modes of infection, relatively confined lesion distribution, milder disease severity, and a greater array of treatment modalities available. The management of NTM infections frequently entails the administration of multiple antimicrobial agents over extended durations, requiring vigilant clinical and laboratory monitoring. Nevertheless, the dearth of well-structured controlled trials investigating first-line treatment regimens, including optimal drug selection, dosage, and duration, poses challenges in formulating evidence-based guidelines for effectively managing a wide array of NTM species and associated diseases. Consequently, regimen selection should generally be guided by drug susceptibility testing. This testing involves assessing the susceptibility of the NTM isolate to various antimicrobial drugs, allowing for informed decisions on the most appropriate therapeutic approach. According to the results of drug sensitivity tests, our recommended treatment choices were summarized in Table 1. The establishment of rigorous clinical trials will be instrumental in addressing these knowledge gaps and facilitating the development of more effective and targeted treatment strategies for NTM skin infections. Waiting for species identification and susceptibility before treatment is reasonable without any delay for most superficial cases. However, the correlation between clinical outcomes and in vitro susceptibility thresholds remains undefined for the majority of NTM species (van Ingen et al., 2012a; Timmins, 2020). Different NTM subspecies have other susceptibility profiles to antimicrobial agents. The susceptible antibiotics against SGM differ from that of RGM (Alffenaar et al., 2021; Sharma et al., 2021). Therefore, subspecies level identification (no higher than the species level) and sensitivity testing of NTM, especially RGM, is recommended. For example, the Clinical and Laboratory Standards Institute (CLSI) recommends (Schoutrop et al., 2018) clarithromycin and amikacin susceptibility testing only for MAC, clarithromycin, and rifampicin for M. kansasii, and clarithromycin for M. abscessus complex. In addition, susceptibility testing should be prolonged as long as 6 weeks for SGM and 2 weeks for macrolides (Dartois and Dick, 2022). Recent advancements in molecular diagnostic techniques have improved the accuracy and speed of identifying NTM species and their drug susceptibilities, allowing for more precise and targeted treatment. However, over time, the stability of some antimycobacterial drugs is gradually affected by the pathogen, leading to a variable minimum inhibitory concentration (MIC), which then affects the final interpretation of the DST result. This partly explains why drug susceptibility testing results do not necessarily translate to a positive clinical response. The local microenvironments (Dey et al., 2010; Dartois and Dick, 2022), which can decrease therapeutic concentrations of drugs at the anatomical sites, might be another reason. In addition, there is no well-defined treatment endpoint for superficial NTM infections. In contrast to TB or NTM pulmonary

official ATS/ERS/ESCMID/IDSA clinical practice guidelines, for M. abscessus infections, whether the strains possess inducible or mutational macrolide resistance or not, it is recommended to initiate with a macrolide-inclusive multidrug regimen, which should encompass at least three drugs proven effective in vitro. An observational study (Da et al., 2020) showed that all strains of the M. abscessus group were susceptible to amikacin, linezolid, clofazimine, and tigecycline and suggested a prolonged drug resistance testing of 14 days to determine the presence of inducible resistance to macrolides is necessary. Monotherapy (clarithromycin) has shown promising efficacy in uncomplicated non-pulmonary disease, probably because its hand and foot lesions may represent a self-limited characteristic (Lee et al., 2015). However, invasive or disseminated M. abscessus and M. bolletii infections are complicated to treat; a combination of medication and a more comprehensive treatment course are necessary (Comba et al., 2021). Surgical resection of the infected tissues following chemotherapy to lessen the extensive progress might be a possible curative treatment for complex cases. In the context of treating M. abscessus infection, the preclinical and clinical data derived from a study (Singh et al., 2023) suggest that the inclusion of omadacycline at a dosage of 300 mg per day in combination regimens holds promise for potential evaluation in Phase III trials involving patients with pulmonary involvement of M. abscessus. Such investigations could potentially bear significant guiding implications for addressing skin-related issues as well. Moreover, bacteriophages have also been explored as a potential therapeutic option. A study (Gorzynski et al., 2023) revealed that the lytic efficiency of phages is influenced by environmental factors, particularly when dealing with biofilm and intracellular states of M. abscessus. This observation has important implications, as it aids in the identification of therapeutic phages capable of reducing bacterial fitness by hindering antibiotic efflux function and attenuating the intrinsic resistance mechanisms of M. abscessus through targeted therapeutic interventions. Thiostrepton, a promising novel therapeutic drug candidate, has demonstrated substantial inhibition of M. abscessus growth in various contexts, including wild-type strains, subspecies, clinical isolates, and drugresistant mutants, as evidenced by in vitro experiments and macrophage models. Additionally, it exhibited a dose-dependent reduction in proinflammatory cytokine production, suggesting its potential as an anti-inflammatory agent in the context of M. abscessus infection (Kim et al., 2019).

2.2.4 Other RGM According to the in vitro antimicrobial drug susceptibility testing, A study (Cantillon et al., 2022) using an open drug discovery approach found that oxazolidinones such as linezolid and doxycycline have excellent tissue penetration properties and are actively potent against M. chimaera. Two case reports (Shimizu et al., 2012; Wang C. J. et al., 2022) recommend combined therapy with adequate debridement and sensitive antibiotic administration for soft tissues in patients infected with M. smegmatis.

3 Discussion Since more and more extrapulmonary NTM-infected cases have been reported recently and no unified treatment proposal could be Frontiers in Pharmacology 05 frontiersin.org Wang et al. 10.3389/fphar.2023.1242156

TABLE 1 The summary of preferred options for treating NTM skin infection. Recommended choicesa Unrecommended choices Supplementary choices M. marinum

Ethambutol, Azithromycin, Isoniazid, Pyrazinamide, Rifampicin, Clarithromycin, Sulfonamides, Doxycycline, Minocycline Azithromycin, Isoniazid, Pyrazinamide, Levofloxacin, Ciprofloxacin, Quinolones Surgeryb Hot Compress Therapy

M. kansasii

Rifampin, Ethambutol, Clarithromycin, Clarithromycin, Aminoglycosides, Fluoroquinolones, Moxifloxacin Clofazimine, Pyrazinamide, Linezolid, Isoniazid Surgery MAC Clarithromycin, Ethambutol, Amikacin, Rifabutin, Streptomycin

Linezolid, Isoniazid. Clofazimine, Rifampicin Moxifloxacin Linezolid Surgery Other SGM Azithromycin, Ethambutol, Ethambutol, Rifabutin Unavailable Surgery M. fortuitum complex

Amikacin, Ciprofloxacin, Doxycycline, Clofazimine, TrimethoprimSulfamethoxazole, Linezolid, Tetracyclines, Quinolones, Gepotidacin, Minocycline Clarithromycin, Tobramycin Macrolides, Imipenem Surgery M. chelonae

Clarithromycin, Cefoxitin, Fluoroquinolones, Tobramycin, Omadacycline Macrolide (Inducible Resistant) Surgery Bacteriophage Therapy M. abscessus complex Amikacin, Linezolid, Clofazimine, Tigecycline, Clarithromycin, Omadacycline, Thiostrepton

Macrolide (Inducible Resistant) Surgery Bacteriophage Therapy Other RGM Amikacin, Linezolid, Doxycycline, Moxifloxacin, Moxifloxacin, Ciprofloxacin Unavailable Surgery Species Slow-growing mycobacteria (SGM)

Rapid-growing mycobacteria (RGM) a

Monotherapy or combined therapy depends on the specific situation (NTM, species, infection sites, and disease severities). The surgery operations include excision, debridement, drainage, and amputation, etc.

b establish a more standardized and evidence-based approach for defining the treatment endpoint of skin NTM infection, further research and clinical investigations are necessary. The low susceptibility of NTM to a wide range of antibiotics is attributed to their several characteristics. 1. Intrinsic resistance mechanisms: the first barrier is the unique metabolic condition [hydrophobicity of cell wall, and thereby low permeability (van Ingen et al., 2012a)] and the absence of porin or ABC transporter superfamily of the cell wall, which weakens the uptake and biotransformation of drugs and decreases the affinity with the drug target. 2. Inducible resistance mechanisms (Alffenaar et al., 2021): the second barrier is the genomic mutations of NTM, which could confer high-level resistance. Resistant strains are due to mutations at nucleotides. For instance, the changes of the 23S rRNA (functional erm genes) in M. abscessus isolates and of the RNA polymerase binding protein A (RbpA) in M. smegmatis are linked to the resistance to the macrolides and rifampicin (Dey et al., 2010). Comparative genomics and population genetics studies can provide insights into the genetic variability, evolution, and adaptation of NTM species. 3. Adaptative resistance mechanisms: he adaptability of NTM is the third barrier. NTM has extraordinary abilities in generation-upgrade time, and metabolic capabilities, which means they can adapt to stress before the cells are killed. They can form biofilms on the skin, which are complex microbial communities encased in an extracellular matrix. For example, one of the persistence strategies of NTM is hidden in biofilms (Slany et al., 2016), which generally leads to ten times less susceptibility to antibiotics than their counterparts. Understanding the mechanisms and dynamics of NTM biofilm formation on the

diseases, where the treatment endpoint can be determined by sputum specimen culture conversion and imaging results, defining the endpoint of treatment for superficial NTM infections remains uncertain. Typically, a treatment duration of 2–4 months is recommended for skin and soft-tissue NTM infections, while NTM pulmonary diseases often require at least 12 months of therapy after sputum culture reversion. To improve treatment efficacy while minimizing the risk of drug resistance, long-term and multidrug therapy is often necessary for NTM infections. However, this approach may lead to challenges such as drug interactions, drugrelated adverse reactions (AEs), and high medication costs, potentially compromising treatment efficacy and patient compliance. Another method for determining the endpoint of treatment involves obtaining post-treatment specimens for culture to assess treatment efficacy, but this invasive procedure carries a heightened risk of reinfection, particularly in individuals with compromised immune systems. Finding a consensus on a specific and effective treatment endpoint for superficial NTM infections is imperative and demands further research and clinical investigation to ensure optimal patient outcomes and successful management of these challenging infections (Haworth et al., 2017; Wi, 2019). Currently, the determination of the treatment endpoint for skin NTM infection primarily relies on the assessment of changes in the patient’s clinical manifestations. These assessments typically involve evaluating the complete or substantial disappearance of preexisting skin lesions, the absence of new skin lesions, and the persistence of unchanged skin lesions after a specific duration of treatment. However, it is important to note that this criterion is subjective and lacks well-defined objective measures. To

TABLE 2 Recommendations on treatments of NTM skin infections. Recommendations 1. The characteristics required for novel anti-NTM drugs

1). Are ideally active against a broader spectrum of NTM; 2). Are bactericidal ideally against growing, and various drug-tolerant persist pathogens; 3). Could penetrate the multilayered structure of granulomas; 4). Drug interactions should be as minimal as possible

2. Choose the right treatment choices for each patient

After careful interpretation of the drug sensitivity results and the characteristics of the different cases, the choice of using a single therapy, a combination of antibiotics, physical therapy, or multiple parallel approaches is made

3. Drug monitoring and sensitivity tests are necessary

Therapeutic drug monitoring and prolonged drug sensitivity tests are always necessary during treatment. Clinical and laboratory monitoring of patients is essential. Treatment should be also tailored to the NTM species and susceptibility profile

4. Develop/screen drugs with the help of new platforms and new ideas

Referring to formal pharmacokinetics/pharmacodynamics research (such as CRISPR/ Cas9 system and nanotechnology) might lead to safer and shorter-duration regimens. Novel molecular diagnostic technology can offer more effective, targeted multidrug treatments at the species level

5. Prevention and skin care are essential

Prevention is equally essential during percutaneous invasive operations or trauma. Immunosuppressed hosts need to pay more attention to infection during antimicrobial therapy. Proper wound care is also an important aspect of NTM skin disease management

6. Patient education and condition explanation

Counseling patients about the characteristics of NTM infections, such as choices of treatment, length of treatment, and possible side effects, to moderate their expectations for an unrealistic solution. Patients should also be advised to promptly report any new symptoms or changes in the affected skin to their healthcare provider

7. Multidisciplinary Cooperation

Multidisciplinary approach involving dermatologists, infectious disease specialists, and surgeons are recommended. Collaboration among healthcare professionals is important in determining the appropriate treatment plan, monitoring treatment response, and addressing potential complications

skin is an active area of research, aiming to develop strategies to disrupt biofilms for improved treatment outcomes, including the use of biofilm-targeting agents and biofilm-disrupting techniques (such as enzymes, peptides, nanoparticles, and ultrasound). In addition, some studies (Huh et al., 2019) believe that NTM can enter a nonreplicating state and exhibit phenotypic drug resistance. However, up to now, the survey of resistance mechanisms associated with NTM still needs to be completed. Except for macrolides, the resistance mechanisms of many drugs still need to be clarified. It is essential to understand the basis for resistance and, more importantly, how to revise treatment choices to prevent the development of resistance. For uncomplicated skin-involved cases, primary empirical treatments and antibiotic monotherapy could respond well in most patients. Single-drug or combined (clarithromycin, rifampin, and ethambutol) treatments depend on the specific characteristics of the hosts, location, and identification of species. When a poor response to treatment or rapid progression is found, in vitro susceptibility testing should be addressed throughout the treatment. Compared to antimicrobial agents’ therapy alone, additional surgical operation of the localized infection with medication has proven to have better outcomes for extracutaneous involvement. Regular monitoring of the patient’s clinical response to treatment, as well as laboratory testing to assess the effectiveness of antimicrobial therapy, is important in the management of NTM skin infections. Follow-up appointments with the treating physician should be scheduled as recommended to monitor progress and make any necessary adjustments to the treatment plan. Our recommendations for treating NTM skin

infections and recommended procedures are summarized in Table 2 and Figure 1. Emerging strategies are being explored to overcome drug resistance and improve treatment efficacy of complicated cases. 1. Screen existing drugs and new drugs: Novel antimicrobial drugs have shown promising activity against NTM species and may be considered in the treatment of NTM skin infections, particularly in cases where standard treatment regimens have failed or in the presence of drug-resistant strains. A study (Kaushik et al., 2019) showed that the new β-lactamase inhibitors relebactam and vaborbactam in combination with β-lactams have potent against M. abscessus complex clinical isolates in vitro. Clofazimine (Meir and Barkan, 2020), used for treating leprosy, is repurposed against M. abscessus. Besides, delamanid, pretomanid, and PIPD1 were also tested against M. abscessus. Telacebec is a promising novel drug with the potency of shorter duration and better tolerability (Lee and Pethe, 2022). However, the use of newer drugs may be limited by their potential side effects, higher costs, and availability. 2. Recombination of existing drugs: this is a very economical and efficient option. Previous studies (van Ingen et al., 2012b; Lee and Pethe, 2022) found that some antibiotics could increase cell wall permeability for the uptake of the second drug and accelerate durable cure, which indicates that the synergistic drug interactions could provide additional support in treating NTM infections. 3. Find new drugs according to new targets (Dartois and Dick, 2022): RNA polymerase, DNA gyrase, the ribosome, F-ATP synthase, and several enzymes. For instance, antibiotics that target oxidative phosphorylation energy-generate pathways could be a new choice. Alternatively, MmpL3 (Sethiya et al., 2020), a transporter crucial for exporting trehalose monomycolates to the periplasmic space and outer membrane, Frontiers in Pharmacology

assays, nonreplicating assays, biofilm assays, animal models, and lesion- or infection-site-specific pharmacokinetic assays, which can help us focus on skin and soft tissue, are instrumental methods to measure and evaluate effects when developing new anti-NTM drugs (Wu et al., 2018). For example, interferon-gamma, a cytokine that plays a role in the immune response against mycobacterial infections, has been used as an adjunct to antimicrobial therapy in some cases of NTM skin infections, particularly in patients with underlying immunosuppressive conditions. Other immune-enhancing agents, such as granulocyte-macrophage colony-stimulating factor (GMCSF), have also been studied in the management of NTM infections. Fragment-based drug discovery (Togre et al., 2022) (FBDD) can concentrate on designing optimal inhibitors against potential therapeutic targets of NTM. A rabbit model could provide an acceptable surrogate model to study antibiotic penetration and simulate pharmacokinetic-pharmacodynamic tracks in vivo (Kaya et al., 2022). Our article also has many limitations. First, randomized studies need to be added, and data regarding optimal treatment are limited. Clinical data on the efficacy of different treatment of NTM skin diseases in humans is limited, and further research is needed to determine its safety and effectiveness in clinical practice. Second, the resistance mechanism of NTM (genetic and pathogenic variations among species) infections needs to be understood more. In summary, a comprehensive understanding of the various aspects discussed in this study is crucial for the effective management of cutaneous involvement caused by NTM. The ideal therapeutic approach should encompass a broader spectrum of anti-NTM activities while simultaneously considering the specific characteristics of cutaneous infections. The optimal treatment approach for NTM infections is still evolving, continuous research, clinical trials, and innovative therapeutic strategies are essential in the quest for safer, more effective, and tailored treatment options to combat NTM cutaneous involvement effectively. By addressing these aspects, clinicians can enhance patient outcomes and reduce the burden of NTM infections in affected populations.

FIGURE 1 Procedure of NTM skin infection treatment. *: NTM, nontuberculosis mycobacteria 1: The treatment should distinguish between mild and severe, drug resistance and non-resistance, initial and continuous stages, drug composition and dosage, children and adults, and HIV and non-HIV, etc. 3: Anti-NTM drugs include clarithromycin, azithromycin, ethambutol, amikacin, ciprofloxacin, moxifloxacin, rifampicin, rifampicin, isoniazid, cefoxitin, linezolid, chlorfazimine, tegacycline, imipenem/cilastatin, doxycycline, minocycline and compound sulfamethoxazole, etc. 4: Formulate the chemotherapy plan for NTM skin infections, the drugs should be selected according to the above-mentioned results. The type of medication and course of treatment are different for different NTM species. Experimental treatment of suspected NTM infections is not recommended. 5. Other treatment modalities are added depending on the patient’s condition. For patients with extensive lesions, abscess formation and poor drug efficacy, surgical debridement or foreign body removal can be actively used. 6. Monitor blood routine, liver and kidney function, blood electrolyte, urine routine, body mass, mycobacterium culture, hearing, visual field and color vision, electrocardiogram, etc. 7. Provide good patient education and explanation of the condition. For example, reduce contact with patients with NTM disease, and protect against human-to-human transmission. 8. Treatment outcome includes bacteriological negative conversion, bacteriological cure, clinical cure, cure, treatment failure, bacteriological recurrence, and death.

Author contributions Conceptualization and design: JL, literature search and writing (original draft): X-YW, methodology and writing (review and editing): Q-NJ. All authors contributed to the article and approved the submitted version.

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中文

# 非结核分枝杆菌皮肤感染的治疗

**类型** 综述 **发表日期** 2023年9月5日 **DOI** 10.3389/fphar.2023.1242156 **开放获取**

**非结核分枝杆菌皮肤感染的治疗**

**编辑** Exequiel Oscar Jesus Porta,英国杜伦大学

**作者** 王新宇†,贾倩楠†,李军*

**单位** 中国医学科学院北京协和医院皮肤科与性病科(东单校区),北京,中国

**审稿人** Esteban Panozzo Zenere,阿根廷罗萨里奥国立大学 毕建斌,中国医科大学

**通讯作者** 李军,lijun06321@pumch.cn † 本文共同第一作者

**收稿日期** 2023年6月18日 **录用日期** 2023年8月25日 **发表日期** 2023年9月5日

**引用格式** Wang X-Y, Jia Q-N and Li J (2023), Treatment of non-tuberculosis mycobacteria skin infections. Front. Pharmacol. 14:1242156. doi: 10.3389/fphar.2023.1242156

**版权声明** © 2023 Wang, Jia and Li. 本文为开放获取文章,依据知识共享署名许可协议(CC BY)发布。在其他论坛使用、分发或转载时,须注明原作者和版权持有人,并引用本期刊的原始发表信息,符合公认的学术规范。任何不符合上述条件的使用、分发或转载均不被允许。

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近年来,非结核分枝杆菌(NTM)皮肤感染的发病率日益上升,给临床管理带来了独特的挑战。本综述探讨了局限于浅表组织的NTM感染的复杂性,并为优化治疗策略提供了有价值的见解。抗生素的选择应基于NTM菌种及其药敏谱。建议采用综合考虑浅表组织独特特征的综合治疗方法,以提高治疗效果并减少不良反应、感染复发和治疗失败的发生率。感染控制措施、患者教育和密切监测应作为治疗策略的补充,以实现对NTM皮肤感染的良好管理。仍需进一步努力阐明导致治疗耐药和复发的因素及机制。未来研究应侧重于探索新型治疗选择、创新药物开发/递送平台以及确定治疗疗程的精确方法。还需要开展纵向研究来评估综合治疗方案的长期安全性。

**关键词** 非结核分枝杆菌(NTM),皮肤疾病,感染性,抗菌,分枝杆菌感染,非结核性,非典型分枝杆菌

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## 1 引言

非结核分枝杆菌(NTM)(Sharma and Upadhyay, 2020; Pavlik et al., 2022),即除结核分枝杆菌和麻风分枝杆菌以外的分枝杆菌,已成为感染的重要来源(Kumar et al., 2021; Nogueira et al., 2021)。在NTM感染的多种临床表现中,皮肤和软组织受累是常见的临床表现。尽管这些感染不构成直接的生命威胁,但可导致显著的发病率并影响患者的生活质量。值得注意的是,浅表NTM感染的全球报告病例呈上升趋势(Mei et al., 2019; Philips et al., 2019; Gopalaswamy et al., 2020),其促成因素包括免疫缺陷人群的扩大(Blakney et al., 2022; Toth et al., 2022),这些人群在受伤或接受美容操作时易感性增高(Ahmed et al., 2020; Wang C. J. et al., 2022; Ni et al., 2023)。此外,NTM感染的增加在一定程度上可归因于NTM对人类宿主的持续适应。NTM在多样化的皮肤环境中茁壮成长的同时有效逃避免疫应答的卓越能力,也在这些感染发病率上升中发挥了作用(Luo et al., 2021)。

鉴于上述观察,理解和有效管理NTM皮肤感染对公共卫生和患者福祉至关重要。关于NTM感染的治疗选择,由于这些感染的独特性质,需要考虑多种因素。NTM感染的危险因素包括接触受污染的水源,如在受污染的水体中游泳或接触鱼缸,以及皮肤损伤如割伤或擦伤,这些为细菌提供了侵入途径。慢生长分枝杆菌(SGM)感染的临床表现通常涉及在侵入部位形成结节或隆起性皮损,逐渐扩大并可能导致不愈合的伤口或脓肿形成(Riccardi et al., 2022)。感染区域可能出现疼痛和肿胀,感染可沿淋巴管呈线性扩散。SGM感染靶向治疗的最终目标是促进康复、缩短治疗疗程,并防止病原体进一步向深部组织进展以避免多灶性播散。

一般而言,NTM感染的治疗选择取决于分离出的特定菌种和药敏模式,以及感染的严重程度和范围(Pennington et al., 2021)。当前的治疗策略通常参考美国感染病学会(IDSA)和美国胸科学会(ATS)关于肺部NTM感染性疾病的指南(Daley et al., 2020)。然而,需要注意的是,ATS/IDSA关于肺部疾病的指南可能无法直接应用于所有皮肤受累的病例,因为皮肤NTM感染具有独特的特征。侵袭性或播散性NTM感染可能需要更多种类的药物和更长的治疗疗程(Liu et al., 2023)。对于浅表受累的病例,必须考虑由不同感染途径导致的病原体类型潜在变异。与其他解剖部位相比,皮肤独特的生理结构和功能(Gravitz, 2018)也可能影响药物的吸收和分布,因此需要量身定制的治疗方案。此外,局部微生物群(Grice and Segre, 2011)的影响和宿主免疫应答的差异(Nguyen and Soulika, 2019)不可低估,因为它们显著影响治疗结局。由于感染部位的解剖学差异,手术治疗、光疗(Yang et al., 2022)和热疗(Lee and Lee, 2017)也应被视为可行的替代治疗选择。此外,新发明的抗分枝杆菌药物的出现,如MmpL3抑制剂和外排泵抑制剂(Rindi, 2020; North et al., 2023),被认为对慢生长分枝杆菌(SGM)和快生长分枝杆菌(RGM)具有强效活性,这也凸显了及时修订治疗方案的必要性。最后,尽管NTM与结核分枝杆菌具有相似的生理特征、毒力因子和遗传药物靶点(Rifat et al., 2021; Mei et al., 2023),但仍不宜完全照搬结核病的治疗方案。许多正在开发的用于治疗结核病的药物对NTM不表现出任何抗菌活性(Saxena et al., 2021)。总之,上述因素凸显了更新靶向治疗策略以改善皮肤受累患者预后的必要性。

由各种NTM亚型引起的皮肤感染的管理面临重大挑战,需要在治疗获益与潜在风险之间谨慎平衡。优化多样化的治疗方案以及减轻不良反应和感染复发仍然是关键目标。通过本综述,我们的目的是对NTM皮肤感染的治疗策略进行深入分析,并阐明处理这些临床问题所涉及的复杂性。

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## 2.1 慢生长分枝杆菌(SGM)

慢生长分枝杆菌(SGM)(在固体培养基上形成成熟菌落需>7天)主要包括海分枝杆菌(M. marinum)、堪萨斯分枝杆菌(M. kansasii)、鸟分枝杆菌复合群(MAC)等(Yan et al., 2023)。SGM皮肤感染的常见危险因素包括接触受污染的水源(如在受污染水体中游泳或处理鱼缸)以及皮肤损伤(如割伤或擦伤),后者为细菌提供了侵入途径。SGM感染的临床表现通常涉及在侵入部位形成结节或隆起性皮损,逐渐扩大并可能导致伤口不愈合或脓肿形成(Riccardi et al., 2022)。感染区域可能出现疼痛和肿胀,感染可沿淋巴管呈线性扩散。SGM感染靶向治疗的最终目标是促进康复、缩短治疗疗程,并防止病原体进一步向深部组织进展以避免多灶性播散。

### 2.1.1 海分枝杆菌(Mycobacterium marinum)

海分枝杆菌是导致SGM感染的主要病原体,常引起皮肤和软组织感染(Hashish et al., 2018)。海分枝杆菌感染的早期诊断和及时治疗面临重大挑战,尤其是在非典型阶段,可能使后续药物治疗过程复杂化(Trčko et al., 2021)。目前,在药物选择、剂量和治疗疗程方面,以及将手术治疗作为辅助治疗选择的考量方面,尚缺乏标准化规范(Seidel et al., 2022)。根据IDSA/ATS指南的建议,治疗通常包括使用两种活性药物联合方案,如乙胺丁醇-大环内酯类联合,并在症状消退后继续治疗1-2个月。然而,必须承认的是,该领域尚未开展随机对照试验,现有数据不足以建立关于药物疗效和耐受性具有统计学显著性的证据。已验证数据的缺乏需要进一步研究以全面评估不同海分枝杆菌感染治疗方案的有效性和安全性。

#### 2.1.1.1 海分枝杆菌的药敏试验和耐药特征

体外药敏试验(Hendrikx et al., 2022; Seidel et al., 2022)显示,海分枝杆菌对链霉素中度敏感,对阿奇霉素、异烟肼和吡嗪酰胺耐药。左氧氟沙星、环丙沙星和喹诺酮类对海分枝杆菌的最低抑菌浓度(MIC)较高,而对利福平、莫西沙星、乙胺丁醇、克拉霉素、利奈唑胺和四环素类的MIC较低。研究结果表明(Koushk-Jalali et al., 2019; Yeo et al., 2019; Castillo et al., 2020; Strobel et al., 2022),利福平、克拉霉素、磺胺类、多西环素、米诺环素和乙胺丁醇是更合适的选择。因此,鉴于海分枝杆菌对多种抗生素敏感,可首先开始经验性治疗,尤其是在无法获得药敏试验结果时(Oh et al., 2018)。然而,在经过充分治疗后病情未改善,或数月后分枝杆菌培养仍为阳性时,则需要进行药敏试验。

#### 2.1.1.2 单药还是联合使用抗生素?

多项研究(Rallis et al., 2012; Chung et al., 2018; Franco-Paredes et al., 2018)表明,口服单药治疗(如克拉霉素、甲氧苄啶和环丙沙星等单一抗生素)仅对免疫功能正常患者的早期浅表皮肤海分枝杆菌感染有效,这也建议合适的治疗疗程需持续3-6个月,或病灶局限后再继续1-2个月(Aubry et al., 2017)。在深部组织受累、播散性皮肤外感染和宿主免疫抑制状态下,建议联合使用多种抗分枝杆菌活性药物(Holden et al., 2018)。优选方案包括克拉霉素联合利福平、克拉霉素联合乙胺丁醇、乙胺丁醇联合利福平,或三联方案(Strobel et al., 2022)。治疗疗程取决于感染的严重程度和治疗效果,可根据宿主-药物相互作用适度延长。

#### 2.1.1.3 其他治疗方法?

当海分枝杆菌感染较深或长期疗效不佳时,需要手术治疗(切开引流)。这可能包括脓肿引流、感染组织清除,或对抗菌治疗无反应的结节或病灶的切除。保持患处清洁干燥,避免可能损伤皮肤的活动,并使用适当的敷料或绷带保护受累皮肤免受进一步刺激或污染,这些都是必要的。还建议,在由多重耐药菌株引起的严重皮肤感染情况下,可考虑截肢(Hendrikx et al., 2022)。除此之外,热敷治疗(Strobel et al., 2022)因其对高温的不耐受性(最适温度为30摄氏度)可能是一种选择。

### 2.1.2 堪萨斯分枝杆菌(Mycobacterium kansasii)

堪萨斯分枝杆菌引起的皮肤感染主要影响免疫缺陷宿主,包括患有糖尿病或接受过肾移植的个体(Zhang et al., 2017; Okuno et al., 2020)。这些皮肤感染常与肺部受累同时存在。因此,在管理浅表组织的堪萨斯分枝杆菌感染时,参考已建立的肺部NTM感染治疗指南是合理的。根据ATS/ERS/ESCMID/IDSA官方临床实践指南,对于利福平敏感的堪萨斯分枝杆菌患者,建议采用包含利福平、乙胺丁醇以及异烟肼或大环内酯类的治疗方案,疗程超过12个月。

ATS/IDSA指南与英国胸科学会(BTS)共识之间存在一些差异(Haworth et al., 2017)。利福平和乙胺丁醇相同,但联合异烟肼或克拉霉素的部分不同。上述两种方案均需数年的治疗疗程。最近的一项研究(Chapagain et al., 2020)表明,BTS方案和新方案(利福喷汀+特地唑胺+米诺环素)对肺部疾病的堪萨斯杆菌疗效更好。另一项研究(Moon et al., 2019)发现,含大环内酯类的方案与含异烟肼的方案同样有效,这可能减少长期使用抗结核药物的累积副作用。在一项关于氯法齐明单药治疗堪萨斯分枝杆菌抗菌效果的观察性研究中(Srivastava and Gumbo, 2018),氯法齐明仅显示出中等至较差的效果,该研究使用了堪萨斯分枝杆菌的细胞感染空心纤维模型。

尽管堪萨斯分枝杆菌的体外药敏试验结果与临床结局通常相关性不大,但仍有值得借鉴之处。根据药敏试验结果(Zhang et al., 2017; Bakuła et al., 2018; Wang et al., 2019),堪萨斯分枝杆菌对乙胺丁醇、利福平、克拉霉素、氨基糖苷类和氟喹诺酮类敏感,这可能为复杂病例的临床工作提供指导。堪萨斯分枝杆菌对吡嗪酰胺耐药,其潜在耐药机制不一定与基因突变相关,而与全球范围内的巨大遗传多样性有关(Guo et al., 2022)。

### 2.1.3 鸟分枝杆菌复合群(MAC)

鸟分枝杆菌复合群(MAC)(Daley, 2017),如鸟分枝杆菌(M. avium)、胞内分枝杆菌(M. intracellulare)、奇美拉分枝杆菌(M. chimaera)、印度分枝杆菌(M. indicuspranii),是一组常见于严重免疫抑制状态患者呼吸系统中的SGM(To et al., 2020)。在这种情况下,MAC感染往往倾向于从初始感染部位播散,累及其他器官和组织。因此,影响皮肤和软组织的MAC感染的管理需要采用类似于治疗侵袭性或播散性病例的综合方法(Chen et al., 2020; Crilly et al., 2020)。一项为期3年的横断面研究(Akrami et al., 2023)发现,MAC对阿米卡星、莫西沙星和克拉霉素敏感,而对利奈唑胺、利福平、异烟肼和氯法齐明耐药。在一份经组织直接聚合酶链式反应-核酸侧流免疫层析法确诊的肺部和播散性MAC患者的病例报告中(Fukushi et al., 2022),临床医生使用克拉霉素(CAM,800 mg/天)、利福平(RFP,600 mg/天)和乙胺丁醇(EB,700 mg/天)治疗两名患者一年。治疗期间未发现不良反应或复发。在空心纤维系统模型中测试了奥马环素作为肺部MAC的潜在治疗选择,可能作为新MAC方案的替代治疗。一项回顾性研究(Mok et al., 2019)对88株分离株的药敏试验结果显示,奇美拉分枝杆菌可能对克拉霉素、阿米卡星、利福布汀和链霉素敏感,而对莫西沙星和利奈唑胺耐药概率较高,这可能影响整体治疗策略。多项药敏试验研究(Maurer et al., 2019; Li et al., 2022; Schulthess et al., 2023)发现,奇美拉分枝杆菌和MAC其他成员通常具有相似的药敏特征(克拉霉素、阿米卡星和利福布汀)。总之,对于大环内酯类敏感的MAC感染,优选至少包含一种大环内酯类和乙胺丁醇的三药方案,而非仅使用大环内酯类或乙胺丁醇的单药治疗。

### 2.1.4 其他较少见的SGM

较少见的菌种包括蟾蜍分枝杆菌(M. xenopi)、玛尔摩分枝杆菌(M. malmoense)、猿猴分枝杆菌(M. simiae)和苏尔加分枝杆菌(M. szulgai)。尽管这些菌种之间具有密切的系统发育关系,但它们表现出不同的流行病学特征和致病行为。因此,这些SGM的管理需要一种细致入微的方法,仔细考虑每个菌种的独特特征。根据已建立的共识,推荐的治疗方法包括联合使用2-3种抗生素,在培养转阴后至少持续治疗12个月(Yan et al., 2023)。

例如,对于蟾蜍分枝杆菌感染,根据ATS/ERS/ESCMID/IDSA官方临床实践指南,推荐每日至少使用三种药物的方案:利福平、乙胺丁醇,以及大环内酯类或氟喹诺酮类(如莫西沙星)。然而,关于少见NTM菌种治疗建议(如阿奇霉素、克拉霉素、利福平、乙胺丁醇、阿米卡星和莫西沙星)的共识,很大程度上基于已发表科学文献中的低质量证据。

此外,在一项涉及10名SGM皮肤感染患者的研究中,6名患者接受了单药治疗,4名患者接受了联合抗生素治疗,包括克拉霉素-米诺环素、克拉霉素-环丙沙星、克拉霉素-甲氧苄啶/磺胺甲噁唑(TMP-SMX)和环丙沙星-TMP/SMX。治疗疗程从10周到40周不等。仅3名接受相同延长疗程治疗的复杂感染患者获得了满意的临床结果,这意味着免疫抑制宿主比免疫功能正常人群发生持续性SGM感染的风险更高。此外,体外和体内实验研究结果(Ahmad et al., 2022)表明,吉泊达星(gepotidacin)——一种首创的三氮杂并萘拓扑异构酶抑制剂——表现出有前景的潜在新作用机制,使其能够逃避现有的耐药机制。这些结果凸显了吉泊达星作为一种有价值的治疗候选药物的潜力,其具有克服现有抗菌药物常见耐药挑战的能力。

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## 2.2 快生长分枝杆菌(RGM)

与SGM感染类似,RGM的直接接种可通过多种途径发生,包括创伤、外科手术操作、注射、纹身及其他涉及皮肤屏障破坏的操作。在此类情况下,RGM可能扩散至深部组织并引起超出初始侵入部位的感染。RGM皮肤感染的临床表现通常涉及在侵入部位形成结节、脓肿或溃疡。这些皮肤病变可伴有疼痛、发红,并可能含有脓液。在免疫缺陷个体或患有基础疾病的个体中,RGM感染可能更为严重。

RGM感染的治疗包括不同反应率的各种方案(Kasperbauer and De Groote, 2015)。抗生素的选择主要基于药敏试验结果。根据研究结果(Chang and Whipps, 2015; Dumic and Lutwick, 2021),RGM对替加环素、妥布霉素、克拉霉素和阿米卡星更为敏感。然而,药敏谱因菌种而异。耐药性(Forbes et al., 2018; Shrivastava et al., 2020)仍然是成功治疗的重大挑战,因为erm41基因的存在可导致对大环内酯类的诱导性耐药,从而延长治疗疗程并增加药物诱导毒性的发生率。以下是最常见RGM菌种的详细信息。

### 2.2.1 偶然分枝杆菌复合群(Mycobacterium fortuitum complex)

偶然分枝杆菌复合群包括佩氏分枝杆菌(M. peregrinum)、猪分枝杆菌(M. porcinum)、偶然分枝杆菌(M. fortuitum)等。通常需要联合抗生素治疗,手术治疗可作为可选方案(Philips et al., 2019)。在回顾多项体外抗菌药敏研究后(Forbes et al., 2018; Yeo et al., 2019; Da et al., 2020; Kumar et al., 2021; Das et al., 2022),我们发现偶然分枝杆菌菌株对多种抗生素敏感。分离株对阿米卡星(中度至高度敏感)、环丙沙星(高度敏感)、多西环素(中度敏感)、氯法齐明、甲氧苄啶-磺胺甲噁唑(TMP-SMX)和利奈唑胺敏感,对所有抗结核药物耐药,对大环内酯类的敏感性降低(由于诱导性敏感)且对亚胺培南的敏感性不同。一项对86株分离株的研究(Chew et al., 2021)显示,偶然分枝杆菌对克拉霉素和妥布霉素耐药,但对四环素类和喹诺酮类敏感。同样,一项对18例皮肤偶然分枝杆菌复合群感染患者的回顾性病例系列研究(Wang J. et al., 2022)发现,5例非复杂感染病例对治疗反应良好。1例患者接受多西环素单药治疗8周,无复发;其余4例患者接受联合抗生素治疗,包括克拉霉素-米诺环素、克拉霉素-环丙沙星、克拉霉素-TMP-SMX和环丙沙星-TMP/SMX。治疗疗程从10周到40周不等。仅3例接受相同延长疗程治疗的复杂感染患者获得了满意的临床结果,这意味着免疫抑制宿主比免疫功能正常人群发生持续性SGM感染的风险更高。

### 2.2.2 龟分枝杆菌(Mycobacterium chelonae)

药敏试验结果(Franco-Paredes et al., 2018; Uslu et al., 2019; Watanabe et al., 2022)表明,龟分枝杆菌通常对大环内酯类、头孢西丁、氟喹诺酮类和妥布霉素敏感。单药治疗(克拉霉素)对于局限性或浅表感染可能足够,但对于产生潜在耐药性的患者则不足。对于这些复杂病例,建议至少使用两种抗生素(口服大环内酯类联合头孢西丁、阿米卡星或亚胺培南)进行4-6个月的系统治疗。一份生物制剂副作用诱导的病例报告(Frizzell et al., 2020)显示,奥马环素单药治疗(每日口服300 mg,持续4个月)对龟分枝杆菌皮肤和皮肤结构感染有效,1年随访期间无复发。在治疗中推荐外科清创、切开引流和感染源控制,如果龟分枝杆菌感染广泛累及肺外部位(Dumic and Lutwick, 2021)。与海分枝杆菌类似,热疗因其热敏感性而有效。此外,在常规治疗(抗菌和外科治疗)基础上加用单一噬菌体(Little et al., 2022)显示出稳定的疾病改善,且无细菌对噬菌体耐药的证据。噬菌体疗法涉及使用病毒感染和靶向特定细菌,从而破坏和消除细菌种群。鉴于当前抗菌素耐药性带来的挑战,噬菌体疗法已成为一种有前景且有吸引力的治疗选择。

### 2.2.3 脓肿分枝杆菌群(Mycobacterium abscessus group)

脓肿分枝杆菌群(M. abscessus、M. massiliense和M. bolletii)是RGM皮肤受累的主要来源(Jeong et al., 2017; Franco-Paredes et al., 2018)。脓肿分枝杆菌对多种抗NTM药物具有不规则的耐药模式(Lee et al., 2015; To et al., 2020; Kumar et al., 2021)。与M. massiliense相比,部分脓肿分枝杆菌和M. bolletii分离株(非全部)由于功能性erm41基因的存在而具有诱导性大环内酯类耐药,这可能导致对以大环内酯类为主的治疗方案反应不足。因此,强烈建议在开始治疗前对所有临床意义显著的分离株进行药敏试验。药敏谱应至少包括阿米卡星、头孢西丁、亚胺培南、克拉霉素、利奈唑胺、多西环素、替加环素、环丙沙星和莫西沙星。根据ATS/ERS/ESCMID/IDSA官方临床实践指南,对于脓肿分枝杆菌感染,无论菌株是否具有诱导性或突变性大环内酯类耐药,建议启动含大环内酯类的多药方案,该方案应至少包含三种经体外证实有效的药物。一项观察性研究(Da et al., 2020)显示,脓肿杆菌群所有菌株对阿米卡星、利奈唑胺、氯法齐明和替加环素敏感,并建议延长药敏试验至14天以确定是否存在对大环内酯类的诱导性耐药。单药治疗(克拉霉素)在无并发症的肺外疾病中显示出有前景的疗效,这可能是因为其手足病变可能代表自限性特征(Lee et al., 2015)。然而,侵袭性或播散性脓肿分枝杆菌和M. bolletii感染治疗复杂,需要联合用药和更全面的治疗疗程(Comba et al., 2021)。在化疗后手术切除受累组织以减少广泛进展,可能是复杂病例的治愈性治疗选择。

在治疗脓肿分枝杆菌感染的背景下,一项研究的临床前和临床数据(Singh et al., 2023)表明,在联合方案中加入奥马环素(每日300 mg剂量)有望在涉及脓肿分枝杆菌肺部受累患者的III期试验中进行评估。此类研究也可能对解决皮肤相关问题具有重要的指导意义。此外,噬菌体也被探索为潜在的治疗选择。一项研究(Gorzynski et al., 2023)揭示了噬菌体的裂解效率受环境因素影响,特别是在处理脓肿分枝杆菌的生物膜和细胞内状态时。这一观察结果具有重要意义,因为它有助于鉴定能够通过阻碍抗生素外排功能降低细菌适应性、并通过靶向治疗干预减弱脓肿分枝杆菌固有耐药机制的治疗性噬菌体。硫链丝菌素(Thiostrepton)是一种有前景的新型治疗候选药物,已在体外实验和巨噬细胞模型中证明对脓肿分枝杆菌生长具有显著抑制作用,包括野生型菌株、亚种、临床分离株和耐药突变体。此外,其还表现出剂量依赖性促炎细胞因子产生减少,提示其作为脓肿分枝杆菌感染背景下抗炎剂的潜力(Kim et al., 2019)。

### 2.2.4 其他RGM

根据体外抗菌药敏试验,一项采用开放式药物发现方法的研究(Cantillon et al., 2022)发现,利奈唑胺和多西环素等噁唑烷酮类药物具有优异的组织渗透特性,并对奇美拉分枝杆菌具有强效活性。两份病例报告(Shimizu et al., 2012; Wang C. J. et al., 2022)建议对偶发分枝杆菌(M. smegmatis)感染软组织患者采用充分清创和敏感抗生素给药的联合治疗。

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## 3 讨论

由于近年来肺外NTM感染病例的报告日益增多,且尚无统一的治疗方案可供参考,因此需要一种更安全、更有效、依从性更高、抗NTM活性谱更广且更具皮肤特异性的治疗策略。为此,我们回顾了近年来涉及皮肤或软组织的NTM感染的治疗,以就该主题提出一些建议。

NTM皮肤受累与其他NTM感染表现相比表现出独特的治疗差异,这归因于皮肤独特的结构特征、药物分布模式的变异、多样化的感染方式、相对局限的病灶分布、较轻的疾病严重程度以及更多可用的治疗方式。NTM感染的管理通常需要在长时间内使用多种抗菌药物,需要密切的临床和实验室监测。然而,缺乏关于一线治疗方案(包括最佳药物选择、剂量和疗程)的良好结构化对照试验,这给制定有效管理多种NTM菌种和相关疾病的循证指南带来了挑战。因此,方案选择通常应以药敏试验为指导。该试验涉及评估NTM分离株对各种抗菌药物的敏感性,从而为最合适的治疗方法提供决策依据。

根据药敏试验结果,我们总结的治疗选择推荐见表1。严格的临床试验的建立将有助于填补这些知识空白,并促进开发更有效和更具针对性的NTM皮肤感染治疗策略。在等待菌种鉴定和药敏结果的同时开始治疗是合理的,对于大多数浅表病例不应有任何延迟。然而,对于大多数NTM菌种,临床结局与体外药敏阈值之间的相关性仍未明确(van Ingen et al., 2012a; Timmins, 2020)。不同的NTM亚型对抗菌药物具有不同的药敏谱。SGM的敏感抗生素与RGM不同(Alffenaar et al., 2021; Sharma et al., 2021)。因此,建议进行亚水平鉴定(不高于菌种水平)和NTM药敏试验,尤其是RGM。例如,临床和实验室标准协会(CLSI)建议(Schoutrop et al., 2018)仅对MAC进行克拉霉素和阿米卡星药敏试验,对堪萨斯分枝杆菌进行克拉霉素和利福平药敏试验,对脓肿杆菌复合群进行克拉霉素药敏试验。此外,SGM的药敏试验应延长至6周,大环内酯类应延长至2周(Dartois and Dick, 2022)。分子诊断技术的最新进展提高了鉴定NTM菌种及其药敏性的准确性和速度,从而实现更精确和靶向的治疗。然而,随着时间推移,一些抗分枝杆菌药物的稳定性逐渐受到病原体的影响,导致最低抑菌浓度(MIC)变化,进而影响药敏试验结果的最终解读。这在一定程度上解释了为什么药敏试验结果不一定转化为积极的临床反应。局部微环境(Dey et al., 2010; Dartois and Dick, 2022)可能降低解剖部位的治疗药物浓度,这可能是另一个原因。

此外,浅表NTM感染尚无明确的治疗终点。与结核病或NTM肺部疾病不同,浅表NTM感染的治疗终点定义不明确。

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**表1 NTM皮肤感染治疗优选方案总结**

| 菌种 | 推荐选择 | 不推荐选择 | 补充选择 | |------|---------|-----------|---------| | **海分枝杆菌** | 乙胺丁醇、利福平、克拉霉素、磺胺类、多西环素、米诺环素 | 阿奇霉素、异烟肼、吡嗪酰胺、左氧氟沙星、环丙沙星、喹诺酮类 | 手术、热敷治疗 | | **堪萨斯分枝杆菌** | 利福平、乙胺丁醇、克拉霉素、氨基糖苷类、氟喹诺酮类、莫西沙星 | 氯法齐明、吡嗪酰胺、利奈唑胺、异烟肼 | 手术 | | **MAC** | 克拉霉素、乙胺丁醇、阿米卡星、利福布汀、链霉素 | 利奈唑胺、异烟肼、氯法齐明、利福平、莫西沙星 | 利奈唑胺、手术 | | **其他SGM** | 阿奇霉素、乙胺丁醇、利福布汀 | 暂无数据 | 手术 | | **偶然分枝杆菌复合群** | 阿米卡星、环丙沙星、多西环素、氯法齐明、TMP-SMX、利奈唑胺、四环素类、喹诺酮类、吉泊达星、米诺环素 | 克拉霉素、妥布霉素 | 大环内酯类、亚胺培南、手术 | | **龟分枝杆菌** | 克拉霉素、头孢西丁、氟喹诺酮类、妥布霉素、奥马环素 | 大环内酯类(诱导性耐药) | 手术、噬菌体疗法 | | **脓肿杆菌复合群** | 阿米卡星、利奈唑胺、氯法齐明、替加环素、克拉霉素、奥马环素、硫链丝菌素 | 大环内酯类(诱导性耐药) | 手术、噬菌体疗法 | | **其他RGM** | 阿米卡星、利奈唑胺、多西环素、莫西沙星、环丙沙星 | 暂无数据 | 手术 |

*注:单药或联合治疗取决于具体情况(NTM菌种、感染部位和疾病严重程度)。手术操作包括切除、清创、引流和截肢等。*

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**菌种分类:** - **慢生长分枝杆菌(SGM)** - **快生长分枝杆菌(RGM)**

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*Frontiers in Pharmacology*

b 为皮肤非结核分枝杆菌(NTM)感染的治疗终点建立更加标准化和循证的方法,仍需进一步的研究和临床调查。 NTM对多种抗生素的低敏感性归因于其多种特性。1. 固有耐药机制:第一道屏障是其独特的代谢条件(细胞壁的疏水性,从而导致低渗透性(van Ingen等,2012a))以及细胞壁中孔蛋白或ABC转运蛋白超家族的缺失,这削弱了药物的摄取和生物转化,降低了与药物靶点的亲和力。2. 诱导性耐药机制(Alffenaar等,2021):第二道屏障是NTM的基因组突变,可导致高水平耐药。耐药菌株源于核苷酸水平的突变。例如,M. abscessus分离株中23S rRNA(功能性erm基因)的变化以及M. smegmatis中RNA聚合酶结合蛋白A(RbpA)的变化与大环内酯类和利福平的耐药性相关(Dey等,2010)。比较基因组学和群体遗传学研究可揭示NTM物种的遗传变异、进化和适应性。3. 适应性耐药机制:NTM的适应性构成第三道屏障。NTM具有极强的代时更新能力和代谢能力,意味着它们能在细胞被杀灭前适应应激环境。它们可在皮肤上形成生物膜,即被胞外基质包裹的复杂微生物群落。例如,NTM的持久性策略之一即隐藏于生物膜中(Slany等,2016),这通常导致其对抗生素的敏感性比浮游状态低十倍。理解NTM在皮肤上生物膜形成的机制与动态是当前活跃的研究领域,旨在开发破坏生物膜的策略以改善治疗效果,包括使用生物膜靶向剂和生物膜破坏技术(如酶、肽、纳米颗粒和超声波)。此外,一些研究(Huh等,2019)认为NTM可进入非复制状态并表现出表型耐药性。然而,迄今为止,与NTM相关耐药机制的研究仍不完善。除大环内酯类外,许多药物的耐药机制尚需阐明。理解耐药的基础,更重要的是如何调整治疗方案以防止耐药性的发展,至关重要。

对于累及皮肤的轻症病例,初始经验性治疗和抗生素单药治疗在多数患者中反应良好。单药或联合治疗(克拉霉素、利福平、乙胺丁醇)的选择取决于宿主的具体特征、感染部位及菌种鉴定。若治疗反应差或病情快速进展,应在整个治疗过程中进行体外药敏试验。与单纯抗菌药物治疗相比,局部感染在药物治疗基础上联合手术治疗已被证明对皮肤外受累具有更好的疗效。定期监测患者的临床治疗反应,并通过实验室检测评估抗菌治疗效果,是管理NTM皮肤感染的重要环节。应按照建议安排随访复诊,以监测进展并根据需要调整治疗方案。我们关于NTM皮肤感染治疗的建议及推荐流程总结于表2和图1。

为克服耐药性并提高复杂病例的治疗效果,目前正在探索新兴策略。1. 筛选现有药物和新药:新型抗菌药物已显示出对NTM物种的强效活性,可考虑用于NTM皮肤感染的治疗,尤其在标准治疗方案失败或存在耐药菌株的情况下。一项研究(Kaushik等,2019)表明,新型β-内酰胺酶抑制剂relebactam和vaborbactam与β-内酰胺类联用,在体外对M. abscessus复合群临床分离株具有强效。氯法齐明(Meir和Barkan,2020)原用于治疗麻风病,现被重新用于抗M. abscessus。此外,delamanid、pretomanid和PIPD1也已在M. abscessus中测试。Telacebec是一种有前景的新药,具有疗程短、耐受性好的优势(Lee和Pethe,2022)。然而,新药的使用可能受限于其潜在副作用、较高成本和可及性。2. 现有药物的重新组合:这是一种经济高效的选择。先前研究(van Ingen等,2012b;Lee和Pethe,2022)发现,某些抗生素可增加细胞壁通透性以促进第二种药物的摄取,并加速持久治愈,表明协同药物相互作用可为NTM感染治疗提供额外支持。3. 基于新靶点发现新药(Dartois和Dick,2022):RNA聚合酶、DNA旋转酶、核糖体、F-ATP合酶及多种酶。例如,靶向氧化磷酸化能量生成途径的抗生素可能成为新选择。此外,MmpL3(Sethiya等,2020)是一种负责将海藻糖单霉菌酸转运至周质空间和外膜的转运蛋白,Frontiers in Pharmacology

非复制状态检测、生物膜检测、动物模型以及病灶或感染部位特异性药代动力学检测等方法,有助于聚焦皮肤和软组织,是开发新型抗NTM药物时衡量和评估效果的重要工具(Wu等,2018)。例如,干扰素-γ是一种在抗分枝杆菌免疫应答中起作用的细胞因子,已在部分NTM皮肤感染病例中作为抗菌治疗的辅助手段,尤其适用于有基础免疫抑制状态的患者。其他免疫增强剂,如粒细胞-巨噬细胞集落刺激因子(GM-CSF),也在NTM感染管理中得到研究。基于片段的药物发现(FBDD)(Togre等,2022)可专注于设计针对NTM潜在治疗靶点的最优抑制剂。兔模型可作为研究抗生素渗透性并模拟体内药效-药代动力学轨迹的可接受替代模型(Kaya等,2022)。

本研究也存在诸多局限性。首先,需增加随机研究,关于最佳治疗的数据有限。目前关于不同治疗方案对人类NTM皮肤病疗效的临床数据有限,需进一步研究以确定其在临床实践中的安全性和有效性。其次,NTM感染的耐药机制(种间遗传和致病性变异)仍需深入理解。

综上所述,全面理解本研究讨论的各个方面对于有效管理NTM引起的皮肤受累至关重要。理想的治疗方法应涵盖更广谱的抗NTM活性,同时兼顾皮肤感染的具体特征。NTM感染的最佳治疗方案仍在持续演进中,持续的研究、临床试验和创新治疗策略对于寻求更安全、更有效、个体化的治疗方案以有效应对NTM皮肤受累至关重要。通过解决上述问题,临床医生可改善患者预后,减轻受影响人群中NTM感染的负担。

图1 NTM皮肤感染治疗流程。*:NTM,非结核分枝杆菌 1:治疗应区分轻症与重症、耐药与非耐药、初始与持续阶段、药物组成与剂量、儿童与成人、HIV与非HIV等。 3:抗NTM药物包括克拉霉素、阿奇霉素、乙胺丁醇、阿米卡星、环丙沙星、莫西沙星、利福平、异烟肼、头孢西丁、利奈唑胺、氯法齐明、替加环素、亚胺培南/西司他丁、多西环素、米诺环素及复方磺胺甲噁唑等。 4:制定NTM皮肤感染化疗方案时,应根据上述结果选择药物。不同NTM菌种的用药类型和治疗疗程不同。疑似NTM感染不推荐经验性治疗。 5:根据患者病情增加其他治疗方式。对于病灶广泛、脓肿形成及药物疗效差的患者,可积极采用手术清创或异物取出。 6:监测血常规、肝肾功能、血电解质、尿常规、体重、分枝杆菌培养、听力、视野与色觉、心电图等。 7:提供良好的患者教育与病情解释。例如,减少与NTM病患者接触,预防人际传播。 8:治疗结局包括细菌学转阴、细菌学治愈、临床治愈、治愈、治疗失败、细菌学复发及死亡。

作者贡献 概念与设计:JL;文献检索与初稿撰写:X-YW;方法论与稿件审阅修订:Q-NJ。所有作者均对本文作出贡献并同意投稿版本。