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针对对新型结核病药物具有广泛耐药性患者的临床最佳护理实践。

Clinical best practices for caring for people with expanded resistance to newer TB drugs.

作者信息

Nkomo T, Udwadia Z, Vambe D, van Rie A, Thi S S, Stillo J, Stambekova A, Sinha A, Rich M L, Reuter A, Patel J, Otto-Knapp R, Motta I, Mesic A, McKenna L, Maru S, Lessem E, Lange C, Kiria N, Kherabi Y, Günther G, Guglielmetti L, Decroo T, Chen L, Ashesh A, Abubakirov A, Furin J

机构信息

National Tuberculosis Control Program, Manzini, Eswatini.

Hinduja Hospital and Research Center, Mumbai, India.

出版信息

IJTLD Open. 2025 Jun 13;2(6):315-323. doi: 10.5588/ijtldopen.25.0240. eCollection 2025 Jun.

DOI:10.5588/ijtldopen.25.0240
PMID:40530383
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12168730/
Abstract

BACKGROUND

Strains of with resistance to the new and repurposed drugs included in the all-oral shorter TB regimens recommended by WHO for the treatment of multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) are becoming increasingly common globally. When strains of have resistance to one or more of these drugs (bedaquiline, linezolid, third-generation fluoroquinolones, delamanid, pretomanid, or clofazimine), they are more challenging to treat.

METHODS

In the absence of trial data on how to care for these individuals, a group of clinical, programmatic and civil society experts came together to generate a series of best clinical practices. These practices are based on the published literature and on experience caring for individuals with these forms of TB.

RESULTS

We discuss best clinical practices in the following areas: 1) drug susceptibility testing; 2) regimen design; 3) adverse event monitoring and management; 4) special populations; 5) shared decision making and informed consent; 6) holistic packages of support; and 7) pre-approval access/compassionate use of newer TB compounds.

CONCLUSION

While we await systematic studies of treatment approaches to generate the necessary evidence base, the clinical practices described here can be used to guide the programmatic care of people with strains of that have expanded resistance.

摘要

背景

对世界卫生组织推荐用于治疗耐多药/利福平耐药结核病(MDR/RR-TB)的全口服短程结核病治疗方案中所包含的新型和重新利用药物产生耐药性的结核分枝杆菌菌株在全球范围内正变得越来越普遍。当结核分枝杆菌菌株对这些药物中的一种或多种(贝达喹啉、利奈唑胺、第三代氟喹诺酮类药物、地拉曼id、普瑞玛尼德或氯法齐明)产生耐药性时,治疗会更具挑战性。

方法

在缺乏关于如何照料这些个体的试验数据的情况下,一组临床、项目和民间社会专家齐聚一堂,制定了一系列最佳临床实践。这些实践基于已发表的文献以及照料这些类型结核病患者的经验。

结果

我们讨论以下领域的最佳临床实践:1)药物敏感性测试;2)治疗方案设计;3)不良事件监测与管理;4)特殊人群;5)共同决策与知情同意;6)全面支持方案;以及7)新型结核病化合物的预先批准获取/同情用药。

结论

在我们等待对治疗方法进行系统研究以建立必要的证据基础时,此处描述的临床实践可用于指导对具有广泛耐药性的结核分枝杆菌菌株感染者的项目性照料。

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本文引用的文献

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Bedaquiline Resistance and Treatment Outcomes Among Patients With Tuberculosis Previously Exposed to Bedaquiline in India: A Multicentric Retrospective Cohort Study.印度曾接触过贝达喹啉的结核病患者的贝达喹啉耐药性及治疗结果:一项多中心回顾性队列研究
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Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043-02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial.抗结核候选药物BTZ-043在南非的安全性、杀菌活性和药代动力学研究(泛亚ACEA-BTZ-043-02):一项开放标签、剂量扩展、随机、对照的1b/2a期试验。
Lancet Microbe. 2025 Feb;6(2):100952. doi: 10.1016/j.lanmic.2024.07.015. Epub 2025 Jan 7.
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Transmission as a Key Driver of Resistance to the New Tuberculosis Drugs.传播作为对新型结核病药物耐药性的关键驱动因素。
N Engl J Med. 2025 Jan 2;392(1):97-99. doi: 10.1056/NEJMc2404644.
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Safety, pharmacokinetics, and early bactericidal activity of quabodepistat in combination with delamanid, bedaquiline, or both in adults with pulmonary tuberculosis: a randomised, active-controlled, open-label trial.喹博地司他与地拉曼尼、贝达喹啉或两者联合用于成人肺结核的安全性、药代动力学及早期杀菌活性:一项随机、活性对照、开放标签试验
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First data of a quabodepistat containing novel regimen for drug-susceptible tuberculosis.关于含新型方案的喹博地司他治疗药物敏感型肺结核的首批数据。
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Considering best practice standards for routine whole-genome sequencing for TB care and control.考虑结核病防治中常规全基因组测序的最佳实践标准。
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Towards shorter, safer, flexible, and more effective treatment regimens for drug-resistant tuberculosis.朝着更短、更安全、更灵活且更有效的耐多药结核病治疗方案发展。
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Impact of bedaquiline resistance probability on treatment decision for rifampicin-resistant TB.贝达喹啉耐药概率对耐利福平结核病治疗决策的影响。
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