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
National Tuberculosis Control Program, Manzini, Eswatini.
Hinduja Hospital and Research Center, Mumbai, India.
IJTLD Open. 2025 Jun 13;2(6):315-323. doi: 10.5588/ijtldopen.25.0240. eCollection 2025 Jun.
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.
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.
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.
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.
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。
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。
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。
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。