在欧洲，利福平耐药结核病的贝达喹啉、普托马尼德、利奈唑胺和莫西沙星（BPaL（M））方案的药物供应和耐药检测情况。
Availability of drugs and resistance testing for bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaL(M)) regimen for rifampicin-resistant tuberculosis in Europe.
机构信息
Department of Pulmonary Medicine and Allergology, Inselspital, Bern University Hospital, University of Bern, Switzerland; Department of Medical Sciences, School of Medicine, University of Namibia, Windhoek, Namibia.
Sorbonne Université, INSERM, U1135, Centre d'Immunologie et des Maladies Infectieuses, Cimi-Paris, Paris, France; Assistance Publique Hopitaux de Paris, Groupe Hospitalier Universitaire Sorbonne Université, Hopital Pitié -Salpetiere, Centre National de Reference des Mycobacteries et de la Resistance des Mycobacteries aux Antituberculeux, Paris, France.
出版信息
Clin Microbiol Infect. 2024 Sep;30(9):1197.e1-1197.e4. doi: 10.1016/j.cmi.2024.03.009. Epub 2024 Mar 13.
OBJECTIVES
Multidrug-resistant/rifampicin-resistant tuberculosis is a major obstacle to successful tuberculosis control. The recommendation by the WHO to use bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaL(M)) for 6 months, based on results of two trials with high efficacy and low toxicity, has revolutionized treatment options.
METHODS
In this study, representatives of the Tuberculosis Network European Trials group in 44 of 54 countries of the WHO Europe region documented the availability of the medicines and drug susceptibility testing (DST) of the BPaL(M) regimen through a structured questionnaire between September and November 2023.
RESULTS
In total, 24 of 44 (54.5%), 42 of 44 (95.5%), 43 of 44 (97.7%), and 43 of 44 (97.7%) countries had access to pretomanid, bedaquiline, linezolid, and moxifloxacin, respectively. Overall, 23 of 44 (52.3%) countries had access to all the drugs composing the BPaL(M) regimen. In total, 21 of 44 (47.7%), 37 of 44 (84.1%), 40 of 44 (90.9%), and 41 of 44 (93.2%) countries had access to DST for pretomanid, bedaquiline, linezolid, and moxifloxacin, respectively. Overall, DST was available for all medicines composing the BPaL(M) regimen in 21 of 44 (47.7%) countries, including countries where pretomanid DST was available at specialized laboratories. The availability of DST for the drugs the countries had access to, varied from 87.5% to 95.3% (pretomanid 21 of 24 (87.5%), bedaquiline 37 of 42 (88.1%), linezolid 40 of 43 (93.1%) and moxifloxacin 41 of 43 (95.3%)).
DISCUSSION
In only about half of the countries participating in the survey, clinicians had access to all the BPaL(M) regimen drugs. A complete DST for the BPaL(M) medicines was possible in less than half of the countries, because of the low accessibility of DST for pretomanid. Equal access to new regimens is urgently needed in Europe and a rapid scale up of DST, especially for pretomanid, is important to prevent unnoticed spread of drug resistance.
目的
耐多药/利福平耐药结核病是成功控制结核病的主要障碍。世界卫生组织（WHO）建议使用贝达喹啉、德拉马尼、利奈唑胺和莫西沙星（BPaL（M））治疗 6 个月，这是基于两项具有高疗效和低毒性的试验结果，这一建议彻底改变了治疗选择。
方法
在这项研究中，结核病网络欧洲试验组的代表在世界卫生组织欧洲区域的 54 个国家中的 44 个国家，于 2023 年 9 月至 11 月期间通过结构化问卷，记录了 BPaL（M）方案中药物的可获得性和药物敏感性试验（DST）。
结果
共有 24 个（54.5%）、42 个（95.5%）、43 个（97.7%）和 43 个（97.7%）国家可获得德拉马尼、贝达喹啉、利奈唑胺和莫西沙星，分别。总体而言，23 个（52.3%）国家可获得组成 BPaL（M）方案的所有药物。共有 21 个（47.7%）、37 个（84.1%）、40 个（90.9%）和 41 个（93.2%）国家可获得 DST 用于德拉马尼、贝达喹啉、利奈唑胺和莫西沙星，分别。总体而言，21 个（47.7%）国家可获得组成 BPaL（M）方案的所有药物的 DST，包括在专门实验室可获得德拉马尼 DST 的国家。各国可获得的 DST 药物种类从 87.5%到 95.3%不等（德拉马尼 21 个/24 个（87.5%）、贝达喹啉 37 个/42 个（88.1%）、利奈唑胺 40 个/43 个（93.1%）和莫西沙星 41 个/43 个（95.3%））。
讨论
在参与调查的国家中，只有约一半的国家的临床医生能够获得所有 BPaL（M）方案药物。由于缺乏对德拉马尼的 DST，不到一半的国家能够进行完整的 BPaL（M）药物 DST。欧洲迫切需要平等获得新方案，迅速扩大 DST，特别是对德拉马尼的 DST，对于防止耐药性的无察觉传播至关重要。
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