Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumour Research Institute, Beijing, PR China.
Clinical Center on TB, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, PR China.
Clin Microbiol Infect. 2021 Apr;27(4):597-602. doi: 10.1016/j.cmi.2020.06.004. Epub 2020 Jun 15.
Bedaquiline treatment significantly improves multidrug-resistant tuberculosis (MDR-TB) patient treatment outcomes. However, safety and efficacy data are lacking for bedaquiline used with background regimens to treat Chinese TB patients. Here, we describe our initial clinical experience for bedaquiline treatment of a large multicentre cohort of MDR-TB and extensively drug-resistant tuberculosis (XDR-TB) patients in China.
Patients (177) received 24-week bedaquiline treatment combined with personalized anti-TB drug background regimens. As primary efficacy endpoints, times to initial sputum culture conversion were measured.
Of 177 MDR-TB patients completing the 24-week treatment course, sputum culture conversion occurred for 151/177 (85.3%), while 26 had unfavourable outcomes, including 3/177 (1.7%) deaths and 23/177 (13.0%) non-responders at treatment completion. The median time to sputum culture conversion was 4 (interquartile range 2-8) weeks. Conversion rates were 33/39 (84.6%, 95% confidence interval (CI) 73.3-95.9) for MDR-TB patients, 47/56 (83.9%, 95% CI 74.3-93.6) for pre-XDR-TB patients and 71/82 (86.6%, 95% CI 79.2-94.0) for XDR-TB patients. Multivariate analysis demonstrated that patients with low body mass index (odds ratio 7.356; 95% CI 2.652-20.401) were at significantly high risk of unfavourable outcomes, with serious adverse events noted in 15 (8.5%) patients, including six with corrected QT interval (QTc) prolongation times (>500 ms).
Bedaquiline, when included in background regimens for treatment of MDR-TB and XDR-TB patients in China, was safe and associated with a high rate of culture conversion.
贝达喹啉治疗可显著改善耐多药结核病（MDR-TB）患者的治疗结局。然而，对于中国结核病患者使用背景方案治疗的贝达喹啉的安全性和疗效数据尚缺乏。在此，我们描述了在中国大规模多中心 MDR-TB 和广泛耐药结核病（XDR-TB）患者中使用贝达喹啉治疗的初步临床经验。
患者（177 例）接受 24 周贝达喹啉联合个体化抗结核药物背景方案治疗。主要疗效终点为初始痰培养转阴时间。
177 例 MDR-TB 患者完成 24 周治疗疗程，177 例中有 151 例（85.3%）痰培养转阴，26 例不良结局，包括 3 例（1.7%）死亡和 23 例（13.0%）治疗结束时无应答者。痰培养转阴的中位数时间为 4（四分位距 2-8）周。MDR-TB 患者的转阴率为 33/39（84.6%，95%置信区间（CI）73.3-95.9），耐多药前 XDR-TB 患者为 47/56（83.9%，95%CI 74.3-93.6），XDR-TB 患者为 71/82（86.6%，95%CI 79.2-94.0）。多变量分析表明，低体重指数（比值比 7.356；95%CI 2.652-20.401）的患者发生不良结局的风险显著增加，15 例（8.5%）患者出现严重不良事件，包括 6 例校正 QT 间期（QTc）延长（>500ms）。
贝达喹啉在中国 MDR-TB 和 XDR-TB 患者的背景方案中使用是安全的，与高转阴率相关。
