Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People's Republic of China.
National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People's Republic of China.
Antimicrob Agents Chemother. 2018 Mar 27;62(4). doi: 10.1128/AAC.02149-17. Print 2018 Apr.
We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn] under identifier ChiCTR1800014800.).
我们进行了一项多中心、前瞻性、随机研究，以调查氯法齐明（CLO）治疗中国广泛耐药结核病（XDR-TB）的疗效和安全性。49 例感染 XDR-TB 的患者被随机分配到对照组或 CLO 组，两组均接受 36 个月的个体化定制治疗。主要终点是固体培养基痰培养转阴时间。在治疗完成时评估患者的临床结局。实验组的 22 例患者中，有 7 例（31.8%）符合“治愈”的治疗标准，1 例（4.5%）为“完全治疗”，总共有 8 例（36.4%）未复发，治疗结果成功。在对照组中，有 6 例（22.2%）治愈，6 例（22.2%）在研究结束时完成治疗。统计分析显示 CLO 组和对照组的治疗成功率无显著差异。实验组的平均痰培养转阴时间为 19.7 个月，与对照组（20.3 个月）无统计学差异（ = 0.57）。在 CLO 组的 22 例患者中，有 12 例（54.5%）在开始 CLO 治疗后出现不良事件。最常见的不良事件是肝损伤，CLO 组有 31.8%（7/22 例）的患者出现这种不良事件，而对照组有 11.1%（3/27 例）的患者出现这种不良事件。我们的研究表明，在 XDR-TB 的背景治疗方案中加入 CLO 的益处有限，特别是因为 CLO 治疗会引起肝障碍等主要不良事件。（本研究在中国临床试验注册中心（ChiCTR，www.chictr.org.cn）注册，注册号 ChiCTR1800014800。）
