北京地区贝达喹啉和德拉马尼联合应用在耐多药结核病患者中的疗效和安全性

Can Guo, Lihui Nie, Yanhua Song, Rongmei Liu, Xiaoguang Wu, Yuanyuan Shang, Xuxia Zhang, Yu Pang, Mengqiu Gao
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摘要

目的:联合使用贝达喹啉和德拉马尼(BDQ-DLM)受到延长QTc间期风险增加的限制。我们回顾性评估了在结核病专科医院接受含DLM/ bdq方案的患者。我们的目的是提供中国患者的临床疗效和安全性数据。方法:本病例对照研究纳入单用BDQ或BDQ加DLM治疗的耐多药结核病患者。结果:共纳入96例患者:BDQ组64例,BDQ + DLM组32例。治疗初期痰培养阳性的96例患者中,BDQ组46例(71.9%),BDQ-DLM组29例(90.6%)在治疗过程中痰培养转化。两组间痰培养转化率无显著差异。BDQ- dlm组痰培养转化时间明显短于BDQ组。最常见的不良事件是QTc间期延长;然而,不良事件的频率在两组之间没有差异。结论:综上所述,我们的研究结果表明,BDQ和DLM联合使用对中国耐多药结核病患者有效且耐受。BDQ- dlm组患者痰培养转化较BDQ组早。
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Efficacy and Safety of Combined Bedaquiline and Delamanid Use among Patients with Multidrug-Resistant Tuberculosis in Beijing, China.

Objectives: The combined use of bedaquiline and delamanid (BDQ-DLM) is limited by an increased risk of prolonging the QTc interval. We retrospectively evaluated patients who received DLM/BDQ-containing regimens at a TB-specialized hospital. We aimed to present clinical efficacy and safety data for Chinese patients.

Methods: This case-control study included patients with multidrug-resistant tuberculosis (MDR-TB) treated with BDQ alone or BDQ plus DLM.

Results: A total of 96 patients were included in this analysis: 64 in the BDQ group and 32 in the BDQ + DLM group. Among the 96 patients with positive sputum culture at the initiation of BDQ alone or BDQ combined with DLM, 46 patients (71.9%) in the BDQ group and 29 (90.6%) in the BDQ-DLM group achieved sputum culture conversion during treatment. The rate of sputum culture conversion did not differ between the two groups. The time to sputum culture conversion was significantly shorter in the BDQ-DLM group than in the BDQ group. The most frequent adverse event was QTc interval prolongation; however, the frequency of adverse events did not differ between the groups.

Conclusion: In conclusion, our results demonstrate that the combined use of BDQ and DLM is efficacious and tolerable in Chinese patients infected with MDR-TB. Patients in the BDQ-DLM group achieved sputum culture conversion sooner than those in the BDQ group.

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