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在中国北京耐多药结核病患者中联合使用贝达喹啉和地拉曼的疗效与安全性

Efficacy and Safety of Combined Bedaquiline and Delamanid Use among Patients with Multidrug-Resistant Tuberculosis in Beijing, China.

作者信息

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

机构信息

Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China.

Department of Bacteriology and Immunology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China.

出版信息

Biomed Environ Sci. 2024 Oct 20;37(10):1195-1203. doi: 10.3967/bes2024.088.

Abstract

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.

摘要

目的

贝达喹啉和地拉米啶联合使用(BDQ-DLM)受到QTc间期延长风险增加的限制。我们回顾性评估了在一家结核病专科医院接受含DLM/BDQ方案治疗的患者。我们旨在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了单用BDQ或BDQ加DLM治疗的耐多药结核病(MDR-TB)患者。

结果

本分析共纳入96例患者:BDQ组64例,BDQ + DLM组32例。在单用BDQ或BDQ联合DLM治疗开始时痰培养阳性的96例患者中,BDQ组46例(71.9%)、BDQ-DLM组29例(90.6%)在治疗期间实现了痰培养转阴。两组痰培养转阴率无差异。BDQ-DLM组痰培养转阴时间明显短于BDQ组。最常见的不良事件是QTc间期延长;然而,两组不良事件的发生率无差异。

结论

总之,我们的结果表明,BDQ和DLM联合使用对中国耐多药结核病感染患者有效且耐受性良好。BDQ-DLM组患者痰培养转阴时间早于BDQ组。

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