MDR-Chin研究解析:耐多药肺结核全口服短程治疗方案在中国的应用前景

doi:10.19982/j.issn.1000-6621.20230325

中国防痨杂志 ›› 2024, Vol. 46 ›› Issue (1): 18-22.doi: 10.19982/j.issn.1000-6621.20230325

MDR-Chin研究解析:耐多药肺结核全口服短程治疗方案在中国的应用前景

付亮, 邓国防()

南方科技大学附属深圳市第三人民医院肺二科/国家感染性疾病临床医学研究中心/深圳市结核病临床研究中心,深圳 518000

收稿日期:2023-09-06 出版日期:2024-01-10 发布日期:2024-01-04
通信作者: 邓国防,Email:jxxk1035@yeah.net
基金资助:
国家自然科学基金(82070016);广东省结核病临床研究中心(2020B1111170014);深圳市结核病临床研究中心(20210617141509001);佛山市开放课题(FSSYKF-2020001005597);佛山市科技创新计划(2020001005597);深圳市第三人民医院课题(G2021023);深圳市第三人民医院课题(G2022155)

MDR-Chin study analysis: prospects of using all-oral short-course treatment regimens for multidrug-resistant pulmonary tuberculosis in China

Fu Liang, Deng Guofang()

Division Two of Pulmonary Diseases Department, Department of Pulmonary Medicine, Shenzhen Third People’s Hospital, National Clinical Research Center for Infectious Disease (Shenzhen), Shenzhen Clinical Research Center for Tuberculosis, Southern University of Science and Technology, Shenzhen 518000, China

Received:2023-09-06 Online:2024-01-10 Published:2024-01-04
Contact: Deng Guofang, Email: jxxk1035@yeah.net
Supported by:
National Natural Science Foundation of China(82070016);Guangdong Provincial Clinical Research Center for Tuberculosis Project(2020B1111170014);Shenzhen Clinical Research Center for Tuberculosis(20210617141509001);Summit Plan for Foshan High-Level Hospital Construction(FSSYKF-2020001005597);Foshan Science and Technology Innovation Plan(2020001005597);Shenzhen Third People’s Hospital(G2021023);Shenzhen Third People’s Hospital(G2022155)

摘要/Abstract

摘要：

全球耐多药结核病(multidrug-resistant tuberculosis,MDR-TB)的治疗研究趋势是缩短疗程。MDR-Chin研究是中国第一项探索全口服短程方案治疗MDR-TB和准广泛耐药结核病(pre-extensive drug-resistant tuberculosis,pre-XDR-TB)的队列研究,主要验证了3种不同治疗方案的有效性和安全性。结果表明,在停药后12个月的随访期内,96%的MDR-TB患者和83.3%的pre-XDR-TB患者达到了良好结局;总体良好结局率为92.9%。虽然3级或更高级别的不良事件很常见(48.1%),但大多可管可控,且严重不良事件较少(7.7%)。该研究保持了低失访率,体现了全口服短程方案的优势,并展示了在资源有限的环境中的应用潜力。本文中,笔者介绍了MDR-Chin研究的概况,分析其优点和缺点,并探讨全口服短程治疗方案在中国实施的可能性及未来的临床研究方向。

关键词: 结核,肺, 抗药性,多药, 临床方案, 治疗应用

Abstract:

The global trend in the treatment of multidrug-resistant tuberculosis (MDR-TB) is to shorter treatment durations. The MDR-Chin study is China’s first cohort study to explore all-oral short-course regimens for the treatment of MDR-TB and pre-extensive drug-resistant tuberculosis (pre-XDR-TB), validating the efficacy and safety of three different treatment regimens. The results indicated that within a 12-month follow-up after the drug withdrawal, 96% of MDR-TB patients and 83.3% of pre-XDR-TB patients achieved favorable outcomes; the overall rate of favorable outcomes was 92.9%. Although grade 3 or higher adverse events (AEs) were quite common (48.1%), most were manageable and controllable, with relatively rare serious AEs (7.7%). In the study, loss-to-follow-up rate was low, the advantages of the all-oral short-course regimen were reflected and the potential for application in resource-limited settings was displayed. In this article, the author provides an overview of the MDR-Chin study, analyzesthe advantages and disadvantages, and discusses the application and future directions of clinical research for all-oral, short-course treatment regimens in China.

Key words: Tuberculosis, pulmonary, Drug resistance, multiple, Clinical protocols, Therapeutic uses

中图分类号:

付亮, 邓国防. MDR-Chin研究解析:耐多药肺结核全口服短程治疗方案在中国的应用前景[J]. 中国防痨杂志, 2024, 46(1): 18-22. doi: 10.19982/j.issn.1000-6621.20230325

Fu Liang, Deng Guofang. MDR-Chin study analysis: prospects of using all-oral short-course treatment regimens for multidrug-resistant pulmonary tuberculosis in China[J]. Chinese Journal of Antituberculosis, 2024, 46(1): 18-22. doi: 10.19982/j.issn.1000-6621.20230325

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MDR-Chin研究解析:耐多药肺结核全口服短程治疗方案在中国的应用前景

MDR-Chin study analysis: prospects of using all-oral short-course treatment regimens for multidrug-resistant pulmonary tuberculosis in China

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