耐药结核病全口服短程治疗专家共识

doi:10.19982/j.issn.1000-6621.20250087

中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (7): 830-839.doi: 10.19982/j.issn.1000-6621.20250087

耐药结核病全口服短程治疗专家共识

中国防痨协会, 《中国防痨杂志》编辑委员会, 首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所

收稿日期:2025-03-06 出版日期:2025-07-10 发布日期:2025-07-03
通信作者: 初乃惠,Email:dongchu1994@sina.com; 聂文娟,Email:94642975@qq.com
基金资助:
国家重点研发计划(2024YFC2311203);广州国家实验室2024年专项-结核病短程治疗项目(GZNL2024A01030);中国防痨协会全球结核病药物研发联盟合作项目(CATA/TBA-20210310HQ7);北京市临床医学发展专项“扬帆3.0”计划项目(ZLRK202331);北京市卫生健康委员会研究型病房卓越临床研究计划(BRWEP2024W042160109)

Expert consensus on all-oral short-course therapy for drug-resistant tuberculosis

Received:2025-03-06 Online:2025-07-10 Published:2025-07-03
Contact: Chu Naihui, Email: dongchu1994@sina.com; Nie Wenjuan, Email: 94642975@qq.com
Supported by:
National Key Research and Development Program(2024YFC2311203);Special Project of Guangzhou National Laboratory for 2024-Short Term Treatment of Tuberculosis(GZNL2024A01030);Global Tuberculosis Drug Research and Development Alliance Cooperation Project of China Anti-TB Association(CATA/TBA-20210310HQ7);Beijing Clinical Medicine Development Special Project “Sailing 3.0”(ZLRK202331);Beijing Municipal Health Commission Research Ward Excellent Clinical Research Program(BRWEP2024W042160109)

摘要/Abstract

摘要：

世界卫生组织发布的《耐药结核病治疗指南(2016年更新版)》中针对耐药结核病治疗推荐了全口服治疗方案。既往研究显示,使用口服短程治疗方案与含注射剂治疗方案或长程治疗方案相比,可在保证治疗成功率的基础上,获得更好的用药安全性和耐受性,以及更优的治疗依从性。世界卫生组织在《结核病整合指南模块4:耐药结核病治疗(2022年更新版)》中提出了针对耐药结核病治疗的6个月短程治疗方案(6BPaLM;其中,B:贝达喹啉,Pa:普托马尼,L:利奈唑胺,M:莫西沙星),开启了耐药结核病的全口服短程治疗时代。2024年6月世界卫生组织发布了耐药结核病新治疗方案的快速通告,新方案与世界卫生组织既往推荐的短程口服耐药方案相比更符合我国实际情况。为制定符合我国实际的全口服耐药结核病治疗方案,由中国防痨协会牵头,联合首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所、《中国防痨杂志》编辑委员会,组织业内专家撰写了《耐药结核病全口服短程治疗专家共识》。本共识根据近年来国内外耐药结核病全口服方案的研究进展,推荐了适宜我国国情的耐药结核病全口服短程治疗方案及适用人群,并且对全口服治疗方案使用的注意事项及不良反应处理提出了共识意见。期望通过本共识的颁布,为我国耐药结核病短程治疗方案的全面应用提供技术指引,从而进一步提高我国耐药结核病患者的治疗成功率。

关键词: 结核, 抗药性, 抗结核药, 治疗应用, 总结性报告(主题)

Abstract:

The World Health Organization (WHO) Treatment Guidelines for Drug-Resistant Tuberculosis (2016 Update) recommend an entirely oral treatment regimen for drug-resistant tuberculosis (DR-TB). Previous studies have shown that compared to injection-containing or longer-course treatment regimens, short-course oral treatment regimens can achieve better medication safety, tolerability, and treatment adherence, while maintaining treatment success rates. In the WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment of Drug-Resistant Tuberculosis (2022 Update), a 6-month short-course treatment regimen for DR-TB (6BPaLM; where B: bedaquiline, Pa: pretomanid, L: linezolid, M: moxifloxacin) was proposed, marking the dawn of an era of entirely oral short-course treatment for DR-TB. In June 2024, the WHO issued a rapid communication on new treatment regimens for DR-TB, which are more aligned with the actual situation in China compared to previously recommended short-course oral regimens. To develop a fully oral DR-TB treatment regimen tailored to China’s context, the Chinese Antituberculosis Association took the lead in collaborating with Beijing Chest Hospital/Beijing Tuberculosis and Thoracic Tumor Research Institute affiliated to Capital Medical University and the Editorial Board of the Chinese Journal of Antituberculosis to organize experts in the field to draft the Expert consensus on all-oral short-course therapy for drug-resistant tuberculosis. Based on recent domestic and international research progress on entirely oral regimens for DR-TB, this consensus recommends a short-course, entirely oral treatment regimen suitable for China’s national conditions and identifies the appropriate patient populations. It also provides consensus opinions on precautions for using entirely oral treatment regimens and the management of adverse reactions. It is hoped that the publication of this consensus will provide technical guidance for the comprehensive application of short-course treatment regimens for DR-TB in China, thereby further improving the treatment success rates for DR-TB patients in the country.

Key words: Tuberculosis, Drug resistance, Antitubercular agents, Therapeutic uses, Consensus development conferences as topic

中图分类号:

中国防痨协会, 《中国防痨杂志》编辑委员会, 首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所. 耐药结核病全口服短程治疗专家共识[J]. 中国防痨杂志, 2025, 47(7): 830-839. doi: 10.19982/j.issn.1000-6621.20250087

Chinese Antituberculosis Association, Editorial Board of Chinese Journal of Antituberculosis, Beijing Chest Hospital Capital Medlical University/Beijing Tuberculosis and Thoracic Tumor Research Institute. Expert consensus on all-oral short-course therapy for drug-resistant tuberculosis[J]. Chinese Journal of Antituberculosis, 2025, 47(7): 830-839. doi: 10.19982/j.issn.1000-6621.20250087

图/表 3

表1

表2

表3

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推荐强度	具体描述
强推荐(1级)	明确显示干预措施利大于弊
弱推荐(2级)	利弊不确定或无论质量高低的证据均显示利弊相当

证据级别	定义
高质量(A)	非常确信估计的效应值接近真实的效应值:进一步研究也不可能改变该估计效应值的可信度
中等质量(B)	对估计的效应值确信程度中等:估计值有可能接近真实值,但仍存在二者不相同的可能性,进一步研究有可能改变该估计效应值的可信度
低质量(C)	对估计的效应值的确信度有限:估计值与真实值可能大不相同。进一步研究极有可能改变该估计效应值的可信度
极低质量(D)	对估计的效应值几乎没有信心:估计值与真实值很可能完全不同。对效应值任何估计都很不确定

治疗方案	BDLLfx(C)	BLMZ	BLLfxCZ	BDLLfxZ
方案组成	贝达喹啉、德拉马尼、利奈唑胺、左氧氟沙星(氯法齐明)	贝达喹啉、利奈唑胺、莫西沙星、吡嗪酰胺	贝达喹啉、利奈唑胺、左氧氟沙星、氯法齐明、吡嗪酰胺	贝达喹啉、德拉马尼、利奈唑胺、左氧氟沙星、吡嗪酰胺
疗程	6个月	9个月
氟喹诺酮类耐药情况	氟喹诺酮类药物耐药或未知	氟喹诺酮类药物敏感
适用人群及条件	1.确诊为利福平耐药结核病的儿童和成年患者,无论其是否对异烟肼和(或)氟喹诺酮类药物耐药; 2.既往未暴露于方案中的药物(使用少于1个月)或既往使用时间超过1个月,但排除了所使用药物耐药可能,仍可以使用本方案	1.所有年龄段人群,包括成人、青少年、儿童和孕妇; 2.氟喹诺酮类药物敏感且无二线抗结核药物暴露史的耐多药/利福平耐药结核病患者; 3.既往未暴露于方案中的药物(使用少于1个月),或既往使用时间超过1个月,但排除了所使用药物耐药可能,仍可以使用本方案
备注	对于治疗第4个月后痰培养仍阳性的治疗效果不佳的患者,疗程可延长至9个月	1.推荐顺序为BLMZ>BLLfxCZ>BDLLfxZ 2.无法服用利奈唑胺或贝达喹啉,推荐DMCZ

耐药结核病全口服短程治疗专家共识

Expert consensus on all-oral short-course therapy for drug-resistant tuberculosis

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