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中国防痨杂志 ›› 2024, Vol. 46 ›› Issue (11): 1313-1319.doi: 10.19982/j.issn.1000-6621.20240281

• 研究方案 • 上一篇    下一篇

含新药口服短程方案治疗利福平耐药肺结核患者的多中心随机对照临床试验

聂文娟1, 孙峰2, 王雪钰1, 任燕飞2, 刘人羽2, 李旻翰2, 李琦1, 张文宏2(), 初乃惠1()   

  1. 1首都医科大学附属北京胸科医院结核一科,北京 101149
    2复旦大学附属华山医院感染病科/国家传染病医学中心,上海 101207
  • 收稿日期:2024-07-07 出版日期:2024-11-10 发布日期:2024-10-31
  • 通信作者: 张文宏,Email: zhangwenhong@fudan.edu.cn;初乃惠,Email: chunaihui1994@sina.com
  • 作者简介:注:孙峰、王雪钰和聂文娟对本文有同等贡献,为并列第一作者
  • 基金资助:
    北京市医管中心扬帆项目3.0(ZLRK202331)

Multi center randomized controlled clinical trial of shorter oral regimen containing new drugs in the treatment of rifampicin-resistant pulmonary tuberculosis

Nie Wenjuan1, Sun Feng2, Wang Xueyu1, Ren Yanfei2, Liu Renyu2, Li Minhan2, Li Qi1, Zhang Wenhong2(), Chu Naihui1()   

  1. 1The First Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
    2Department of Infectious Diseases, Huashan Hospital Affiliated to Fudan University/National Center for Infectious Disease Medicine, Shanghai 101207, China
  • Received:2024-07-07 Online:2024-11-10 Published:2024-10-31
  • Contact: Zhang Wenhong, Email: zhangwenhong@fudan.edu.cn; Chu Naihui, Email: chunaihui1994@sina.com
  • Supported by:
    Beijing Medical Management Center Yangfan Project 3.0(ZLRK202331)

摘要:

背景: 耐药结核病治疗疗程长,治愈率低,不良反应发生率高,世界卫生组织推广的大部分全口服短程耐药方案因药物品种和药品耐受性的问题,无法在我国全面推广,亟须探索适合我国的、更安全有效的治疗方案和药物。方法: 采用前瞻性多中心随机对照临床试验,以分子药物敏感性试验或表型药物敏感性试验确诊的利福平耐药肺结核患者为研究对象,随机分为采用世界卫生组织推荐的18个月长程治疗方案作为对照组,以及采用含贝达喹啉、康替唑胺、德拉马尼、莫西沙星或左氧氟沙星(对氟喹诺酮类药物耐药的患者改为氯法齐明)的6个月口服短程耐药方案,评估含康替唑胺的新口服6个月方案治疗利福平耐药肺结核的有效性和安全性。讨论: 本研究旨在缩短利福平耐药肺结核的治疗时间,提升治愈率,优化方案的安全性,为开发利福平耐药肺结核新药和新短程治疗方案提供依据,为世界卫生组织制定耐药结核病治疗指南提供中国数据。同时,本研究包含我国Ⅰ类创新药,代表我国在医药创新领域的最新成果。但本研究并非头对头临床试验,而是将两种不同治疗方案进行比较,获得整体治疗方案的结局。未来还需要验证方案中新药的适宜剂量,以及验证更多适合中国人群的全口服短程耐药方案,为我国利福平耐药肺结核患者制定不同适宜方案提供更多选择。

关键词: 结核, 抗药性, 多中心研究, 临床试验(主题)

Abstract:

Background: The treatment course of drug-resistant tuberculosis is long, the cure rate is low, and the incidence of adverse reactions is high. Most of the full oral short-range drug resistance programs promoted by the World Health Organization cannot be fully promoted in China due to the problem of drug varieties and drug tolerance. It is urgent to explore safer and more effective treatment programs and drugs suitable for China. Methods: The prospective multi-center randomized controlled clinical trial was used in the trial. The patients with rifampicin-resistant pulmonary tuberculosis confirmed by molecular drug sensitivity test or phenotypic drug sensitivity test were randomly divided into the 18-month long-term treatment scheme recommended by the World Health Organization as the control group, and the 6-month oral short-term drug resistance scheme containing bedaquiline, contezolid, delamanid, moxifloxacin or levofloxacin (the patients resistant to fluoroquinolones were changed to clofazimine) to evaluate the efficacy and safety of the new 6-month oral drug resistance scheme containing contezolid in the treatment of rifampicin-resistant pulmonary tuberculosis. Discussion: This study aims to shorten the treatment time of rifampicin-resistant pulmonary tuberculosis, improve the cure rate, optimize the safety of the plan, provide the basis for the development of new drugs and new short-term treatment plans for rifampicin-resistant pulmonary tuberculosis, and provide Chinese data for the World Health Organization to develop treatment guidelines for drug-resistant tuberculosis. Meanwhile, this study includes Class 1 innovative drugs in China, representing the latest achievements in the field of pharmaceutical innovation in China. However, this study is not a head to head clinical trial, but rather a comparison of two different treatment regimens to obtain the overall treatment outcome. In the future, it is necessary to verify factors such as the appropriate dosage of new drugs in the regimen to obtain more specific research conclusions.

Key words: Tuberculosis, Drug resistance, Multicenter study, Clinical trials as topic

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