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中国防痨杂志 ›› 2022, Vol. 44 ›› Issue (1): 38-44.doi: 10.19982/j.issn.1000-6621.20210655

• 专题笔谈 • 上一篇    下一篇

Pretomanid (PA-824)治疗耐多药结核病的应用建议

中国防痨协会中国疾病预防控制中心结核病预防控制中心, 中国疾病预防控制中心结核病预防控制中心   

  • 收稿日期:2021-11-17 出版日期:2022-01-10 发布日期:2021-12-29
  • 基金资助:
    中国防痨协会-全球结核病药物研发联盟合作项目(CATA/TBA-20210310HQ7)

Recommendations on pretomanid (PA-824) in the treatment of multidrug-resistant tuberculosis

Chinese Antituberculosis Association , National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention   

  • Received:2021-11-17 Online:2022-01-10 Published:2021-12-29
  • Supported by:
    Chinese Antituberculosis Association-TB Alliance collaboration project(CATA/TBA-20210310HQ7)

摘要:

耐多药结核病治疗疗程长达18~24个月、药物不良反应重、患者治疗依从性差,部分患者因耐药谱广泛,不能选择二线抗结核药物组成有效的治疗方案,导致死亡率高。因此,耐多药结核病治疗新药的研究是全球结核病控制的重要问题,也是我国改变耐多药结核病防治现状亟待解决的问题。全球结核病药物研发联盟研发的pretomanid(PA-824)与贝达喹啉和利奈唑胺组成的BPaL方案,针对严重耐多药结核病的治疗,具有疗程短、全程口服、治疗依从性高、治愈率高等优势,为严重耐多药结核病患者的治疗带来了新的希望。该方案于2020年被世界卫生组织在全球推荐使用。目前,贝达喹啉和利奈唑胺两种药品已经在我国上市,并作为二线抗结核药物用于耐多药结核病治疗。因此,亟待PA-824能早日在我国获批使用,以挽救更多耐多药结核病患者的生命。为此,中国防痨协会联合中国疾病预防控制中心结核病预防控制中心组织全国结核病防治、临床和基础研究等领域的专家,经反复讨论撰写了《Pretomanid(PA-824)治疗耐多药结核病的应用建议》,以期为加快PA-824及BPaL方案在我国的注册使用提供参考。

关键词: 结核, 抗药性,多药, Pretomanid(PA-824), 治疗应用, 总结性报告(主题)

Abstract:

The duration of treatment of multidrug-resistant tuberculosis (MDR-TB) is 18-24 months, and severe adverse effect, poor treatment compliance, and no second-line anti-tuberculosis drugs to form an effective treatment regimen for some patients due to the wide drug resistance spectrum and led to high mortality always happened in the treatment. Therefore, the research of new drugs for MDR-TB treatment is an important issue for global tuberculosis control, as well as the key to improve the status of MDR-TB control and prevention in China. Pretomanid (PA-824), which was developed by the TB Alliance, combined with bedaquiline and linezolid to form the BPaL regimen. The new regimen had advantages of short course, oral drugs in the whole treatment, improved treatment compliance, high cure rate, brings new hope for severe MDR-TB patients, and was recommended by World Health Organization in 2020. Currently, bedaquiline and linezolid are available in China and used as second-line anti-tuberculosis drugs for the MDR-TB treatment. Therefore, it is urgent for PA-824 to be approved in China to save more MDR-TB patients. The Chinese Antituberculosis Association and the Chinese Center for Disease Control and Prevention co-organized domestic experts on TB control, clinical and basic research to write Recommendations on pretomanid (PA-824) in the treatment of multidrug-resistant tuberculosis after discussions, to provide reference for accelerating the registration and application of PA-824 and BPaL regimen in China.

Key words: Tuberculosis, Drug resistance,multiple, Pretomanid (PA-824), Therapeutic uses, Consensus development conferences as topic

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