《4个月含利福喷丁抗结核治疗方案疗效观察》解读

Interpretation of Four-month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis

2021年5月,《新英格兰医学杂志》发表了一篇《4个月含利福喷丁抗结核治疗方案疗效观察》的多中心、开放、随机对照非劣效Ⅲ期临床试验研究的论文。2021年6月,世界卫生组织向全球推荐了该方案。该研究设计严谨、合理,质量控制系统、全面,研究结果可信。研究结果显示,4个月含利福喷丁抗结核治疗方案在治疗效果、安全性及耐受性等方面均不劣于6个月标准化疗方案。该方案中利福喷丁使用剂量(1200 mg/d)是中国药典规定(成人用量为600 mg/次,1~2次/周)的7~14倍。抗结核药物应用是造成中国药物性肝损伤的主要原因之一。中国目前利福平应用有一定比例达不到现行推荐剂量(600 mg/d),主要原因是医务人员对肝损伤的顾虑。结合中国药典规定、全国利福平使用情况及影响因素等综合分析,该短程方案在中国推广应用前需要开展试点研究,并出台相关专业指导意见。

In May 2021,the New England Journal of Medicine published a multi-center,open,randomized controlled non-inferiority phaseⅢclinical trial study of the Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis.World Health Organization recommended this chemotherapy regimen to all of the world in June 2021.Upon review and analysis,the clinical trial study was with rigorous and reasonable research design,systematic and comprehensive quality control measures,and the research results were credible.The study results showed that the 4-month anti-tuberculosis chemotherapy regimen was not inferior to the 6-month standard chemotherapy regimen in terms of therapeutic effect,safety and tolerability.The dosage of rifapentine(1200 mg/d)in this regimen is 7-14 times of that recommended by Chinese Pharmacopoeia(600 mg per time for adults,1-2 times per week).Usage of anti-tuberculosis drugs is one of the important cause of drug-induced liver damage in China.At present,a certain proportion of rifampicin in China does not reach the current recommended dose(600 mg/d),mainly due to medical staff’s concerns about liver injury.Combined with the comprehensive analysis of Chinese Pharmacopoeia regulations,national rifampicin use and influencing factors,this short-course regimen needs to be piloted before it is promoted and applied in China,and relevant professional guidance should be issued.