Abstract:

In May 2021, the New England Journal of Medicine published a multi-center, open, randomized controlled non-inferiority phase Ⅲ clinical 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.

Key words: Rifapentine, Moxifloxacin, Clinical protocols, Drug therapy,combination, Comment, Problem-based learning