抗结核药品临床试验疗效评价指标的研究进展  

Research progress of clinical endpoints in clinical trials of novel antituberculosis agents

作　　者：段鸿飞[1] 初乃惠[1] DUAN Hong-fei;CHU Nai-hui(Department of Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]首都医科大学附属北京胸科医院结核科,101149

出　　处：《中国防痨杂志》2021年第1期96-99,共4页Chinese Journal of Antituberculosis

基　　金：“十三五”重大新药创制国家科技重大专项(2017ZX09304009);“十三五”重大传染病防治国家科技重大专项(2018ZXl0302302-004)。

摘　　要：评价抗结核药品疗效的方法,需要其指标能准确预测灭菌效果和杀菌效果。传统抗结核药品临床试验Ⅱ期临床试验采用早期杀菌活性和痰分枝杆菌培养阴转预测杀菌效果和灭菌效果,Ⅲ期临床试验用已治愈且无复发来评价疗效。新的研究显示,痰培养阴转速度、CT和正电子发射体层摄影(positron emission tomography,PET)-CT病灶定量分析和GeneXpert MTB/RIF的循环阈值在预测抗结核药品疗效方面有一定价值。Bactericidal activity and sterilizing activity should be evaluated in clinical trials of novel antituberculosis agents.Early bactericidal activity and sputum culture conversion used to be main indicators for evaluating clinical responses in phaseⅡtrials,while cure without relapse were frequently used as endpoint in phaseⅢtrials.Recent studies showed that sputum culture conversion time,quantification of CT and PET-CT lesions and GeneXpert MTB/RIF threshold cycle could be used as surrogate endpoints of clinical trials.

关 键 词：抗结核药 临床试验 Ⅱ期 临床试验 Ⅲ期 药物评价 临床前 

分 类 号：R969.4[医药卫生—药理学]