抗结核新药早期杀菌活性研究方法专家共识

结核病疫情依然严峻,迫切需要抗结核新药。新药临床试验是新药研发的最重要阶段,早期杀菌活性(early bactericidal activity,EBA)研究是新型抗结核药物首次用于结核病患者治疗时进行的临床研究,也是单个抗结核药物和新的联合方案临床评价的关键。为了规范开展以及更好地推进我国抗结核新药研发进程,首都医科大学附属北京胸科医院和《中国防痨杂志》编辑委员会共同组织结核病临床研究和基础研究领域的专家,经反复讨论,撰写了《抗结核新药早期杀菌活性研究方法专家共识》,就抗结核新药EBA的意义、设计、实施,以及影响因素等内容进行阐述。

Expert consensus on the study of early bactericidal activity of new anti-tuberculosis drugs

The tuberculosis epidemic is still severe, and new anti-tuberculosis drugs are urgently needed. Clinical trials of new drugs are the most important stage of new drug development. Early bactericidal activity (EBA) is the first step in clinical study of new anti-tuberculosis drugs used in the treatment of tuberculosis patients, and it is also the key of clinical evaluation of the single anti-tuberculosis drug and a new regimen. In order to standardize and better promote the development of new anti-tuberculosis drugs in China, after repeated discussions by experts in the field of tuberculosis clinical and basic research organized by Beijing Chest Hospital affiliated to Capital Medical University and the Editorial Board of Chinese Journal of Antituberculosis, the Expert consensus on the study of early bactericidal activity of new anti-tuberculosis drugs has been formulated on the significance, design, implementation, and influencing factors of the EBA study on the new anti-tuberculosis drugs.