我国抗菌药物临床疗效评价标准的思考与确定

我国新修订的《抗菌药物临床研究技术指导原则》即将颁布,在征求意见过程中,研发者对新修订的临床疗效评价标准部分,存在较多争议和疑问。因此,本文将结合目前国内在该类药物临床疗效评价中存在的问题,对该指导原则中临床疗效评价标准的思考和确定进行介绍,以期使研发者更好地理解相应内容,并科学地评价抗菌药物的临床疗效。

Considerations and determination on the evaluation criterion for clinical efficacy of antibacterial agents in China

Now,the newly revised guidelines for clinical research of antibacterial agents will be published in China.In order to help researc- her understand the clinical efficacy evaluation criterion in the guidelines better,we analyzed the existing issues in clinical efficacy evaluation of domestic antibacterial agents and introduced the consideration of the de- termination on clinical efficacy evaluation criterion in the newly revised guidelines in this article.