多囊卵巢综合征不孕症中医药临床试验方案设计特色与评价

Design characteristics and evaluation of traditional Chinese medicine therapy for infertility with PCOS

文章介绍中医药治疗多囊卵巢综合征(PCOS)不孕症临床试验方案设计,对此研究方案设计特色进行评价。以PCOS不孕症患者为目标人群,以活产率为主要结局指标,采用多中心、随机、双盲、安慰剂对照试验研究,通过科学的试验设计和规范化的试验实施,客观评价中医药治疗PCOS不孕症的临床疗效,探索中医药促排助孕的有效性和安全性,探讨中医药的疗效机制。中医药治疗PCOS不孕症临床试验方案设计具有科学性、可行性及实用性,展现了中医药研究的国际化。

To introduce the clinical trial design of traditional Chinese medicine for infertility women with PCOS and to evaluate the features of this design.Targeted PCOS infertility patients,with live birth rate as the main outcome index,using multi-center,randomized,double blind placebo-controlled trial.Through scientific trial design and standard implementation,to evaluate the clinical efficacy and safety of traditional Chinese medicine for infertility women with PCOS,to research mechanism of treatment of traditional Chinese medicine.The clinical trial protocol of traditional Chinese medicine for infertility women with PCOS was scientific,practicability and applicability,meanwhile it also promoted the internationalization of Chinese medicine.