中医药治疗不孕症随机对照试验评价指标研究

Evaluation index research of the randomized controlled trial of infertility treated by Traditional Chinese Medicine

目的收集分析中医药治疗不孕症随机对照试验评价指标,为后续中医妇科不孕症核心指标集及评价指标体系的构建奠定基础。方法检索中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)、万方数据库(Wanfang)、中国生物医学文献服务系统(SinoMed)、PubMed和Cochrane Library中2011年1月1日-2020年12月31日已公开发表的中医治疗不孕症RCT,按照纳入与排除标准筛选文献后,对纳入文献指标进行统计,并针对具体病因分析不孕症常规指标及病因特色指标。结果共纳入95个RCT,包含患者9069例,年龄20~39岁,平均每项RCT研究的样本量为95例,共涉及78个评价指标,频次使用最高的指标为总有效率,病因-指标分析发现总有效率、妊娠率、中医证候积分等为常规指标,LH、FSH、输卵管通畅程度等为常见病因的特色指标。结论中医药治疗不孕症临床试验评价指标存在数量差异大、使用不规范等问题,需根据不同病因开展不孕症核心指标集及评价指标体系的构建研究。

Objective To collect and analyze the evaluation index of infertility treated by Traditional Chinese Medicine(TCM),which will lay a foundation for the establishment of the core index and evaluation index system of TCM treating infertility.Methods By retriving the published literatures of randomized controlled trials of infertility treated by TCM in the database of CNKI,VIP,Wanfang,SinoMed,PubMed and Cochrane Library from January 1,2011 to December 31,2020,and after the screening according to the creteria of inclusion and exclusion,this paper analyzed the normal indexes of infertility and the pathogenic indexes of TCM.Results A total of 95 RCTs were included,including 9069 patients aged between 20-39 years old.The average sample size of each RCT study was 95,involving 78 evaluation criteria.The highest frequency of use was the total effective rate,etiological-index analysis found that the general indicators of infertility such as the total effective rate,pregnancy rate,TCM syndrome scores,and common etiological factors such as LH,FSH are the characteristic indicators.Conclusion There are many problems in the evaluation indexes of clinical trials of treating infertility by TCM,such as great differences in number and not standardized usage.It is necessary to carry out research on the construction of core indicator and evaluation indicator systems of infertility according to different etiologies.