中医药治疗多囊卵巢综合征随机对照试验临床评价指标研究现状

Research status of clinical evaluation indexes in randomized controlled trials of Chinese medicine for treating polycystic ovary syndrome

目的 探析中医药治疗多囊卵巢综合征(PCOS)疗效评价指标的研究现状。方法 分别在CNKI、Wan Fang data、VIP、SinoMed、Web of Science、PubMed等数据库检索近5年中医药干预PCOS的临床随机对照试验(RCT)。根据纳排标准,筛选出符合要求的相关文献,提取资料并进行分析。结果 最终纳入190个RCTs,共涉及182个疗效评价指标。单个研究采用指标数量为3~29个,中位数为10个。使用频次排前16位的依次为血清黄体生成素(LH)、睾酮、卵泡刺激素(FSH)、总有效率、雌激素、排卵率、妊娠率、LH/FSH、中医证候积分、卵巢体积、胰岛素抵抗指数、空腹胰岛素、体质指数、子宫内膜厚度、空腹血糖和卵泡数量。指标数量和指标种类在不同研究中存在较大差异;部分研究指标脱离临床需求,缺乏实用性,对远期预后及安全性指标的关注度欠佳。结论 中医药治疗PCOS临床试验评价指标需要采取客观、统一的标准,同时兼顾中医特色,以提高相关临床研究的临床价值和方法学质量。

Objective To explore the research status of clinical efficacy evaluation indexes in the treatment of polycystic ovary syndrome(PCOS)with Chinese medicine.Methods CNKI,WanFang data,VIP,SinoMed,Web of Science,PubMed and other databases were used to search the clinical randomized controlled trials(RCTs)of Chinese medicine intervention in PCOS in the past 5 years.According to the inclusion and exclusion criteria,the relevant literatures meeting the requirements were screened out,and the data were extracted and analyzed.Results Finally,190 RCTs were included,involving a total of 182 efficacy evaluation indicators.The number of indicators used in a single study ranged from 3 to 29,with a median of 10.The top 16 indexes in the frequency of use were:serum luteinizing hormone(LH),testosterone,follicle stimulating hormone(FSH),total effective rate,estrogen,ovulation rate,pregnancy rate,LH/FSH,Chinese medicine syndrome score,ovarian volume,insulin resistance index,fasting insulin,body mass index,endometrial thickness,fasting blood glucose,and number of follicles.There were great differences in the number and type of indicators in different studies.Some of the study indicators were divorced from clinical needs,lack of practicability,and lack of attention in long-term prognosis and safety indicators.Conclusion Objective and unified criteria should be adopted to evaluate clinical trials of PCOS treated by Chinese medicine,taking into account the characteristics of Chinese medicine,so as to improve the clinical value and methodological quality of relevant clinical studies.