摘要
目的:评价中药人工周期疗法治疗多囊卵巢综合征(PCOS)的临床效果和安全性。方法:通过检索1981年1月至2017年3月中国期刊全文数据库(CNKI)、维普中刊数据库(VIP)、万方数据库中关于中药人工周期治疗PCOS的所有中文文献,纳入随机对照试验,根据Jadad评分标准评价纳入文献的质量。以有效率、妊娠率、周期排卵率作为结局指标。用Meta分析对资料进行评价。结果:检索到51篇文献,最终纳入14个符合要求的RCTs(n=978),试验的方法学质量普遍偏低。Meta分析表明:中药人工周期联合西药方案在治疗PCOS的有效率、妊娠率及周期排卵率上均优于单用西药,其中,在有效率(P<0.000,01)、妊娠率(P<0.000,01)方面,差异有统计学意义,在周期排卵率上(P=0.14),差异虽无统计学意义,但较西药有明显增高。纯中药人工周期方案在治疗PCOS有效率(P=0.28)、妊娠率(P=0.77)上均高于西药,但差异无统计学意义。结论:现有的临床资料表明中药人工周期治疗PCOS的疗效肯定,在有效率、妊娠率、周期排卵率方面优于单用西药治疗,且未见明显不良反应,但纳入的临床试验数量有限,在随机化、不良反应报道等方面存在缺陷,建议进一步开展多中心、大样本、高质量的随机对照试验,并对不良反应做充分的研究和报道。
Objective： To assess the effectiveness and safety of traditional Chinese medicine periodic treat- ment of polycystic ovary syndrome （PCOS）. Methods： All Chinese papers in the CNKI, VIP, WanFang data were searched, and RCTs from January of 1981 to March of 2017 were collected. All papers collected were assessed by the Jadad scale. The effects were assessed in the aspect of effective rate, pregnancy rate and cycle ovulation rate. The data were assessed by Meta- analysis. Results： A total of 51 papers were collected and only 14 RCTs （n=978） met the requirements and were included. Methodology of RCTs was generally of low quality. The Meta- analysis indicated that the combined treatment of traditional Chinese medicine periodic treatment and western medicine is superior to treatment of western medicine for PCOS in the aspect of effective rate, pregnancy rate and cycle ovulation rate. Effective rate （P〈0.000,01） and pregnancy rate （P〈0.000,01） have significant difference. Although cycle ovulation rate （P=0.14） has no statistical significance, it is significantly higher than western medicine. Traditional Chinese medicine periodic treatment is superior to treatment of western medicine for PCOS in the aspect of effective rate （P=0.28）, pregnancy rate （P=0.77）, but it has no statistical significance. The rea- son may be related to the less number of relevant papers. Conclusion： The clinical data available indicate that traditional Chinese medicine periodic treatment is superior to treatment of western medicine for PCOS in the as- pect of effective rate, pregnancy rate and cycle ovulation rate. Moreove, it has a definite therapeutic effect with no obvious side effects. However, the number of RCTs collected is limited, and there are limitations in aspects of randomization and side effects. Hence, we suggested that multi center, large sample and high quality RCTs should be developed and enough researches on obvious side effects should be done.
作者
许华云
金毓莉
付金荣
陈琼
XU Hua-yun;JIN Yu-li;FU Jin-rong;CHEN Qiong(l.Shanghai First Peoples Hospital,Shanghai 200080,Chin;Longhna Hospital Shanghai University of TCM,Shanghai 200032,China)
出处
《中医药导报》
2018年第15期113-117,共5页
Guiding Journal of Traditional Chinese Medicine and Pharmacy
基金
上海市科学技术委员会医学引导类科技支撑项目(16401934500)
海派中医蔡氏妇科流派传承研究基地(ZY3-CCCX-1-1006)
