逍遥散加减治疗高泌乳素血症有效性和安全性的Meta分析

Meta-analysis of Efficacy and Safety of Modified Xiaoyao Powder for the Treatment of Hyperprolactinemia

目的系统评价逍遥散加减对比常规西药治疗高泌乳素血症(HPRL)的有效性及安全性。方法检索中国知识资源总库(CNKI)、中文科技期刊数据库(维普网)、中国生物医学文献数据库(CBM)、万方数据知识服务平台(万方数据)、EMbase、PubMed、Cochrane Library、Web of Science建库至2022年1月31日国内外公开发表的关于逍遥散加减治疗HPRL的随机对照试验(RCT)研究,对经筛选纳入的文献进行信息提取、Meta分析及证据质量评价。结果最终纳入13项研究,涉及患者888例,其中试验组447例,对照组441例。试验组干预措施为中药逍遥散组方加减,对照组均使用西药溴隐亭治疗。Meta分析结果:与对照组比较,试验组治疗HPRL的总有效率[OR=1.05,95%CI(0.71,1.54),Z=0.23,P=0.82]、治疗后PRL水平[MD=2.48,95%CI(-0.51,5.48),Z=1.62,P=0.10]、妊娠率[OR=2.19,95%CI(0.82,5.82),Z=1.56,P=0.12]均差异无统计学意义;复发率[OR=0.23,95%CI(0.11,0.47),Z=4.03,P<0.0001]、不良反应发生率[OR=0.03,95%CI(0.01,0.09),Z=6.40,P<0.00001]均低于对照组。结论逍遥散加减治疗HPRL疗效显著,且复发率、不良反应率均低于溴隐亭治疗。但本结果因纳入研究数量有限且水平偏低,今后仍有必要开展更多大范围、高标准的RCT研究以提供更高质量证据支持。

Objective To systematically evaluate the efficacy and safety of modified Xiaoyao Powder for the treatment of hyperprolactinemia(HPRL)compared with conventional Western treatment.Methods RCTs about modified Xiaoyao Powder for the treatment of HPRL were retrieved from CNKI,VIP,CBM,Wanfang,EMbase,Cochrane Library,and Web of Science from the establishment of the databases to 31st,January 2022.Information extraction,meta analysis and evidence quality evaluation were conducted for the selected literature.Results Totally 13 RCTs were included,with a total of 888 patients.There were 447 cases in experimental group and 441 cases in control group.The intervention measure of the experimental group was modified Xiaoyao Powder,and the control group were treated with bromoyinting.Meta-analysis results:compared with the control group,the total effective rate[OR=1.05,95%CI(0.71,1.54),Z=0.23,P=0.82],PRL level after treatment[MD=2.48,95%CI(-0.51,5.48),Z=1.62,P=0.10]and pregnancy rate[OR=2.19,95%CI(0.82,5.82),Z=1.56,P=0.12]of experimental group were not significantly different.The recurrence rate[OR=0.23,95%CI(0.11,0.47),Z=4.03,P<0.0001]and the probability of adverse reactions[OR=0.03,95%CI(0.01,0.09),Z=6.40,P<0.00001]were lower than the control group.Conclusion Xiaoyao Powder is effective in the treatment of hyperprolactinemia,and the recurrence rate and adverse reaction rate are lower than bromocriptine.However,due to the limited number and quality of included studies,it is necessary to carry out more large-scale and high-standard RCTs in the future to provide higher quality evidence.