从肝肾论治围绝经期失眠的临床疗效Meta分析

摘要

Objective To systematically evaluate the clinical efficacy and safety of the traditional Chinese medicine(TCM) therapy on perimenopausal insomnia from the standpoint of regulating liver and kidney.Methods Randomized controlled trials(RCT) on PubMed, EMbase, CNKI, Wanfang Database and VIP database from their inception to April 2016 were searched.Two researchers separately screened the literature, extracted data and evaluated the literature bias risk according to inclusive criteria and exclusive criteria.Then the Meta-analysis was operated using Rev Man 5.3 software.Results Altogether nine RCT with 678 patients were eligible.The result of Meta-analysis showed: the clinical effectiveness of experimental group (TCM therapy group) was superior to that of control group(RR=1.30,95%CI[1.11,1.52],P<0.05);the PSQI scores showed significant differences between the two groups (SMD=-1.16,95%CI[-2.12,-0.20],P<0.05),but SPIEGEL score did not.Although adverse reactions were appeared in five studies, the adverse reaction rate of the experimental group was lower significantly (RR=0.09,95%CI[0.04,0.22],P<0.05).Conclusion The experimental group achieved obvious clinical efficacy with less adverse effect.%目的 系统评价围绝经期失眠从肝肾论治的临床疗效及安全性.方法 检索PubMed,EMbase,中国知网,万方及维普5个数据库,检索时限从建库至2016年4月,纳入有关从肝肾论治围绝经期失眠的随机对照试验.由2名研究者按纳入排除标准独立对文献筛检、提取资料、文献偏倚风险评价.使用RevMan5.3软件进行Meta分析.结果 纳入9个随机对照试验,包括678例患者.Meta分析结果显示:肝肾论治组临床有效率高于对照组(RR=1.30,95%CI[1.11,1.52],P<0.05).通过运用匹茨堡睡眠质量指数量表(PSQI)显示,肝肾论治组与对照组在治疗后睡眠质量上有显著差异(SMD=-1.16,95%CI[-2.12,-0.20],P<0.05),但在SPIEGEL量表评分上2组无统计学差异.有5个研究发生了不良反应,其中肝肾论治组的不良反应发生率低于对照组,其差异有统计学意义(RR=0.09,95% CI[0.04,0.22],P<0.05).结论 Meta分析结果表明,从肝肾论治围绝经期失眠具有显著的临床疗效,且不良反应少.