膈下逐瘀汤治疗气滞血瘀型原发性痛经有效性和安全性的Meta分析

Meta-Analysis on the Efficacy and Safety of Gexia Zhuyu Decoction in Treating Primary Dysmenorrhea of Qi Stagnation and Blood Stasis

目的通过对临床文献的研究,系统评价膈下逐瘀汤治疗气滞血瘀型原发性痛经(Primary Dysmenorrhea,PD)的有效性及安全性。方法计算机检索PubMed、Embase、Cochrane Library、Web of Science、中国知网(CNKI)、万方数据库(WF)、中国生物医学文献数据库(CBM)、维普期刊数据库(VIP)等国内外数据库中有关膈下逐瘀汤治疗原发性痛经的随机对照试验(RCTs),检索时限均为数据库建立之日至2020年10月15日,由2名研究人员筛选文献并提取相关结局指标,经偏倚风险评估后使用RevMan 5.3.0软件对纳入研究进行Meta分析。结果对所包含1330例患者的16篇纳入文献进行Meta分析,结果显示:治疗组治疗总有效率高于对照组[亚组①RR=1.12,95%CI(1.03,1.22),Z=2.58,P=0.010;亚组②RR=1.39,95%CI(1.29,1.49),Z=9.23,P<0.0001];治疗组视觉模拟评分(VAS)低于对照组[SMD=-1.81,95%CI(-2.76,-0.86),Z=3.75,P=0.0002];治疗后治疗组痛经症状评分低于对照组[SMD=-2.21,95%CI(-2.90,-1.51),Z=6.22,P<0.00001];治疗后治疗组复发情况优于对照组[RR=0.31,95%CI(0.14,0.66),Z=3.01,P=0.003];已有数据尚不能证明治疗组不良反应发生率低于对照组[RR=0.11,95%CI(0.16,2.29),Z=0.73,P=0.46],但不良反应均较轻微。结论膈下逐瘀汤治疗气滞血瘀型PD具有显著疗效,能有效改善疼痛症状及痛经相关症状,且复发率较低,不良反应较轻微,安全性较好。

Objective To systematically evaluate the efficacy and safety of Gexia Zhuyu Decoction in the treatment of Primary Dysmenorrhea(PD)with Qi stagnation and blood stasis through the study of clinical literature.Methods The databases including PubMed,Embase,Cochrane Library,Web of Science,CNKI,WF,VIP and CBM were searched by computer about randomized controlled trials(RCTs)of Gexia Zhuyu Decoction for treating primary dysmenorrhea in domestic and foreign databases.The retrieval time is the date of database establishment until October 15,2020.After two researchers independently screened the literature,extracted relevant data and evaluated the bias risk of the included study,RevMan 5.3.0 software was used for Meta-analysis.Results Meta-analysis of 16 included literatures of 1330 patients showed that the total effective rate of treatment in the treatment group was higher than that in the control group[subgroup①RR=1.12,95%CI(1.03,1.22),Z=2.58,P=0.010;subgroup②RR=1.39,95%CI(1.29,1.49),Z=9.23,P<0.0001];the visual analog scale(VAS)treatment group is lower than the control group[SMD=-1.81,95%CI(-2.76,-0.86),Z=3.75,P=0.0002];the dysmenorrhea symptom score after treatment in the treatment group is lower than the control group[SMD=-2.21,95%CI(-2.90,-1.51),Z=6.22,P<0.00001].Recurrence after treatment in the treatment group is better than the control group[RR=0.31,95%CI(0.14,0.66),Z=3.01,P=0.003];existing data cannot prove that the incidence of adverse reactions in the treatment group is lower than the control group[RR=0.11,95%CI(0.16,2.29),Z=0.73,P=0.46],but the adverse reactions were mild.Conclusion Gexia Zhuyu Decoction has a significant curative effect in the treatment of PD with Qi stagnation and blood stasis.It can effectively improve pain symptoms and dysmenorrhea related symptoms,with a low recurrence rate,mild adverse reactions and good safety.