中医药导报2023，Vol.29Issue(12)：133-139,147,8.DOI:10.13862/j.cn43-1446/r.2023.12.026
四逆散及其联合治疗方案治疗失眠有效性及安全性的Meta分析
Meta-analysis of the Effectiveness and Safety of Sini Powder(四逆散)and Its Combination Therapy in the Treatment of Insomnia
摘要
Abstract
Objective:To systematically evaluate the effectiveness and safety of Sini Powder and its combi-nation therapy in the treatment of insomnia.Methods:Randomized controlled trials(RCT)of Sini Powder and its combination therapy for insomnia published before December 31,2021 were searched in databases such as Pubmed,EMbase,Web of Science,Cochrane Library,Sinomed,CNKI,VIP,and Wanfang.According to the in-clusion criteria,the RCTs obtained were further screened by two researchers and a quality assessment were completed with the aid of the Cochrane Risk of Bias tool.Meta-analysis of outcome indicators was performed using RevMan 5.3 and Stata 16.0.Results:A total of 11 articles were included,involving 739 patients.Meta analysis showed that the effective rate of the experimental group[RR=1.23,95％CI(1.14,1.33),P＜0.001]was higher than that of the control group,and the improvement of Pittsburgh Sleep Quality Index(PSQI)[MD=2.34,95％CI(1.45,3.22),P＜0.001],Hamilton Anxiety Index(HAMA)[MD=6.77,95％CI(2.69,10.85),P=0.001],Tradi-tional Chinese Medicine(TCM)Syndrome Score[MD=2.91,95％CI(2.22,3.61),P＜0.001],and Self-Rating Scale of Sleep(SRSS)[MD=7.81,95％CI(5.38,10.23),P＜0.001]was better than that of the control group.Subgroup analysis showed that when the experimental group was treated with Sini Powder or modified Sini Powder[MD=4.12,95％CI(2.14,5.60),P＜0.001],Sini Powder combined with Suanzaoren Decoction(酸枣仁汤)[MD=3.05,95％CI(2.53,3.57),P＜0.001],Sini Powder combined with acupuncture and alprazolam[MD=2.56,95％CI(1.76,3.36),P＜0.001],and Sini Powder combined with transcranial magnetic stimulation[MD=2.23,95％CI(1.08,3.38),P＜0.001],the im-provement in PSQI in the experimental group was better than that in the control group.When using diagnostic criteria other than the Chinese Classification and Diagnostic Standards for Mental Disorders,the improvement in TCM syndrome scores in the experimental group was greater than that in the control group[MD=2.91,95％CI(2.22,3.61),P＜0.001].There was no statistically significant difference in the incidence of adverse reactions between the experimental group and the control group[RR=0.09,95％CI(0.00,4.98),P=0.24].The efficiency funnel plot shows no publication bias.Conclusion:Sini Powder and its combination therapy were superior to conventional western medicine in enhancing the efficiency of insomnia treatment and improving PSQI,TCM syndrome,HAMA,and SRSS scores.The effect is similar to that of conventional western medicine in terms of reducing the rate of adverse reactions.However,due to the low methodological quality of the included studies,there is still a demand for a considerable number of scientifically designed clinical studies to verify this conclusion.关键词
失眠/四逆散/有效性/安全性/Meta分析Key words
insomnia/Sini Powder/effectiveness/safety/Meta-analysis分类
医药卫生引用本文复制引用
齐颖慧,薛秀娟,李淮安,张淑杰,杨云峰..四逆散及其联合治疗方案治疗失眠有效性及安全性的Meta分析[J].中医药导报,2023,29(12):133-139,147,8.基金项目
河北省中医药管理局科研计划项目(2021385) （2021385）
