小柴胡汤治疗功能性消化不良肝郁脾虚证临床疗效及安全性的Meta分析

Meta-analysis of clinical efficacy and safety of Xiaochaihu decoction in the treatment of functional dyspepsia syndrome of liver-stagnation and spleen-deficiency

目的:对小柴胡汤治疗功能性消化不良(Functional Dyspepsia,FD)肝郁脾虚证的临床疗效及安全性进行系统性评价。方法:系统检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、PubMed、Embase等数据库,检索出小柴胡汤治疗FD肝郁脾虚证的随机对照试验(RCT),并采用Cochrane评价标准和工具、RevMan5.4软件及STATA15.0软件对纳入的研究进行Meta分析。结果:最终纳入6项研究,总样本量554例,其中治疗组281例,对照组273例。Meta分析结果显示:治疗组对比对照组临床总有效率更高[RR=1.35,95%CI(1.21,1.50),P=0.000<0.05];治疗组对比对照组治疗后中医证候总积分更低[SMD=-1.63,95%CI(-1.86,-1.40),P=0.000<0.05];治疗组对比对照组治疗后血清胃泌素(GAS)水平更高[SMD=2.92,95%CI(2.06,3.78),P=0.000<0.05];治疗组对比对照组治疗后血清胃动素(MTL)水平更高[SMD=2.212,95%CI(1.789,2.635),P=0.000<0.05];纳入文献中治疗组及对照组均无不良反应发生,故未能进行相关分析。结论:基于现有研究及本文分析,小柴胡汤治疗FD肝郁脾虚证能提高患者的临床总有效率,降低中医证候积分,改善血清GAS、MTL水平,但后期仍需要进行更高质量的RCT对研究结果进行进一步验证。

Objective:To systematically evaluate the clinical efficacy and safety of Xiaochaihu decoction in the treatment of Functional Dyspepsia(FD)with liver-stagnation and splee-deficiency syndrome.How:CNKI,VIP,Wanfang,PubMed,Embase and other databases were systematically searched to retrieve the randomized controlled trial(RCT)of Xiaochaihu decoction in the treatment of FD liver-stagnation and splee-deficiency syndrome.Cochrane evaluation criteria and tools,RevMan5.4 software and STATA15.0 software were used to conduct meta-analysis of the included studies.Results:6 studies were included,with a total sample size of 554 cases,including 281 cases in the treatment group and 273 cases in the control group.The results of meta-analysis showed that the total clinical effective rate of the treatment group was higher than that of the control group(RR=1.35,95%CI(1.21,1.50),P=0.000<0.05).The total score of TCM syndrome in the treatment group was lower than that in the control group(SMD=-1.63,95%CI(-1.86,-1.40),P=0.000<0.05).The serum gastrin(GAS)level in the treatment group was higher than that in the control group(SMD=2.92,95%CI(2.06,3.78),P=0.000<0.05).Serum motilin(MTL)level in the treatment group was higher than that in the control group after treatment(SMD=2.212,95%CI(1.789,2.635),P=0.000<0.05).There were no adverse reactions in the treatment group and the control group in the included literature,so the relevant analysis could not be conducted.Conclusion:Based on the existing studies and the analysis in this paper,Xiaochaihu decoction can improve the total clinical effective rate of patients with FD liver-stagnation and splee-deficiency syndrome,reduce TCM syndrome scores,and improve serum GAS and MTL levels.However,higher quality RCT is still needed in the later stage to further verify the research results.