气滞胃痛制剂治疗功能性消化不良疗效与安全性的系统评价

Systematic review on the effect and safety of Qizhi Weitong preparation for functional dyspepsia

[目的]系统评价气滞胃痛制剂治疗功能性消化不良的疗效与安全性。[方法]计算机检索中国期刊全文数据库、维普数据库、万方数据库及Pub Med数据库,检索期限均从建库至2014年12月。收集气滞胃痛制剂治疗功能性消化不良的所有随机对照试验(RCT),两名评价者独立进行文献筛选与数据提取,纳入研究方法学质量评价采用Cochrane系统评价手册方法,争议通过讨论解决。[结果]检索到908条文献目录,按照纳入排除标准筛选后有8个RCT纳入本研究,共795例患者。Meta分析结果提示,单用气滞胃痛制剂临床疗效优于西药[RR=1.17,95%CI(1.08,1.26)](P<0.000 1);气滞胃痛制剂联合西药临床疗效优于单用西药[RR=1.29,95%CI(1.13,1.48)](P=0.000 2);气滞胃痛组报告头晕和大便次数增加4例不良事件(对照组有10例不良事件报告)均自行缓解。[结论]数据分析提示气滞胃痛制剂治疗功能性消化不良有效,安全性好。但因所纳入研究样本较小,文献方法学质量偏低,证据级别有待提高。

[Objective] This study aimed to evaluate the efficacy and safety of Qizhi Weitong preparation in treating functional dyspepsia. [Methods] Literature searching was conducted in four databases including CNKI, VIP, ChinaInfo and PubMed up to December 2014. The type of eligible studies was randomized controlled trials （RCTs）. Two authors independently performed literature screening and data extraction. Quality of included trials was evaluated according to the criteria recommended in Cochrane Handbook. Disagreements were resolved by discussion. [Results] A total of 908 titles were retrieved by literature searching. After screening, 8 RCTs including 795 patients were enrolled in this study according to the inclusion criteria. Meta-analysis showed Qizhi Weitong preparation is more effective than western medicine in clinical efficacy （RR=I.17; 95%CI [1.08,1.26]; P〈0.0001）; Qizhi Weitong preparation in combination with western medicine is more effective than western medicine alone in clinical efficacy （RR=l.29; 95%CI [1.13,1.48]; P=0.0002）. There were 4 cases of adverse events （mild dizziness and increase of defecation） in Qizhi Weitong group and 10 cases in the control group. All the adverse events dismissed without intervention. [Conclusion] Based on the above results, we concluded that Qizhi Weitong preparation has good effect and high safety in treating functional dyspepsia. Due to the limited number of eligible RCTs and poor methodological quality, the advantages of Qizhi Weitong preparation in treating functional dyspepsia need high quality RCTs to further prove.