莫沙必利对比质子泵抑制剂治疗功能性消化不良疗效与安全性的系统评价

Systematic Review of the Efficacy and Safety of Mosapride versus Proton Pump Inhibitors in the Treatment of Functional Dyspepsia

目的:系统评价莫沙必利对比质子泵抑制剂(PPI)治疗功能性消化不良(FD)的疗效和安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、EMBase、Medline、Cochrane图书馆、中国期刊全文数据库、万方数据库,纳入莫沙必利(试验组)对比PPI(对照组)治疗FD的随机对照试验(RCT),提取资料并评价质量后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入12项RCT,合计1 750例患者。Meta分析结果显示,试验组患者总缓解率[OR=0.56,95%CI(0.45,0.70),P<0.000]、反酸缓解率[MD=0.63,95%CI(0.50,0.75),P<0.000]、腹痛缓解率[MD=0.65,95%CI(0.57,0.80),P<0.000]均显著低于对照组,而腹胀缓解率[MD=-0.01,95%CI(-0.18,0.16),P=0.91]、不良反应发生率[OR=1.83,95%CI(0.73,4.59),P=0.19]与对照组比较差异无统计学意义。结论:PPI治疗FD的疗效优于莫沙必利,安全性相当。由于受纳入研究样本量的限制及文献质量的影响,该结论有待大样本、高质量的RCT进一步验证。

OBJECTIVE：To systematically review the efficacy and safety of mosapride versus Proton pump inhibitors（PPI）in the treatment of Functional dyspepsia（FD）and provide evidence-based reference for clinical treatment.METHODS：Pub Med,EMBase,Medline,Cochrane Library,CJFD and Wanfang Database were retrieved to collect the ramdomized control trials（RCT）of mosapride（test group）versus PPI（control group）in the treatment of FD.After information collection and quality evaluation,Meta-analysis was performed by Rev Man 5.2 software.RESULTS：There were totally 12 RCT,including 1 750 patients.The results of Meta-analysis showed that the total effective rate[OR=0.56,95%CI（0.45,0.70）,P〈0.000],acid regurgitation [MD=0.63,95%CI（0.50,0.75）,P〈0.000] and release rate of stomachache [MD=0.65,95%CI（0.57,0.80）,P〈0.000] in test group were significantly lower than control group,and there were no significant differences between the release rate of abdominal distention[MD=-0.01,95%CI（-0.18,0.16）,P=0.91] and ADR[OR=1.83,95%CI（0.73,4.59）,P=0.19].CONCLUSIONS：PPI has better efficacy than mosparide in the treatment of FD with similar safety.Due to the small sample and low quality of included studies,it remains to be further verified with large-sample and high-quality RCT.