埃索美拉唑与泮托拉唑对幽门螺杆菌阳性消化性溃疡患者疗效与安全性的Meta评价

Meta-evaluation of the Efficacy and Safety of Esomeprazole and Pantoprazole in Patients with Helicobacter Pylori-positive Peptic Ulcer

目的:系统分析埃索美拉唑与泮托拉唑对幽门螺杆菌(Helicobacter pylori,Hp)阳性消化性溃疡患者的疗效与安全性,为Hp阳性消化性溃疡患者的合理用药提供参考。方法:以中英文的“埃索美拉唑”“泮托拉唑”“幽门螺杆菌”“消化性溃疡”等作为关键词,在PubMed、Cochrane图书馆、中国知网、万方数据库和重庆维普等数据库中检索关于埃索美拉唑与泮托拉唑治疗Hp阳性消化性溃疡的随机对照试验(randomized controlled trial,RCT)和前瞻性观察性研究(prospective observational study,POS),采用Meta分析法分析所得文献资料中埃索美拉唑与泮托拉唑对Hp阳性消化性溃疡患者的疗效与安全性。结果:经过初步检索,共获取文献988篇,筛查后最终纳入21篇(涉及病例4382例),其中15篇为RCT,6篇为POS;疗效评价结果显示,埃索美拉唑对消化性溃疡患者的疗效优于泮托拉唑(OR=1.77,95%CI为1.23~2.56,Z=3.06,P=0.002);Hp根除率比较显示,埃索美拉唑对消化性溃疡患者的Hp根除效果优于泮托拉唑(OR=1.40,95%CI为1.16~1.68,Z=3.76,P=0.0004);针对快代谢型(extensive metabolizer,EM)和慢代谢型(poor metabolizer,PM)CYP3C19基因型患者的研究显示,埃索美拉唑与泮托拉唑对EM或PM患者的Hp根除率基本相当;而安全性评价结果显示,埃索美拉唑与泮托拉唑的药物不良反应发生率基本相当(OR=0.97,95%CI为0.72~1.30,Z=0.21,P=0.83)。结论:针对Hp阳性消化性溃疡患者,以埃索美拉唑为基础的治疗方案在疗效和Hp根除效果方面均优于以泮托拉唑为基础的治疗方案,并且埃索美拉唑的药物安全性并不弱于泮托拉唑,但由于本研究所纳入文献可能存在不充分、不完整,以及研究方法上的不足,故仍需要更多、更大规模的相关研究进行验证。

Objective:To systematically analyze the efficacy and safety of esomeprazole and pantoprazole in patients with Helicobacter pylori(Hp)positive peptic ulcer,and provide reference for rational drug use in patients with Hp positive peptic ulcer.Methods:The randomized controlled trials(RCT)and prospective observational studies(POS)of esomeprazole and pantoprazole in the treatment of Hp positive peptic ulcer were searched from the databases such as PubMed,Cochrane Library,CNKI,Wanfang database and VIP using"esomeprazole","pantoprazole","Helicobacter pylori"and"peptic ulcer"in Chinese and English as keywords,and the efficacy and safety of esomeprazole and pantoprazole in patients with Hp-positive peptic ulcer in the obtained documents and literatures were analyzed by meta-analysis.Results:After preliminary search,a total of 988 literatures were obtained,and 21 articles were finally included after screening(4382 cases involved),of which 15 articles were RCT and 6 articles were POS.The efficacy evaluation results showed that esomeprazole had better efficacy than pantoprazole in patients with peptic ulcer(OR=1.77,95%CI:1.23-2.56,Z=3.06,P=0.002).The comparison of Hp eradication rate showed that esomeprazole was superior to pantoprazole in the eradication effect of Hp in patients with peptic ulcer(OR=1.40,95%CI:1.16-1.68,Z=3.76,P=0.0004).The studies on patients with extensive metabolizer(EM)and poor metabolizer(PM)CYP3C19 genotypes showed that esomeprazole was comparable to pantoprazole in the eradication rate of Hp in patients with EM or PM.The safety evaluation results showed that the incidence of adverse drug reactions between esomeprazole and pantoprazole was basically the same(OR=0.97,95%CI:0.72-1.30,Z=0.21,P=0.83).Conclusion:For patients with Hp positive peptic ulcer,esomeprazole-based therapy is superior to pantoprazole-based therapy in terms of efficacy and Hp eradication effect,and the drug safety of esomeprazole is not weaker than that of pantoprazole.However,since the literatures included in this study may be insufficient and incomplete,and the research methods may have deficiency,more and larger-scale studies are required for verification.