PPI与H_2RA比较预防内镜黏膜下剥离术后溃疡出血和促进溃疡愈合的Meta分析

PPI versus H_2RA for Both the Prevention of Bleeding and the Healing of Ulcer after ESD: A Meta-Analysis

目的系统评价质子泵抑制剂(PPI)与H2受体阻断剂(H2RA)比较预防内镜黏膜下剥离(ESD)术后溃疡出血和促进溃疡愈合的作用及其安全性。方法计算机检索PubMed、Cochrane Central Register of Controlled Trials、CENTRAL、EMbase、Google Scholar、VIP、CNKI、CBM和WanFang Data数据库,查找所有比较PPI与H2RA预防ESD后溃疡出血和促进溃疡愈合作用的随机对照试验(RCT),检索时限均为建库至2012年10月26日,同时手检纳入文献的参考文献。按纳入和排除标准由4位研究者独立进行文献筛选、资料提取和质量评价后,采用RevMan 5.1软件进行Meta分析。结果最终纳入6个RCT,共616例患者。Meta分析结果显示:PPI预防ESD后溃疡出血的作用优于H2RA[OR=0.51,95%CI(0.29,0.89),P=0.02],而且疗程为8周时,与H2RA相比,PPI预防ESD后溃疡出血的作用也更明显[OR=0.43,95%CI(0.22,0.82),P=0.01];然而合并组、疗程为4周和8周组中,H2RA和PPI在促进ESD后溃疡愈合作用上均无明显差异[OR=0.85,95%C(I0.39,1.86),P=0.69;OR=1.33,95%C(I0.28,6.27),P=0.72;OR=0.75,95%CI(0.31,1.79),P=0.52]。结论对于预防ESD后溃疡出血,PPI作用明显优于H2RA;但两组促进溃疡愈合的作用无明显差异;推荐临床使用PPI预防ESD后溃疡出血。受纳入研究数量和质量限制,需要开展更多高质量、大样本、多中心的RCT进一步论证其安全性。

Objective To compare proton pump inhibitors （PPI） and H2 receptor antagonists （H2RA） for both the prevention of bleeding and the healing of ulcer after endoscopic submucosal dissection （ESD）, so as to provide best evidence for treating ESD-induced ulcer in clinic. Methods Databases including PubMed, CENTRAL, EMbase, ISI Web of Knowledge, VIP, CNKI, CBM and WanFang Data were searched from the date of their establishment to October 26, 2012 to collect the randomized controlled trials （RCTs） about comparison of PPI and H2RA on the prevention of bleeding and the healing of ulcer after ESD. Meanwhile the references of the included studies were also retrieved manually. According to the inclusion and exclusion criteria, literature selection, data extraction and quality assessment were performed by four reviewers independently, and meta-analysis was performed using RevMan 5.1 software. Results A total of 6 studies involving 616 patients were included finally. The results of meta-analysis showed that： for the prevention of ulcer bleeding after ESD, PPI preceded H2RA apparently （OR=0.51, 95%CI 0.29 to 0.89, P=0.02）, especially when the treatment course was 8-week （OR=0.43, 95%CI 0.22 to 0.82, P=0.01）; but among the merged, 8-week and 4-week groups, there were no significant differences between PPI and H2RA in the healing of ESD-induced ulcer （OR=0.85, 95%CI 0.39 to 1.86, P=0.69; OR=1.33, 95%CI 0.28 to 6.27, P=0.72; OR=0.75, 95%CI 0.31 to 1.79, P=0.52）. Conclusion PPI is superior to H2RA for the prevention of ulcer bleeding induced by ESD, but there is no significant difference between them in the healing of ulcer, so PPI is recommended to prevent ESD-induced ulcer bleeding in clinic. Due to the limitation of quantity and quality of the included studies, the safety of PPI has to be further proved by conducting more high quality, large scale and multi-center RCTs.