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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 evaluate the efficacy and safety of proton pump inhibitor (PPI) and H2 receptor antagonist (H2RA) in preventing ulcer bleeding and promoting ulcer healing after endoscopic submucosal dissection (ESD). Methods All randomized controlled trials comparing PPI with H2RA to prevent ulcer bleeding and promote ulcer healing after ESD were searched by PubMed, Cochrane Central Register of Controlled Trials, CENTRAL, EMbase, Google Scholar, VIP, CNKI, CBM and WanFang Data RCT), the search time limit is the library building to October 26, 2012, at the same time hand-checked into the literature reference. According to inclusion and exclusion criteria, four researchers independently conducted literature screening, data extraction and quality evaluation, and Meta-analysis was performed using RevMan 5.1 software. The results eventually included 6 RCTs, a total of 616 patients. Meta analysis showed that PPI was superior to H2RA in preventing ulcer bleeding after ESD [OR = 0.51, 95% CI (0.29, 0.89), P = 0.02], and PPI was superior to H2RA in preventing PPI However, the combined effects of H2RA and PPI in promoting ulceration healing after ESD were better than those in the control group (OR = 0.43, 95% CI 0.22, 0.82, P = 0.01) OR = 1.33, 95% C (I0.28, 6.27), P = 0.72; OR = 0.75, 95% CI (I0.39, 1.86) (0.31, 1.79), P = 0.52]. Conclusions PPI is better than H2RA in preventing ulcer hemorrhage after ESD. However, there is no significant difference between the two groups in promoting the healing of ulcer. PPI is recommended to prevent ulcer bleeding after ESD. Enrolled in the number of studies and quality constraints, more high-quality, large sample, multicenter RCTs need to be developed to further demonstrate their safety.