国产与进口注射用奥美拉唑钠治疗消化性溃疡出血的系统评价

Domestic vs.Imported Omeprazole Sodium for Injection in Treatment of Peptic Ulcer Hemorrhage:Systematic Review

目的:系统评价国产与进口注射用奥美拉唑钠治疗消化性溃疡出血的疗效及安全性。方法:计算机检索CNKI、维普中文数据库、万方数据库,手工检索相关会议文献,文种限于中文。收集有关国产与进口注射用奥美拉唑钠治疗消化性溃疡出血的随机、对照试验,根据纳入和排除标准筛选文献、提取资料,并采用Cochrane协作网推荐的方法评价纳入研究的方法学质量,采用RevMan5.0软件进行Meta分析。结果:共纳入11个随机对照试验,共包括1 058例患者。Meta分析结果显示,国产与进口注射用奥美拉唑钠2组患者平均止血时间的合并效应量为:MD=0.07,95%CI=-0.02～0.16,P平均止血时间>0.05,差异无统计学意义;2组患者显效率的合并效应量为:OR=0.92,95%CI=0.69～1.22,P显效率>0.05,2组患者总有效率的合并效应量为:OR=0.82,95%CI=0.82～1.37,P总有效率>0.05,差异均无统计学意义;2组患者不良反应发生率的合并效应量为:OR=1.46,95%CI=0.43～4.95,P不良反应>0.05,差异无统计学意义。敏感性分析未发现可以显著影响结果稳定性的因素。结论:研究结果表明,国产注射用奥美拉唑钠治疗消化性溃疡出血的疗效及安全性与进口注射用奥美拉唑钠相当,但尚需更多高质量的随机、对照试验以确定疗效及安全性的差异程度。

To conduct a systematic evaluation on the efficacy and safety of domestic vs. imported omeprazole sodium for injection in treatment of peptic ulcer hemorrhage. METHODS ： CNKI, VIP database and Wanfang database were retrieved by computer and the relevant conference literature （limited to the Chinese language ）was collected by manual retrieval. The literature （ limited to Chinese literature） of randomized controlled trials on the efficacy and safety of domestic vs. imported omeprazole sodium for injection in treatment of peptic ulcer hemorrhage were retrieved collected for screening and data retrieval of pertinent literature according to inclusion and exclusion criteria. The methodological quality of the included studies was evaluated by using the method recommended by the Cochrane Collaboration. Meta-analysis of the data was performed by using RevMan5.0 software. RESULTS： A total of 11 randomized controlled trials（RCTs）including 1 045 patients were included. The meta-analysis showed that the merged effect values of average time to hemostasis of the two P ge ti h is 〉 0. 05 ） ; the merged effect values of groups was as follows： MD = 0. 07 （ 95% CI = - 0.02-0. 16, obvious effective rate and total effective rate of the two groups were OR = O. 92 （95 % CI = 0. 69-1.22, P obvi ffecti 〉 0. 05 ） and OR = O. 82 （ 95 % CI = O. 82-1.37, Ptotal ,ffecti 〉 0. 05 ）, showing no significant differences between the two groups, and the merged effect values of incidence of adverse drug reaction（ADR） of two groups were OR = 1.46 （95% CI = 0. 43-4.95, PADR 〉 0. 05 ）. The sensitivity analysis revealed no factor that could significantly affect the stability of the results. CONCLUSION ： The results showed that the domestic omeprazole sodium for injection was as effective and safe as the imported omeprazole sodium for injection in treatment of peptic ulcer hemorrhage;however, the RCTs of high quality need to be done to identify the differences between the domestic and imported omeprazole sodium for injection in efficacy and safety.