注射用奥美拉唑钠治疗消化性溃疡出血临床观察

Clinical evaluation of injectable omeprazole sodium for patients with peptic ulcer

目的:比较国产与进口注射用奥美拉唑钠对消化性溃疡出血的疗效及安全性。方法:对内镜证实的179例出血性消化性溃疡随机双盲分为试验组(n=65)和对照组(n=68),另设开放组(n=46),试验组和开放组用国产注射用奥美拉唑40mg,iv,bid,疗程3～5d;对照组用进口奥美拉唑钠注射液40mg,iv,bid,疗程3～5d;观察三组72及120h的临床症状改善、实验室指标或内镜下止血征象。结果:止血平均天数试验组为(3.08±1.92)d,对照组为(3.12±1.88)d,两组比较差异无显著性(P>0.05);总有效率试验组及开放组均为100.0%,对照组为98.5%,差异也无显著性(P>0.05)。不良反应发生率三组相似,均无严重不良反应发生。结论:国产注射用奥美拉唑钠治疗消化性溃疡出血与进口药疗效和安全性相似。

Objective:To compare the clinical hemostatic effects of domestic omeprazole sodium injection (Aoke) and imported omeprazole sodium injection(Losec) for patients with hemorrhagic peptic ulcer. Methods: 179 patients with hemorrhagic peptic ulcer were randomized to i. v. administer either Aoke (40mg, n=65) or Losec (40mg, n=68) and open group (Aoke 40mg, n=46) twice daily for 3～5 days. The primary endpoint was to measure the clinical hemostatic effects in 72h and 120h after the initial injection, respectively. Results: The mean hemostatic onset was (3.08±1. 92) days in the Aoke group, compared with the (3.12±1.88) days in the Losec group (P>0. 05). The Aoke group and open group had an overall response rate of 100. 0 percent compared with 98. 5 percent of Losec patients (P>0. 05). No serious side effects were reported. Conclusion: The Aoke for injection offers bioequivalent effects in the treatment of hemorrhagic peptic ulcer to Losec for injection.