Objective To compare the effects and safety of combination of Teprenone and short - term use of Ome-prazole and exclusive long - term use of Omeprazole or Teprenone in preventing the re - bleeding of NSAIDs - related ulcer. Methods Sixty - seven cases of NSAIDs - related ulcer were enrolled and randomly divided into three groups after spraying of liquid Monteggia to stop the bleeding: the therapeutic alliance group [ 25 cases, long - term use of Teprenone ( 50 mg, tid ) combined with 8 weeks of Omeprazole use (20 mg, bid ) ]; the Teprenone group [19 cases, exclusive long - term use of Teprenone ( 50 mg, tid ) ]; and the Omeprazole group [ 23 cases, exclusive long - term use of Omeprazole (20 mg, bid ) ]. During the treatment course of 40 weeks, incidence rates of re - bleeding and adverse reactions of the two groups were measured at the 8th and the 40th week. Results During the period of the first 8 weeks, re - bleeding rates of the three groups were 8. 0% , 36. 8% and 13. 0% , respectively ( P ＜ 0. 05 ); re - bleeding rate in the therapeutic alliance group was significantly lower than in the Teprenone group ( P ＜ 0. 05 ). From the 9th week to the 40th week, re - bleeding rates were 12. 0% , 10. 5% , and 17. 4% , respectively, with no statistical differences among the three groups ( P ＞0. 05 ). Incidence rates of adverse reactions were 8. 0% , 5.3%, and 4. 3% in the three groups respectively during the first 8 weeks with no significant differences among the three groups ( P ＞0. 05 ); from the 9th week to the 40th week, adverse reaction rates were 12. 0% , 5. 3% , and 26. 1% respectively ( P ＜ 0. 05 ) with the therapeutic alliance group and the Teprenone group significantly lower than the Omeprazole group ( P ＜0. 05 ). Adverse reaction rate in the Omeprazole group was significantly lower during the first 8 weeks compared with after 9 to 40 weeks of treatment ( P ＜ 0. 01 ). Conclusion Combination of long - term Teprenone and short -term Omeprazole is equivalent to PPI in preventive effects, while without the complications of long - term PPI, in preventing the re - bleeding of NSAIDs - related ulcer.%目的 比较替普瑞酮联合短期使用奥美拉唑与长期单独使用替普瑞酮或奥美拉唑对预防非甾体抗炎药(NSAIDs)相关性溃疡及出血的疗效和安全性.方法 选取67例长期使用NSAIDs所致溃疡出血的患者,经胃镜喷洒孟氏液止血后,随机分为3组:联合组(25例),长期服用替普瑞酮50 mg/次,3次/d,加用8周疗程的奥美拉唑20 mg/次,2次/d;替普瑞酮组(19例),长期服用替普瑞酮50 mg/次,3次/d;奥美拉唑组(23例),长期服用奥美拉唑20 mg/次,2次/d.疗程共40周.观察3组患者治疗0～8、9～40周再出血发生率和不良反应发生率.结果 (1)治疗0～8周联合组、替普瑞酮组、奥美拉唑组患者再出血发生率分别为8.0%、36.8%和13.0%,组间比较差异有统计学意义(P＜0.05＝;其中联合组再出血发生率显著低于替普瑞酮组,差异有统计学意义(P＜0.05＝;治疗9～40周3组患者再出血发生率分别为12.0%、10.5%和17.4%,组间比较差异无统计学意义(P＞0.05).(2)治疗0～8周联合组、替普瑞酮组、奥美拉唑组患者不良反应发生率分别为8.0%、5.3%和4.3%,3组间比较差异无统计学意义(P＞0.05);而治疗9～40周3组不良反应发生率分别为12.0%、5.3%和26.1%,3组间比较差异有统计学意义(P＜0.05＝,其中联合组及替普瑞酮组不良反应发生率均显著低于奥美拉唑组,差异均有统计学意义(P＜0.05＝;治疗0～8周奥美拉唑组不良反应发生率显著低于治疗9～40周,差异有统计学意义(P＜0.01).结论 短期使用替普瑞酮联合奥美拉唑后长期继续使用替普瑞酮的方法,在预防和治疗NSAIDs所致的溃疡和出血上,可以达到与目前临床普遍采用的长期使用质子泵抑制剂(PPI)相同的疗效,并可避免因长期使用PPI而引起的并发症.
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