奥美拉唑镁肠溶片与奥美拉唑胶囊治疗消化性溃疡的临床随机对照研究

目的　验证奥美拉唑镁肠溶片与奥美拉唑胶囊治疗消化性溃疡的生物等效性及评价其不良反应。方法　采用随机对照和开放试验的方法治疗经胃镜检查证实的消化性溃疡共 171例 ,其中奥美拉唑镁肠溶片组 (试验组 ) 68例 ,胃溃疡 2 1例 ,十二指肠溃疡 47例 ;奥美拉唑胶囊组 (对照组 ) 67例 ,其中胃溃疡 2 1例 ,十二指肠溃疡 46例 ;开放试验组 3 6例 ,其中十二指肠溃疡 2 9例 ,胃溃疡 7例。结果　试验组中胃溃疡的愈合率和总有效率分别为 80 9%和 10 0 %十二指肠溃疡的愈合率和总有效率分别为87 2 %和 97 8% ;对照组中胃溃疡的愈合率和总有效率为 85 7%和 95 2 % ,十二指肠溃疡的愈合率和总有效率为 84 7%和 97 8% ;开放试验组中胃溃疡的愈合率和总有效率均为 10 0 0 %十二指肠溃疡的愈合率和总有效率分别为 86 2 %和 10 0 % ;试验组中疼痛消失率及其他消化道症状的消失率在胃溃疡为 95 2 %和 89 0 %在十二指肠溃疡则为 97 8%和 98 3 % ;对照组中疼痛及其他消化道症状的消失率在胃溃疡为 95 2 %和 92 7% ,在十二指肠溃疡为 97 8%和 98 7%。两组在愈合率、总有效率、疼痛消失率和其他消化道症状消失率方面相比均无显著差别 (P >O 0 5 )。两组在治疗过程中均未见明显的不良反应。结论　奥美拉唑镁肠溶片与奥

A clinical study of omeprazole magnesium enteric-coated tablets and omeprazole capsule on peptic ulcer

Objective To validate the biologic equivalent of omeprazole magnesium enteric coated tablets and omeprazole capsule in treating peptic ulcer and evaluate the adverse reaction Methods A total of 171 patients with peptic ulcer proven by endoscopy treated by stochastic comparison and opening experiment. Sixty_eight patients received omeprazole magnesium enteric coated tablets, including 47 DU and 21 GU; 67 patients received omeprazole capsule including 46 DU and 21 GU; the opening experiment group have 36 patients including 29 DU and 7 GU Results The healing and total effective rate of GU and DU are 80 9% , 100% and 87 2% , 97 8% respectively in the experiment group;the rate of GU and DU are 85 7% , 95 2% and 84 7% , 97 8% respectively in the comparison group. The healing and total effective rate are all 100% in GU, 86 2% , 100% in DU in the opening experiment group. The pain and other symptom of the alimentary canal relief rate are 95 2% and 89 0% in GU, 97 8%, 98 3% in DU in the experiment group,and the rate are 95 2% and 92 7% in GU, 97 8%, 98 7% in DU in the comparison group. Two groups are not difference in the healing and total effective rate, and pain and other symptom of the alimentary canal relief rate ( P >0 05). There are not obvious adverse reaction in the treatment in two groups Conclusions Omeprazole magnesium enteric coated tablets and omeprazole capsule have the equal effect in the treatment of peptic ulcer. Omeprazole magnesium enteric coated tablets is an effective and safety drug in the treatment of peptic ulcer