论文部分内容阅读
目的研究多司马酯片对消化性溃疡的临床疗效及安全性。方法采用多中心随机双盲双模拟平行阳性药对照研究,235例消化性溃疡(116例胃溃疡和119例十二指肠溃疡)患者随机分配进入试验组和对照组。试验组服用多司马酯1500 mg,每天2次,硫糖铝空白片2片,每天4次;对照组服用多司马酯空白片3片,每天2次,硫糖铝片1000 mg,每天4次,疗程4周。结果共有213例可供疗效分析,232例可供评价不良反应。胃溃疡试验组4周有效率和愈合率分别为92．5％和62．3％,与对照组(分别为82．0％和50．0％)相比差异无统计学意义(P>0．05),十二指肠溃疡试验组4周有效率和愈合率分别为88．9％和80．4％,与对照组(分别为61．1％和50．0％)相比差异无统计学意义(P> 0．05)。试验组不良反应发生率为2．61％,与对照组的2．56％相比差异无统计学意义(P>0．05)。结论多司马酯片是安全有效的消化性溃疡治疗药物。
Objective To study the clinical efficacy and safety of polysmazole tablet on peptic ulcer. METHODS: A multicenter, randomized, double-blind, double-dummy parallel, positive control study was conducted in which 235 patients with peptic ulcer (116 with gastric ulcer and 119 with duodenal ulcer) were randomized into the experimental group and the control group. The test group took polysilizumab 1500 mg twice a day, sucralfate blank tablets 2 tablets 4 times a day; the control group took 3 tablets of doxorubicin twice a day, sucralfate 1000 mg 4 times a day , Treatment for 4 weeks. Results A total of 213 cases were available for efficacy analysis, 232 cases were available for evaluation of adverse reactions. The 4-week effective rate and healing rate of gastric ulcer test group were 92.5% and 62.3%, respectively, which were not significantly different from those of the control group (82.0% and 50.0%, respectively) (P> 0 .05). In the duodenal ulcer group, the 4-week effective rate and healing rate were 88.9% and 80.4%, respectively, which were significantly lower than those in the control group (61.1% and 50.0% respectively) Statistical significance (P> 0.05). The incidence of adverse reactions in the experimental group was 2.61%, which was no significant difference compared with 2.56% in the control group (P> 0.05). Conclusion Dysmabicate tablets are safe and effective treatment of peptic ulcer.