摘要
目的:验证与评估国产磷酸铝凝胶治疗消化性溃疡的临床疗效和安全性。方法:运用随机配对方法将126例消化性溃疡患者分为试验组和对照组各63例,分别接受国产和进口磷酸铝凝胶20g,每日4次,治疗6周,胃镜观察溃疡愈合情况。结果:试验组和对照组十二指肠溃疡愈合率分别为65.6%和53.1%,总有效率分别为90.6%和87.5%;胃溃疡愈合率分别为64.5%和61.3%,总有效率分别为93.0%和90.3%。经统计学检验,两组间均无显著性差异(P>0.05)。在疼痛的消失率和其他消化道症状的缓解率方面两组间亦无显著性差异(P>0.05)。两组患者主要的不良反应是便秘,无1例终止治疗。结论:国产磷酸铝凝胶与同类进口产品相同,是治疗消化性溃病安全。有效的药物之一。
AIM: To evaluate the efficacy and safety of domestic aluminum phosphate gel in treating adults with peptic ulcer. METHODS: 126 patients with peptic ulcer were randomly assigned to receive domestic or imported aluminum phosphate gel 20g oral qid for 6 weeks. Endoscopies were performed before and after the treatment .RESULTS: After 6 weeks of treatment, the ulcer- healing rates of duodenal ulcer achieved 65.6% and 53.1% ,and those of gastric ulcer achieved 64.5% ,61.3% in test group and control group, respectively .The total effective rates were 90.6% ,87.5% in patients with duodenal ulcer and 93.0% , 90.3% in patients with gastric ulcer respectively .No significant differences were observed(P >0.05) .With respect to pain and other gastrointestinal symptoms, pronounced improvement was obtained after the treatment, without significant intergroup diffcrence(P > 0.05) .The main adverse event observed was constipation which, however, was hardly ever severe enough to warrant discontinuing treatment .CONCLUSION: These results suggested that domestic aluminum phosphate gel was as effective and safe as imported product in treating peptic ulcer.
出处
《中国医院用药评价与分析》
2001年第2期98-99,共2页
Evaluation and Analysis of Drug-use in Hospitals of China