国产马来酸伊索拉定片临床生物等效性试验  

Study on efficacy and safety of maleate irsogladine tablet in patients with active gastric ulcer

作　　者：傅颖君[1] 戴群[2] 孙萍 

机构地区：[1]江西医学院药理教研室,江西南昌330006 [2]江西医学院基础部功能中心,江西南昌330006 [3]江西制药有限责任公司,江西南昌330006

出　　处：《中国药学杂志》2002年第7期544-546,共3页Chinese Pharmaceutical Journal

摘　　要：目的　评价国产马来酸伊索拉定片 (MIT)的有效性和安全性。方法　采用随机双盲对照试验 ,选用日本产马来酸伊索拉定片 (商品名为盖斯隆 )为对照药 ,共治疗活动性胃溃疡 12 0例 ,其中MIT和盖斯隆分别为 6 0例。结果　MIT溃疡痊愈率为 6 3.3% ,总有效率为 86 .7% ,疼痛缓解率为 96 .1% ;盖斯隆相应为 5 6 .7% ,85 .0 % ,94 .5 % ;MIT和盖斯隆的不良反应发生率分别为 3.2 %和 8.1% ;以上结果经统计学处理 ,两组无明显差异。结论　MIT在药效和不良反应方面与盖斯隆相似 ,是一种疗效确切。OBJECTIVE: To evaluate the efficacy and safety of maleate irsogladine tablet (MIT). METHODS: A double-blind randomized study was conducted in 120 patients with active gastric ulcer. They were divided to receive MIT or Gaslon N. RESULTS: The gastric ulcer cure rate, total effective rate and the rate of relief acute-phase pain were 63.3%, 86.7% and 96.1%, respectively, and for those of Gaslon N were 56.7%, 85.0% and 94.5%, respectively. The rate of side reactions for MIT and Gaslon N were 3.2 % and 8.1%, respectively. There were no significance between the two groups (P > 0.05). CONCLUSION: MIT appeared to be an effective and safe gastric mucosa protective agent in the treatment of active gastric ulcer. Its ascertain efficacy and less ADR are similar to that of Gaslon N.

关 键 词：生物等效性试验 马来酸伊索拉定 盖斯隆 活动性胃溃疡 疗效 安全性 

分 类 号：R573.1[医药卫生—消化系统] R975[医药卫生—内科学]