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国产盐酸依托必利片Ⅱ期临床研究总结 被引量:3

Itopride in treatment of functional despepsia: a multicenter, double-blind study
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摘要 目的 观察国产依托必利对功能性消化不良的疗效及安全性。方法 进行多中心双盲随机对照研究 ,共观察功能性消化不良患者 2 38例。随机分为实验组 :119例 ,盐酸依托必利片 5 0mg 1日 3次 ;对照组 :119例 ,多潘立酮 10mg 1日 3次。疗程均为 4周。结果 治疗 2 8d时 ,依托必利组 ,上腹疼痛、上腹饱胀、嗳气、早饱、进食减少、反酸、烧心、恶心、呕吐等症状的总有效率分别为 87.5 %、81.3%、81.3%、86 .4 %、86 .2 %、90 .9%、89.6 %、91.7%、96 .8%。多潘立酮组分别为 82 .0 %、82 .9%、79.3%、85 .5 %、76 .0 %、84 .2 %、86 .0 %、93.3%、86 .7%。两组间比较 ,在上腹疼痛、上腹饱胀、嗳气、烧心及恶心等症状疗效无明显差别。在早饱、进食减少、反酸及呕吐等症状依托必利优于多潘立酮。两组治疗后均能使胃排空率明显增加 ,胃半排空时间及口盲时间明显缩短 ,但两组间比较均无明显差别。结论 依托必利是疗效较好、副作用较小的全胃肠道促动力药。 Objective To evaluate the clinical efficacy and adverse reactions of itopride in treating functional despepsia. Methods Two hundred and thirty eight patients with functional despepsia were divided into two groups. Group itopride 119 patients(M 44,F 75;age 41.20±8.15) were treated with itopride 50mg po,tid for 4 wk. Group domperidone 119 patients(M 42, F77;age 37.89±8.55) were treated with domperidone 10mg,po,tid for 4 wk. Results In the group itopride, the general effective rates of itopride treating for the symptom of epigastric pain, epigastric fullness, belch, early satiety, decrease of food intake, reflux acid, heartburn, nausea, vomiting were 87.5%、81.3%、81.3%、86.4%、86.2%、90.9%、89.6%、91.7%、96.8% respectively. In the group domperidone, they were 82.0%、82.9%、79.3%、85.5%、76.0%、84.2%、86.0%、93.3%、86.7% respectively. The gastric emptyings were significantly increased after treatment in the groups itopride and domperidone, and there was not any difference between the two groups. Concultion Itopride is a new safety efficacious drug for treating functional despepsia.
出处 《重庆医学》 CAS CSCD 2003年第9期1149-1151,共3页 Chongqing medicine
关键词 依托必利 多潘立酮 功能性消化不良 胃排空 口盲时间 催乳素 itopride domperidone functional despepsia gastric emptying prolactin
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