盐酸依托必利片治疗功能性消化不良的临床研究

Clinical Study of Itopride Hydrochloride on Treatment of Functional Despepsia

目的:评价盐酸依托必利片在功能性消化不良治疗中的疗效及安全。方法:采用随机、双盲双模拟、平行对照、多中心试验方法,以多潘立酮片为阳性对照药,236%随机分放试验组(119例)或对照组(117组),进行4周的双盲治疗,试验组给药剂量为盐酸依托必利片50 mg,每日3次、每次1片;对照组给药剂量为多潘立酮片10 mg,每日3次、每次1片,疗程4周。结果:试验组和对照组总症状改善率分别为(78.33±22.55)%和(75.08±24.55)%。两组比较无显著差异。两组在上腹胀和早饱症状改善的有效率和胃排空改善的有效率两组无显著差异,各有3例不良反应,不良反应发生率分别为2.52%和2.61%。结论:盐酸依托必利能安全、有效地治疗功能性消化不良。

AIM： To evaluate the clinical efficacy and safety of itopride hydrochloride. METHODS： 236 cases of functional despepsia were randomised, multicentric, double-blinded divided into Itopride group （119 cases） which was treated with Itopride hydrochloride 50 nag three times daily for 4 weeks and domperidone group （117 cases） which was treated with domperidone three times daily for 4 weeks. RESULTS： The general efficacy of hopride group was 78.33±23.55 % and domperidone group was 75.08±24.55 %, there was no significant deference between two groups. The improvement of symptoms of the epigastric fullness, early satiety and the rating of gastric emptyings was 61.95% and 64.29 %. Whereas was 70.37 % and 62.50% in domperidone group. There was no significant deference between two groups. The adverse effect rate of Itopride group was 2.52% and 2.61% in domperidone group. CONCLUSION： hopride hydrochloride can treat functional despepsia effectively and safely.