马来酸多潘立酮治疗功能性消化不良63例的Ⅱ期临床试验

Effects of domperidone maleate on 63 patients with functional dyspepsia: a multicenter, double-blind, double-dummy phase Ⅱ clinical trial

目的:观察马来酸多潘立酮片治疗功能性消化不良(FD)的疗效和安全性.方法:采用随机、双盲、双模拟、阳性药对照、多中心设计.研究对象为141例FD病人,年龄18～65 a,治疗组(63例)口服马来酸多潘立酮片,12.72 mg,tid;对照组(69例)口服多潘立酮,10 mg,tid,疗程均为4 wk.评价指标有症状评分、胃排空功能、临床症状总积分以及不良反应等.结果:用药2,4 wk后,2组病人主要症状积分均有显著下降(P＜0.05或P＜0.01).治疗组用药后早饱、腹胀、恶心、呕吐、上腹部疼痛、食欲不振、烧心和嗳气等8项主要症状的有效率分别为85%,89%,90%,90%,86%,81%,81%和86%;对照组分别为87%,93%,91%,82%,66%,81%,92%和94%,2组比较均无显著差异(P＞0.05),2组病人均无严重不良反应.结论:马来酸多潘立酮片治疗FD安全、有效.

AIM ：To evaluate the clinical efficacy and safety of domperidone maleate in the treatment of functional dyspepsia. METHODS：A total of 141 patients with functional dyspepsia were randomly divided into two groups. Testing group of 63 patients was treated with domperidone maleate 12.72 mg, po, tid for 4 wk and control group of 69 patients was treated with domperidone 10 mg, po, tid for 4 wk. RESULTS：In the testing group, the total effective rates of domperidone maleate in treating early satiety, epigastric fullness, nausea, vomiting, epigastric pain, decrease of food intake, heartburn and belch were respectively 85 % ,89 % ,90 % ,90 % ,86 % ,81%, 81% and 86 % ; and those were 87 % ,93 % ,91% , 82 % ,66 % ,81% ,92 % and 94 % ,respectively in control group. The differences in effective rates of clinical symptoms and gastric emptying between two the groups were insignificant （ P 〉 0. 05 ）. CONCLUSION ：Domperidone maleate is an efficacious and reliable agent in the treatment of functional dyspepsia.