复方消化酶治疗消化不良患者的疗效和安全性随机双盲安慰剂对照多中心临床试验

Efficacy and safety of Minilase-s on patients with dyspepsia： a randomized placebo-controlled double blind multicenter clinical trial

目的评估复方消化酶（商品名：美尼）治疗消化不良的疗效和安全性。方法采用随机双盲、安慰剂平行对照的多中心研究。应用视觉模拟评分法（visual analogue scale，VAS），食欲不振、饱胀、腹部不适和腹胀症状总积分≥20分的消化不良患者240例，随机均分为安慰剂组和治疗组，分别服用安慰剂和复方消化酶2粒／次，3次／d，疗程为2周；评价两组在治疗1、2周和停药后1周消化不良症状的缓解程度和不良反应的发生。结果216例患者完成本研究，其中治疗组105例，安慰剂组111例。治疗组在治疗1、2周及停药1周消化不良总症状积分下降程度明显优于安慰剂组（P〈0．01）；治疗组在治疗1、2周和停药后1周总有效率分别为64．76％、77．05％和66．99％，明显高于安慰剂组的27．93％、37．84％和29．36％（P〈0．05）。两组在治疗过程中及停药后均未出现严重不良反应。结论复方消化酶治疗消化不良具有良好的疗效及安全性。

Objective To investigate the efficacy and safety of Minilase-S on patients with dyspepsia. Methods A randomized, placebo-controlled, double blind and multicenter study was conducted. Two hundred and forty patients with dyspepsia symptoms（anorexia, fullness, abdominal discomfort and distension） were collected according to total symptom scores over 20 with visual analog scales. Each patient was randomly received either Minilase-S（2 capsules t. i. d） or placebo（2 capsules t. i. d） for 2 weeks. The symptoms scores were evaluated at treatment week 1, week 2, and 1 week after discontinued therapy. Results Two hundred and sixteen patients（105 patients in Minilase group and 111 patients in placebo group） finished the study. There was no difference in demographic data, anorexia, fullness, discomfort and distension score and the total symptom score between two groups. However, at treatment week 1, week 2 and 1 week after discontinued therapy, symptoms and total symptom score were significantly decreased in Minilase-S group compared to placebo group（all P value d0.05）. The total effective rates in treatment week 1, week 2 and 1 week after discontinued therapy were 64.76 %, 77.05 % and 66.99%, respectinely, which were higer that those in placebo group（27.93%, 37.84 % and 29.36 %, respectively） （P 〈 0. 05）. There was no severe side effects in both Minilase-S and placebo groups. Conclusions Minilase-S can significantly improve symptoms in patients with dyspepsia, which may he as one choice in the management of dyspepsia or in combined therapy.