摘要
多种消化酶制剂(商品名:达吉,含胃蛋白酶、木瓜蛋白酶、淀粉酶、纤维素酶、胰脂酶和胰酶6种消化酶以及熊去氧胆酸)对一些慢性消化系疾病(如胃肠、肝胆和胰腺疾病)的消化不良症状是否有改善作用,我国目前尚少随机对照的临床资料。目的:评价多种消化酶制剂治疗各种病因相关的慢性消化不良症状的临床疗效、安全性和依从性。方法:本研究采用多中心、随机、安慰剂、双盲、平行对照设计方案。上海市7个临床中心共收治胃肠疾病、肝源性、胆源性和胰腺疾病等相关的消化不良137例,随机分成2组。多种消化酶制剂治疗组68例,男42例,女26例;年龄48.4岁±10.7岁(19-71岁)。餐后立即服用多种消化酶制剂胶囊2粒,每日3次,疗程2周。安慰剂对照组69例,男37例,女32例;年龄46.9岁±11.0岁(24-71岁)。餐后立即服用安慰剂胶囊2粒,每日3次,疗程2周。分组治疗前每例均有2周药物清洗期。于治疗前以及疗程结束后观察消化不良症状的改善情况、安全性和依从性等。结果:2组患者均完成了规定的疗程。多种消化酶制剂治疗组各种病因相关的消化不良症状的总有效率优于安慰剂对照组(分别为92.6％和53.6％,P=0.001);食欲不振、胃饱胀、腹部不适和腹胀症状的有效率(分别为70.6％、79.4％、77.9％和76.5％)亦均优于安慰剂对照组(46.4％、49.3％
Background: Each multiple digestive enzymes (MDE) capsule (brand name Dages) contains ursodeoxycholic acid and 6 kinds of digestive enzymes: pepsin, papain, diastase, cellulase, pan-crelipase and pancreatin, which have been treating for dyspeptic symptoms from various origins, i.e. gastrointestinal, hepatic, biliary and pancreatic diseases. However, so far there are no documentary data of randomized controlled clinical study in China. Aims: To evaluate the clinical efficacy, safety and patient compliance of MDE capsules for chronic dyspeptic symptoms of various origins. Methods: A multicenter, randomized, placebo, double-blind, parallel and controlled study was carried out in 7 hospitals in Shanghai. A total of 137 patients with dyspepsia from various gastrointestinal, hepatic, biliary and pancreatic diseases were recruited and divided randomly into 2 groups. In MDE treatment group (n = 68), 42 were males and 26 females, with the mean ages 48.4 years ±10.7 years (range 19-71 years). After a drug washout period for 2 weeks, 2 MDE capsules were given orally after meal 3 times a day for 2 weeks. In placebo control group (n = 69), 37 were males and 32 females, with the mean ages 46.9 years ±11.0 years (range 24-71 years). After a drug washout period for 2 weeks, 2 placebo capsules were administered orally after meal 3 times a day for 2 weeks. After treatment the dyspeptic symptoms, safety and patient compliance were evaluated. Results: All patients had completed a course of the clinical study. In the MDE treatment group the total rate of effectiveness for the dyspeptic symptoms caused by various origins was higher than that in placebo control group (92.6% vs 53.6%, P= 0.001). When each symptom was compared, the rates of effectiveness were higher in MDE treatment group than in placebo control group (anorexia, 70.6% vs 46.4%, P= 0.004; satiety, 79.4% vs 49.3%, P = 0.001; abdominal discomfort, 77.9% vs 39.1%, P= 0.001; abdominal distention, 76.5% vs 44.9%, P=0.001). However, there was no significant difference in the dyspeptic symptoms improved between the patients with dyspepsia from various origins. Conclusions: MDE capsules are safe with no serious side-effects, and effective in relieving dyspeptic symptoms commonly seen in gastrointestinal, hepatic, biliary and pancreatic diseases.
出处
《胃肠病学》
2003年第2期79-82,共4页
Chinese Journal of Gastroenterology
