消化酶片治疗消化不良的多中心随机双盲平行对照临床研究  

A multicenter,randomized,double-blind and paralled clinical study of Digestive Enzyme Tablets in treatment of dyspepsia

作　　者：张颖[1] 金思岑[1] 孙克宏[1] 李张宇[1] 刘佳[1] 桑勤 

机构地区：[1]太极集团有限公司,重庆401147

出　　处：《现代医药卫生》2013年第1期4-6,共3页Journal of Modern Medicine & Health

摘　　要：目的观察消化酶片对于食欲减退、恶心、呕吐、腹胀、嗳气、打嗝等消化不良症状的改善情况,评价消化酶片的有效性及安全性。方法以多酶片为对照,采用多中心、随机、双盲、平行对照的方法。在重庆、青岛、南宁等地选择4家国家药物临床试验机构进行临床观察,共完成220例消化不良患者的随访,随机分为试验组111例,口服消化酶片,每天3次,每次3片;对照组109例,口服多酶片,每天3次,每次3片。疗程均为2周(14 d)。结果治疗2周(14 d)后,试验组、对照组对缓解食欲减退、恶心、呕吐、腹胀、嗳气、打嗝等消化不良症状的疗效相当。试验组改善消化不良症状的起效时间明显早于对照组。结论消化酶片治疗消化不良安全、有效,其优势在于起效时间快、作用迅速,是一种高效价的复合酶制剂,值得临床推广应用。Objective To observe the improvement of dyspepsia symptoms such as anorexia,nausea,vomiting,abdominal distension,belching and hiccup in the treatment of dyspepsia by Digestive Enzyme Tablets,and to evaluate its efficacy and safety.Methods Multienzyme Tablets was used as control therapy by adopting the multicenter,randomized,double-blind and paralled method.Clinical observation of 4 national drug trial institutions was carried in Chongqing,Qingdao,Nanning and so on.220 patients with dyspepsia were randomly divided into the experimental group（oral Digestive Enzyme Tablets,3 tablets each time,3 times each day,n=111） and the control group（oral Multienzyme Tablets,3 tablets each time,3 times each day,n=109）,and 2 weeks were regarded as a treatment course.Results After a treatment course,the alleviation of dyspepsia like anorexia,nausea,vomiting,abdominal distension,belching and hiccup in both groups was equivalent in therapeutic effect,but the onset time of alleviating dyspepsia in the experimental group appeared ealier than that in the control group.Conclusion Digestive Enzyme Tablets is safe,effective and rapid in treating dyspepsia,so it is one of high-efficiency compound enzymes preparation and worthy of clinical application.

关 键 词：消化不良 片剂 多中心研究 双盲法 随机对照试验 消化酶片 多酶片 

分 类 号：R758.63[医药卫生—皮肤病学与性病学]