都梁软胶囊治疗风寒头痛的临床试验  

Duliang Soft Capsule for Wind-cold Headache:Clinical Trial

作　　者：杨国汉[1] 单兆伟[2] 周晓波[2] 

机构地区：[1]第三军医大学大坪医院中医科,重庆市400042 [2]江苏省中医院内科,南京市210029

出　　处：《中国药房》2007年第21期1657-1659,共3页China Pharmacy

摘　　要：目的:评价都梁软胶囊治疗风寒头痛的安全性和有效性。方法:采用随机单盲、阳性对照的临床试验设计,观察150例风寒头痛受试者,其中治疗组100例、对照组50例,疗程3d。结果:2组头痛疗效比较,愈显率分别为77.00%和34.00%(P<0.01),总有效率分别为96.00%和95.00%(P>0。05);2组鼻塞不通疗效比较,愈显率分别为69.00%和40,00%(P<0.05),总有效率分别为91.00%和88.27%(P>0.05);2组中医证候疗效比较,愈显率分别为71.00%和38.00%(P<0.01),总有效率分别为95.45%和88.00%(P>0.05)。整个试验未发现与试验药物有关的不良反应。结论:都梁软胶囊治疗风寒头痛安全、有效。OBJECTIVE： To evaluate the safety and efficacy of Duliang soft capsule （DLSC） in the treatment of wind-cold headache. METHODS： In a randomized, single-blind, positive-controlled clinical trial, 150 patients with wind-cold headache were randomly divided into DLSC group（ n = 100） and control group（ n = 50）.The course of treatment was 3 days. RESULTS： Efficacy on headache in DLSC vs. control group： the cure rates were 77.00% vs. 34.00% （P〈0.01） and the total effective rates were 96.00% vs. 95.00% （P〉 0.05） . In terms of nasal discharge and obstruction： .the cure rates were 69.00% vs. 40.00% （P〈0.05） and the total effective rates were 91.00% vs. 88.27% （P 〉0.05）. In terms of traditional Chinese medicine symptoms： the cure rates were 71.00% vs. 38.00% （P〈0.01）, and the total effective rates were 95.45% vs. 88.00% in the two groups respectively （P 〉0.05）. No ADRs were found in the two groups during the whole trial. CONCLUSION： DLSC is safe and effective in the treatment of wind-cold headache.

关 键 词：都梁软胶囊 风寒头痛 临床试验 

分 类 号：R969.4[医药卫生—药理学] R238.65[医药卫生—药学]