中药复方芪明颗粒治疗糖尿病视网膜病变双盲双模拟随机对照多中心临床研究  

Randomized Controlled Double-blind Multicentric Clinical Trail on Non-proliferative Diabetic Retinopathy Treated by Qi-ming Granule

作　　者：段俊国[1] 廖品正[1] 吴烈[2] 李毓敏[3] 余杨桂[4] 邱波[5] 李传课[6] 

机构地区：[1]成都中医药大学,四川成都610075 [2]中国中医研究院广安门医院,北京100053 [3]浙江大学医学院第一附属医院,浙江杭州310002 [4]广州中医药大学第一附属医院,广东广州510405 [5]广东省中医院,广东广州510120 [6]湖南中医学院第一附属医院,湖南长沙410007

出　　处：《成都中医药大学学报》2006年第2期1-5,共5页Journal of Chengdu University of Traditional Chinese Medicine

基　　金：国家"十五"科技攻关课题(任务编号:2001BA701A13a)

摘　　要：目的:初步评价中药复方芪明颗粒治疗糖尿病视网膜病变(DR)非增殖期的有效性和安全性。方法:采用双盲双模拟、随机对照、多中心临床试验研究方法,在5家医院收集212例DR患者,试验组(芪明颗粒)107例,对照组(导升明胶囊)105例,疗程3个月,治疗结束后以眼底检查、眼底荧光血管造影、视力等指标综合评价疗效,同时检测、血、尿便常规及心电图、肝肾功能等安全性指标。结果:试验组显效率40.2%,总有效率81.3%;对照组显效率29.5%,总有效率71.4%,两组疾病疗效相当(P>0.05)。中医证候试验组显效率28.0%,总有效率75.7%;对照组显效率12.4%,总有效率59.0%。试验组疗效优于对照组(P<0.05)。试验组不良反应发生率为0.935%,对照组为7.619%。结论:中药复方芪明颗粒治疗DR非增殖期安全有效。Objective： To evaluate the efficacy and salty of the Qi-ming granule in treatment of non-proliferative diabetic retinopathy （DR）. Methods： Designing randomized parallel multicentric clinical trail, There are 212 eyes of 212 patients with non-proliferative DR who were enrolledand treated in the 5 medical centers with the same inclusion and exclusion criteria, Qi-ming granule group 107, Doxium-controlled group 105. Patients received periodic detailed ophthalmic examinations with fundus photography, fundus fluorescein angiography, symptom of TCM, general physical examinations with electrocardiograms, and blood routine , urine routine, hepatorenal function . Patients were treat 3 months each clincal center . Results： The excellence rate and total effective rate in Qi-ming granule group is 40.2%, 81.3%, Doxiumcontrolled group 29.5%, 71.4% （P 〉 0.05）. The excellence rate and total effective rate of TCM in Qi-ming granule group is 28.0%, 75.7%, Doxium-controlled group 12.4%, 59.0% （P 〈 0.05）. Adverse effect rate in Oi-ming granule group is 0.935 %, Doxium-controlled group 7.619 %. Conclusion： Chinese compound medicine Qi-ming granule is safe and effective , and has superiority on treating non-proliferative diabetic retinopathy versus Doxium Tablets.

关 键 词：糖尿病视网膜病变 芪明颗粒 导升明胶囊 临床研究 

分 类 号：R276.7[医药卫生—中医五官科学] R774[医药卫生—中医学]