【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。更多还原

【Abstract】 Objective: To evaluate the efficacy and safty 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%,Doxium-controlled 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 Qi-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.更多还原