双丹明目胶囊治疗糖尿病视网膜病变的多中心临床研究  

Multicentric clinical study of Shuangdan Mingmu capsule on diabetic retinopathy

作　　者：秦裕辉[1] 李芳[1] 涂良钰 邱波 张明亮[3] 曹建辉[4] 宋立[4] 王育良[5] 胡世兴[6] 金明[7] 

机构地区：[1]湖南省中医药研究院,湖南长沙410007 [2]广州中医药大学第二附属医院,广东广州510100 [3]湖南中医药大学第一附属医院,湖南长沙410007 [4]北京中医药大学附属东直门医院,北京100700 [5]南京中医药大学附属医院,江苏南京210029 [6]中国中医科学院眼科医院,北京100040 [7]北京中日友好医院,北京100029

出　　处：《湖南中医药大学学报》2010年第1期46-51,共6页Journal of Hunan University of Chinese Medicine

基　　金：湖南省卫生厅中医药科研基金资助项目(98065)

摘　　要：目的通过Ⅱ、Ⅲ期临床试验观察双丹明目胶囊治疗糖尿病视网膜病变的有效性和安全性。方法采用多中心、随机、盲法、对照,先后开展Ⅱ、Ⅲ期临床试验研究,安全性观察和疗效性观察。疗效性观察包括临床症状和体征,舌象及脉象,视力,视野,眼底,眼底荧光血管造影。以西药导升明作对照,Ⅱ期观察16周、Ⅲ期观察12周为1个疗程。结果双丹明目胶囊对糖尿病视网膜病变总有效率Ⅱ、Ⅲ期分别为97.0%、98.4%,均优于对照药导升明(P<0.05,P<0.01);对中医证候总有效率II、III期分别为88.1%、91%,均优于对照药导升明(P<0.01);能明显改善患者的眼科检查指标,治疗后患者微血管瘤数目,出血、渗出、渗漏、毛细血管无灌注区面积,视野缺损区面积均有明显减少,视力明显提高,中心视野光敏感度有所提高;对患者视物模糊、双目干涩、头晕耳鸣、咽干口燥、五心烦热、腰膝酸软等临床症状均有较好的改善作用和较高的消失率。2组治疗后均有部分病例血、尿常规,肝肾功能,心电图检测功能出现异常,但未证实其与试验药物有因果关系。结论双丹明目胶囊对糖尿病视网膜病变有较好的疗效,且临床使用安全。Objective To evaluate the efficacy and safty of Shuangdan Mingmu capsule for diabetic retinopathy. Method The designing randomly, parallel multicentric clinical study were used for conducted Ⅱ period and Ⅲ period clinical test, the securety observations included general physical examinations, routine examinations of blood, urine and stool, and functions examinations of heart, liver and kidney, fasting plasma glucose, effective observation included clinical symptoms and signs, tongue, pulse, vision, fundus and fundus fluorescein angiography. And Doxium was used as control, 16 weeks was one treatment course for Ⅱ period and 12 weeks for Ⅲ period. Result The total effective rate of Shuangdan Mingmu capsule for diabetic retinopathy were 97% and 98.4%, which were better than Doxium. The total effective rate of the capsule for syndromes in TCM were 88.1%, 91%, which were also better than Doxium. The new medicine could tumor microvessel, area decreased, the significantly improve the eye examination indicators. After the treatment, the bleeding, leakage, the capillary non-perfusion area and vision defected vision in central visual field enjoys was improved, and the clinical symp-toms, like blurred vision, dry eyes, dizziness, ringing in the ears, dry throat, irritation, pains in waist and knee were improved and high efficiency of losing rate. In both groups, some patients were abnormal in blood and urine routine, liver and kidney function and ECG detection, but there was no evidence to prove the relationship betweenthe symptoms and the testing medicine.Conclusion Shuangdan Mingmu capsule is safe and effective for diabetic retinopathy.

关 键 词：糖尿病视网膜病变 双丹明目胶囊 多中心临床研究 

分 类 号：R587.2[医药卫生—内分泌] R774.12[医药卫生—内科学]