双丹明目胶囊治疗糖尿病视网膜病变的多中心临床研究

目的通过Ⅱ、Ⅲ期临床试验观察双丹明日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、双日干涩、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。结论双丹明日胶囊对糖尿病视网膜病变有较好的疗效，且临床使用安全。

Multicentric clinical study of Shuangdan Mingmu capsule on diabetic retinopathy

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 includ-ed general physical examinations,routine examinations of blood,urine and stool,and functions examinations of heart,liver and kidney,fasting plasma glucose,effective observation includ-ed clinical symptoms and signs,tongue,pulse,vision,fundus and fundu...