双丹明目胶囊治疗糖尿病视网膜病变的临床研究

Efficacy and safety of Shuangdan Mingmu capsule in treating diabetic retinopathy

目的:研究双丹明目胶囊治疗糖尿病视网膜病变(单纯型)的临床疗效与安全性。方法:202例糖尿病视网膜病变(单纯型)患者随机分为双丹明目胶囊组(102例)和导升明组(100例),治疗16周。于治疗前、治疗后第8周、16周分别进行视力、视野、眼底荧光血管造影及糖尿病视网膜病变各项临床症状与体征变化检查。结果:两组治疗后患者眼科检查中的视网膜微血管瘤数目、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。组间比较,治疗8周后、16周后眼科检查总分及微血管瘤计分、治疗16周后视力检查计分比较,差异有显著性意义(P<0.01,0.05);疾病显效率、总有效率,差异有显著性意义(P<0.05),双丹明目胶囊组高于导升明组。双丹明目胶囊组药物不良反应率低于导升明组。结论:双丹明目胶囊对糖尿病视网膜病变(单纯型)患者安全有效。在减少视网膜微血管瘤数目、提高视力及改善双目干涩症状方面优于导升明。

Objective ：To investigate the efficacy and safe of Shuangdan Mingmu capsule in treating simple diabetic retinopathy. Methods：The diagnostic criteria of diabetic retinopathy were based on Diagnostics of Ophthalmology and Practical Ophthalmology（ published by Peopleg Medical Publishing House）. A total of 202 patients with diabetic retinopathy were randomly divided into two groups. They were treated with Shuangdan Mingmu capsule for 16 weeks （n = 102）,or with Daoshengming for 16 weeks （n = 100）. All the patients were inspected before treatment,and 8 and 16 weeks after treatment. The items of inspection were acuity of vision,campus visualis,fluorescence fundus angiography, and other clinical symptoms and signs of diabetic retinopathy. Results：The numbers of retina microaneurysm, haemorrhage, effusion,leakage,and the areas of capillary nonperfusion and defect of field vision were significantly decreased and the acuity of vision was significantly increased 16 weeks after treatment in both groups. The scores of ophthalmology inspection and scores of microaneurysm at 8 and 16 weeks after treatment were significantly better in Shuangdan Mingmu Capsule group than in Daoshengming group （ P 〈 0.01 or P 〈 0.05 ）. The score of visual activity test 16 weeks after treatment was significantly better in Shuangdan Mingmu capsule group than in Daoshengming group （ P 〈 0.01 or P 〈 0.05 ）. The markedly effective rate and total effective rate of disease were significantly better in Shuangdan Mingmu capsule group （P 〈 0. 05 ）. The rate of adverse reactions was less in Shuangdan Mingmu capsule group than in Daoshengming group. Conclusion： Shuangdan Mingmu capsule is safe and effective in patients with simple diabetic retinopathy, and is better than Daoshengming in decrease of numbers of retina microaneurysm,increase of acuity of vision and improvement of dryness of eyes.