糖网康胶囊治疗糖尿病视网膜病变Ⅱ期研究

A phase Ⅱ clinical trial of TangWangKang capsules for the treatment of diabetic retinopathy

目的初步评价糖网康胶囊治疗糖尿病视网膜病变的有效性和安全性。方法采用平行对照、随机、双盲、多中心临床试验方法 ,240例受试者随机分为试验组和对照组,分别服用糖网康胶囊和羟苯磺酸钙胶囊,疗程均为12周。结果试验组疾病综合疗效总有效率为63.7%,中医症候疗效总有效率为87.3%;对照组分别为44.4%和65.1%。两组比较,差异均有统计学意义(P<0.05)。结论糖网康胶囊治疗糖尿病视网膜病变安全有效。

Objective To evaluate the effect and safety of TangWangKang capsules on diabetic retinopathy.Methods A parallel-controlled,random,double-blind,multi-center clinic trial was designed.240 subjects were randomly divided into trial group and control group w ho w ould respectively take TangWangKang capsules and calcium dobesilate capsules.The curse of treatment w as 12 w eeks.Results The total effective rate of comprehensive effect in trial group and traditional medicine symptoms w ere 63.7% and 87.3%; they w ere 44.4% and 65.1% in control group respectively.There w as significant difference betw een the tw o groups（P0.05）.Conclusion TangWangKang capsule is safe and effective in treating diabetic retinopathy.