羟苯磺酸钙胶囊治疗2型糖尿病肾病和视网膜病变

Clinical Efficacy of Calcium Dobesilate in the Treatment of Diabetic Retinopathy and Nephropathy: A Phase Two Clinical Trial in Chinese Population

目的:观察国产羟苯磺酸钙胶囊治疗糖尿病肾病和视网膜病变的疗效及安全性。方法:多中心的临床研究,按病种双盲、随机、平行、对照的原则分组。试验组（为国产羟苯磺酸钙胶囊）、对照组（为进口羟苯磺酸钙胶囊）及开放组（为国产羟苯磺酸钙胶囊）剂量均为500mg每日2次,口服。糖尿病视网膜病变疗程12周,糖尿病肾病疗程4周,下肢静脉曲张及痔疮疗程2周。结果:共观察164例患者。其中,糖尿病视网膜病变试验组30例（51例眼）,对照组30例（53例眼）:糖尿病肾病试验组34例,对照组34例;开放组下肢静脉曲张27例,痔疮9例。结果:①糖尿病视网膜病变患者的视力、眼底微血管瘤、眼底出血、眼底渗漏等检查的总积分值,试验组左右眼分别为6.66±2.34（n=25）和 6.58±2.04（n-26）,对照组左右眼分别为6.20±1.84（n=27）和6.42±1.68（n=26）,两组无显著性差异。②糖尿病肾病:试验组尿白蛋白下降26.7％,对照组下降26.3％,两组间比较无显著性差异。③下肢静脉曲张患者用药前、后的踝周长径分别为26.0±4.2和24.3±3.3cm。用药后有显著性缩小（P<0.01）。④未见肝肾功能损害等严重药物不良反应。其它不良事件的发生率试验组与对照组相近,约为3％。结论:国产羟苯磺酸钙用于治疗糖尿病肾病和糖尿病视网膜病变。

OBJECTIVE: To evaluate the efficacy and safety of domestic capsules of calcium dobesilate in the treatment of diabetic retinopathy (DR) or diabetic nephropathy (DN).METHOD: A multi-center, double-blind, randomized, parallel, with imported(Ebewe Arzneimittel GmbH,Austria) controlled clinical trial in the patients with DR or DN. Patients randomized in the test group or in the control group were assigned to receive 500mg of domestic calcium dobesilate or imported twice daily for 12 weeks in the patients with DR or for 4 weeks in whom with DN. While other patients with varix of lower limb or piles were assigned to receive 500mg of domestic calcium dobesilate for 2 weeks.RESULTS: A total of 164 cases were evaluable for the final analysis in which 30 cases (51 eyes) with DR were in the test group, 30 cases (53 eyes) with DR were in the control group, while 34 cases with DN were in the test group and 34 cases with DR were in the control group. 1). DR: According to the test of sight, numbers of microangioma of fundus of eye, bleeding area and leakage area of fundus of eye, the mean total score of the left andright eye of the test group are 6.66 ± 2.34 (n=25) and 6.58 ± 2.04 (n=26) separately, while those of the left and right eye of the control group are 6.20 ± 1.84 (n=27) and 6.42 ± 1.68 (n=26) separately. There is no significant difference between the two groups. 2). DN: UAER decreased by 26.7% and 26.3% in the test group and in the control group separately. There is no significant difference between the two groups. 3). Varix of lower limb: The circumference of the patients ankle decreased from 26.0 ±4.2 to 24.3 ± 3.3cm after treatment (P<0.01). There is no liver or kidney damage been found. The proportion of patients reporting adverse experiences was comparable between two groups.CONCLUSIONS: Our data suggests that domestic calcium dobesilate can be used in treating DR and DN which is as effective and safe as treatment with the same dosage of imported.