丹红注射液配合羟苯磺酸钙治疗糖尿病视网膜病变临床研究

目的：评价丹红注射液配合羟苯磺酸钙治疗糖尿病视网膜病变(diabetic retinopathy, DR)的临床疗效。方法按随机数字表法将符合纳入标准的81例DR患者随机分为羟苯磺酸钙组(40例)和联合治疗组(41例)。2组患者治疗期间均控制血糖，使FPG维持在4.5～6.5 mmol/L，2hPG≤10.0 mmol/L。羟苯磺酸钙组给予口服羟苯磺酸钙片；联合治疗组采用静脉滴注丹红注射液和口服羟苯磺酸钙片。均治疗3个月。评价视野灰度值、眼部血管瘤体积、出血斑面积和黄斑厚度的变化以及临床疗效。结果治疗后，联合治疗组视野灰度值(1.53±0.22)%比(2.13±0.16)%；t＝17.315， P＜0.01]、血管瘤体积(11.33±3.21)cm3比(13.44±4.01)cm3；t＝3.259， P＜0.01]、出血斑面积(1.11±0.24)mm2比(2.01±0.53)mm2；t＝9.885，P＜0.01]、黄斑厚度(308.12±13.29)?m比(369.31±14.57)?m；t＝24.556， P＜0.01]均显著低于羟苯磺酸钙组。联合治疗组视力改善眼的百分比显著高于羟苯磺酸钙组（63.1%比35.0%；χ2＝8.748，P＝0.003）。联合治疗组总有效为39例(95.1%)、61眼(93.8%)，羟苯磺酸钙组为27例(67.5%)、37眼(61.7%)，2组比较差异有统计学意义(χ2值分别为8.489、17.226，P值分别为0.004、0.001)。结论丹红注射液与羟苯磺酸钙联用，可改善DR患者的视力和视野缺损。

A clinical study of Danhong injection combined with calcium dobesilate for diabetic ;retinopathy

Objective To evaluate the therapeutic effect of Danhong injection combined with calcium dobesilate for diabetic retinopathy (DR). Methods A total of 81 DR patients were recruited and randomly divided into a calcium dobesilate group (41 patients) and a combined treatment group (40 patients). Blood glucose was controlled (fasting blood sugar 4.5-6.5 mmol/L, postprandial 2 h blood glucose ≤10.0 mmol/L) in all patients. The calcium dobesilate group received oral calcium dobesilate tablets (0.5 g, 3/day), and the combined treatment group received intravenous Danhong Injection and oral calcium dobesilate tablets (0.5 g, 3/day) for 3 months. The changes of the gray scale of the visual field, microaneurysm volume, ecchymosis area, the thickness of the macula lutea, and the therapeutic effect were evaluated. Results After the treatment, the gray scale of the visual field (1.53%± 0.22%vs. 2.13%± 0.16%;t=17.315, P<0.01), microaneurysm volume (11.33 ± 3.21 cm3 vs. 13.44 ± 4.01 cm3; t=3.259, P<0.01), ecchymosis area (1.11 ± 0.24 mm2 vs. 2.01 ± 0.53 mm2; t=9.885, P<0.01), the thickness of the macula lutea (308.12 ± 13.29?m vs. 369.31 ± 14.57?m;t=24.556, P<0.01). The percentage of eyes with visual acuity improvement was in the combined treatment group was significantly higher than that in the calcium dobesilate group (63.1%vs. 35.0%;χ2=8.748, P=0.003). The total effective rates in the combined treatment group were significantly higher than those in the calcium dobesilate group for patients (95.1%vs. 67.5%;χ2=8.489, P=0.004) and for eyes (93.8%vs. 61.7%;χ2=17.226, P=0.001). Conclusions Danhong injection combined with calcium dobesilate can improve visual acuity and visual field loss in patients with DR.