中文摘要：

目的观察通络驻景丸对非增生型糖尿病视网膜病变（NPDR）的临床疗效。方法将符合纳入标准的54例NPDR患者分为2组。治疗组27例54只眼,对照组27例54只眼,2组均在血糖控制的基础上分别予口服通络驻景丸,一次3 g,每日3次;羟苯磺酸钙分散片,一次0.5 g,每日3次,疗程16周。通过ETDRS视力表、眼底照相、荧光素眼底血管造影等检查,观察2组患者治疗前后的视力、微血管瘤、出血、渗出、血管渗漏及无灌注区等眼底体征及中医证候积分变化,评价通络驻景丸的疗效;通过血、尿常规,心电图、肝、肾功检查,评价通络驻景丸的安全性。结果 2组各脱失2例患者。治疗前糖尿病相关的常规全身检查显示未见明显异常。视力评分（ETDRS视力表）：治疗前,治疗组34.64±7.78,对照组32.34±8.13;治疗后,治疗组44.62±6.33,对照组43.38±6.94。2组治疗后视力评分均有提高（P〈0.001）,但组间差异无统计学意义（P〉0.05）。眼底体征疗效：治疗组显效16只眼（32%）,有效26只眼（52%）,稳定8只眼（16%）,恶化0只眼（0%）,总有效率84%。对照组25例（50只眼）,显效11只眼（22%）,有效21只眼（42%）,稳定12只眼（24%）,恶化6只眼（12%）,总有效率64%,治疗组好于对照组（Mann-Whitney U检验,Z=-2.212,P=0.027）。中医证候疗效：治疗组显效9例（36%）,有效13例（52%）,无效3例（12%）,总有效率88%。对照组25例,显效5例（20%）,有效9例（36%）,无效11例（44%）,总有效率56%。治疗组疗效好于对照组（Mann-Whitney U检验,Z=-2.245,P=0.025）。治疗观察期间,患者内科情况稳定。结论通络驻景丸可控制或改善NPDR患者视力、眼底体征及自觉症状,防止糖尿病视网膜病变的进一步发展恶化。

英文摘要：

OBJECTIVE To observe the clinical effect of Tongluo Zhujing pill on non-proliferative diabetic retinopathy（NPDR）. METHODS Fifty-four patients with NPDR met inclusion criteria were randomly divided into2 groups. Based on good glycemic management, the treatment group including 27 cases（54 eyes）, took Tongluo Zhujing pill orally 3 gram each time, three times a day, and the control group including 27 cases（54 eyes） took calcium dobesilate dispersible tablets orally 0.5 gram each time, three times a day. The course of treatment lasted 16 weeks.Through the examination of ETDRS visual acuity chart, fundus photography, fundus fluorescein angiography（FFA）,to observe the changes about the visual acuity, fundus signs including microaneurysm, hemorrhage, exudation, vas-cular leakage, non-perfusion area, and TCM syndrome of 2 groups before and after treatment, and curative effect of Tongluo Zhujing pill was evaluated. Through the blood and urine routine, ECG, liver and kidney function test, secu-rity of Tongluo Zhujing pill was evaluated. RESULTS Each group lost 2 patients separately. Conventional general examinations related diabetes before the treatment showed no obvious abnormality. Visual acuity score（ETDRS vision）： the treatment group was 7.78±32.34 before the treatment, and the control group was34.64 ±8.13; after treatment, the treatment group was44.62±6.33, the control group was 43.38±6.94. The visual acuity of the 2 groups both improved after treat-ment, while the difference was not statistically significant（P0.05）. The efficacy of ocular fundus signs： in the treatment group, remarkable effect was obtained in 16 eyes（32%）, effective in 26 eyes（52%）, stabled in 8 eyes（16%）,worse in 0 eyes（0%）, the total effective rate was 84%. In control group, 25 patients（50 eyes）, 11 eyes（22%） were markedly effective, 21 eyes（42%） were effective, stabled in 12 eyes（24%）, worsen in 6 eyes（12%）, the total ef fective rate was 64%, the treatment group was better than the