六味地黄丸联合银杏叶片防治2型糖尿病早期视网膜病变临床观察

Treatment of Early Diabetic Retinopathy by Liuwei Dihuang Pill Combined Ginkgo Leaf Tablet

目的观察六味地黄丸联合银杏叶片对2型糖尿病早期视网膜病变(diabetic retinopathy,DR)的防治作用和临床疗效。方法采用随机、双盲、双模拟、平行对照的研究方法,选择140例2型糖尿病门诊患者,随机分为治疗组及对照组,每组70例,两组均给予西医基础治疗(控制血糖、血压等),治疗组给予六味地黄丸(8粒/次,3次/天)联合银杏叶片(19.2 mg/次,3次/天),对照组给予六味地黄丸安慰剂加银杏叶片安慰剂,每月随访观察,连续治疗24个月,收集两组一般人口学资料,治疗前后血糖代谢指标、血压、血脂及DR情况进行统计分析。结果两组治疗前后血糖代谢指标、血压、血脂水平比较,差异无统计学意义(P>0.05)。治疗组治疗后DR新增率[3.1%(2/64)]低于对照组[18.6%(11/59),P<0.05];治疗组DR患病率[6.3%(4/64)]低于对照组[20.0%(13/59),P<0.05]。结论六味地黄丸及银杏叶片对2型糖尿病早期视网膜病变有较好的防治作用。

Objective To observe the prevention and clinical efficacy of combination of Liuwei Dihuang Pill（LDP） and Ginkgo Leaf Tablet（GLT） for early diabetic retinopathy（DR）.Methods Using randomized,double-blind,double simulation,parallel controlled clinical trial,1 40 type 2 diabetes mellitus（T2DM） outpatients were recruited and assigned to the treatment group and the control group,70 in each group.All patients received basic Western medicine treatment（such as blood glucose and pressure control）.Patients in the treatment group took LDP（8 pills each time,3 times per day） and GLT（19.2 mg each time,3 times per day）,while those in the control group took LDP placebos and GLT placebos.All treatment lasted for 24 consecutive months.All subjects were followed-up every month.The general clinical data as sex,age,and metabolic data such as blood glucose,blood pressure,blood lipid,and DR prevalence rate were collected and statistically analyzed.Results There was no significant difference in levels of blood glucose,blood pressure,or blood lipid between the two groups（P 〈0.05）.After treatment the DR incidence rate was significantly lower in the treatment group than in the control group[3.1%（2 /64） vs18.6%（11/5 9）,P 〈0.05）].Meanwhile,the DR prevalence rate of the treatment group was also significantly lower than that of the control group[6.3%（4/64） vs 2 0.0%（1 3/5 9）,P0.05].Conclusion Combination of LDP and GLT could effectively prevent and treat the development of DR in T2 DM patients.