补肾明目胶囊对肝肾阴虚兼血瘀型非增生型糖尿病视网膜病变的随机对照研究  

Randomized and controlled trial study on no-proliferative diabetic retinopathy cases in liver-kidney yin deficiency and blood stasis syndrome by Bushen Mingmu capsule

作　　者：李亚敏[1] 张风梅 王瑛璞 

机构地区：[1]河南中医药大学,郑州450002 [2]河南中医药大学第二附属医院,郑州450002

出　　处：《中国中医眼科杂志》2017年第5期300-304,共5页China Journal of Chinese Ophthalmology

基　　金：河南省科学技术厅科技发展计划资助项目(122102310176)

摘　　要：目的评价补肾明目胶囊对肝肾阴虚兼血瘀型非增生型糖尿病视网膜病变(NPDR)的临床疗效。方法前瞻性随机对照临床研究。以2016年1月—2017年1月在河南中医药大学第二附属医院眼科诊断为肝肾阴虚兼血瘀型NPDR为研究对象,依照纳入、排除标准选择受试者。纳入受试者按照1:1比例随机分为观察组、对照组。两组均依照中国糖尿病防治指南原则进行基础治疗,在此基础上,观察组予口服补肾明目胶囊,对照组予口服芪明颗粒。两组均治疗观察12周,观察两组治疗前后视力、中医证候积分、眼底体征及闪光视网膜电图(F-ERG)振荡电位(OPs)变化,同期观察不良反应发生情况。结果共纳入患者80例(160只眼),观察组40例(80只眼),对照组40例(80只眼)。观察组的视力疗效、中医证候疗效优于对照组(视力疗效总有效率92.50%>72.50%,P=0.004;中医证候疗效总有效率87.50%>62.50%,P=0.020),眼底体征疗效与对照组大致相当(总有效率82.50%>80.00%,P=0.809)。治疗后,两组患者被观察眼的OPs子波振幅均较治疗前提高(P<0.05),子波时值较治疗前缩短(P<0.05);观察组的OP_1、OP_2振幅及各子波振幅总和明显高于同期对照组(P<0.05),OP_1、OP_2时值明显低于对照组(P<0.05)。治疗期间两组患者空腹血糖及尿糖水平控制良好。检测一般项目(体温、心率、呼吸、血压)、心电图、血尿常规、肝肾功能未见明显异常。对照组在服药期间有5例患者出现腹痛、便溏等胃肠道不适,对症处理后症状缓解。结论补肾明目胶囊对肝肾阴虚兼血瘀型NPDR有较好疗效,可以提高患眼视力,减轻眼底病变,改善内层视网膜功能及患者的中医症状,但更为确切的结论有待更大样本的多中心研究进行验证。OBJECTIVE To evaluate the clinical effect of Bushen Mingmu capsule on non-proliferative diabetic retinopathy（NPDR） patients in liver-kidney yin deficiency and blood stasis syndrome. METHODS It was a prospective, randomized, controlled trial study. The NPDR patients in liver-kidney yin deficiency and blood stasis syndrome in the second affiliated hospital of Henan University of TCM from January 2016 to January 2017 was se-lected according to the inclusion and exclusion criteria and then randomly divided into observation group and control group evenly. All cases were treated according to the guideline of Chinese diabetes prevention guidelines, and the observation group was administered with Bushen Mingmu capsule while the control group was given Qiming granule.The two groups were followed up for 12 weeks and changes in terms of visual acuity, scores of symptoms of TCM, oc-ular fundus signs, the amplitudes and latent durations of flash electroretinogram（F-ERG） oscillatory potentials（OPs） before and after treatment as well as adverse reactions were recorded. RESULTS There were 80 patients（160） eyes） in total, 40 （80 eyes） in the observation group and 40（80 eyes） in the control group. The effect of their visual acuity and symptoms of TCM in the observation group was significantly better than that of the control group（92.50% VS 72.50%, P=0.004; 87.50%VS62.50%, P=0.020）.The effect of their ocular fundus signs was similar（82.50% VS 80.00%, P=0.809）. After treatment, the amplitudes of F-ERG OPs in both groups was improved（P〈0.05）, and the latent duration of F-ERG OPs decreased（P〈0.05）. The amplitudes of F-ERG OP_1, OP_2 and their totality in the observation group were higher than that of the control group（P〈0.05） and the latent duration of F-ERG OP_1, OP_2 was significantly lower than that of the control group（P〈0.05）.During the treatment, all subjects were under control of fasting glucose and urine sugar levels. Their general parameters of life as body temperature

关 键 词：补肾明目胶囊 非增生型糖尿病视网膜病变 视网膜电图 振荡电位 芪明颗粒 肝肾阴虚 随机对照试验 

分 类 号：R774.1[医药卫生—眼科]