Zhao Yue, Yu Jiangyi, Liu Jingshun, An Xiaofei
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Nanjing University of Chinese Medicine), Nanjing, China.
Evid Based Complement Alternat Med. 2016;2016:7931314. doi: 10.1155/2016/7931314. Epub 2016 Dec 19.
To observe the clinical prophylactic and therapeutic efficacy of Liuwei Dihuang Pills and Ginkgo Leaf Tablets for type 2 diabetic vascular complications. It was a randomized, double-blind and placebo-controlled clinical trial. 140 outpatients with type 2 diabetes were recruited and randomly divided into the treatment group and control group. The two groups were given basic therapy (management of blood sugar, blood pressure, etc.). Additionally, the treatment group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets, while the control group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets placebos. All subjects were followed up for consecutive 36 months and observed monthly. The clinical data as urinary microalbumin to urinary creatinine ratio (Umalb/cr), carotid intima-media thickness (IMT), diabetic nephropathy (DN) and diabetic retinopathy (DR) prevalence, cardiovascular and cerebrovascular events, blood glucose, and blood pressure were collected and analyzed statistically. After 36-month treatment, the Umalb/cr level and DN and DR prevalence in treatment group were all significantly lower than control group ( < 0.05). However, the IMT level and the incidence of cardiovascular and cerebrovascular events were not significantly different between the two groups ( > 0.05). Liuwei Dihuang Pills and Ginkgo Leaf Tablets are beneficial to diabetic microvascular complications, while the efficacy to diabetic macrovascular complications needs more observations.
观察六味地黄丸联合银杏叶片对2型糖尿病血管并发症的临床防治效果。这是一项随机、双盲、安慰剂对照的临床试验。招募140例2型糖尿病门诊患者，随机分为治疗组和对照组。两组均给予基础治疗（血糖、血压等管理）。此外，治疗组给予六味地黄丸和银杏叶片，对照组给予六味地黄丸和银杏叶片安慰剂。所有受试者连续随访36个月，每月观察一次。收集临床数据，如尿微量白蛋白与尿肌酐比值（Umalb/cr）、颈动脉内膜中层厚度（IMT）、糖尿病肾病（DN）和糖尿病视网膜病变（DR）患病率、心脑血管事件、血糖和血压，并进行统计学分析。治疗36个月后，治疗组的Umalb/cr水平以及DN和DR患病率均显著低于对照组（<0.05）。然而，两组的IMT水平以及心脑血管事件发生率差异无统计学意义（>0.05）。六味地黄丸联合银杏叶片对糖尿病微血管并发症有益，而对糖尿病大血管并发症的疗效尚需更多观察。
