目的：观察丹蛭降糖胶囊联合阿托伐他汀钙对糖尿病不伴有高血压病患者颈动脉内膜中层厚度（IMT）的疗效及安全性。方法：196 例颈动脉IMT 增厚的糖尿病不伴有高血压病患者，随机分为对照组（98 例）和治疗组（98 例）。2 组均给予常规糖尿病治疗，对照组给予阿托伐他汀钙20 mg/晚，治疗组在对照组基础上加用丹蛭降糖胶囊9.0 g/晚，治疗12 个月。分别于治疗前后检测2 组颈动脉IMT、斑块面积和空腹血糖（FPG）、空腹胰岛素（FIns）、胰岛紊抵抗指数（HOMA-IR）、糖化血红蛋白（HbA1c）、血脂、肝肾功能等。结果：颈动脉IMT 与FIns、HOMA-IR、HbA1c、低密度脂蛋白（LDL-C）呈显著正相关。治疗12 个月后，治疗组总有效率为85.87%，与对照组比较有显著性差异（P＜0.05）；治疗组FPG、FIns、HOMA-IR、HbA1c 与对照组比较无差异；与对照组相比，治疗组TC、LDL-C 明显降低（P＜0.05），HDL-C 明显升高（P＜0.05）；治疗组颈动脉IMT 由（0.11±0.01）cm 减少为（0.08±0.01）cm，与对照组比较差异有统计学意义（P＜0.05）；治疗组58 例颈动脉粥样硬化斑块面积由（0.37±0.56）cm2 降为（0.21±0.25）cm2，与对照组比较差异无统计学意义；对照组发生不良事件5 例，治疗组9 例，2 组间比较无差异。结论：丹蛭降糖胶囊联合阿托伐他汀钙可以调节脂代谢，降低颈动脉IMT。

This study was aimed to observe the curative effect and safety of Danzhi Jiangtang Capsule (DJC) combined with atorvastatin on carotid artery intima-media thickness (IMT) in diabetes patients without hypertension. A total of 196 diabetes patients without hypertension with incrassate carotid artery IMT were randomly divided into the control group (98 cases) and the treatment group (98 cases). The conventional diabetes therapy was given to both groups. The atorvastatin of 20 mg/night was given to the control group. And the atorvastatin 20 mg/night added with DJC 9.0 g/night were given to the treatment group. The treatment course was 12 months. Carotid artery IMT, carotid atherosclerotic plaque area, FPG, FIns, HOMA -IR, HbA1c, blood lipids, hepatorenal function and etc. were examined before and after the treatment respectively. The results showed that there was a significant positive correlation between carotid artery IMT and FIns, HOMA -IR,HbAlc, LDL -C. After 12 -month treatment, the total effectiveness is 85.87% in the treatment group. And there was significant difference compared with the control group (P < 0.05). The levels of FPG, FIns, HOMA-IR, HbAlc of the treatment group had no difference compared with the control group. Compared with the control group, TC and LDL-C of the treatment group was obviously decreased (P < 0.05). And HDL-C was significantly increased (P < 0.05). The carotid artery IMT of the treatment group decreased from (0.11 ±0.01) cm to (0.08 ±0.01) cm. And compared with the control group, there was statistical significance (P <0.05). The carotid atherosclerotic plaque area of 58 cases in the treatment group decreased from (0.37 ±0.56) cm2 to (0.21 ±0.25) cm2. However, there was no statistical significance compared to the control group.There were 5 adverse events in the control group and 9 adverse events in the treatment group. And there was no difference between two groups. It was concluded that DJC combined with atorvastatin can regulate lipid metabolism and reduce carotid artery IMT.

国家中医药管理局国家中医临床研究基地建设项目（20081211）：糖尿病重点研究病种，负责人：方朝晖；国家中医药管理局中医药重点学科（20091221）：中医内分泌学，负责人：方朝晖；国家科技部国家科技支撑计划（2012BA126B00）：新安医学传承与发展研究--新安医学防治消渴病（糖尿病）临床研究，总课题负责人：王键，子课题负责人：方朝晖。