目的：评价益心通脉汤防治糖尿病合并冠心病冠脉内支架植入术后再狭窄的疗效性和安全性。方法：选择病例60 例，随机分为西药常规治疗加益心通脉汤组（治疗组）和西医常规治疗组（对照组），观察用药前后1 年支架内再狭窄的发生及用药前后的中医证候量表、中医证候单症状的变化，同时观察益心通脉汤对血糖的影响及其他不良反应。结果：疗效性评价，试验组再狭窄率6.90%，对照组再狭窄率17.24%，2 组差异有统计学意义（P＜0.05）。根据中医证候疗效标准，试验组总有效率86.21%，对照组总有效率31.03%，2 组差异有统计学意义（P＜0.05）；安全性评价，研究期间2 组安全性检测未见明显异常，对血糖水平无影响，未发生与药物相关的不良反应。结论：益心通脉汤能降低糖尿病合并冠心病（胸痹心痛）气虚血瘀、痰浊阻滞证冠脉内支架置入术后再狭窄率，且能明显改善患者的中医证候及单症状，同时具有良好的安全性。

This study was aimed to evaluate the efficacy and safety of Yixin Tongmai Decoction in prevention and treatment of diabetes mellitus complicated with coronary heart disease (CHD) after coronary stenting restenosis. Sixty cases were randomly divided into the conventional western medicine treatment plus Yixin Tongmai Decoction group (treatment group) and conventional treatment of western medicine group (control group). Observation was given on the in-stent restenosis before treatment and one-year after treatment. And the traditional Chinese medicine (TCM) Syndrome Scale, changes of single symptom in TCM syndrome, effect of Yixin Tongmai Decoction on blood glucose and other adverse reactions were also observed before and oneyear after treatment. The results showed that in the curative effect evaluation, the restenosis rate of treatment group was 6.90%, and the restenosis rate of control group was 17.24%. There was significant difference between two groups (P < 0.05). According to the standard of TCM syndrome curative effect, the total effectiveness in the treatment group was 86.21%, and that of the control group was 31.03%. And there was significant difference between two groups (P < 0.05). In the safety evaluation, there were no obvious abnormalities during safety detection in the clinical study of two groups. There was no influence on blood sugar levels. And no drug related adverse reactions occurred. It was concluded that Yixin Tongmai Decoction can reduce coronary stent restenosis rate in diabetes complicated with CHD (chest pain) with the syndrome of qi deficiency and blood stasis, phlegm-turbid stasis. It can significantly improve the TCM syndrome and single symptom of patients with good safety.

四川省中医药管理局科研项目（CSZYJ2011006）：益心通脉汤对糖尿病合并冠心病冠脉内支架植入术后再狭窄的多中心、随机临床试验，负责人：许勇。