目的：探讨具有益气养阴活血功效的丹蛭降糖胶囊对2 型糖尿病模型大鼠血浆可溶性血栓调节蛋白（sTM）、可溶性内皮细胞蛋白C 受体（sEPCR）的影响及其防治糖尿病血管病变作用机制。方法：将60 只SD 雄性大鼠适应性喂养1 周后，按体重分层随机分为2 组：空白组（N 组）12 只，高脂饲料组48 只。4 周后，高脂饲料组大鼠腹腔注射链脲佐菌素（STZ），诱发出2 型糖尿病大鼠模型，再根据血糖水平分层随机分为3 组：模型组（M 组）、盐酸吡格列酮组（P 组）、加用丹蛭降糖胶囊组（D 组）。盐酸吡格列酮组和加用丹蛭降糖胶囊组均给予盐酸吡格列酮10 mg·kg-1·d-1 灌胃，加用丹蛭降糖胶囊组在此基础上加用丹蛭降糖胶囊0.47 g·kg-1·d-1 灌胃，空白组与模型组予生理盐水5 mL·kg-1·d-1 灌胃，给药4 周后分别检测各组sTM、sEPCR、PT、APTT、FIB 水平。结果：与对照组比较，模型组、盐酸吡格列酮组和加用丹蛭降糖胶囊sTM、sEPCR、FIB 均明显增高（P<0.05），PT、APTT 水平明显降低（P<0.05）；与盐酸吡格列酮组相比，加用丹蛭降糖胶囊组大鼠血浆sTM、sEPCR、FIB 水平均显著降低（P<0.01），APTT 水 平明显升高（P<0.05），但在升高PT 方面二者无明显差异。结论：益气养阴活血法能降低sTM、sEPCR 水平，有效改善凝血功能。其防治糖尿病血管病变的机制可能是通过降低sTM、sEPCR 含量增强抗凝与纤溶活性，调节凝血功能来改善血液高凝状态，从而保护血管内皮功能。

This study was aimed to observe the effect of Danzhi Jiangtang Capsule (DJC) on expression of soluble thrombomodulin (sTM) and soluble endothelial cell protein C receptor (sEPCR) in experimental rats of type 2 diabetes mellitus (T2DM). This study also explored possible mechanisms of Yiqi Yangyin Huoxue method on vascular endothelial tissue and discussed mechanisms of prevention and management of T2DM vascular lesions.A total of 60 male Sprague-Dawley (SD) rats were fed for one week and then randomly divided into the normal control group (group N, n = 12, rats were fed with routine food) and diabetes mellitus group (n = 48,rats were fed with high-fat diet). After 4 weeks, rats in the diabetes mellitus group were injected with streptozotocin (STZ) to induce T2DM. According to the blood glucose level, rats were divided into three groups, which were the model group (group M), pioglitazone (group P), and pioglitazone combined with DJC (group D). Group P was treated with pioglitazone (10 mg·kg-1·d-1), group D was given pioglitazone (10 mg·kg-1·d-1) and DJC (0.47 g·kg-1·d-1). The group N and group M were treated with sodium chloride (5 mL·kg -1·d-1). After four-week drug administration, the levels of sTM, sEPCR, PT, APTT and FIB in each group were tested. The results showed that compared with the control group, the levels of sTM, sEPCR and FIB in group M, group P and group D were significantly increased (P < 0.05), and the levels of PT and APTT were obviously reduced (P < 0.05). Compared with group P, the levels of sTM, sEPCR, FIB of group D were significantly reduced (P< 0.01), and the level of APTT was significantly increased (P < 0.05). However, there was no significant difference in the increasing of PT. It was concluded that the Yiqi Yangyin Huoxue method can reduce the levels of sTM and sEPCR, and effectively improve coagulation. The possible mechanisms of protective effect on the vascular endothelium can be from reducing levels of sTM and sEPCR in order to enhance the activity of anticoagulation and fibrinolysis, regulate the function of blood coagulation to improve hypercoagulable state.

国家中医药管理局国家中医药临床研究基地建设项目（20081211）：糖尿病重点研究病种研究，负责人：方朝晖；国家中医药管理局国家中医药重点学科（20091221）：内分泌学科，负责人：方朝晖；国家科技部国家科技重大专项课题（2010ZX09102）：糖尿病血管病变治疗药——丹蛭降糖胶囊临床前研究，总课题负责人：王健，子课题负责人：方朝晖。