目的 探讨益肾活血方联合依帕司他片治疗肾虚血瘀型糖尿病周围神经病变 （DPN） 患者的临床疗效及对血清纤维凝胶蛋白 3 （ficolin-3） 水平的影响。方法 将 106 例肾虚血瘀型 DPN 患者随机分为对照组和观察组，每组各 53 例。2 组患者均给予基础降血糖药物控制血糖，在此基础上，对照组给予口服依帕司他片治疗，观察组给予益肾活血方联合依帕司他片治疗，疗程为 12 周。观察 2 组患者治疗前后中医证候积分、Fugl-Meyer评价量表 （FMA） 、多伦多临床神经病变评分系统 （TCSS） 评分、双下肢肌电图指标、血糖、血脂及血清一氧化氮 （NO） 、内皮素 1 （ET-1） 、ficolin-3 水平的变化情况，并评价 2 组患者的临床疗效及治疗安全性。结果（1） 治疗后，2 组患者中医证候积分、TCSS 评分均较治疗前降低 （P＜0.05） ，FMA 评分升高 （P＜0.05） ，且观察组中医证候积分、TCSS 评分低于对照组 （P＜0.05） ，FMA 评分高于对照组 （P＜0.05） 。 （2） 治疗后，2 组患者的双下肢腓总神经运动神经传导速度 （MCV） 、腓肠神经感觉神经传导速度 （SCV） 均较治疗前明显升高 （P＜0.05） ，且观察组的升高幅度均明显大于对照组 （P＜0.05） 。 （3） 治疗后，2 组患者的空腹血糖 （FPG） 、糖化血红蛋白（HbA1c） 、总胆固醇 （TC） 、甘油三酯 （TG） 水平均较治疗前明显降低 （P＜0.05） ，且观察组的降低幅度均明显大于对照组 （P＜0.05） 。 （4） 治疗后，2 组患者的血清 NO 水平均较治疗前明显升高 （P＜0.05） ，血清 ET-1、ficolin-3水平降低 （P＜0.05） ，且观察组血清 NO 水平高于对照组，血清 ET-1、ficolin-3 水平低于对照组 （P＜0.05） 。 （5）治疗后，观察组的总有效率 （90.57%） 明显高于对照组 （73.58%）（P＜0.05） 。 （6） 2 组患者不良反应发生率比较，差异无统计学意义（P＞0.05） 。结论 益肾活血方联合依帕司他片治疗肾虚血瘀型 DPN 患者效果良好，可有效调节患者的血糖、血脂水平，改善患者的双下肢神经功能及传导速度，调节血管内皮功能，增强下肢运动功能。

Objective To investigate the clinical efficacy of Yishen Huoxue Prescription combined with epalrestat tablets in the treatment of diabetic peripheral neuropathy（DPN）patients with kidney deficiency and blood stasis type，and to explore its influence on serum ficolin-3 level. Methods A total of 106 DPN patients with kidney deficiency and blood stasis type were randomly divided into the control group and the observation group，with 53 cases in each group. Both groups were given basic hypoglycemic drugs to control blood glucose，and then the control group was given eparastat tablets orally，the observation group was given Yishen Huoxue Prescription combined with eparastat tablets. The two groups were treated for 12 weeks. The changes of traditional Chinese medicine （TCM） syndrome Fugl-Meyer assessment scale （FMA），Toronto clinical neuropathy scale （TCSS），electromyography of lower limbs parameters，blood glucose，blood lipids，serum nitric oxide （NO），endothelin-1 （ET-1） and ficolin-3 levels were observed before and after treatment， the clinical efficacy and safety of the two groups were evaluated. Results （1） After treatment，the scores of TCM syndrome and TCSS in both groups decreased （P＜0.05），while the FMA scores increased （P＜0.05）. The scores of TCM syndrome and TCSS in the observation group were lower than those in the control group （P＜0.05），FMA score was higher than that of control group （P＜0.05）. （2） After treatment，the motor nerve conduction velocity （MCV） of common peroneal nerve and the sensory nerve conduction velocity （SCV）of sural nerve in bilateral lower limbs of the two groups were significantly higher than those before treatment（P＜0.05），the increasing range of the observation group was obviously larger than that of the control group （P＜0.05）.（3） After treatment，the levels of fasting plasma glucose（FPG），glycosylated hemoglobin（HbA1c），total cholesterol（TC），and triglyceride（TG）in both groups were significantly lower than those before treatment （P＜0.05），the decreasing range of the observation group was obviously larger than that of the control group（P＜0.05）.（4） After treatment，the serum NO levels in both groups were significantly higher than those before treatment （P＜0.05），while the levels of ET-1 and ficolin-3 were lower than those before treatment （P＜0.05）. Moreover， the serum NO level of the observation group was higher than that of control group，the levels of ET-1 and ficolin-3 in serum of the observation group were lower than those in control group（P＜0.05）.（5）After treatment，the total effective rate was 90.57% in the observation group，which was significantly higher than that of 73.58% in the control group（P＜0.05）.（6）There was no significant difference in the occurrence of adverse reactions between two groups （P＞0.05）. Conclusion Yishen Huoxue Prescription combined with epalrestat tablets is effective in treating DPN patients with kidney deficiency and blood stasis type，which can effectively regulate the blood glucose and blood lipid levels of the patients，improve the nerve function and conduction velocity of bilateral lower limbs，regulate the vascular endothelial function，and enhance the motor function of the lower limbs.

R259.872

国家自然科学基金项目（81774304）