【目的】 探讨加味补阳还五汤治疗 2型糖尿病周围神经病变气虚血瘀型患者的疗效及其对血清成纤维细胞生长因子 21 （FGF21）、25-羟维生素D[25（OH）D]、内皮素1（ET-1）水平和高凝状态的影响。【方法】 将2019年12月至2022年12月海口市 中医医院收治的124例2型糖尿病周围神经病变气虚血瘀型患者按随机数字表法随机分为对照组和观察组，每组各62例。对 照组给予西医常规治疗，观察组在对照组的基础上联合加味补阳还五汤治疗，疗程为 12周。观察 2组患者治疗前后中医证 候积分、血糖指标、血液流变学指标、神经传导速度及血清 FGF21、25（OH）D、ET-1和白细胞介素 6（IL-6）水平的变化情 况，并评价 2 组患者的临床疗效。【结果】（1）疗效方面，治疗 12 周后，观察组的总有效率为 96.77%（60/62），对照组为 83.87%（52/62），组间比较（χ2检验），观察组的疗效明显优于对照组（P < 0.05）。（2）中医证候方面，治疗后，2组患者的肢体 疼痛、感觉减退、多食易饥、肢体麻木等各项中医证候积分及总积分均较治疗前降低（P < 0.05），且观察组的降低幅度均明 显优于对照组（P < 0.05）。（3）血液流变学方面，治疗后，2组患者的血细胞比容、全血高切黏度、血浆黏度等各项血液流变 学指标均较治疗前降低（P < 0.05），且观察组的降低幅度均明显优于对照组（P < 0.05）。（4）神经传导速度方面，治疗后，2组 患者的腓总神经和正中神经运动传导速度均较治疗前升高（P < 0.05），且观察组的升高幅度均明显优于对照组（P < 0.05）。 （5）血糖指标方面，治疗后，2组患者的血清空腹血糖（FBG）、糖化血红蛋白（HbA1C）水平均较治疗前降低（P < 0.05），且观 察组的降低幅度均明显优于对照组（P < 0.05）。（6）血清FGF21、25（OH）D、ET-1、IL-6水平方面，治疗后，2组患者的血清 FGF21、ET-1、IL-6 水平均较治疗前降低（P < 0.05），血清 25（OH）D 水平均较治疗前升高（P < 0.05），且观察组对血清 FGF21、ET-1、IL-6水平的降低幅度及对血清25（OH）D水平的升高幅度均明显优于对照组（P < 0.05）。【结论】 对于2型糖尿 病周围神经病变气虚血瘀型患者，在西医常规治疗基础上联合加味补阳还五汤治疗，有助于减轻炎症反应，减轻血管内皮 功能损伤，调节血糖水平，改善神经机能，提高临床疗效。

Objective To investigate the therapeutic efficacy of modified Buyang Huanwu Decoction in the treatment of type 2 diabetes mellitus（T2DM）patients with peripheral neuropathy of qi deficiency and blood stasis type，and to observe its effects on serum fibroblast growth factor 21（FGF21），25-hydroxyvitamin D[25（OH）D]， endothelin 1（ET-1）levels and hypercoagulable state of the patients. Methods A total of 124 T2DM patients with peripheral neuropathy of qi deficiency and blood stasis type who admitted to Haikou Hospital of Traditional Chinese Medicine from December 2019 to December 2022 were randomly divided into a control group and an observation group，with 62 cases in each group according to the random number table method. The control group was treated with conventional western medicine， and the observation group was treated with modified Buyang Huanwu Decoction on the basis of treatment for the control group. The course of treatment for the two groups covered 12 weeks. The changes of traditional Chinese medicine（TCM）syndrome scores，blood glucose indicators，hemorheology indicators，nerve conduction velocity（NCV）and levels of serum FGF21，25（OH）D，ET-1，interleukin 6（IL-6） in the two groups before and after treatment were observed. After treatment， the therapeutic efficacy of the two groups was evaluated. Results（1）After 12 weeks of treatment，the total effective rate of the observation group was 96.77%（60/62）and that of the control group was 83.87%（52/62），and the intergroup comparison（tested by chi-square test）showed that the therapeutic efficacy of the observation group was significantly superior to that of the control group（P < 0.05）. （2）After treatment， the total TCM syndrome scores and the scores of TCM symptoms such as limb pain，hypoesthesia，excessive eating with frequent hunger，and limb numbness in the two groups were decreased when compared with those before treatment（P < 0.05），and the decrease in the observation group was significantly superior to that in the control group（P < 0.05）.（3） After treatment， the levels of hemorheology indicators such as hematocrit，whole blood viscosity at high-shear rate，and plasma viscosity in the two groups of patients were decreased when compared with those before treatment（P < 0.05），and the decrease in the observation group was significantly superior to that in the control group（P < 0.05）.（4）After treatment，the motor conduction velocity of the common peroneal nerve and the median nerve in the two groups of patients was increased when compared with that before treatment（P < 0.05），and the increase in the observation group was significantly superior to that in the control group（P < 0.05）.（5）After treatment，the serum levels of blood glucose indicators such as fasting blood glucose（FBG）and glycosylated hemoglobin（HbA1C）in the two groups of patients were decreased when compared with those before treatment（P < 0.05），and the decrease in the observation group was significantly superior to that in the control group（P < 0.05）.（6）After treatment，the serum FGF21，ET-1， and IL-6 levels in the two groups were decreased（P < 0.05），and serum 25（OH）D level was increased（P < 0.05），and the decrease of serum FGF21，ET-1，and IL-6 levels as well as the increase of serum 25（OH）D level in the observation group was significantly superior to that in the control group（P < 0.05）. Conclusion For T2DM patients with peripheral neuropathy of qi deficiency and blood stasis type， the combination of modified Buyang Huanwu Decoction with conventional treatment in western medicine is helpful for reducing the inflammatory response， alleviating the damage of vascular endothelial function， regulating the levels of blood glucose，improving the neurologic function，and enhancing the clinical efficacy.

R259.872

海南省卫生健康行业科研项目（编号：20A200076）