清热祛湿法治疗糖尿病周围神经病变临床研究

Clinical Study of Therapy of Clearing Heat and Dispelling Dampness for Treatment of Diabetic Peripheral Neuropathy

【目的】观察清热祛湿法治疗糖尿病周围神经病变(DPN)的临床疗效。【方法】将64例DPN(湿热交阻证)患者随机分为试验组和对照组,每组各32例。2组患者均给予糖尿病基础治疗,在此基础上,试验组给予清热祛湿法(口服加味四妙汤)治疗,对照组给予口服甲钴胺片治疗,疗程为6周。观察2组患者治疗前后中医证候评分、脂代谢指标[胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]、血清25羟基维生素D3(25OHD3)水平、低氧诱导因子1α(HIF-1α)、踝肱指数(ABI)、晚期糖基化终末产物(AGEs)的变化情况,并观察25OHD3、AGEs与其他指标的相关性。【结果】(1)治疗后,2组患者的中医证候评分和HDL-C、HIF-1α、ABI、AGEs水平及试验组的TC、TG、LDL-C、25OHD3水平均较治疗前明显改善(P<0.05或P<0.01),且试验组对中医证候评分和TC、TG、LDL-C、25OHD3、HIF-1α、ABI、AGEs水平的改善作用均明显优于对照组,组间治疗后及差值比较,差异均有统计学意义(P<0.05或P<0.01)。(2)相关性分析结果提示,25OHD3与TC、LDL-C、AGEs水平呈负相关,与HDL-C、ABI水平呈正相关,与TG、HIF-1α无明显相关性;AGEs与TG、TC、LDL-C、HIF-1α水平呈正相关,与HDL-C、ABI水平呈负相关。【结论】应用清热祛湿法治疗DPN湿热交阻证疗效显著,可有效改善患者临床症状,调节糖脂代谢和周围血管压力,其作用机制可能与改善血清25OHD3、AGEs水平有关。

Objective To observe the clinical effect of therapy of clearing heat and dispelling dampness on diabetic peripheral neuropathy(DPN). Methods Sixty-four DPN patients with damp-heat obstruction syndrome were randomly divided into trial group and control group, 32 cases in each group. Both groups were given basic treatment for diabetes mellitus. And additionally, the trial group was treated with oral use of modified Simiao Decoction which has the actions of clearing heat and dispelling dampness,and the control group was treated with oral use of mecobalamin tablets for 6 weeks. Before and after treatment,we observed the changes of traditional Chinese medicine(TCM)syndrome scores,lipid metabolism indexes such as total cholesterol(TC),triglyceride(TG),low-density lipoprotein cholesterol(LDL-C)and high-density lipoprotein cholesterol(HDL-C),serum25OH vitamin D3(25OHD3) level, hypoxia inducible factor 1 A(HIF-1α), ankle brachial index(ABI)and advanced glycation end products(AGEs)in the two groups. Meanwhile,the correlation of 25OHD3 and AGEs with other observation indexes was also investigated. Results(1)After treatment,obvious improvement was shown in the scores of TCM syndromes,HDL-C,HIF-1α,ABI and AGEs of the two groups,and in the levels of TC,TG,LDL-C and 25OHD3 of the trial group(P<0.05 or P<0.01 compared with those before treatment). The trial group had stronger effect on improving the scores of TCM syndromes and the levels of TC, TG, LDL-C,25OHD3,HIF-1α,ABI and AGEs than the control group,and the differences of the index levels after treatment together with those of their pre-and post-treatment difference values between the two groups were statistically significant(P < 0.05 or P<0.01).(2)The results of correlation analysis showed that 25OHD3 was negatively correlated with TC, LDL-C and AGEs, and was positively correlated with HDL-C and ABI, but was not correlated with TG and HIF-1α. AGEs was positively correlated with TG,TC,LDL-C and HIF-1α,and was negatively correlated with HDL-C and ABI. Conclusion The treatment of diabetic peripheral neuropathy with damp-heat obstruction syndrome by therapy of clearing heat and dispelling dampness is effective on relieving clinical symptoms and regulating glucose and lipid metabolism as well as the peripheral vascular pressure. Its mechanism may be related to the improvement of serum levels of 25OHD3 and AGEs.