木丹颗粒联合甲钴胺片治疗气虚血瘀型糖尿病周围神经病变的疗效观察

Observation on effect of Mudan Granules combined with mecobalamine tablets in treating diabetic peripheral neuropathy with Qi deficiency and blood stasis type

目的探讨木丹颗粒联合甲钴胺片治疗气虚血瘀型糖尿病周围神经病变(DPN)的临床疗效。方法选取2019年5月至2022年3月北京中医药大学房山医院内分泌科门诊就诊的92例DPN患者作为研究对象,根据随机数字表分为观察组和对照组,每组46例。对照组给予常规治疗联合甲钴胺片治疗,观察组在对照组的基础上加用木丹颗粒治疗,疗程12周。观察记录两组治疗前后腓肠神经的感觉神经传导速度(SNCV)、多伦多临床评分系统(TCSS)评分、中医证候评分、血清超氧化物歧化酶(SOD)、Klotho蛋白水平,以及糖化血红蛋白(HbA1c)、空腹血糖(FBG)、餐后2 h血糖(2 h PBG)水平和不良反应发生情况。结果两组治疗后腓肠神经SNCV均较治疗前增快,且观察组快于对照组(P<0.05)。两组治疗后TCSS评分、中医证候评分均较治疗前降低,且观察组低于对照组(P<0.05)。两组治疗后血清SOD及Klotho水平均较治疗前升高,且观察组血清SOD水平高于对照组(P<0.05)。两组治疗后HbA1c、FBG、2 h PBG水平均较治疗前降低(P<0.05)。与对照组比较,观察组临床总有效率(89.13%vs.73.91%)和中医症候总有效率(69.57%vs.63.04%)更高,但差异无统计学意义(P>0.05)。两组治疗期间均未出现不良反应。结论木丹颗粒联合甲钴胺片可改善DPN患者临床疗效。

Objective To study the clinical effect of Mudan Granules combined with mecobalamine tablets in the treatment of diabetic peripheral neuropathy(DPN)with Qi deficiency and blood stasis type.Methods Ninety-two cases of DPN diagnosed and treated in the endocrinology outpatient department of Fangshan Hospital of Beijing University of Chinese Medicine from May 2019 to March 2022 were selected as the study subjects and divided into the observation group and control group by the random number table method,46 cases in each group.The control group received the conventional treatment combined with mecobalamine tablets,and the observation group was treated with Mudan Granules on the basis of the control group.The treatment course lasted for 12 weeks.The sensory nerve conduction velocity(SNCV)of sural nerve,Toronto Clinical Scoring System(TCSS)scores,Traditional Chinese medicine(TCM)syndrome scores,serum superoxide dismutase(SOD)and Klotho protein levels,HbA1c,FBG and 2 h PBG levels and adverse reactions occurrence were recorded before and after treatment in both groups.Results SNCV of sural nerve after treatment in the two groups was faster than that before treatment,moreover the observation group was faster than the control group(P<0.05).The TCSS score and Traditional Chinese medicine(TCM)syndrome scores after treatment in the two groups were significantly decreased compared with those before treatment,moreover the observation group was lower than the control group(P<0.05).The serum SOD and Klotho levels after treatment in the two groups were increased compared with those before treament,moreover the serum SOD level in the observation group was higher than that in the control group(P<0.05).The glycated hemoglobin(HbA1c),fasting blood glucose(FBG)and 2 h postprandial blood glucose(2 h PBG)levels after treatment in the two groups were decreased compared with those before treatment(P<0.05).Compared with the control group,the total effective rate and TCM syndrome scores were higher(89.13%vs.73.91%,69.57%vs.63.04%),but the difference was not statistically significant(P>0.05).Conclusion Mudan Granules combined with mecobalamine tablets may improve the clinical efficacy in DPN patients.