八段锦结合甲钴胺片治疗2型糖尿病周围神经病变临床研究

Clinical study of Baduanjin combined with mecobalamin tablets for the patients with type 2 diabetic peripheral neuropathy

目的评价八段锦结合甲钴胺片治疗T2DM中DPN的疗效。方法将符合入选标准2019年3月1日-2020年10月31日上海中医药大学附属市中医医院T2DM中DPN患者80例,采用随机数字表法分为2组,每组40例。全部患者均积极控制血糖,对照组在此基础上口服甲钴胺片,治疗组在对照组基础上习练八段锦。2组均连续观察12周。采用多伦多临床评分系统(Toronto Clinical Scoring System,TCSS)评估DPN病变程度;应用肌电诱发电位仪检测胫神经的运动传导速度(motor conduction velocity,MCV)和腓浅神经的感觉传导速度(sensory conduction velocity,SCV);以全自动血流变测试仪检测全血低切黏度、全血高切黏度及血浆黏度;评价临床疗效,记录不良事件。结果治疗过程中,2组分别脱落1例,最终各有39例进入疗效统计。治疗组总有效率为87.2%(34/39)、对照组为64.1%(25/39),2组比较差异有统计学意义(χ^(2)=5.64,P=0.018)。治疗后,治疗组TCSS评分低于对照组(t=-6.23,P<0.01);治疗组胫神经MCV[(43.06±4.19)m/s比(39.55±4.30)m/s,t=3.65]、腓浅神经SCV[(43.23±4.31)m/s比(39.92±3.74)m/s,t=3.62]均高于对照组(P<0.01);治疗组全血高切黏度、低切黏度及血浆黏度均低于对照组(t值分别为-10.36、-14.21、-13.88,P值均<0.001)。治疗期间,2组均未发生严重不良事件。结论八段锦结合甲钴胺片可有效降低T2DM中DPN患者的血液黏度,提高神经传导速度,改善临床症状与体征,提高临床疗效。

Objective To evaluate the efficacy of Baduanjin combined with mecobalamin tablets in the treatment of type 2 diabetic peripheral neuropathy.Methods Eighty patients with type 2 diabetic peripheral neuropathy who met the inclusion criteria were randomly divided into two groups with 40 patients in each group(n=40).The control group took oral mecobalamin tablets and self-management,and the treatment group were treated with Baduanjin on the basis of the control group.All patients were treated for 12 weeks.The clinical symptoms were evaluated by Toronto Clinical Scoring System(TCSS),and the motor nerve conduction velocity(MCV)of tibial nerve and the sensory conduction velocity(SCV)of superficial peroneal nerve were measured by EMG evoked potential instrument.The hemorheological indexes(whole blood low shear viscosity,whole blood high shear viscosity and plasma viscosity)were measured before and after treatment.The clinical efficacy was evaluated and adverse events were recorded.Results In the course of treatment,39 patients in each group completed the study with each one dropout.The total effective rate was 87.2%(34/39)in the treatment group and 64.1%(25/39)in the control group.There was significant difference between the two groups(χ2=5.64,P=0.018).After treatment,the TCSS score of the treatment group was significantly lower than that of the control group(t=-6.23,P<0.01),the tibial nerve MCV(43.06±4.19 m/s vs.39.55±4.30 m/s,t=3.65),the superficial peroneal nerve SCV(43.23±4.31 m/s vs.39.92±3.74 m/s,t=3.62)in the treatment group were significantly higher than the control group(P<0.001),while the whole blood high shear viscosity,the whole blood low shear viscosity,and the plasma viscosity in the treatment group were significantly lower than the control group(t value were-10.36,-14.21,-13.88,all Ps<0.001).During the treatment,no serious adverse events occurred in both groups.Conclusion Baduanjin combined with mecobalamin tablets in the treatment of type 2 diabetic peripheral neuropathy can reduce blood viscosity,promote blood circulation,increase nerve conduction velocity,improve clinical symptoms and signs,and improve clinical efficacy.