【摘要】 目的观察血塞通胶囊联合α-硫辛酸治疗气虚血瘀证2型糖尿病周围神经病变(DPN)的疗效和安全性以及对病人血清肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)的影响。方法选取2016年10月至2018年10月在阜阳市人民医院就诊的DPN病人,采用随机数字表法分为治疗组40例,对照组40例。入组病人在糖尿病基础治疗的基础上,治疗组予以α-硫辛酸注射液600 mg静脉滴注,1次/天,同时予以中成药血塞通胶囊0.1 g冲服,3次/天,共12周。对照组静脉滴注α-硫辛酸注射液600mg,1次/天,共12个周。记录病人治疗前后的临床疗效、主侧正中神经、腓总神经的运动神经传导速度(MCV)及感觉神经传导速度(SCV),进行多伦多临床评分系统(TCSS)评分、中医证候评分与安全性观察,于治疗前、治疗6周、12周,利用ELISA法检测血清TNF-α、IL-1β水平。结果经过12个周治疗后,治疗组和对照组总有效率分别为87.5%(35/40)、67.5%(27/40),治疗组的疗效比对照组提升明显(P<0.05)。两组病人的MCV、SCV均比治疗前有明显提升,且治疗组的提高更加明显(P<0.05)。治疗组病人治疗后TCSS评分(7.2±3.0)分和中医证候评分(7.5±2.4)分均较治疗前TCSS评分(10.1±2.9)分和中医证候评分(13.7±2.8)分及对照组治疗后TCSS评分(8.6±2.9)分和中医证候评分(9.4±3.1)分明显下降(P<0.05)。两组病人随着治疗时间的延长,血清中的TNF-α、IL-1β水平逐渐降低(P<0.05),且治疗组6周TNF-α(28.2±2.7)mg/L、IL-1β(18.5±2.1)mg/L水平,12周TNF-α(19.8±3.2)mg/L、IL-1β(11.3±2.0)mg/L水平均低于对照组6周TNF-α(32.6±4.5)mg/L、IL-1β(23.9±2.0)mg/L水平,12周TNF-α(28.5±3.4)mg/L、IL-1β(16.6±1.9)mg/L水平(P<0.05)。治疗组和对照组均未出现明显不良反应。结论血塞通胶囊联合α-硫辛酸治疗气虚血瘀证DPN病人疗效显著,安全性好,能降低病人血清TNF-α、IL-1β的表达。更多还原

【Abstract】 Objective To observe the efficacy and safety of xuesaitong capsule combined with α-lipoic acid in the treatment oftype 2 diabetic peripheral neuropathy(DPN)with qi-deficiency and blood stasis syndrome,and the effect on serum TNF-α and IL-1β of the patients.MethodsFrom October 2016 to October 2018,DPN patients who were treated in Fuyang People’s Hospitalwere selected through random number table method,80 DPN patients were randomly divided into two groups,40 in the treatmentgroup and 40 in the control group.On the basis of the basic treatment of diabetes,the treatment group was given intravenous infu-sion of alpha-lipoic acid injection 600 mg,once a day,and Chinese patent medicine xuesaitong capsule 0.1 g,3 times a day for 12 weeks.The control group received intravenous infusion of alpha-lipoic acid injection 600 mg once a day for 12 weeks.The clinical ef-ficacy,motor nerve conduction velocity(MCV)and sensory nerve conduction velocity(SCV)of the central median nerve and thecommon peroneal nerve before and after treatment were recorded,and perform multiple rounds of clinical scoring system(TCSS)score,TCM syndrome score and safety observation.Before treatment,6 weeks,12 weeks of treatment,serum TNF-α and IL-1β levelswere detected by ELISA.ResultsAfter 12 weeks of treatment,the total effective rate of the treatment group and the control groupwas 87.5%(35/40)and 67.5%(27/40),respectively.The therapeutic effect of the treatment group was significantly improved com-pared with that of the control group(P<0.05).MCV and SCV in both groups were significantly improved compared with that be-fore treatment,and the improvement was more obvious in the treatment group(P<0.05).After treatment,TCSS score(7.2±3.0)andTCM syndrome score(7.5±2.4)in treatment group were significantly lower than before treatment TCSS score(10.1±2.9)and TCMsyndrome score(13.7±2.8)(P<0.05),and after treatment TCSS score(8.6±2.9)and TCM syndrome score(9.4±3.1)in control group.The serum levels of TNF-α and IL-1β in the two groups decreased gradually with the prolongation of treatment time(P<0.05),and the levels of 6 weeks TNF-α(28.2±2.7)mg/L and IL-1β(18.5±2.1)mg/L and 12 weeks TNF-α(19.8±3.2)mg/L and IL-1βIL-1β(11.3±2.0)mg/L in the treatment group were lower than the levels of 6 weeks TNF-α(32.6±4.5)mg/L and IL-1β(23.9±2.0)mg/Land 12 weeks TNF-α(28.5±3.4)mg/L and IL-1β(16.6±1.9)mg/L in the control group(P<0.05).No significant adverse reactionsoccurred in the treatment group and the control group.Conclusion Xuesaitongcapsule combined with α-lipoic acid is effectiveand safe in the treatment of diabetic peripheral neuropathy with qi-deficiency and blood stasis,and can reduce the expression ofTNF-α and IL-1β in serum.更多还原