硫辛酸联合益气通络法中药熏洗治疗2型糖尿病性周围神经病变患者的疗效观察

Therapeutic Effect of Lipoic Acid Combined with Chinese Medicine Fumigation and Washing on Type 2 Diabetic Peripheral Neuropathy

目的 探讨硫辛酸联合益气通络法中药熏洗治疗2型糖尿病性周围神经病变(Diabetic peripheral neuropathy,DPN)的临床疗效。方法 选取2021年1月—2022年9月期间张家港市中医医院收治的100例DPN患者,按随机数字表法分为西医组与中西医组,每组各50例。两组患者均给予降糖治疗、饮食干预及运动干预、加强血脂与血脂管理,上述基础上,西医组给予硫辛酸治疗,中西医组给予硫酸锌注射液+益气通络法中药熏洗。治疗4周后,观察比较两组患者临床疗效、不良反应情况,治疗前后中医证候(肢体麻木、肢体冰凉、疼痛、神疲倦怠、气短懒言)积分、神经病变评分(Michigan Diabetic Neuropathy Score,MDNS)、神经传导速度[感觉神经传导速度(Sensory nerve conduction velocity,SNCV)、运动神经传导速度(Motor nerve conduction velocity,MNCV)]、血清氧化应激指标[总抗氧化能力(Total antioxidant capacity,T-AOC)、超氧化物歧化酶(Superoxide Dismutase,SOD)、丙二醇(Maleic dialdehyde,MDA)、还原型谷胱甘肽(Glutathione peroxidase,GSH-PX)]水平。结果 治疗后两组患者肢体麻木、肢体冰凉、疼痛、神疲倦怠、气短懒言评分均较治疗前降低,差异有统计学意义(P<0.05);且中西医组肢体麻木、肢体冰凉、疼痛、神疲倦怠、气短懒言评分低于西医组,差异有统计学意义(P<0.05)。治疗后中西医组临床疗效总有效率93.88%(46/49)明显高于西医组81.63%(40/49),差异有统计学意义(P<0.05)。治疗后两组患者MDNS评分均较治疗前降低,差异有统计学意义(P<0.05);且中西医组MDNS评分低于西医组,差异有统计学意义(P<0.05)。治疗后两组患者SNCV、MNCV(腓总神经、正中神经、胫后神经)水平均较治疗前升高,差异有统计学意义(P<0.05);且中西医组SNCV、MNCV(腓总神经、正中神经、胫后神经)水平高于西医组,差异有统计学意义(P<0.05)。治疗后两组患者血清T-AOC、SOD及GSH-PX水平较治疗前升高,MDA水平较治疗前降低,差异有统计学意义(P<0.05);且中西医组血清T-AOC、SOD及GSH-PX水平高于西医组,MDA水平低于西医组,差异有统计学意义(P<0.05)。治疗期间,两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论 硫辛酸联合益气通络法中药熏洗治疗DPN效果显著,安全性高,有利于抑制神经病变,缓解临床症状,改善DPN患者周围神经传导速度,且可能与纠正氧化-抗氧化失衡作用机制有关。

Objective To explore the clinical efficacy of lipoic acid combined with fumigation and washing with Yiqi Tongluo Decoction in treating type 2 diabetic peripheral neuropathy(DPN).Methods One hundred patients with DPN treated in Zhangjiagang Hospital of Traditional Chinese Medicine from January 2021 to September 2022 were randomized into a western medicine group(n=50)and an integrated Chinese and western medicine group(n=50)according to the random number table method.Both groups received hypoglycemic treatment,diet intervention,and exercise intervention,and strengthened blood lipid management.In addition,the western medicine group was treated with lipoic acid,and the integrated Chinese and western medicine group with zinc sulfate injection + fumigation and washing with Yiqi Tongluo Decoction.Both groups were treated for 4 weeks.The clinical efficacy and adverse reactions were compared between the two groups after treatment.The TCM symptom scores(limb numbness,limb cold,pain,mental fatigue,shortness of breath,and laziness to speak),Michigan diabetic neuropathy score(MDNS),nerve conduction velocity[sensory nerve conduction velocity(SNCV)and motor nerve conduction velocity(MNCV)],serum levels of oxidative stress indicators[total antioxidant capacity(T-AOC),superoxide dismutase(SOD),malondialdehyde(MDA),and reduced glutathione(GSH-PX)]were determined before and after treatment.Results After treatment,the TCM symptom scores in the two groups were lower than those before treatment,and the scores in the integrated Chinese and western medicine group were lower than those in the western medicine group(P<0.05).The total response rate in the integrated Chinese and western medicine group was 93.88%(46/49),which was higher than that(81.63%,40/49)in the western medicine group(P<0.05).After treatment,MDNS declined compared with that before treatment,and it was lower in the integrated Chinese and western medicine group than in the western medicine group(P<0.05).The treatment in both groups increased the SNCV and MNCV(common peroneal nerve,median nerve,and posterior tibial nerve),and the integrated Chinese and western medicine group had higher SNCV and MNCV(common peroneal nerve,median nerve,and posterior tibial nerve)than the western medicine group after treatment(P<0.05).The treatment in both group elevated the serum T-AOC,SOD,and GSH-PX levels and lowered the MDA level,and the integrated Chinese and western medicine group had higher T-AOC,SOD,and GSH-PX levels and lower MDA level than the western medicine group after treatment(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups during the treatment period(P>0.05).Conclusion Lipoic acid combined with fumigation and washing with Yiqi Tongluo Decoction has significant effect and high safety in the treatment of DPN.This therapy may inhibit neuropathy,relieve clinical symptoms,and improve the peripheral nerve conduction velocity of patients by correcting the oxidation-antioxidation imbalance.