硫辛酸联合胰激肽原酶肠溶片治疗2型糖尿病周围神经病变的临床观察

Clinical observation of Lipoic Acid combined with Pancreatic Kininogenase Enteric-Coated Tablets in the treatment of type 2 diabetic peripheral neuropathy

目的比较硫辛酸和硫辛酸联合胰激肽原酶肠溶片(怡开)对2型糖尿病周围神经病变的治疗效果。方法纳入2018年1月—2019年1月在南京医科大学附属淮安第一医院内分泌科住院的糖尿病周围神经病变患者60例,采用随机数字表法将患者分为观察组和对照组,每组30例。对照组给予硫辛酸静脉输注,观察组予以静脉输注硫辛酸联合怡开口服,治疗2周,分别评估两组临床疗效,治疗前后肌电图、氧化应激及炎症指标。结果治疗后,观察组治疗总有效率高于对照组(P<0.05);两组腓总神经、正中神经感觉传导速度(SNCV)及运动传导速度(MNCV)治疗前比较,差异无统计学意义(P>0.05),治疗后,两组腓总神经、正中神经SNCV及MNCV均高于治疗前,且观察组腓总神经、正中神经SNCV及MNCV均高于对照组,差异均有统计学意义(均P<0.05);治疗前两组丙二醛(MDA)、活性氧(ROS)、晚期氧化蛋白产物(AOPPs)、超氧化物歧化酶(SOD)比较,差异无统计学意义(P>0.05),治疗后两组MDA、ROS、AOPPs均低于治疗前,SOD高于治疗前,且观察组SOD高于对照组,而MDA、ROS、AOPPs低于对照组,差异均有统计学意义(均P<0.05);两组超敏C反应蛋白(hs-CPR)、白介素-6(IL-6)和肿瘤坏死因子-α(TNF-α)治疗前比较,差异无统计学意义(P>0.05),治疗后两组hs-CPR、IL-6、TNF-α均低于治疗前,且观察组hs-CPR、IL-6、TNF-α低于对照组,差异均有统计学意义(均P<0.05)。结论静脉输注硫辛酸联合怡开口服可以切实改善2型糖尿病周围神经病变患者临床症状,可能与减轻氧化应激、改善微炎症状态有关,起到较好的协同效果,值得临床推广。

Objective To compare the therapeutic effect of Lipoic Acid and Lipoic Acid combined with Pancreatic Kininogenase Enteric-Coated Tablets(Yikai)on type 2 diabetic peripheral neuropathy.Methods From January 2018 to January 2019,60 patients with diabetic peripheral neuropathy were hospitalized in the Department of Endocrinology,the Affiliated Huai′an No.1 People′s Hospital of Nanjing Medical University were enrolled.The patients were divided into the observation group and the control group by random number table method,with 30 patients in each group.The control group was given intravenous infusion of Lipoic Acid,and the observation group was given intravenous infusion of Lipoic Acid combined with Yikai oral administration for two weeks.The clinical efficacy was evaluated,electromyography,oxidative stress and inflammation indexes of the two groups before and after treatment were evaluated respectively.Results After treatment,the total effective rate of the observation group was higher than that of the control group(P<0.05).Sensory conduction velocity(SNCV)and motor conduction velocity(MNCV)of the common peroneal and median nerves in the two groups were not significantly different from those before treatment(P>0.05).After treatment,SNCV and MNCV of the common peroneal nerve and median nerve in both groups were higher than those before treatment,and SNCV and MNCV of the observation group were higher than those of the control group,with statistically significant differences(all P<0.05).Malondialdehyde(MDA),reactive oxygen species(ROS),advanced oxidizing protein products(AOPPs)and superoxide dismutase (SOD) in the two groups were not significantly different before treatment (P > 0.05). After treatment, MDA, ROS and AOPPs in both groups were lower than those before treatment, SOD was higher than that before treatment, SOD in the observation group was higher than that in the control group, while MDA, ROS and AOPPs were lower than those in the control group, with statistically significant differences (all P < 0.05). Comparison of hypersensitive C-reactive protein (hs-CPR), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) before treatment between the two groups showed no significant difference (P > 0.05). After treatment, hs-CPR, IL-6 and TNF-α in the two groups were all lower than those before treatment, and hs-CPR, IL-6 and TNF-α in the observation group were lower than those in the control group, with statistically significant differences (all P < 0.05). Conclusion Intravenous infusion of Lipoic Acid combined with Yikai oral administration can effectively improve the clinical symptoms of patients with type 2 diabetes peripheral neuropathy, which may be related to reducing oxidative stress and improving the state of micro-inflammation. It plays a good synergistic effect and is worthy of clinical promotion.