目的 观察八味芪丹胶囊联合依帕司他治疗2型糖尿病周围神经病变的临床疗效及对患者血清铁蛋白及氧化应激指标的影响，探讨其可能的作用机制。方法 将62例糖尿病周围神经病变（diabetic peripheral neuropathy，DPN）患者随机分成观察组和对照组，每组31例。两组均以个体化降糖为基础治疗，对照组另口服依帕司他，观察组在对照组疗法的基础上加用八味芪丹胶囊，疗程均为4周。分别采用中医证候评分、多伦多临床评分系统（Toronto clinical scoring system，TCSS）评定临床疗效，采用神经电检诊仪检测神经传导速度，采用化学比色法检测血清铁蛋白（serum ferritsn，SF），硫代巴比妥酸法检测丙二醛（malondialdehyde，MDA）水平，化学发光法检测超氧化物歧化酶（superoxide dismutase，SOD）水平。结果 治疗后两组患者中医证候评分、TCSS评分均较治疗前明显减少（P<0.05），且观察组减少程度大于对照组（P<0.05）。治疗后两组患者神经传导速度均较治疗前明显提高（P＜0.05），且观察组较对照组提高更为明显（P＜0.05）。治疗后两组患者血清SF、MDA水平均较治疗前明显降低（P<0.05），SOD水平明显升高（P<0.05）；且观察组SF、MDA水平的降低程度以及SOD水平的升高程度均大于对照组（P<0.05）。结论 八味芪丹胶囊联合依帕司他治疗2型糖尿病周围神经病变的疗效优于单用依帕司他，且能有效提高神经传导速度，其机制可能与调节铁代谢途径、改善氧化应激反应有关。
Objective To investigate the clinical effect of Bawei Qidan Capsule combined with epalrestat in the treatment of type 2 diabetic peripheral neuropathy, its influence on serum ferritin (SF) and oxidative stress indices, and possible mechanism of action. Methods A total of 62 patients with diabetic peripheral neuropathy (DPN) were enrolled and randomly divided into observation group and control group, with 31 patients in each group. The patients in the control group were given individualized hypoglycemic therapy and oral epalrestat, and those in the observation group were given Bawei Qidan Capsule in addition to the treatment in the control group; the course of treatment was 4 weeks for both groups. Traditional Chinese medicine (TCM) syndrome score and Toronto clinical scoring system (TCSS) were used to evaluate clinical outcome; a neuroelectric detective and diagnostic instrument was used to measure nerve conduction velocity; chemical colorimetry was used to measure SF, the thiobarbituric acid method was used to measure the level of malondialdehyde (MDA), and chemiluminescence was used to measure the level of superoxide dismutase (SOD). Results After treatment, both groups had significant reductions in TCM syndrome score and TCSS score (P<0.05), and the observation group had significantly greater reductions than the control group (P<0.05). After treatment, both groups had a significant increase in nerve conduction velocity (P<0.05), and the observation group had a significantly greater increase than the control group (P<0.05). After treatment, both groups had significant reductions in the levels of SF and MDA (P<0.05) and a significant increase in the level of SOD (P<0.05), and compared with the control group, the observation group had significantly greater reductions in SF and MDA and a significantly greater increase in SOD (P<0.05). Conclusion Bawei Qidan Capsule combined with epalrestat has a better clinical effect than epalrestat alone in the treatment of type 2 diabetic peripheral neuropathy and can effectively improve nerve conduction velocity, possibly by regulating iron metabolic pathways and improving oxidative stress response.
张进军,陈晓雯,金 虹,张景景,王 静.八味芪丹胶囊联合依帕司他治疗2型糖尿病周围神经病变临床观察[J].安徽中医药大学学报,2021,40(1):21-25复制