国际医药卫生导报 ›› 2025, Vol. 31 ›› Issue (22): 3794-3800.DOI: 10.3760/cma.j.cn441417-20250528-22020

• 临床研究 • 上一篇    下一篇

加味当归芍药散辅助依帕司他片治疗老年糖尿病周围神经病变患者的临床观察

徐彦娜1  王亮2  吴红群1   

  1. 1商洛市中心医院中西医结合科(含老年病科),商洛 726000;2商洛市中医医院神经内一科,商洛726000
  • 收稿日期:2025-05-28 出版日期:2025-11-01 发布日期:2025-11-19
  • 通讯作者: 王亮,Email:149554883@qq.com
  • 基金资助:
    陕西省重点研发计划(2024SF-ZDCYL-01-12)

Clinical observation of Jiawei Danggui Shaoyao San combined with epalrestat tablets in the treatment of elderly patients with diabetic peripheral neuropathy

Xu Yanna1, Wang Liang2, Wu Hongqun1   

  1. 1Department of Integrated Traditional Chinese and Western Medicine (Including Geriatrics Department), Shangluo Central Hospital, Shangluo 726000, China; 2First Department of Neurology, Shangluo Hospital of Traditional Chinese Medicine, Shangluo 726000, China
  • Received:2025-05-28 Online:2025-11-01 Published:2025-11-19
  • Contact: Wang Liang, Email: 149554883@qq.com
  • Supported by:
    Key Plan of Research and Development in Shaanxi (2024SF-ZDCYL-01-12)

摘要: 目的 分析加味当归芍药散辅助依帕司他片治疗老年糖尿病周围神经病变(DPN)的疗效。方法 采用前瞻性研究,选取2021年1月至2023年1月在商洛市中心医院就诊的120例老年DPN患者,按便利抽样法分为试验组(60例)和对照组(60例)。对照组男29例、女31例,年龄(69.14±4.31)岁,给予依帕司他片治疗;试验组男30例、女30例,年龄(69.39±4.26)岁,在对照组基础上联合加味当归芍药散治疗。两组均连续治疗3个月。对比两组中医证候评分、双下肢肌电图指标[腓肠神经感觉神经传导速度(SCV)、双下肢腓总神经运动神经传导速度(MCV)]、血糖状况[空腹血糖(FPG)、餐后2 h血糖(2 hPG)、糖化血红蛋白(HbA1c)]、神经病变情况[密歇根糖尿病神经病变(MDNS)评分、多伦多神经病变(TCSS)评分]、氧化应激反应[丙二醛(MDA)、超氧化物歧化酶(SOD)]、血清水平[血清脑源性神经营养因子(BDNF)、一氧化氮(NO)、内皮素1(ET-1)、纤维凝胶蛋白3(ficolin-3)]及不良反应发生状况。统计学方法采用t检验、χ2检验。结果 治疗后,试验组主证[(2.19±0.37)分]、次证[(1.39±0.28)分]、MDNS[(13.67±2.18)分]、TCSS评分[(6.03±0.78)分]及FPG[(5.08±0.66)mmol/L]、HbA1c[(6.77±0.92)%]、2 hPG[(9.13±1.61)mmol/L]、MDA[(2.48±1.75)U/ml]、ET-1[(24.41±3.87)ng/L]、ficolin-3[(9.71±2.62)μg/L]均低于对照组[(5.24±0.85)分、(2.86±0.47)分、(17.11±2.79)分、(7.91±0.93)分、(7.02±1.20)mmol/L、(7.22±1.03)%、(12.22±2.64)mmol/L、(4.19±1.82)U/ml、(34.73±4.32)ng/L、(12.45±3.70)μg/L],腓肠神经SCV[(43.01±4.13)m/s]、腓总神经MCV[(51.91±4.91)m/s]、SOD[(133.21±12.33)U/ml]、BDNF[(6.17±0.71)ng/L]、NO水平[(3.96±0.72)μmol/L]均高于对照组[(38.65±3.81)m/s、(46.45±3.35)m/s、(121.31±18.03)U/ml、(4.25±0.36)ng/L、(3.34±0.63)μmol/L],差异均有统计学意义(均P<0.05)。试验组不良反应发生率为3.33%(2/60),低于对照组的16.67%(10/60),差异有统计学意义(χ2=5.926,P=0.015)。结论 加味当归芍药散联合依帕司他片治疗老年DPN患者,可有效改善症状和神经功能,调控血糖,减轻神经病变程度,提升抗氧化及调节相关因子水平,且具有较高安全性。

关键词:

糖尿病神经病变, 周围神经系统疾病, 加味当归芍药散, 依帕司他片, 神经传导

Abstract:

Objective To evaluate the therapeutic efficacy of Jiawei Danggui Shaoyao San combined with epalrestat tablets in the treatment of diabetic peripheral neuropathy (DPN) in elderly patients. Methods A prospective study was conducted on 120 elderly DPN patients treated at Shangluo Central Hospital from January 2021 to January 2023. Using a convenience sampling method, the patients were divided into an experimental group (60 cases) and a control group (60 cases). In the control group, there were 29 males and 31 females, with an age of (69.14±4.31) years; in the experimental group, there were 30 males and 30 females, with an age of (69.39±4.26) years. The control group received epalrestat tablets, while the experimental group received Jiawei Danggui Shaoyao San and epalrestat. The treatment duration was 3 months. The TCM syndrome scores, EMG indicators of lower limbs [sensory nerve conduction velocity(SCV) and motor nerve conduction velocity(MCV)], blood glucose status [fasting plasma glucose (FPG), 2-hour postprandial glucose (2 hPG), and glycated hemoglobin(HbA1c)], neuropathy [Michigan Diabetic Neuropathy Score(MDNS) score and Toronto Clinical Scoring System(TCSS) score], oxidative stress [malondialdehyde(MDA) and superoxide dismutase(SOD)], serum levels [brain-derived neurotrophic factor(BDNF), nitric oxide(NO), endothelin-1 (ET-1), and ficolin-3], and adverse reactions were compared between the two groups. Statistical methods employed t test and χ2 test. Results After the treatment, the scores of main syndrome, secondary syndrome, MDNS, and TCSS, FPG, HbA1 c, 2 hPG, MDA, ET-1, and ficolin-3 in the experimental group were lower than those in the control group [2.19±0.37 vs. 5.24±0.85, 1.39±0.28 vs. 2.86±0.47, 13.67±2.18 vs. 17.11±2.79, 6.03±0.78 vs. 7.91±0.93, (5.08±0.66) mmol/L vs. (7.02±1.20) mmol/L, (6.77±0.92)% vs. (7.22±1.03)%, (9.13±1.61) mmol/L vs. (12.22±2.64) mmol/L, (2.48±1.75) U/ml vs. (4.19±1.82) U/ml, (24.41±3.87) ng/L vs. (34.73±4.32) ng/L, and (9.71±2.62) μg/L vs. (12.45±3.70) μg/L], and the SCV of sural nerve, MCV of common peroneal nerve, and levels of SOD, BDNF, and NO were higher [(43.01±4.13) m/s vs. (38.65±3.81) m/s, (51.91±4.91) m/s vs. (46.45±3.35) m/s, (133.21±12.33) U/ml vs. (121.31±18.03) U/ml, (6.17±0.71) ng/L vs. (4.25±0.36) ng/L, and (3.96±0.72) μmol/L vs. (3.34±0.63) μmol/L], with statistical differences (all P<0.05). The incidence rate of adverse reactions in the experimental group was lower than that in the control group [3.33%(2/60) vs. 16.67%(10/60)], with a statistical difference (χ2=5.926; P=0.015). Conclusions Jiawei Danggui Shaoyao San combined with epalrestat tablets in the treatment of elderly patients with DPN can effectively improve their symptoms and neurological function, regulate blood glucose, reduce the degree of neuropathy, improve the level of antioxidant and regulatory factors, and have high safety.

Key words: Diabetic neuropathy, Peripheral nervous system disease, Jiawei Danggui Shaoyao San, Epalrestat tablets, Nerve conduction