黄芪桂枝五物汤治疗糖尿病周围神经病变疼痛疗效观察

Observational study on the efficacy of Huangqi Guizhi Wuwu Decoction in treating pain of diabetic peripheral neuropathy

关键词:  黄芪桂枝五物汤  糖尿病周围神经病变  疼痛  抗炎  疗效

Key words:  Huangqi Guizhi Wuwu Decoction  diabetic peripheral neuropathy  pain  anti-inflammatory  clinical efficacy

摘要:

[目的] 探讨黄芪桂枝五物汤对糖尿病周围神经病变（DPN）患者病理性疼痛的综合疗效。[方法] 选取石家庄市中医院在2023年6月至2024年12月期间收治入院的DPN患者168例，依据随机数字表法将其分为对照组84例和观察组84例。对照组在糖尿病常规基础上口服依帕司他片，观察组在常规基础上口服黄芪桂枝五物汤，两组均治疗3个月，均随访3个月。比较两组患者治疗前后疗效、神经病理性疼痛（DN4）评分、视觉模拟疼痛（VAS）评分、中医证候积分、多伦多临床评分系统（TCSS）评分、神经传导速度、超敏C反应蛋白（hs-CRP）、肿瘤坏死因子-α（TNF-α）、白细胞介素-6（IL-6）、神经生长因子（NGF）、脑源性神经营养因子（BDNF）、丙二醛（MDA）及超氧化物歧化酶（SOD）水平，记录两组治疗期间不良反应。[结果] 两组总体疗效分布比较，差异有统计学意义（P<0.001）。治疗后观察组DN4评分、VAS评分、中医证候积分、TCSS评分均显著低于对照组，观察组正中神经和腓总神经的运动神经传导速度（MNCV）、感觉神经传导速度（SNCV）均高于对照组，差异有统计学意义（P<0.05）。治疗后，观察组DPN患者血清hs-CRP、IL-6及TNF-α炎症因子水平低于对照组，NGF、BDNF生长因子水平高于对照组，血清MDA低于对照组，SOD水平高于对照组，差异有统计学意义（P<0.05）。DPN患者中位疼痛缓解时间为51 d，CRP降幅≤2 mg/L、DPN病程≤4年和BDNF升高幅度≤7 ng/mL的患者疗效更显著。[结论] 黄芪桂枝五物汤治疗DPN患者病理性疼痛可提高疗效、减轻患者疼痛，改善神经传导速度且安全性好，炎症水平较高的DPN患者是黄芪桂枝五物汤治疗的最佳获益人群。

Abstract:

[Objective] To investigate the comprehensive therapeutic effect of Huangqi Guizhi Wuwu Decoction on pathological pain in patients with diabetic peripheral neuropathy（DPN）. [Methods] A total of 168 DPN patients admitted to Shijiazhuang Hospital of Traditional Chinese Medicine from June 2023 to December 2024 were enrolled and randomly divided into a control group（84 cases） and an observation group（84 cases） according to a random number table. Both groups received conventional diabetes management. The control group was additionally treated with oral Epalrestat tablets，while the observation group received Huangqi Guizhi Wuwu Decoction. The treatment duration was 3 months for both groups，followed by a 3-month follow-up. Outcome measures included clinical efficacy，neuropathic pain（DN4） score，visual analog scale（VAS） pain score，traditional Chinese medicine syndrome score，toronto clinical scoring system（TCSS） score，nerve conduction velocity（NCV），and serum levels of hs-CRP，TNF-α，IL-6，NGF，BDNF，MDA，and SOD before and after treatment. Adverse reactions were also recorded. [Results] The distribution of overall clinical efficacy differed significantly between the two groups（P<0.001）. After treatment，the observation group showed significantly lower DN4，VAS，traditional Chinese medicine syndrome，and TCSS scores compared to the control group（P<0.05）. The motor and sensory NCV of the median and common peroneal nerves were significantly higher in the observation group（P<0.05）. Furthermore，post-treatment levels of serum hs-CRP，IL-6，TNF-α，and MDA were lower，while levels of NGF，BDNF，and SOD were higher in the observation group compared to the control group（P<0.05）. The median pain relief time was 51 days. Patients with a hs-CRP decrease of >2 mg/L，a DPN duration of ≤4 years，and a BDNF increase of >7 ng/mL demonstrated more significant therapeutic benefits. [Conclusion] Huangqi Guizhi Wuwu Decoction can improve clinical efficacy，alleviate pain，enhance nerve conduction velocity，and demonstrates a good safety profile in DPN patients with pathological pain. DPN patients with higher baseline inflammatory levels may derive the greatest benefit from this treatment.