Clinical study on the treatment of type 2 diabetic peripheral neuropathy (qi deficiency and blood stasis type) with Xiaobi Xunxi Formula combined with moxibustion
消痹熏洗方联合艾灸治疗2型糖尿病性周围神经病变（气虚血瘀型）的临床研究

摘要

目的 观察中药消痹熏洗方联合艾灸治疗2型糖尿病性周围神经病变的效果。方法 开展随机对照临床试验，试验对象对出现周围神经病变的2型糖尿病患者，试验样本合计60例，样本选择时间段为2023年6月-2024年6月。对样本实施随机分组后实施不同的治疗， 分为对照组（n=30）和观察组（n=30）。对照组实施常规西药（甲钴胺）治疗，治疗时间2个月。观察组联合实施消痹熏洗方+足三里灸法治疗，治疗时间2个月。治疗前对两组临床症状体征严重程度实施评估，治疗2个月后评估疗效，并再次进行临床症状体征严重程度评估。开展安全性观察，对两组不同治疗方案的实施过程中不良反应发生情况进行统计。结果 治疗前对两组临床症状体征严重程度实施评估，比较并检验评分结果，对照组得分高于观察组，但差异不明显，（P＞0.05）；治疗2个月后评估疗效，对照组总有效率为73.33%，明显低于观察组93.33%，（P<0.05）；治疗2个月后再次进行临床症状体征严重程度评估，比较评分组间差异，对照组高于观察组，且差异显著，（P<0.05）；治疗2个月后，与治疗前的临床症状体征严重程度评分结果组内比较，两组评分均显著下降，（P<0.05）。两组均未出现严重不良反应，观察组3例熏洗后局部皮肤轻微红肿，自行缓解。结论 消痹熏洗方联合艾灸可有效改善DPN患者症状及体征，安全性良好。

Abstract

Objective To observe the effect of the traditional Chinese medicine Xiaobi Xunxi Formula combined with moxibustion in the treatment of type 2 diabetic peripheral neuropathy.
Methods A randomized controlled clinical trial was conducted. The subjects of the trial were type 2 diabetic patients with peripheral neuropathy. A total of 60 trial samples were included, and the sample selection period was from June 2023 to June 2024. After random grouping of the samples, different treatments were implemented and they were divided into the control group (n=30) and the observation group (n=30). The control group was treated with conventional Western medicine (mecobalamin) for 2 months. The observation group was treated jointly with the Xiaobi Xunxi Formula and Zusanli moxibustion method, and the treatment period was 2 months. Before the treatment, the severity of clinical symptoms and signs in the two groups was evaluated. The therapeutic effect was evaluated two months after the treatment, and the severity of clinical symptoms and signs was evaluated again. Safety observations were carried out, and the occurrence of adverse reactions during the implementation of the two groups of different treatment regimens was statistically analyzed.
Results Before treatment, the severity of clinical symptoms and signs in both groups was evaluated. The scoring results were compared and tested. The score of the control group was higher than that of the observation group, but the difference was not significant (P > 0.05). The therapeutic effect was evaluated after 2 months of treatment. The total effective rate of the control group was 73.33%, which was significantly lower than that of the observation group (93.33%) (P<0.05). Two months after the treatment, the severity of clinical symptoms and signs was evaluated again. The differences between the groups were compared and evaluated. The control group was higher than the observation group, and the difference was significant (P<0.05). After 2 months of treatment, compared with the severity score results of clinical symptoms and signs before treatment within the group, the scores of both groups decreased significantly (P<0.05). No serious adverse reactions occurred in either group. In the observation group, 3 cases had slight redness and swelling of the local skin after fumigation and washing, which relieved spontaneously.
Conclusion   The Xiaobi Xunxi formula combined with moxibustion can effectively improve the symptoms and signs of patients with DPN, and has good safety.