芪椒通络洗剂治疗糖尿病周围神经病变阳虚血瘀证的临床疗效观察  

Observation of clinical efficacy of Qijiao Tongluo Washing Lotion for diabetic peripheral neuropathy with Yang deficiency and blood stasis syndrome

作　　者：经加吻 林逸轩 方朝晖[2,3,4] 朱梦燕 张银玉 李瑜璠 汪四海 吕溪涓[1] Jing Jiawen;Lin Yixuan;Fang Zhaohui;Zhu Mengyan;Zhang Yinyu;Li Yufan;Wang Sihai;Lyu Xijuan(First Clinical Medical College,Anhui University of Chinese Medicine,Hefei Anhui 230031;First Affiliated Hospital,Anhui University of Chinese Medicine,Hefei Anhui 230031;Key Laboratory of Xin′an Medicine of the Ministry of Education,Hefei Anhui 230012;Institute of Xin′an Medicine and Modernization of TCM,Hefei National Comprehensive Science Center for Health,Hefei Anhui 230012)

机构地区：[1]安徽中医药大学第一临床医学院,安徽合肥230031 [2]安徽中医药大学第一附属医院,安徽合肥230031 [3]新安医学教育部重点实验室,安徽合肥230012 [4]合肥综合性国家科学中心大健康研究院新安医学与中医药现代化研究所,安徽合肥230012

出　　处：《山西中医药大学学报》2024年第8期922-927,共6页Journal of Shanxi University of Chinese Medicine

基　　金：国家自然科学基金项目(82174153);合肥综合性国家科学中心大健康研究院新安医学与中医药现代化研究所揭榜挂帅项目(2023cxmmtcm003);安徽省重大疑难疾病中西医协同攻关项目(2021-70-6);安徽省中医药领军人才及培养对象项目(2019ahszyyljrcxm20190027);2型糖尿病中医药循证能力提升项目(2023-24);安徽省高校协同创新项目(GXXT-2020-025)。

摘　　要：目的:探讨芪椒通络洗剂治疗糖尿病周围神经病变(diabetic peripheral neuropathy,DPN)阳虚血瘀证的临床疗效。方法:采用随机数字表法将2022年7月1日—2023年7月1日就诊于安徽省中医药大学第一附属医院的68例DPN阳虚血瘀证患者者随机分配到对照组和治疗组,每组各34例。治疗组予芪椒通络洗剂+依帕司他片+基础治疗,对照组予芪椒通络洗剂模拟剂+依帕司他片+基础治疗,1个疗程为2周。结局指标包括总有效率、TCSS评分、MNSI问卷评分、MNSI体检评分、双侧腓总神经及腓肠神经肌电图、血糖水平、肝肾功能、不良反应发生率等。结果:治疗组总有效率高于对照组,差异有统计学意义(P=0.036);两组肝肾功能及不良反应发生率比较,差异无统计学意义(P>0.05);治疗后,与对照组比较,治疗组TCSS临床评分、MNSI问卷评分、MNSI体检评分、空腹血糖、餐后2 h血糖降低,腓总神经及腓肠神经的传导速度、波幅水平升高,潜伏期缩短,差异均有统计学意义(P<0.05,P<0.01)。结论:芪椒通络洗剂能显著改善DPN患者的临床症状,提高神经传导功能,增强疗效,且具有良好的安全性。Objective:To investigate the clinical efficacy of Qijiao Tongluo Washing Lotion in treating diabetic peripheral neuropathy(DPN)with Yang deficiency and blood stasis syndrome.Methods:Sixty-eight patients with DPN and Yang deficiency and blood stasis diagnosed in the First Affiliated Hospital of Anhui University of Chinese Medicine from July 1,2022 to July 1,2023 were randomly assigned to the control group and the treatment group,with 34 patients in each group.The treatment group was treated with Qijiao Tongluo Washing Lotion,Epalrestat tablets and basic therapy,while the control group was treated with Qijiao Tongluo Washing Lotion simulant,Epalrestat tablets and basic therapy,with one course of treatment lasting for two weeks.The outcome indicators included total effective rate,TCSS score,MNSI questionnaire score,MNSI physical examination score,bilateral common fibular nerve and peroneal nerve electromyography,blood glucose level,liver and kidney function,and incidence of adverse reactions.Results:The overall effective rate was significantly higher in the treatment group compared to the control group(P=0.036).There were no significant differences in liver and kidney functions or the incidence of adverse reactions between the two groups(P>0.05).After treatment,compared to the control group,the treatment group showed statistically significant improvements in TCSS scores,MNSI questionnaire scores,MNSI physical examination scores,the reduction of fasting and 2-hour postprandial blood glucose levels,the increase of conduction velocity and wave amplitude level of the common fibular nerve and peroneal nerve,as well as the shortening of latency(P<0.05,P<0.01).Conclusion:Qijiao Tongluo Washing Lotion can significantly improve the clinical symptoms of DPN patients,improve the nerve conduction function,enhance the therapeutic efficacy,and has a good safety.

关 键 词：糖尿病周围神经病变 芪椒通络洗剂 临床观察 阳虚血瘀 

分 类 号：R244.9[医药卫生—针灸推拿学] R255.5[医药卫生—中医临床基础]