消渴痛痹方治疗痛性糖尿病周围神经病变的临床研究  

Clinical research on painful diabetic peripheral neuropathy treated with Xiaoke Tongbi Formula

作　　者：梁庆顺 刘昀玮 李安香 卢绮韵 陶一鸣[1,2] 刘振杰 罗露露 吴丽燕[1,2] LIANG Qingshun;LIU Yunwei;LI Anxiang;LU Qiyun;TAO Yiming;LIU Zhenjie;LUO Lulu;WU Liyan(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510370,China;Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510370,China;The Second Medical College of Guangzhou University of Chinese Medicine,Guangzhou 510370,China)

机构地区：[1]广州中医药大学第二附属医院,广州510370 [2]广东省中医院 [3]广州中医药大学第二临床医学院

出　　处：《北京中医药大学学报》2023年第11期1554-1560,共7页Journal of Beijing University of Traditional Chinese Medicine

基　　金：国家重点研发计划项目(No.2018YFC2002500);广东省大学生创新创业训练计划项目(No.202210572060);广东省中医院中医药科学技术研究专项(No.YN2022MS15)。

摘　　要：目的探讨消渴痛痹方治疗痛性糖尿病周围神经病变(PDPN)的临床疗效。方法选择2018年8月—2020年12月在广东省中医院就诊的痛性糖尿病周围神经病变患者68例,按随机数字表法分为对照组和观察组,每组34例。剔除脱落病例后,对照组31例,观察组29例。对照组给予普瑞巴林,观察组给予消渴痛痹方,治疗10周。主要评价指标为糖尿病周围神经病变简明疼痛量表(BPI-DPN)评分,次要评价指标为疼痛11点数字评分法(NRS-11)评分、睡眠干扰评分日记(DSID)评分、患者总体印象变化(PGIC)评分、中医证候积分、感觉神经传导速度(SNCV)、运动神经传导速度(MNCV)与不良反应。结果与对照组相比,观察组BPI-DPN评分总有效率为75.9%,高于对照组的54.8%(P=0.019);PGIC评分总有效率为44.8%,高于对照组的9.7%(P=0.002);中医证候积分总有效率为58.6%,高于对照组的41.9%(P=0.049)。观察组治疗期间未发生不良事件,对照组出现头晕、嗜睡、双下肢无力等不良事件,差异有统计学意义(P<0.05)。结论消渴痛痹方能明显改善痛性糖尿病周围神经病变患者的临床症状和生活质量,且具有良好的安全性。Objective To explore the curative effect of Xiaoke Tongbi Formula in treating painful diabetic peripheral neuropathy(PDPN).Methods Sixty-eight patients with PDPN were recruited from August 2018 to December 2020 in Guangdong Prorincial Hospital of Chinese Medicine.They were randomly divided into the control group(n=34)and observation group(n=34);after applying the exclusion criteria,the final sample of the control group comprised 31 patients,and the observation group contained 29.The control group received pregabalin,and the observation group was treated with Xiaoke Tongbi Formula.The Brief Pain Inventory for patients with PDPN(BPI-DPN)score,numerical rating scale-11(NRS-11),daily sleep interference diary(DSID),patients’global impression of change(PGIC),traditional Chinese medicine(TCM)syndrome score,sensory nerve conduction velocity(SNCV),motor nerve conduction velocity(MNCV),incidence of adverse reactions and curative effects were compared between the two groups.Results After treatment,the total effective rate,as determined by the BPI-DPN score,was 75.9%in the observation group and 54.8%in the control group(P=0.019).The total effective rate determined by the PGIC score was 44.8%in the observation group and 9.7%in the control group(P=0.002);The total effective rate demonstrated by the syndrome score was 58.6%in the observation group and 41.9%in the control group(P=0.049).During the treatment period,no adverse events occurred in the observation group,while the control group experienced adverse events such as dizziness,drowsiness,and lower limb weakness,with a statistically significant difference(P<0.05).Conclusion Xiaoke Tongbi Formula effectively treats PDPN and can safely and effectively improve patients'pain symptoms.

关 键 词：痛性糖尿病周围神经病变 消渴痛痹方 普瑞巴林 神经功能 糖尿病周围神经病变简明疼痛量表 

分 类 号：R259.872[医药卫生—中西医结合]