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
梁庆顺,女,硕士,主治医师
# 刘振杰,博士,主任医师,主要研究方向:中西医结合治疗内分泌代谢性疾病,E-mail: yi102@163.com
纸质出版日期:2023-11-30,
网络出版日期:2023-10-25,
收稿日期:2023-04-20,
移动端阅览
梁庆顺, 刘昀玮, 李安香, 等. 消渴痛痹方治疗痛性糖尿病周围神经病变的临床研究[J]. 北京中医药大学学报, 2023,46(11):1554-1560.
LIANG Qingshun, LIU Yunwei, LI Anxiang, et al. Clinical research on painful diabetic peripheral neuropathy treated with
梁庆顺, 刘昀玮, 李安香, 等. 消渴痛痹方治疗痛性糖尿病周围神经病变的临床研究[J]. 北京中医药大学学报, 2023,46(11):1554-1560. DOI: 10.3969/j.issn.1006-2157.2023.11.010.
LIANG Qingshun, LIU Yunwei, LI Anxiang, et al. Clinical research on painful diabetic peripheral neuropathy treated with
目的
2
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
2
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
2
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
2
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
2
To explore the curative effect of
Xiaoke Tongbi
Formula in treating painful diabetic peripheral neuropathy(PDPN).
Methods
2
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
2
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
2
Xiaoke Tongbi
Formula effectively treats PDPN and can safely and effectively improve patients' pain symptoms.
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
painful diabetic peripheral neuropathyXiaoke Tongbi Formulapregabalinnerve functionbrief pain inventory-diabetic peripheral neuropathy
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