Clinical research on painful diabetic peripheral neuropathy treated with <italic style="font-style: italic">Xiaoke Tongbi</italic> Formula

LIANG Qingshun; LIU Yunwei; LI Anxiang; LU Qiyun; TAO Yiming; LIU Zhenjie; LUO Lulu; WU Liyan

doi:10.3969/j.issn.1006-2157.2023.11.010

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

Clinical Studies | 更新时间：2023-12-08

- Clinical research on painful diabetic peripheral neuropathy treated with Xiaoke Tongbi Formula
- Journal of Beijing University of Traditional Chinese Medicine Vol. 46, Issue 11, Pages: 1554-1560(2023)
- 作者机构：
  
  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
- 作者简介：
  
  LIU Zhenjie, Ph.D., Chief Physician. Guangdong Provincial Hospital of Chinese Medicine, No. 36, Yongan Street, Liwan District, Guangzhou 510370. E-mail: yi102@163.com
- 基金信息：
  
  National Key Research and Development Program(2018YFC2002500);Guangdong Province College Students Innovation and Entrepreneurship Training Program(202210572060);The Specific Research Fund for TCM Science and Technology of Guangdong Provincial Hospital of Chinese Medicine(YN2022MS15)
- DOI：10.3969/j.issn.1006-2157.2023.11.010
  CLC： R259.872
- Received：20 April 2023，
  
  Published Online：25 October 2023，
  
  Published：30 November 2023
- 稿件说明：
移动端阅览
LIANG Qingshun, LIU Yunwei, LI Anxiang, et al. Clinical research on painful diabetic peripheral neuropathy treated with Xiaoke Tongbi Formula[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(11): 1554-1560.
DOI：

LIANG Qingshun, LIU Yunwei, LI Anxiang, et al. Clinical research on painful diabetic peripheral neuropathy treated with Xiaoke Tongbi Formula[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(11): 1554-1560. DOI： 10.3969/j.issn.1006-2157.2023.11.010.

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%(

＝0.019)；PGIC评分总有效率为44.8%，高于对照组的9.7%(

＝0.002)；中医证候积分总有效率为58.6%，高于对照组的41.9%(

＝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(

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。

Abstract

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(

=34) and observation group(

=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 (

=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 (

=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 (

=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 (

0.05).

Conclusion

Xiaoke Tongbi

Formula effectively treats PDPN and can safely and effectively improve patients' pain symptoms.

关键词

Keywords

references

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⁰

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

DOI：10.3969/j.issn.1006-2157.2023.11.010

摘要

Abstract

关键词

Keywords

references