通络祛痛膏治疗神经根型颈椎病的多中心、开放标签、平行组随机对照试验

A multicenter, open-label, parallel-group, randomized controlled trial of Tongluo-Qutong rubber plaster for the treatment of cervical spondylotic radiculopathy.

作者信息

Xie Xing-Wen, Wang Chun-Xiao, Zhao Yong-Li, Luo Yong-Sheng, Wang Zhong-Hua, Liu Jing, Li Hui, Li Ding-Peng

机构信息

Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, China.

Tianshui City Hospital of Traditional Chinese Medicine, Tianshui, China.

出版信息

J Back Musculoskelet Rehabil. 2024;37(6):1591-1599. doi: 10.3233/BMR-230431.

DOI:10.3233/BMR-230431

PMID:39093063

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11613120/

Abstract

BACKGROUND

In China, Tongluo-Qutong rubber plaster (TQRP) is commonly used for cervical spondylotic radiculopathy, but lacks high-quality trials.

OBJECTIVE

This study aimed to conduct a multicenter, open-label, parallel-group, randomized controlled trial in China to investigate the practical efficacy and safety of TQRP in the treatment of CSR.

METHODS

A total of 240 patients diagnosed with CSR were recruited for the investigation from multiple hospitals in Gansu province, China. The patients were randomly assigned to either an experimental or a control group. The experimental group received treatment with TQRP, whereas the control group was administered a diclofenac sodium patch (DSP) for a maximum duration of 21 days. The visual analogue scale (VAS) score for pain, the proportion of patients experiencing 50% or more pain relief, the neck disability index (NDI), changes as per the Eaton trial, and recurrence during the follow-up period were evaluated for both groups. The safety and adverse events associated with the concurrent drug therapy were also evaluated.

RESULTS

At each time point, the mean VAS and NDI scores of both groups demonstrated a downward trend. The experimental group exhibited a greater decline in VAS score at each time point compared to the control group (P< 0.01). In the Eaton trial, both the percentage of patients experiencing pain relief of 50% or more and the number of abnormal results exhibited improvement. However, the outcomes in the 21 ± 3d experimental group were significantly superior to those in the control group (P< 0.01). During the follow-up period, the recurrence events in the experimental group were reduced compared to the control group. The difference between the two groups was statistically significant (P< 0.05). The incidence of adverse reactions was 1.74% for TQRP and 3.54% for DSP.

CONCLUSION

TQRP is effective and safe in the treatment of CSR.

摘要

背景

在中国，通络祛痛膏常用于神经根型颈椎病的治疗，但缺乏高质量试验。

目的

本研究旨在在中国开展一项多中心、开放标签、平行组随机对照试验，以探究通络祛痛膏治疗神经根型颈椎病的实际疗效和安全性。

方法

从中国甘肃省多家医院招募了总共240例被诊断为神经根型颈椎病的患者进行研究。患者被随机分为试验组或对照组。试验组接受通络祛痛膏治疗，而对照组则使用双氯芬酸钠贴剂，最长治疗21天。评估两组患者的疼痛视觉模拟评分（VAS）、疼痛缓解50%及以上患者的比例、颈部功能障碍指数（NDI）、根据伊顿试验的变化情况以及随访期间的复发情况。还评估了联合药物治疗相关的安全性和不良事件。

结果

在每个时间点，两组的平均VAS和NDI评分均呈下降趋势。试验组在每个时间点的VAS评分下降幅度均大于对照组（P<0.01）。在伊顿试验中，疼痛缓解50%及以上患者的百分比和异常结果数量均有所改善。然而，21±3天试验组的结果明显优于对照组（P<0.01）。随访期间，试验组的复发事件较对照组减少。两组之间的差异具有统计学意义（P<0.05）。通络祛痛膏的不良反应发生率为1.74%，双氯芬酸钠贴剂为3.54%。