文献类型：期刊文献

英文题名：A multicenter, open-label, parallel-group, randomized controlled trial of TongluoQutong rubber plaster for the treatment of cervical spondylotic radiculopathy

作者：Xie, Xing-Wen[1];Wang, Chun-Xiao[2];Zhao, Yong-Li[1];Luo, Yong-Sheng[3];Wang, Zhong-Hua[4];Liu, Jing[2];Li, Hui[1];Li, Ding-Peng[4]

第一作者：Xie, Xing-Wen

通信作者：Xie, XW[1];Zhao, YL[1]

机构：[1]Gansu Univ Chinese Med, Affiliated Hosp, 732 Jiayuguan West Rd, Lanzhou 730000, Gansu, Peoples R China;[2]Tianshui City Hosp Tradit Chinese Med, Tianshui, Peoples R China;[3]Gansu Prov Hosp Tradit Chinese Med, Lanzhou, Peoples R China;[4]Northwest Univ Nationalities, Affiliated Hosp, Lanzhou, Peoples R China

第一机构：甘肃中医药大学第二附属医院

通信机构：[1]corresponding author), Gansu Univ Chinese Med, Affiliated Hosp, 732 Jiayuguan West Rd, Lanzhou 730000, Gansu, Peoples R China.|[10735b845793de6ae2b30]甘肃中医药大学第二附属医院;[10735]甘肃中医药大学;

年份：2024

卷号：37

期号：6

起止页码：1591

外文期刊名：JOURNAL OF BACK AND MUSCULOSKELETAL REHABILITATION

收录：;Scopus(收录号：2-s2.0-85209828263);WOS:【SCI-EXPANDED(收录号:WOS:001385687200017)】；

基金：This study was funded by the National Natural Sci-ence Foundation of China and the Supporting Fund for Cultivation of Top Talents (Science and Technology) in Gansu Province (grant number: 82160911, 81860864) . The Funding body had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

语种：英文

外文关键词：Cervical spondylotic radiculopathy; Chinese traditional medicine; TQRP; rubber plaster

摘要：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.