{"title":"通络活血膏治疗颈椎病的多中心、开放标签、平行分组、随机对照试验。","authors":"Xing-Wen Xie, Chun-Xiao Wang, Yong-Li Zhao, Yong-Sheng Luo, Zhong-Hua Wang, Jing Liu, Hui Li, Ding-Peng Li","doi":"10.3233/BMR-230431","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In China, Tongluo-Qutong rubber plaster (TQRP) is commonly used for cervical spondylotic radiculopathy, but lacks high-quality trials.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>TQRP is effective and safe in the treatment of CSR.</p>","PeriodicalId":15129,"journal":{"name":"Journal of Back and Musculoskeletal Rehabilitation","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A multicenter, open-label, parallel-group, randomized controlled trial of Tongluo-Qutong rubber plaster for the treatment of cervical spondylotic radiculopathy.\",\"authors\":\"Xing-Wen Xie, Chun-Xiao Wang, Yong-Li Zhao, Yong-Sheng Luo, Zhong-Hua Wang, Jing Liu, Hui Li, Ding-Peng Li\",\"doi\":\"10.3233/BMR-230431\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In China, Tongluo-Qutong rubber plaster (TQRP) is commonly used for cervical spondylotic radiculopathy, but lacks high-quality trials.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>TQRP is effective and safe in the treatment of CSR.</p>\",\"PeriodicalId\":15129,\"journal\":{\"name\":\"Journal of Back and Musculoskeletal Rehabilitation\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-07-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Back and Musculoskeletal Rehabilitation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3233/BMR-230431\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Back and Musculoskeletal Rehabilitation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3233/BMR-230431","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
引用次数: 0
摘要
背景：在中国，通络活血膏（TQRP）常用于治疗颈椎病，但缺乏高质量的试验：在中国，通络活血膏（TQRP）被普遍用于治疗颈椎病，但缺乏高质量的试验：本研究旨在中国开展一项多中心、开放标签、平行组、随机对照试验，以探讨通络活血膏治疗颈椎病的实际疗效和安全性：方法：从甘肃省多家医院共招募了240名CSR患者。这些患者被随机分配到实验组或对照组。实验组接受 TQRP 治疗，而对照组则使用双氯芬酸钠贴片（DSP），疗程最长 21 天。对两组患者的疼痛视觉模拟量表（VAS）评分、疼痛缓解50%或以上的患者比例、颈部残疾指数（NDI）、伊顿试验的变化以及随访期间的复发情况进行了评估。此外，还对与同期药物治疗相关的安全性和不良反应进行了评估：在每个时间点，两组的 VAS 和 NDI 平均得分均呈下降趋势。与对照组相比，实验组在每个时间点的 VAS 评分下降幅度更大（P< 0.01）。在伊顿试验中，疼痛缓解达 50%或以上的患者比例和异常结果的数量均有所改善。然而，21 ± 3d 实验组的结果明显优于对照组（P< 0.01）。在随访期间，实验组的复发率低于对照组。两组之间的差异具有统计学意义（P< 0.05）。TQRP和DSP的不良反应发生率分别为1.74%和3.54%：结论：TQRP治疗CSR有效且安全。
A multicenter, open-label, parallel-group, randomized controlled trial of Tongluo-Qutong rubber plaster for the treatment of cervical spondylotic radiculopathy.
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.
期刊介绍：
The Journal of Back and Musculoskeletal Rehabilitation is a journal whose main focus is to present relevant information about the interdisciplinary approach to musculoskeletal rehabilitation for clinicians who treat patients with back and musculoskeletal pain complaints. It will provide readers with both 1) a general fund of knowledge on the assessment and management of specific problems and 2) new information considered to be state-of-the-art in the field. The intended audience is multidisciplinary as well as multi-specialty.
In each issue clinicians can find information which they can use in their patient setting the very next day.
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