麝香追风止痛膏缓解膝骨关节炎(寒湿痹阻证)疼痛有效性与安全性的随机、双盲、阳性药平行对照、多中心临床试验  

Randomized,double-blind,parallel controlled,multicenter clinical trial of effectiveness and safety of Shexiang Zhuifeng Zhitong Ointment in alleviating pain in knee osteoarthritis(syndrome of cold-dampness obstruction)

作　　者：丰芬[1] 方妤[1] 陈日高[1] 阎博华[1] 黄勇[1] 吴斌[2] 李成荫[2] 段华[3] 张林辉[3] 唐流刚 尉迎丽 汪国友 王丽彬 郭兵[6] 朱鸿飞 姜维成 武丽娜 马林 FENG Fen;FANG Yu;CHEN Ri-gao;YAN Bo-hua;HUANG Yong;WU Bin;LI Cheng-yin;DUAN Hua;ZHANG Lin-hui;TANG Liu-gang;WEI Ying-li;WANG Guo-you;WANG Li-bin;GUO Bing;ZHU Hong-fei;JIANG Wei-cheng;WU Li-na;MA Lin(Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610032,China;Chongqing Traditional Chinese Medicine Hospital,Chongqing 400011,China;Sichuan Provincial People's Hospital,Chengdu 610072,China;Sichuan Province Orthopedic Hospital,Chengdu 610041,China;the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou 646099,China;Beibei District Hospital of Traditional Chinese Medicine,Chongqing 400799,China;Yongchuan District Hospital of Traditional Chinese Medicine,Chongqing 402105,China;Jiangyan Hospital of Traditional Chinese Medicine,Taizhou 225599,China)

机构地区：[1]成都中医药大学附属医院,四川成都610032 [2]重庆市中医院,重庆400011 [3]四川省人民医院,四川成都610072 [4]四川省骨科医院,四川成都610041 [5]西南医科大学附属中医医院,四川泸州646099 [6]重庆市北碚区中医院,重庆400799 [7]重庆市永川区中医院,重庆402105 [8]泰州市姜堰中医院,江苏泰州225599

出　　处：《中国中药杂志》2024年第9期2512-2521,共10页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划“中医药现代化研究”重点专项(2019YFC171250)。

摘　　要：麝香追风止痛膏具有祛风除湿,散寒止痛的功效,用于寒湿痹阻所致关节、肌肉疼痛,扭伤疼痛。为进一步评价麝香追风止痛膏缓解膝骨关节炎(寒湿痹阻证)疼痛的有效性与安全性,该研究开展了随机、双盲、阳性药物平行对照的多中心临床试验。对纳入240例受试者采用分层随机化方法,按1∶1随机分为试验组和对照组,2组中6 h贴敷和12 h贴敷各60例。试验组贴敷麝香追风止痛膏,对照组贴敷麝香追风膏,疗程均为21 d,在治疗后第7、14、21天进行随访。FAS分析显示,(1)主要疗效指标视觉模拟量表(VAS)评分方面,试验组12 h贴敷后与基线差值均数为3.02,对照组为2.31,试验组治疗后VAS评分下降程度优于对照组(P<0.05);试验组6 h贴敷后与基线差值均数为3.19,对照组为2.48,试验组治疗后VAS评分下降程度优于对照组(P<0.05)。(2)VAS评分疼痛缓解有效率方面,试验组12 h贴敷后有效率为93.22%,对照组为73.33%,试验组优于对照组(P<0.05);试验组6 h贴敷后有效率为88.33%,对照组为63.33%,试验组优于对照组(P<0.05)。结果表明,麝香追风止痛膏贴敷12、6 h均能有效缓解膝骨关节炎(寒湿痹阻证)患者疼痛,显著降低疼痛VAS评分,降低西蒙和马斯特大学关节炎指数(WOMAC)量表疼痛、僵硬、关节功能评分,临床主要疗效指标疼痛VAS评分的改善程度明显优于麝香追风膏,其缓解膝骨关节炎(寒湿痹阻证)疼痛疗效肯定。安全性方面,麝香追风止痛膏除导致个别患者用药部位皮肤局部出现中药贴膏剂连续使用常见的轻度过敏反应外,未见其他不良反应,也未见患者肝、肾功能与心电图等有异常影响,安全性较高,临床可继续推广运用。The Shexiang Zhuifeng Zhitong Ointment with the effects of dispelling wind, removing dampness, dissipating cold, and relieving pain is used for treating arthralgia, muscular pain, and sprain pain caused by cold-dampness obstruction. To evaluate the efficacy and safety of Shexiang Zhuifeng Zhitong Ointment in relieving the pain due to knee osteoarthritis(syndrome of cold-dampness obstruction), a randomized, double-blind, parallel controlled, multicenter clinical trial was conducted. The stratified randomization method was used to randomize the 240 subjects into a treatment group and a control group in a ratio of 1∶1. In each group, 60 patients received external application for 12 h and the other 60 patients received external application for 6 h. The treatment group received external application of Shexiang Zhuifeng Zhitong Ointment, while the control group received external application of Shexiang Zhuifeng Ointment. The treatment lasted for 21 days in both groups. Follow-up was conducted on days 7, 14, and 21 of treatment. The results based on the full analysis set were as follows.(1)In visual analog scale(VAS) score, the mean difference in the VAS score between baseline and 12 h post-treatment was 3.02 in the treatment group and 2.31 in the control group, with a significant difference(P<0.05). The mean difference in the VAS score between baseline and 6 h post-treatment was 3.19 in the treatment group and 2.48 in the control group, with a significant difference(P<0.05).(2)Response rate in terms of VAS score, after treatment for 12 h, the response rate was 93.22% in the treatment group and 73.33% in the control group, with a significant difference(P<0.05). After treatment for 6 h, theresponse rate in the treatment group was 88.33%, which was higher than that(63.33%) in the control group(P<0.05).The results showed that Shexiang Zhuifeng Zhitong Ointment applied for 12 and 6 h effectively relieved the knee joint pain of patients with knee osteoarthritis due to cold-dampness obstruction, as demonstrated by the reduc

关 键 词：麝香追风止痛膏 膝骨关节炎 临床试验 安全性 有效性 

分 类 号：R274.9[医药卫生—中西医结合]