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)
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 4尉迎丽 4汪国友 5王丽彬 5郭兵 6朱鸿飞 6姜维成 7武丽娜 1马林8
作者信息
- 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
- 折叠
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).②VAS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(WOM-AC)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.
Abstract
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 effi-cacy and safety of Shexiang Zhuifeng Zhitong Ointment in relieving the pain due to knee osteoarthritis(syndrome of cold-dampness ob-struction),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 ex-ternal 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.①In 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).②Response 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 reduced VAS score,Western Ontario and McMaster Uni-versities Arthritis Index(WOMAC),stiffness,and joint function score.Moreover,Shexiang Zhuifeng Zhitong Ointment outperformed the positive control Shexiang Zhuifeng Ointment in terms of reducing the VAS score,demonstrating a definitetherapeutic effect on the pain due to knee osteoarthritis(syndrome of cold-dampness obstruction).In addition,Shexiang Zhuifeng Zhitong Ointment did not cause other adverse reactions except for mild allergic reactions,which were common in the external application of traditional Chinese medicine plasters on the skin,inseveral patients.Neither other adverse reactions nor abnormalities of liver and kidney functions and electrocardiogram were observed.This ointment had high safety and could be popularized in clinical application.
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Key words
Shexiang Zhuifeng Zhitong Ointment/knee osteoarthritis/clinical trial/safety/efficacy引用本文复制引用
基金项目
国家重点研发计划"中医药现代化研究"重点专项(2019YFC171250)
出版年
2024
NETL
NSTL
万方数据