羌椒熏洗散治疗膝关节骨性关节炎的多中心随机对照临床试验  

Qiang Pepper Fumigation Powder in the Treatment of Knee Osteoarthritis:A Multicentre Randomized Controlled Clinical Trial

作　　者：张焱 向杰 周凯 朱明双[3] Zhang Yan;Xiang Jie;Zhou Kai;Zhu Mingshuang(Nanchong Hospital of Traditional Chinese Medicine,Nanchong 637000,China;Ya′an Hospital of Traditional Chinese Medicine,Ya′an 625000,China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610036,China)

机构地区：[1]南充市中医医院,南充637000 [2]雅安市中医医院,雅安625000 [3]成都中医药大学附属医院,成都610036

出　　处：《成都医学院学报》2022年第4期473-475,479,共4页Journal of Chengdu Medical College

基　　金：四川省中医药管理局基金项目(No:2020LC0152)。

摘　　要：目的揭示羌椒熏洗散对膝关节骨性关节炎(OA)的有效性和安全性,为其临床应用奠定理论基础。方法开展多中心、随机、对照临床研究,采用随机方法,选取2020年12月至2022年3月在南充市中医医院、成都中医药大学附属医院、雅安市中医医院收治的OA患者150例分成试验组和对照组,每组75例。试验组外用羌椒熏洗散熏洗患膝,约30 min/次,2次/d;对照组口服盐酸氨基葡萄糖胶囊(1粒/次,2次/d)和美洛昔康片(1片/次,2次/d),两周为1个疗程。在治疗前后,通过疼痛视觉模拟评分(VAS)、美国纽约特种外科医院(HSS)膝关节评分及《中医病证诊断疗效标准》的相关内容,对治疗后两周的疗效和不良反应进行评估。结果试验组显效25例、有效36例、无效14例,对照组显效23例、有效37例、无效15例。两组总有效率比较,差异无统计学意义(P>0.05)。两组治疗前后,VAS评分、HSS膝关节评分组内比较差异有统计学意义(P<0.05),组间比较差异无统计学意义(P>0.05)。本研究中无1例出现不良反应。结论羌椒熏洗散在OA治疗上有效且安全,可提高患者生活质量。Objective To explore the clinical efficacy and safety of Qiang pepper fumigation powder in the treatment of knee osteoarthritis(OA),and to lay a theoretical foundation for its clinical application.Methods A multicenter,randomized,controlled clinical study was conducted.A total of 150 patients were randomly selected from Nanchong Hospital of traditional Chinese medicine,Affiliated Hospital of Chengdu University of traditional Chinese medicine and Ya′an Hospital of traditional Chinese medicine from December 2020 to March 2022.They were divided into the experimental group(n=75)and the control group(n=75).In the experimental group,the affected knees were fumigated and washed with Qiang pepper fumigation powder for about 30 min/time,2 times/d.And the control group was given oral glucosamine hydrochloride capsules,1 capsule/time,2 times/d and meloxicam tablets,1 tablet/time,2 times/d.Both groups received treatment for two weeks.Visual analogue scale(VAS),Hospital for Special Surgery(HSS)knee rating scale,and Criteria for Diagnosis and Treatment of Diseases in Traditional Chinese Medicine were used to assess the efficacy and adverse reactions.Results After treatment,there were 25 cases with marked effect,36 cases with effective results,and 14 cases with no effect in the experimental group,while there were 23 cases with marked effect,37 cases with effective results,and 15 cases with no effect in the control group.There was no significant difference in the total effective rate between the two groups(P>0.05).In terms of VAS score and HSS knee joint score,there was significant difference within each group before and after treatment(P<0.05),but there was no significant difference between the two groups(P>0.05).No adverse reactions occurred in the two groups.Conclusion Qiang pepper fumigation powder is effective and safe in the treatment of OA.

关 键 词：膝关节骨性关节炎 羌椒熏洗散 多中心随机对照临床试验 

分 类 号：R684.3[医药卫生—骨科学]