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奇正消痛贴膏治疗膝骨关节炎有效性及安全性的多中心、随机对照研究
张洪美1, 林定坤2, 王昌兴3, 赵钟文4, 朱永良5, 陈文君6, 李鑫鑫7, 吴西发8, 王遵来9, 王荣宙10, 蒋铭11, 朱立国1
1.中国中医科学院望京医院, 北京 100102;2.广东省中医院, 广州 510530;3.浙江省新华医院, 杭州 310005;4.福建中医药大学附属第二人民医院, 福州 350003;5.南京市级机关医院, 南京 210008;6.江苏省级机关医院, 南京 210024;7.天津三潭医院, 天津 300193;8.淄博市中心医院, 淄博 255036;9.天津北辰北门医院, 天津 300400;10.天津乐园医院, 天津 300200;11.昆山市中医医院, 昆山 215300
摘要:
[目的]评估奇正消痛贴膏及新型奇正消痛贴膏每日应用8 h、24 h对膝骨关节炎的疗效差异,同时收集相关安全性数据。[方法]采用多中心、随机对照研究方法,共纳入膝骨关节炎患者455名,根据奇正消痛贴膏原型/新型以及每次使用时间8 h/24 h两个因素,将患者随机分为4组,原型短时间组:接受原型奇正消痛贴膏外敷患处,每日1贴,每次贴敷8 h;新型短时间组:接受新型奇正消痛贴膏外敷患处,每日1贴,每次贴敷8 h;原型长时间组:接受原型奇正消痛贴膏外敷患处,每日1贴,每次贴敷24 h;新型长时间组:接受新型奇正消痛贴膏外敷患处每日1贴,每次贴敷24 h。疗程为2周,治疗前、治疗后及治疗结束后1周,分别评价患者的关节疼痛视觉模拟评分法(VAS)评分、西大略湖和麦克马斯特骨关节炎(WOMAC)量表评分、膝骨关节炎指征等级表评分,同时检测相关安全性评价指标。[结果]在治疗后及治疗结束1周后随访时,4组患者膝关节疼痛VAS评分、WOMAC量表评分及膝骨关节炎指征等级评分较治疗前均有显著改善(P<0.01),而随访结果与治疗后结果之间比较无统计学差异;组间比较显示,4组在疗效上无统计学差异(P>0.05)。安全性指标方面,4组对比无统计学差异(P>0.05),但短时间8 h组相比长时间24 h组有更低的不良事件发生率,且不良事件多为轻度瘙痒、烧灼感等,停药后可消失,整个治疗期间未发生严重不良事件。[结论]新型/原型奇正消痛贴膏应用8 h或者24 h,2周疗程,可明显改善膝骨关节炎患者的症状,起到显著的治疗效果,不良反应较少,且每日8 h的贴敷时间,在不降低治疗效果的基础上,同时有助于减少长时间外敷引起的不良反应。而新型奇正消痛贴膏在疗效及安全性方面,与原型奇正消痛贴膏相当。
关键词:  奇正消痛贴膏  膝骨关节炎  随机对照试验
DOI:10.11656/j.issn.1672-1519.2019.03.07
分类号:R684.3
基金项目:国家科技重大专项(2014ZX09301-308-02)。
Evaluation on the efficacy and safety of Qizheng Xiaotong Plaster for the treatment of knee osteoarthritis: a randomized controlled,multicenter study
ZHANG Hongmei1, LIN Dingkun2, WANG Changxing3, ZHAO Zhongwen4, ZHU Yongliang5, CHEN Wenjun6, LI Xinxin7, WU Xifa8, WANG Zunlai9, WANG Rongzhou10, JIANG Ming11, ZHU Liguo1
1.Wang Jing Hospital of CACMS, Beijing 100102, China;2.Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou 510530, China;3.Xinhua Hospital of Zhejiang Province, Hangzhou 310005, China;4.The Second People's Hospital of Fujian Province, Fuzhou 350003, China;5.Nanjing Municipal Government Hospital, Nanjing 210008, China;6.Provincial Government Hospital of Jiangsu, Nanjing 210024, China;7.Tianjin Santan Hospital, Tianjin 300193, China;8.Central Hospital of Zibo, Zibo 255036, China;9.Tianjin Beichen North Gate Hospital, Tianjin 300400, China;10.Tianjin Paradise Hospital, Tianjin 300200, China;11.Traditional Chinese Medicine Hospital of Kunshan, Kunshan 215300, China
Abstract:
[Objective] To assess the efficacy and safety of Qizheng Xiaotong Plaster and the newtype Qizheng Xiaotong Plaster on the treatment of knee osteoarthritis in 8 hours and 24 hours conducted as a randomized controlled,multicenter study.[Methods] A multiple center,randomized controlled study was conducted and 455 knee osteoarthritis patients were involved in this research. The patients were randomly divided into A-D four groups. Group A received 8-hour external application of Qizheng Xiaotong Plaster every day. Group B received 8-hour external application of new type Qizheng Xiaotong Plaster every day. Group C received 24-hour external application of Qizheng Xiaotong Plaster every day;Group D received 24-hour external application of new type Qizheng Xiaotong Plaster every day. The course of treatment was two weeks. The joint pain VAS score,WOMAC questionnaire scores and knee osteoarthritis indications scale score were detected before and after treatment and 1 week after treatment respectively. The related safety evaluation indicators were also tested at the same time.[Results] The knee pain VAS score,WOMAC rating scale and knee osteoarthritis indications ratings in four groups after treatment and follow-up after 1 week were significantly improved than pre-treatment (P<0.01). There was no significant difference between the posttreatment and the follow-up results. And at the same time,no significant difference in efficacy was found between the four groups (P>0.05). In terms of safety indicators,there was no significant difference among the four groups (P>0.05),but the eight-hour group had a lower incidence of adverse events compared with the 24-hour group. The most adverse events were itching,burning sensation,which can disappear when the external application was stopped. There were no deaths during the whole treatment period.[Conclusion] The application the new/prototype Qizheng Xiaotong Plaster 8 hours or 24 hours a day,two weeks of treatment,can obviously improve the symptoms of patients with knee osteoarthritis,and less adverse reaction was found during the treatment. Besides,the application of 8 hours every day can reduce the adverse reaction,but did not reducing the treatment effect. There was no significant difference in the efficacy and safety between the newtype Qizheng Xiaotong Plaster and the Qizheng Xiaotong Plaster.
Key words:  Qizheng Xiaotong Plaster  knee osteoarthritis  randomized controlled study
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