Efficacy and Safety of Zhuanggu Joint Capsules in Combination with Celecoxib in Knee Osteoarthritis： A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Trial  

作　　者：Xian-Long Zhang Jing Yang Liu Yang Jian-Guo Liu Xin-Yu Cai Wei-Ming Fan Xue-Qing Yun Jin-Zhong Ma Xi-Sheng Weng 

机构地区：[1] Department of Orthopaedics, Shanghai No.6 People' s Hospital, Shanghai Jiao Tong University, Shanghai 200233, China [2] Department of Orthopaedics, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [3] Department of Joint Surgery, Southwest Hospital, Third Military Medical University, Chongqing 400038, China [4] Department of Joint Surgery, No.1 Hospital of Jinlin University, Changchun, Jinlin 130021, China [5] Department of Orthopaedics, Shanghai Tenth People' s Hospital, Shanghai Tongji University, Shanghai 200072, China [6] Department of Orthopaedics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China [7] Department of Orthopaedics, Beijing Hospital, Beijing 100730, China [8]Department of Orthopaedics, Shanghai No. 1 People's Hospital, Shanghai Jiao Tong University, Shanghai 200080, China [9]Department of Orthopaedics, Peking Union Medical College Hospital, Beijing 100032, China

出　　处：《Chinese Medical Journal》2016年第8期891-897,共7页中华医学杂志（英文版）

摘　　要：Background：Knee osteoarthritis （KOA） is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling,stiffness,and movement disorders.The therapeutic goal is to alleviate or eliminate pain,correct deformities,improve or restore joint functions,and improve the quality of life.This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA.Methods：This multi-center,randomized,double-blind,double-dummy,parallel controlled trial,started from December 2011 to May 2014,was carried out in 6 cities,including Beijing,Shanghai,Chongqing,Changchun,Chengdu,and Nanjing.A total of 432 patients with KOA were divided into three groups （144 cases in each group）.The groups were treated,respectively,with Zhuanggu joint capsules combined with celecoxib capsule simulants,Zhuanggu joint capsules combined with celecoxib capsules,and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively.The improvement of Western Ontario and McMaster Universities Osteoarthritis （WOMAC） index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment.Intergroup and intragroup comparisons of quantitative indices were performed.Statistically significant differences were evaluated with pairwise comparisons using Chi-square test （or Fisher＆#39;s exact test） and an inspection level ofα =0.0167.Results：Four weeks after treatment,the total efficacies of Zhuanggu group,combination group,and celecoxib group were 65%,80%,and 64%,respectively,with statistically significant differences among the three groups （P =0.005）.Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu （P =0.005） and celecoxib （P =0.003）groups.The difference between the latter two groups was not statistically significant （P 〉 0.0167）.Four weeks after discontiBackground：Knee osteoarthritis （KOA） is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling,stiffness,and movement disorders.The therapeutic goal is to alleviate or eliminate pain,correct deformities,improve or restore joint functions,and improve the quality of life.This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA.Methods：This multi-center,randomized,double-blind,double-dummy,parallel controlled trial,started from December 2011 to May 2014,was carried out in 6 cities,including Beijing,Shanghai,Chongqing,Changchun,Chengdu,and Nanjing.A total of 432 patients with KOA were divided into three groups （144 cases in each group）.The groups were treated,respectively,with Zhuanggu joint capsules combined with celecoxib capsule simulants,Zhuanggu joint capsules combined with celecoxib capsules,and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively.The improvement of Western Ontario and McMaster Universities Osteoarthritis （WOMAC） index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment.Intergroup and intragroup comparisons of quantitative indices were performed.Statistically significant differences were evaluated with pairwise comparisons using Chi-square test （or Fisher＆#39;s exact test） and an inspection level ofα =0.0167.Results：Four weeks after treatment,the total efficacies of Zhuanggu group,combination group,and celecoxib group were 65%,80%,and 64%,respectively,with statistically significant differences among the three groups （P =0.005）.Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu （P =0.005） and celecoxib （P =0.003）groups.The difference between the latter two groups was not statistically significant （P 〉 0.0167）.Four weeks after disconti

关 键 词：CELECOXIB Drug Combination Knee Osteoarthritis Zhuanggu Joint Capsule 

分 类 号：S858.28[农业科学—临床兽医学] Q753[农业科学—兽医学]