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'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 discontinuation,the efficacies of the three groups were 78％,95％,and 65％,respectively,with statistically significant differences (P ＜ 0.0001).Intergroup pairwise comparisons revealed that the efficacy of the combination group was significantly better than that of the Zhuanggu and the celecoxib groups (P ＜ 0.0001).The difference between the latter two groups was not statistically significant (P ＞ 0.0167).The incidences of adverse events in Zhuanggu group,combination group,and celecoxib group were 8.5％,8.5％,and 11.1％,respectively,with insignificant differences (P ＞ 0.05).Conclusions:Zhuanggu joint capsules alone or combined with celecoxib showed clinical efficacy in the treatment of KOA.The safety of Zhuanggu joint capsules alone or combined with celecoxib was acceptable.