Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial
单位：[1]Department of Rheumatology and Immunology, Peking University People’s Hospital, Beijing 100044, China[2]Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[3]Department of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China[4]Department of Rheumatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China北京朝阳医院[5]Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China[6]Department of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China[7]Department of Rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[8]Department of Orthopaedics, Beijing Jishuitan Hospital, Beijing, China[9]Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[10]Department of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China[11]Department of Rheumatology, The First Hospital of China Medical University, Shenyang, China[12]Academic Rheumatology, University of Nottingham, Nottingham NG5 1PB, UK
This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of >= 50 %, and the secondary efficacy endpoint was the proportion of patients with an improvement of >= 25 % from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80 % and significance level of 2.5 % with a non-inferiority margin of -10 %. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6 % [95 % confidence interval, -1.7 to 26.9 %]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis.
基金：
Daiichi Sankyo Co., LtdDaiichi Sankyo Company Limited
第一作者单位：[1]Department of Rheumatology and Immunology, Peking University People’s Hospital, Beijing 100044, China
通讯作者：
推荐引用方式(GB/T 7714)：
Mu Rong,Bao Chunde,Chen Zhiwei,et al.Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial[J].CLINICAL RHEUMATOLOGY.2016,35(1):165-173.doi:10.1007/s10067-014-2701-4.
APA：
Mu, Rong,Bao, Chunde,Chen, Zhiwei,Zheng, Yi,Wang, Guochun...&Li, Zhanguo.(2016).Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial.CLINICAL RHEUMATOLOGY,35,(1)
MLA：
Mu, Rong,et al."Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial".CLINICAL RHEUMATOLOGY 35..1(2016):165-173
