A double-blind, double-dummy, randomized controlled, multicenter trial of ^(99)Tc-methylene diphosphonate in patients with moderate to severe rheumatoid arthritis  

作　　者：Qiong Fu Ping Feng Ling-Yun Sun Xiao-Xia Zuo Dong-Bao Zhao Dong-Yi He Hua-Xiang Wu Wei Zhang Wei Zhang Fang Du Chun-De Bao 

机构地区：[1]Department of Rheumatology,Renji Hospital of Shanghai Jiaotong University School of Medicine,Shanghai 200000,China [2]National Medical Products Administration Key Laboratory for Clinical Research and Evaluation of Innovative Drugs,Institute of Clinical Trials,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China [3]Department of Rheumatology,Nanjing Drum Tower Hospital,Nanjing University Medical School,Nanjing,Jiangsu 210008,China [4]Department of Rheumatology,Xiangya Hospital,Central South University,Changsha,Hunan 410008,China [5]Department of Rheumatology and Immunology,Changhai Hospital,Shanghai 200433,China [6]Department of Rheumatology,Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai 200052,China [7]Department of Rheumatology,The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,Zhejiang 310009,China [8]Department of Quality Control,Cheng Fei Hospital,Chengdu,Sichuan 610091,China

出　　处：《Chinese Medical Journal》2021年第12期1457-1464,共8页中华医学杂志（英文版）

基　　金：funded by the Chengdu Yunke Pharmaceutical Co.,Ltd.

摘　　要：Background:Clinical observational studies revealed that ^(99)Tc-methylene diphosphonate(^(99)Tc-MDP)could reduce joint pain and swollenness in rheumatoid arthritis(RA)patients.This multicenter,randomized,double-blind,double-dummy study aimed to evaluate the effects of ^(99)Tc-MDP plus methotrexate(MTX)vs.MTX alone or ^(99)Tc-MDP alone on disease activity and structural damage in MTX-naïve Chinese patients with moderate to severe RA.Methods:Eligible patients with moderate to severely active RA were randomized to receive ^(99)Tc-MDP plus MTX(n=59)vs.MTX(n=59)alone or ^(99)Tc-MDP(n=59)alone for 48 weeks from six study sites across four provinces in China.The primary outcomes were the American College of Rheumatology 20%improvement(ACR20)response rates at week 24 and changes in modified total Sharp score at week 48.Results:At week 24,the proportion of participants achieving ACR20 was significantly higher in the MTX+^(99)Tc-MDP combination group(69.5%)than that in the MTX group(50.8%)or ^(99)Tc-MDP group(47.5%)(P=0.03 for MTX+^(99)Tc-MDP vs.MTX,and MTX+^(99)Tc-MDP vs.^(99)Tc-MDP,respectively).The participants in the MTX+^(99)Tc-MDP group and the ^(99)Tc-MDP group had significantly less important radiographic progression than the participants in the MTX group over the 48 weeks(MTX+^(99)Tc-MDP vs.MTX:P=0.03,^(99)Tc-MDP vs.MTX:P=0.03,respectively).There was no significant difference in terms of adverse events(AEs)among the groups.No serious AEs were observed.Conclusions:This study demonstrated that the combination of ^(99)Tc-MDP with MTX inhibited structural damage and improved disease activity in RA patients compared with MTX and ^(99)Tc-MDP monotherapies,without increasing the rate of AEs.Additional clinical studies of ^(99)Tc-MDP therapy in patients with RA are warranted.Trial Registration:Chictr.org,ChiCTR-IPR-14005684;http://www.chictr.org.cn/showproj.aspx?proj=10088.

关 键 词：Rheumatoid arthritis METHOTREXATE ^(99)Tc-MDP Efficacy Safety 

分 类 号：R593.22[医药卫生—内科学]