Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis:A 48-Week,Multicentre,Randomized,Double-Blind,and Placebo-Controlled Trial  

作　　者：JIA Qing-yun WANG Yi-ru SUN Da-wei MAO Jian-chun XUE Luan GU Xiao-hua YU Xiang PIAO Xue-mei XU Hao LIANG Qian-qian 

机构地区：[1]Spine Institute,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai(200032),China [2]Spine Institute,Shanghai University of Traditional Chinese Medicine,Shanghai(200032),China [3]Key Laboratory of Theory and Therapy of Muscles and Bones,Ministry of Education(Shanghai University of Traditional Chinese Medicine),Shanghai(201203),China [4]Department of Orthopedics,Linyi People's Hospital,Linyi,Shandong Province(273000),China [5]Department of Orthopedics,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai(200437),China [6]Department of Orthopedics,the Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine,Shanghai(200137),China

出　　处：《Chinese Journal of Integrative Medicine》2025年第2期99-107,共9页中国结合医学杂志(英文版)

基　　金：Supported by National Natural Science Foundation of China(Nos.81920108032,81822050);State Administration of Traditional Chinese Medicine Young Qi Huang Scholar,Shanghai Science and Technology Innovation Action Plan Medical Innovation Research Project(No.21Y11921400);Innovation Team Project of Scientific Research Project of Traditional Chinese Medicine of Shanghai Health Committee(No.2022CX001);the Program for Innovative Research Team of Ministry of Science and Technology of China(No.2015RA4002);"Innovation Team"Development Projects(No.IRT1270);Shanghai TCM Medical Center of Chronic Disease(No.2022ZZ01009);Shandong Provincial Natural Science Foundation(Nos.ZR2022LZY002 and ZR2021QH230)。

摘　　要：Objective:To explore the efficacy and safety of Juan Bi Pill(JBP)in treatment of active rheumatoid arthritis(RA).Methods:From February 2017 to May 2018,115 participants from 4 centers were randomly divided into JBP group(57 cases)and placebo group(58 cases)in a 1:1 ratio using a random number table method.Participants received a dose of JBP(4 g,twice a day,orally)combined with methotrexate(MTX,10 mg per week)or placebo(4 g,twice a day,orally)combined with MTX for 12 weeks.Participants were required with follow-up visits at 24 and 48 weeks,attending 7 assessment visits.Participants were undergo disease activity assessment 7 times(at baseline and 2,4,8,12,24,48 weeks)and safety assessments 6 times(at baseline and 4,8,12,24,48 weeks).The primary endpoint was 28-joint Disease Activity Score(DAS28-ESR and DAS28-CRP).The secondary endpoints included American College of Rheumatology(ACR)criteria for 20%and 50%improvement(ACR20/50),Health Assessment Questionnaire Disability Index(HAQ-DI),clinical disease activity index(CDAI),visual analog scale(VAS),Short Form-36(SF-36)score,Medial Outcomes Study(MOS)sleep scale score,serum erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),tender joint count,swollen joint count,and morning stiffness.The adverse reactions were observed during the treatment.Results:After 12 weeks of treatment,DAS28-ESR and DAS28-CRP scores in both groups were lower than before treatment(both P<0.01),while the remission rate of DAS28-ESR and DAS28-CRP and low disease activity of JBP group were higher than those in the placebo group(both P<0.01).JBP demonstrated better efficacy on ACR20 and ACR50 compliance rate at 12 and 48 weeks comparing to placebo(all P<0.05).The CDAI and HAQ-DI score,pain VAS and global VAS change of RA patients and physicians,the serum ESR and CRP levels,and the number of tenderness and swelling joints were lower than before treatment at 4,8,12,24,48 weeks in both groups(P<0.05 or P<0.01),while the reduction of above indices in the JBP group was more obvious than those in the

关 键 词：Chinese medicine Juan Bi Pill METHOTREXATE active rheumatoid arthritis randomized controlled trial 

分 类 号：R57[医药卫生—消化系统]