中国中西医结合杂志2024，Vol.44Issue(1)：44-48,5.DOI:10.7661/j.cjim.20231106.338
尪痹胶囊治疗活动性类风湿关节炎多中心、随机双盲、平行对照研究
Wangbi Capsule for Active Rheumatoid Arthritis:A Multicenter,Randomized,Double-blind,Parallel-Controlled Study
摘要
Abstract
Objective To evaluate the efficacy and safety of Wangbi Capsule(WBC)in the treatment of active rheumatoid arthritis(RA).Methods Totally 101 patients in line with inclusion criteria from 114 patients with active RA were assigned to the treatment group(52 cases)and the control group(49 cases)by using block randomization method,which was stratified by center with a selected segment length of 2 and the PROC PLAN procedure statement in SAS9.4 Software used to give the number of seeds.Patients in the treatment group took WBC+methotrexate(MTX),while those in the control group took WBC placebo+MTX.The treatment course lasted for 12 weeks.By comparing the 28 joint disease activity scores(DAS28-ESR)based on erythrocyte sedimentation rate(ESR),28 joint disease activity scores(DAS28-CRP)based on C-reactive protein(CRP),DAS28-ESR remission rate,DAS28-CRP remission rate,ESR,CRP,rheumatoid factor(RF),and anti-cyclic citrulline antibody(ACPA)before and after treatment,patient visual analogue score(VAS),physician VAS score,joint pain count,joint swelling count,the therapeutic effect of QBC were evaluated using indicators such as Health Assessment Questionnaire(HAQ)score and traditional Chinese medicine syndrome score.The safety of WBC was assessed by observing safety indicators and adverse reactions.Results Of the 101 patients,5 dropped off during the treatment course,and 96 patients were finally included in analyses,49 patients in the treatment group and 47 patients in the control group.DAS28-CRP score,DAS28-CRP,patient/physician VAS score,joint tenderness number,joint swelling number,HAQ score,traditional Chinese medicine syndrome score all decreased(P＜0.05)in the two groups after treatment.CRP and DAS28-ESR decreased more significantly(P＜0.05)in the treatment group.Compared with the control group after treatment,DAS28-ESR and traditional Chinese medicine syndrome score decreased more significantly in the treatment group(P＜0.05).Conclusions WBC combined with MTX showed better clinical efficacy and safety in the treatment of active RA than using MTX alone(China Clinical Trials Registry,No.ChiCTR1900026079).关键词
类风湿关节炎/尪痹胶囊/甲氨蝶呤/临床疗效和安全性/随机双盲、平行对照研究/中西医结合Key words
rheumatoid arthritis/Wangbi Capsule/Methotrexate/clinical efficacy and safety/randomized double-blind parallel-controlled study/integrative medicine引用本文复制引用
吴金联,苏励,黄清春,王薇萍,苏晓,王勇,翟付明,刘雅文..尪痹胶囊治疗活动性类风湿关节炎多中心、随机双盲、平行对照研究[J].中国中西医结合杂志,2024,44(1):44-48,5.基金项目
上海市科技计划项目(No.18401900900) （No.18401900900）
