昆仙胶囊治疗类风湿关节炎多中心临床研究

作者	单位
杨岫岩	广州中医药大学第一附属医院风湿科
杨少锋	广州中医药大学第一附属医院风湿科
徐强	广州中医药大学第一附属医院风湿科
王笑丹	广州中医药大学第一附属医院风湿科
孙维峰	广州中医药大学第一附属医院风湿科
沈鹰	广州中医药大学第一附属医院风湿科
林昌松	广州中医药大学第一附属医院风湿科
戴冽	广州中医药大学第一附属医院风湿科

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中文摘要:

目的评价昆仙胶囊治疗类风湿关节炎(rheumatic arthritis,RA)的临床疗效和安全性。方法采用随机、阳性平行对照、多中心开放试验的方法。将240例轻中度RA患者随机分为昆仙胶囊组(昆仙组,80例,采用口服昆仙胶囊治疗)、甲氨蝶呤(methotrexate,MTX)组(80例,采用口服MTX治疗)、昆仙胶囊+MTX联合用药组(联合组,80例,同时服用昆仙胶囊及MTX治疗),疗程均为12周。治疗前后分别检测DAS28和ACR20、ACR50,关节疼痛数和疼痛VAS评分、关节肿胀数、疲乏VAS评分、疾病总体状况VAS评分、晨僵时间、双手握力、HAQ评分、血沉(ESR)、C反应蛋白(CRP)、类风湿因子(RF)、抗CCP抗体、血小板变化。结果本研究试验第4周起,联合组DAS28评分变化、DAS28疗效判定、ACR20及ACR50疗效改善均明显优于其余两组,差异有统计学意义(P<0.05)。第12周时,联合组总有效率为88.6%,显效率为51.8%,且3组均较治疗前改善明显,差异有统计学意义(P<0.05)。昆仙组与联合组在VAS疼痛评分及VAS疲乏评分指标的改善方面优于MTX组,联合组在VAS疾病总体状况研究者评定、关节肿胀数、左右手握力、关节疼痛数、VAS疾病总体状况受试者评定、HAQ评分单项指标的改善方面优于其余两组,差异有统计学意义(P<0.05)。3组晨僵时间改善差异没有统计学意义(P>0.05)。3组不良事件发生率差异无统计学意义。结论昆仙胶囊对RA患者具有缓解症状,改善关节功能活动、体征及实验室指标的作用,不良反应较少,且与MTX联合用药具有协同作用。

英文摘要:

Objective To assess the therapeutic efficacy and safety of Kunxian Capsule(KXC) in treatment of rheumatoid arthritis(RA).Methods Randomized positive parallel controlled and multi-center open test method was adopted.240 RA patients of mild/moderate degree were randomly assigned to three groups equally,i.e.,KXC group(who took KXC),the methotrexate(MTX) group(who took MTX),and the KXC+MTX group(who took KXC and MTX simultaneously),respectively.The therapeutic course for them all was 12 weeks.The effect of the treatment was assessed in items of DAS28,ACR20,and ACR50;number of joints with pain and swelling;VAS score of pain,tiredness,and general condition;time of morning stiffness;bilateral grip strength;HAQ score,as well as blood levels of erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF),anti-CCP antibody,and platelet count.Results By the end of the 4th week,the improvement of ACR20,ACR50,DAS28 efficacy judgment,and DAS28 score in the KXC+MTX group were much better than those in the other two groups,with statistical difference(P<0.05).The total effective rate was 88.6% and the markedly effective rate was 51.8% in the KXC+MTX group at the 12th week.The Improvement was more obviously shown in all groups after treatment(all P<0.05).Better effects in reducing VAS scores of pain and tiredness were shown in the KXC group and the KXC+MTX group.The effects of KXC+MTX were superior to the other two groups in terms of swollen joint numbers,pain joints,grip strength(assessed by researcher),as well as VAS score of general condition and HAQ score(assessed by both patients and researcher,P<0.05).But the differences among groups in improving morning stiffness and the incidence rate of adverse events were insignificant.Conclusions KXC could relieve symptoms,improve joint functions,physical signs,and laboratory indices of RA patients with less adverse reaction.It was synergistic with MTX.

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