中成药2018，Vol.40Issue(2)：299-304,6.DOI:10.3969/j.issn.1001-1528.2018.02.010
复方玄驹胶囊联合甲氨蝶呤治疗难治性类风湿关节炎的临床研究
The clinical observation of Compound Xuanju Capsules Combined with methotrexate treating rheumatoid arthritis
摘要
Abstract
AIM To evaluate the clinical effects of Compound Xuanju Capsules (CXC,Polyrhachis vicina Roger,Epimedii Folium,Lycii Fructus,Cnidii Fructus) combined with methotrexate (MTX) on patients with moderate or severe rheumatoid arthritis (RA).METHODS One hundred and eighty RA patients were randomized into 3 groups:CXC group,MTX group and combined group (dosed with both CXC and MTX) for a 48-week intervention.The clinical observation on the changes of the signs and symptoms,erythrocyte sedimentation rate (ESR),C-reactive protein (CRP),health assessment questionnaire (HAQ),visual analogue scale (VAS) and disease active score (DAS) 28 were performed before and after each treatment.ACR20,American College of Rheumatology 20％ improvement criteria was taken as the primary end point,and ACR50 and ACR70 as the secondary end points to standardize the patients' response measurement,and all adverse reactions were recorded as well.RESULTS At the time point right after the 12th week,the ACR20 response rate of the combined group (41.5％) was significantly higher than that of the CXC group (19.6％,P ＜ 0.05) and the MTX group (24.1％,P＜0.05).The respective ACR50 (2.1％) and ACR70 (20.8％) response rate of the combined group were significantly higher than those of CXC group and MTX group (P ＜ 0.05).At the time point right after the 24th week,the combined group still demonstrated its significantly higher ACR20 response rate (81.1％) to the CXC group (30.4％,P ＜ 0.05) and the MTX group (68.5％,P ＜ 0.05).The similar superiority in ACRS0 (60.4％) and ACR70 (54.7％) response rate of the combined group to the CXC group and the MTX group were found (P ＜0.05).After the 48th week,the combined group displayed its significantly higher ACR70 response rate (75.7％) to CXC group and MTX group (P ＜ 0.05).Given the reduction of DAS28,HAQ and VAS from the12thweek's5.26±0.83),(22.2±10.3),(6.0±0.4) to the 24thweek's (4.21 ±0.91),(17.1±10.3),(2.4±2.2),andthe48thweek's (2.19±0.56),(10.4±5.0),(0.8±0.9),the combined group's more outstanding performance compared to CXC group and MTX group started right after the 24th week (P ＜ 0.05).Generally,no difference in adverse events was detected between the combined group and MTX group (P ＞ 0.05).CONCLUSION The combined use of CXC and MTX can be an effective and safe treatment for moderate and severe rheumatoid arthritis.关键词
类风湿关节炎/复方玄驹胶囊/甲氨蝶呤/治疗效果Key words
rheumatoid arthritis (RA)/Compound Xuanju Capsules (CXC)/methotrexate (MTX)/treatment outcome分类
医药卫生引用本文复制引用
王丽萍,王春燕,王晓元,张燕..复方玄驹胶囊联合甲氨蝶呤治疗难治性类风湿关节炎的临床研究[J].中成药,2018,40(2):299-304,6.基金项目
兰州大学第二医院院内中医药项目(YJzy201324) （YJzy201324）
