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

摘要

目的 评估复方玄驹胶囊(黑蚂蚁、淫羊藿、枸杞子、蛇床子)联合甲氨蝶呤治疗中重度活动性类风湿关节炎(RA)的临床疗效及安全性.方法 病情中重度活动的180例RA患者随机分为复方玄驹组、甲氨蝶呤组和联合用药组,疗程均为48周.观察治疗前后临床症状、体征、红细胞沉降率(ESR)、C反应蛋白(CRP),视觉模拟评分(visual analogue scale,VAS)及健康评估问卷(HAQ)的变化,以美国风湿病学会疗效标准达到20％的改善(ACR20)为主要疗效标准,次要标准为ACRS0和ACR70.以疾病活动指数(DAS) 28计算病情活动性.记录在整个观察期间的所有不良反应.结果 治疗12周后,联合组ACR20的改善率为41.5％,复方玄驹组为19.6％,甲氨蝶呤组为24.1％,联合组优于复方玄驹组和甲氨蝶呤组(P＜0.05).联合组ACR50、ACR70的改善率分别为32.1％和20.8％,明显高于复方玄驹组,差异有统计学意义(P＜0.05).治疗24周后,联合组ACR20的改善率为81.1％,复方玄驹组为30.4％,甲氨蝶呤组为68.5％,联合组优于复方玄驹组(P＜0.05).联合组ACR50、ACR70的改善率分别为60.4％和54.7％,明显高于复方玄驹组和甲氨蝶呤组,差异有统计学意义(P＜0.05).治疗48周后,联合组ACR70的改善率为75.7％,明显高于复方玄驹组和甲氨蝶呤组,差异有统计学意义(P＜0.05).联合组DAS28、HAQ、VAS评分治疗12周后分别下降至(5.26 ±0.83)、(22.2±10.3)、(6.0±0.4)分,24周后分别下降至(4.21 ±0.91)、(17.1 ±10.3)、(2.4±2.2)分,48周后分别下降至(2.19 ±0.56)、(10.4±5.0)、(0.8±0.9)分,尤其在治疗24周后DAS28、HAQ、VAS评分的下降明显优于复方玄驹组和甲氨蝶呤组,差异有统计学意义(P＜0.05).联合组不良反应的发生率与甲氨蝶呤组之间差异无统计学意义(P＞0.05).结论 复方玄驹胶囊联合甲氨蝶呤的治疗方案,可以明显改善中重度RA患者的临床症状,降低病情活动度,并且有良好的安全性.%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.