小剂量泼尼松联合甲氨蝶呤及羟氯喹治疗类风湿关节炎的疗效研究

摘要

Objective To investigate the efficacy and safety of low-dose prednisone combined with methotrexate (MTX) and hydroxychloroquine (HCQ) in the treatment of rheumatoid arthritis (RA).Methods In this 12-week study,150 patients with active rheumatoid arthritis were randomly divided into two groups:prednisone group (70 cases who were received prednisone 5 ～ 10 mg/d + MTX 10 mg/w +HCQ 0.2 g/d) and control group (80 cases who were treated by Meloxicam 7.5 mg/d + MTX 10 mg/w +Leflunomide (LEF) 20 mg/d).The primary end-points were tender and swollen joint counts,visual analogue scales (VAS),and global physician and patients assessments of disease.The secondary end-points were morning stiffness time,C-reactive protein,erythrocyte sedimentation rate,the Health Assessment Questionnaire (HAQ),DAS28 and ACR20,ACR50.Results After 12 weeks,in terms of primary endpoints,tender and swollen joint counts,VAS and global physician assessments in the prednisone group were improved significantly [(4.5 ± 2.5),(3.2 ± 3.36),(21 ± 15),(24.2 ± 16.4),(20.2 ± 10.4) vs (6.4 ±5.84),(6.6±5.5),(46±14),(37.9±19.7),(34.1±12.4),P ＜0.05orP ＜0.01].In terms of secondary end-points,the prednisone group produced higher response rates [HAQ score (0.93 ± 0.52),CRP(10.2 ± 5.8) mg/L,ESR(30 ± 14) mm/h,morning stiffness time (32.0 ± 32.3) min,DAS 28 score (3.1±0.9) vs (1.22 ±0.81),(16.3±10.1)mg/L,(33±29)mm/h,(54.7±45.4)min,(4.9±1.9),P ＜0.05 orP ＜0.01].The incidence of adverse events was similar between two groups (43％ vs 49％,P ＞ 0.05).Conclusions Low-dose prednisone combined with MTX and HCQ produced rapid and relevant improvements in RA signs and symptoms.%目的 探讨小剂量泼尼松联合甲氨蝶呤、羟氯喹治疗类风湿关节炎的疗效及安全性.方法 将150例活动性类风湿关节炎患者按随机数字法分2组:泼尼松组(70例)予以泼尼松5 ～10mg/d+甲氨蝶呤10 mg/周+羟氯喹0.2 g/d；对照组(80例)予以美洛昔康7.5 mg/d+甲氨蝶呤10mg/周+来氟米特20 mg/d,疗程12周.观察两组患者主要疗效指标:肿胀、压痛关节数、患者疼痛视觉模拟评分、患者及医师对疾病状况总体评价；次要疗效指标:晨僵持续时间、C-反应蛋白(CRP)、红细胞沉降率(ESR)、健康评价问卷(HAQ)、DAS28评分以及美国风湿病学会疗效评价指标(ACR20,ACP50).结果 治疗12周后,在主要疗效指标方面,与对照组相比,泼尼松组的压痛、肿胀关节数减少,患者疼痛评分和患者及医师总体评价改善[(4.5±2.5)个,(3.2 ±3.36)个,(21±15)分,(24.2±16.4)分,(20.2±10.4)分vs (6.4±5.84)个,(6.6±5.5)个,(46±14)分,(37.9±19.7)分,(34.1±12.4)分,P＜0.05或P＜0.01]；在次要疗效指标方面,与对照组相比,泼尼松组的治疗应答率更高[HAQ评分(0.93 ±0.52)分,CRP(10.2±5.8)mg/L,ESR(30±14) mm/h,晨僵持续时间(32.0 ±32.3)min,DAS 28评分(3.1±0.9)分vs (1.22±0.81)分,(16.3±10.1)mg/L,(33 ±29)mm/h,(54.7±45.4) min,(4.9±1.9)分,P＜0.05或P＜0.01]；两组患者不良事件的发生率相似(43％ vs 49％,P＞0.05).结论 小剂量泼尼松联合甲氨蝶呤、羟氯喹治疗可快速且显著改善RA的症状与体征.