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

Therapeutic effects of low-dose prednisone combined with methotrexate and hydroxychloroquine in the treatment of rheumatoid arthritis

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10mg／周＋羟氯喹0．2g／d；对照组（80例）予以美洛昔康7．5mg／d＋甲氨蝶呤10mg／周＋来氟米特20mg／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，ACR50）。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，DAS28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％vs49％，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。

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, ACRS0. Results After 12 weeks, in terms of primary end- points, 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 〈0.05 orP 〈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）rain, DAS 28 score （3.1±0.9） vs （1.22±0.81）, （16.3 ±10.1）mg/L, （33 ±29）ram/h, （54.7±45.4）rain, （4.9±1.9）, P 〈0. 05 or P 〈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.