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来氟米特治疗幼年特发性关节炎的长期前瞻性真实世界临床经验。

A longterm prospective real-life experience with leflunomide in juvenile idiopathic arthritis.

机构信息

From the Department of Internal Medicine, Faculty of Medicine, Universidade Federal do Ceará, Fortaleza CE, Brazil.

出版信息

J Rheumatol. 2014 Feb;41(2):338-44. doi: 10.3899/jrheum.130294. Epub 2013 Dec 15.

Abstract

OBJECTIVE

To describe a clinical practice with leflunomide (LEF) in juvenile idiopathic arthritis (JIA).

METHODS

Patients with JIA seen between May 2008 and May 2012 and considered nonresponsive to methotrexate (MTX) were given LEF and prospectively followed. Primary outcome was a 28-joint Disease Activity Score (DAS28) of low disease activity (< 3.2) in less than 6 months. Childhood Health Assessment Questionnaire (CHAQ) scores and safety data were recorded.

RESULTS

Forty-three patients (33 female) were included with 25 (58.1%) polyarticular, 10 oligoarticular (7 extended; 3 persistent), 6 systemic, and 2 enthesitis-related. Ten (23.2%) were rheumatoid factor-positive and 7 (16.3%) had antinuclear antibodies. Prior drugs other than MTX: 11 (25.5%) chloroquine diphosphate + MTX and 2 (4.6%) sulfasalazine + MTX; mean prednisone dose was 6.4 ± 9.3 mg. The MTX dose prior to LEF was 14.5 ± 4.5 mg/m(2)/week. LEF dose and duration of therapy were 16.6 ± 5.2 mg/d and 3.6 ± 2.2 years, respectively. Nineteen patients (44.2%) interrupted LEF: 1 entered remission, 11 were nonresponsive, and 7 were intolerant (16.2%). Baseline DAS28 (5.57 ± 0.7) dropped to 3.7 ± 1.2 at final analysis (p < 0.001) and 16 patients (37.2%) had a low DAS28 [< 3.2; 12 (27.9%) while taking LEF + MTX and 4 (9.3%) while taking monotherapy]. At last followup, the number of patients with DAS28 > 5.1 dropped from 34 (79%) to 9 (20.9%) and CHAQ scores from 0.86 ± 0.7 to 0.44 ± 0.5 (p < 0.001).

CONCLUSION

LEF isolated or combined with MTX is effective and safe to treat JIA in patients refractory to MTX.

摘要

目的

描述一种使用来氟米特(LEF)治疗幼年特发性关节炎(JIA)的临床实践。

方法

2008 年 5 月至 2012 年 5 月间,我们对考虑对甲氨蝶呤(MTX)无反应的 JIA 患者使用 LEF 进行治疗,并进行前瞻性随访。主要结局为 28 个关节疾病活动度评分(DAS28)在不到 6 个月内达到低疾病活动度(<3.2)。记录儿童健康评估问卷(CHAQ)评分和安全性数据。

结果

共纳入 43 例患者(33 例女性),25 例(58.1%)为多关节炎,10 例为少关节炎(7 例扩展型;3 例持续型),6 例为全身型,2 例附着点炎相关型。10 例(23.2%)为类风湿因子阳性,7 例(16.3%)抗核抗体阳性。在使用 LEF 之前,除 MTX 以外的其他药物:11 例(25.5%)氯喹二磷酸盐+MTX 和 2 例(4.6%)柳氮磺胺吡啶+MTX;平均泼尼松剂量为 6.4±9.3mg。在使用 LEF 之前,MTX 剂量为 14.5±4.5mg/m2/周。LEF 剂量和治疗持续时间分别为 16.6±5.2mg/d 和 3.6±2.2 年。19 例患者(44.2%)中断了 LEF 治疗:1 例进入缓解期,11 例无反应,7 例不耐受(16.2%)。基线 DAS28(5.57±0.7)在最终分析时降至 3.7±1.2(p<0.001),16 例(37.2%)DAS28<3.2[12 例(27.9%)在使用 LEF+MTX 时,4 例(9.3%)在使用单药治疗时]。末次随访时,DAS28>5.1 的患者从 34 例(79%)降至 9 例(20.9%),CHAQ 评分从 0.86±0.7 降至 0.44±0.5(p<0.001)。

结论

LEF 单独或与 MTX 联合使用治疗对 MTX 无反应的 JIA 患者是有效且安全的。

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