甲氨蝶呤皮下给药在口服甲氨蝶呤治疗失败的幼年特发性关节炎患儿中的作用。

The role of subcutaneous administration of methotrexate in children with juvenile idiopathic arthritis who have failed oral methotrexate.

作者信息

Alsufyani Khayriah, Ortiz-Alvarez Oliva, Cabral David A, Tucker Lori B, Petty Ross E, Malleson Peter N

机构信息

Division of Rheumatology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.

出版信息

J Rheumatol. 2004 Jan;31(1):179-82.

PMID:14705239

Abstract

OBJECTIVE

To describe the outcome of patients with juvenile idiopathic arthritis (JIA) treated with subcutaneous (Sc) methotrexate (MTX) after failing oral MTX (either because of inefficacy or toxicity) in a clinic population.

METHODS

The study cohort was identified from our clinical database, and consisted of 61 children with JIA treated with MTX between 1988-2001. All patients fulfilled International League Against Rheumatism (ILAR) criteria for JIA and had disease duration of >/= 6 months and 3 or more active joints before institution of MTX. All patients had a core set of outcome variables assessed at baseline and at 3 months after achieving both maximum oral and SC MTX. Outcome variables included physician global assessment of disease activity, number of active joints, number of joints with limited range of motion, duration of early morning stiffness, and erythrocyte sedimentation rate (ESR). Improvement was defined as at least 30% improvement from baseline in 3 of 5 variables in the core set, with no more than one of the remaining variables worsening by more than 30%.

RESULTS

A total of 61 patients, 43 females and 18 males with JIA were studied. The disease subtypes were systemic 8, polyarticular 25 (12 rheumatoid factor positive), oligoarticular 14, enthesitis related arthritis 5, and unclassified 4. Thirty-one patients were switched to SC MTX, 13 of whom had not improved, and 18 who had improved, but had nausea (11) or insufficient clinical improvement (7). After 3 months of SC MTX treatment, 76% of patients were classified as improved and 23% as not improved. Toxicity on SC MTX was less than on oral MTX.

CONCLUSION

Our results suggest that for patients failing oral MTX either because of inefficacy or toxicity, the use of SC MTX has a high likelihood of success with more than 70% of patients achieving clinically significant improvement, without clinically significant toxicity.

摘要

目的

描述在临床人群中，口服甲氨蝶呤（MTX）失败（因无效或毒性）后接受皮下注射（Sc）甲氨蝶呤（MTX）治疗的幼年特发性关节炎（JIA）患者的治疗结果。

方法

研究队列从我们的临床数据库中确定，由1988年至2001年间接受MTX治疗的61例JIA儿童组成。所有患者均符合国际抗风湿病联盟（ILAR）的JIA标准，疾病持续时间≥6个月，在开始使用MTX前有3个或更多活动关节。所有患者在达到最大口服和皮下注射MTX剂量时，于基线及之后3个月评估一组核心结局变量。结局变量包括医生对疾病活动的整体评估、活动关节数、活动范围受限的关节数、晨僵持续时间和红细胞沉降率（ESR）。改善定义为核心组5个变量中的3个较基线改善至少30%，其余变量中不超过1个恶化超过30%。

结果

共研究了61例JIA患者，其中43例女性，18例男性。疾病亚型为全身型8例，多关节型25例（12例类风湿因子阳性），少关节型14例，附着点炎相关关节炎5例，未分类4例。31例患者改为皮下注射MTX，其中13例未改善，18例虽有改善，但有恶心（11例）或临床改善不足（7例）。皮下注射MTX治疗3个月后，76%的患者被分类为改善，23%为未改善。皮下注射MTX的毒性低于口服MTX。