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类风湿关节炎患者甲氨蝶呤不耐受与给药频率和给药途径相关因素的横断面研究。

Factors related to dosing frequency and route of administration in methotrexate intolerance among patients with rheumatoid arthritis: a cross-sectional study.

作者信息

Almalag Haya M, Alsabhan Jawza F, Alarfaj Abdurhman S, Alfi Eman, Albalawi Shorouq, Al-Shadaawi Asma A, Alshehri Sahar A, Assiri Ghadah Asaad, Almaghlouth Ibrahim, Omair Mohammed A

机构信息

Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh 11451, P.O. Box 2457, Saudi Arabia.

Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.

出版信息

Ther Adv Drug Saf. 2025 Jun 14;16:20420986251349449. doi: 10.1177/20420986251349449. eCollection 2025.

Abstract

BACKGROUND

Methotrexate is central to the management of rheumatoid arthritis (RA). However, its use is often limited by methotrexate intolerance.

OBJECTIVES

This study aims to explore the association between alternative methotrexate dosing methods and methotrexate intolerance.

DESIGN

A cross-sectional study.

METHODS

A cross-sectional survey was conducted on patients with RA receiving methotrexate for at least 3 months at the outpatient clinic of King Saud University Medical City, Riyadh, Saudi Arabia. The electronic survey collected data on demographics, marital and educational status, methotrexate use, Methotrexate Intolerance Severity Score (MISS), and Health Assessment Questionnaire. Statistical analyses (univariate and linear or logistic regression) were conducted to evaluate the associations between the administration methods and methotrexate intolerance (MISS ⩾6).

RESULTS

The study included 154 patients, predominantly female (89%; mean age (standard deviation, ±SD): 50 (±12) years). Methotrexate tolerance was observed in 64% of the participants, while 36% had a MISS above the cutoff point of 6, indicating intolerance. Methotrexate-intolerant patients were younger (mean age (±SD): 47 (±12) years) than tolerant patients (mean age (±SD): 54 (±12) years;  = 0.005). No significant differences were found between methotrexate-tolerant and methotrexate-intolerant patients regarding dose, frequency, relation to meals, and time of day.

CONCLUSION

Methotrexate tolerance was not associated with different administration methods: split-dose versus single weekly dose, or subcutaneous versus oral administration.

摘要

背景

甲氨蝶呤是类风湿关节炎(RA)治疗的核心药物。然而,其应用常因甲氨蝶呤不耐受而受到限制。

目的

本研究旨在探讨甲氨蝶呤替代给药方法与甲氨蝶呤不耐受之间的关联。

设计

一项横断面研究。

方法

在沙特阿拉伯利雅得国王沙特大学医学城门诊,对接受甲氨蝶呤治疗至少3个月的RA患者进行横断面调查。电子调查问卷收集了人口统计学、婚姻和教育状况、甲氨蝶呤使用情况、甲氨蝶呤不耐受严重程度评分(MISS)以及健康评估问卷等数据。进行统计分析(单因素分析以及线性或逻辑回归分析)以评估给药方法与甲氨蝶呤不耐受(MISS⩾6)之间的关联。

结果

该研究纳入了154例患者,其中以女性为主(89%;平均年龄(标准差,±SD):50(±12)岁)。64%的参与者观察到甲氨蝶呤耐受,而36%的患者MISS高于临界值6,表明存在不耐受。甲氨蝶呤不耐受患者比耐受患者年轻(平均年龄(±SD):47(±12)岁),而耐受患者平均年龄(±SD):54(±12)岁;P = 0.005)。在甲氨蝶呤耐受和不耐受患者之间,在剂量、频率、与进餐的关系以及给药时间方面未发现显著差异。

结论

甲氨蝶呤耐受与不同给药方法无关:分剂量给药与每周单次给药,或皮下给药与口服给药。

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