Division of Pediatric Rheumatology, Department of Pediatrics, Federal University Sao Paulo (Unifesp), Rua Borges Lagoa, 802, Sao Paulo, ZIP CODE: 04038-001, Brazil.
Adv Rheumatol. 2020 Nov 5;60(1):53. doi: 10.1186/s42358-020-00154-4.
Adverse drug reactions (ADRs) are the sixth leading causes of death worldwide; monitoring them is fundamental, especially in patients with disorders like chronic rheumatic diseases (CRDs). The study aimed to describe the ADRs investigating their severity and associated factors and resulting interventions in pediatric patients with CRDs.
A retrospective, descriptive and analytical study was conducted on a cohort of children and adolescents with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM). The study evaluated medical records of the patients to determine the causality and the management of ADRs. In order to investigate the risk factors that would increase the risk of ADRs, a logistic regression model was carried out on a group of patients treated with the main used drug.
We observed 949 ADRs in 547 patients studied. Methotrexate (MTX) was the most frequently used medication and also the cause of the most ADRs, which occurred in 63.3% of patients, followed by glucocorticoids (GCs). Comparing synthetic disease-modifying anti-rheumatic drugs (sDMARDs) vs biologic disease-modifying anti-rheumatic drugs (bDMARDs), the ADRs attributed to the former were by far higher than the latter. In general, the severity of ADRs was moderate and manageable. Drug withdrawal occurred in almost a quarter of the cases. In terms of risk factors, most patients who experienced ADRs due to MTX, were 16 years old or younger and received MTX in doses equal or higher than 0.6 mg/kg/week. Patients with JIA and JDM had a lower risk of ADRs than patients with JSLE. In the multiple regression model, the use of GCs for over 6 months led to an increase of 0.5% in the number of ADRs.
Although the ADRs highly likely affect a wide range of children and adolescents with CRDs they were considered moderate and manageable cases mostly. However, triggers of ADRs need further investigations.
药物不良反应（ADR）是全球第六大死亡原因；监测药物不良反应至关重要，尤其是在患有慢性风湿性疾病（CRD）等疾病的患者中。本研究旨在描述儿科 CRD 患者的 ADR 情况，评估其严重程度和相关因素，以及干预措施。
本研究为回顾性、描述性和分析性研究，纳入了一组幼年特发性关节炎（JIA）、幼年系统性红斑狼疮（JSLE）和幼年皮肌炎（JDM）患儿和青少年患者。研究评估了患者的病历，以确定 ADR 的因果关系和管理措施。为了研究增加 ADR 风险的因素，对一组使用主要药物治疗的患者进行了逻辑回归模型分析。
我们观察到 547 名研究患者中有 949 例 ADR。甲氨蝶呤（MTX）是最常用的药物，也是引起 ADR 的最常见药物，63.3%的患者出现了 ADR，其次是糖皮质激素（GCs）。比较合成的疾病修饰抗风湿药物（sDMARDs）和生物疾病修饰抗风湿药物（bDMARDs），前者引起的 ADR 明显高于后者。总体而言，ADR 的严重程度为中度，易于管理。近四分之一的病例需要停药。在风险因素方面，大多数因 MTX 引起 ADR 的患者年龄在 16 岁或以下，且接受的 MTX 剂量等于或高于 0.6mg/kg/周。与 JSLE 患者相比，JIA 和 JDM 患者的 ADR 风险较低。在多元回归模型中，GCs 的使用时间超过 6 个月，ADR 的发生风险增加 0.5%。
尽管 ADR 可能会对患有 CRD 的儿童和青少年产生广泛的影响，但这些 ADR 通常为中度且易于管理。然而，ADR 的诱因仍需进一步研究。
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