Ducharme James, Pelletier Cindy, Zacharias Ramesh
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
AIM Health Group, Mississauga, Ontario, Canada.
Frontline Gastroenterol. 2011 Oct;2(4):249-254. doi: 10.1136/flgastro-2011-100030. Epub 2011 Aug 11.
The purpose of this study was to identify the association of premedication with the adverse drug reaction (ADR) rate in infliximab infusions.
A retrospective chart review of 684 patients who received 4077 infusions in a network of community clinics over 16.5 months. Data collected included age, weight, sex, diagnosis, dose, premedications and ADR information, which was coded for time of onset, severity and outcome.
Community infusion clinics located in Ontario, Canada.
Patients aged 12-91 years who receive regular infliximab infusions to treat their autoimmune condition, mainly either Crohn's disease or rheumatoid arthritis.
The number of infusions to the occurrence of an acute ADR by presence of premedication.
ADRs are not significantly different (χ(1, n=644, p=0.651)=0.204) between those who always received premedications and those who never did. When controlling for age, sex, weight and diagnosis, patients receiving premedications were just as likely to experience an ADR as patients who never received any (OR 1.1, 95% CI 0.7 to 1.9, p=0.5). When assessing the number of infusions to the occurrence of an ADR using the Kaplan-Meier method, no significant difference was found between the two groups.
The use of premedications is not associated with a decreased risk of ADR in patients receiving infliximab. This held true for patients who had never had an ADR prior to receiving premedications and while controlling for age, sex, weight and diagnosis.
本研究旨在确定在英夫利昔单抗输注中,预处理与药物不良反应(ADR)发生率之间的关联。
对在16.5个月内于社区诊所网络中接受4077次输注的684例患者进行回顾性病历审查。收集的数据包括年龄、体重、性别、诊断、剂量、预处理和ADR信息,这些信息按发作时间、严重程度和结局进行编码。
位于加拿大安大略省的社区输注诊所。
年龄在12至91岁之间,接受定期英夫利昔单抗输注以治疗自身免疫性疾病(主要是克罗恩病或类风湿性关节炎)的患者。
根据是否进行预处理,观察发生急性ADR的输注次数。
在始终接受预处理的患者和从未接受预处理的患者之间,ADR发生率无显著差异(χ(1, n = 644, p = 0.651) = 0.204)。在控制年龄、性别、体重和诊断因素后,接受预处理的患者发生ADR的可能性与从未接受任何预处理的患者相同(OR 1.1,95% CI 0.7至1.9,p = 0.5)。使用Kaplan-Meier方法评估发生ADR的输注次数时,两组之间未发现显著差异。
在接受英夫利昔单抗治疗的患者中,使用预处理与降低ADR风险无关。对于在接受预处理之前从未发生过ADR的患者以及在控制年龄、性别、体重和诊断因素时,情况均如此。