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英夫利昔单抗在炎症性肠病中的应用。是否需要预先用药?

Infliximab in inflammatory bowel disease. Is premedication necessary?

机构信息

Programa Enfermedad Inflamatoria Intestinal, Departamento Gastroenterología, Hospital San Juan de Dios Hospital, Universidad de Chile, Santiago, Chile.

Clínica Las Condes, Santiago, Chile.

出版信息

Gastroenterol Hepatol. 2021 May;44(5):321-329. doi: 10.1016/j.gastrohep.2020.07.018. Epub 2020 Oct 20.

DOI:10.1016/j.gastrohep.2020.07.018
PMID:33386199
Abstract

BACKGROUND

The use of infliximab (IFX) in inflammatory bowel disease (IBD) has been associated with a 1-6% risk of infusion reactions. The usefulness of premedication with corticosteroids, paracetamol and /or antihistamines is controversial.

AIM

The aim of this study is to assess, in IBD patients on IFX, whether there are differences in secondary reactions to the infusion between those who use premedication or not.

METHODS

A retrospective cohort study was performed identifying patients with a diagnosis of IBD who received IFX at our institution between January 2009 and July 2019. Acute reactions were defined as those that occurred in the first 24 hours postinfusion and late reactions for more than 24 hours. Infusion reactions were classified as mild, moderate and severe. Descriptive and association statistics were used (χ; p < 0.05).

RESULTS

Sixty-four patients were included with 1,263 infusions in total, 52% men. Median infusions per patient was 22 (2-66). All induction infusions were administered with premedication, and in maintenance in 57% of them. Premedication was given with hydrocortisone, chlorphenamine and paracetamol. Most of reactions were acute, mild or moderate in severity and no patient needed to discontinue IFX. In the maintenance group, there were 9/718 (1.2%) infusion reactions with premedication and 4/358 (1.1%) without it (p = 0.606). In the induction group, there were 8/187 (4.3%) infusion reactions, significantly higher when compared with both maintenance groups.

CONCLUSIONS

In this group, premedication use during maintenance was not effective at reducing the rate of infusion reactions. These results suggest that premedication would not be necessary.

摘要

背景

英夫利昔单抗(IFX)在炎症性肠病(IBD)中的应用与 1-6%的输注反应风险相关。皮质类固醇、扑热息痛和/或抗组胺药的预处理的有效性存在争议。

目的

本研究旨在评估在接受 IFX 治疗的 IBD 患者中,使用或不使用预处理药物是否会对输注后的继发反应产生差异。

方法

进行了一项回顾性队列研究,确定了 2009 年 1 月至 2019 年 7 月期间在我院接受 IFX 治疗的 IBD 患者。急性反应定义为输注后 24 小时内发生的反应,迟发反应为超过 24 小时的反应。输注反应分为轻度、中度和重度。使用描述性和关联统计学(χ;p < 0.05)。

结果

共纳入 64 例患者,总计输注 1263 次,其中 52%为男性。每名患者的中位输注次数为 22(2-66)次。所有诱导性输注均使用预处理药物,57%的患者在维持治疗中也使用了预处理药物。预处理药物使用了氢化可的松、氯苯那敏和扑热息痛。大多数反应为急性、轻度或中度严重程度,没有患者需要停止使用 IFX。在维持组中,有 9/718(1.2%)次输注有预处理药物,4/358(1.1%)次无预处理药物(p = 0.606)。在诱导组中,有 8/187(4.3%)次输注有反应,与维持组相比显著更高。

结论

在本研究中,维持治疗期间使用预处理药物并不能降低输注反应的发生率。这些结果表明,预处理可能不是必需的。

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