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本文引用的文献

1
Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease.英夫利昔单抗致严重输注反应:炎症性肠病患者的病因、免疫原性和危险因素。
Aliment Pharmacol Ther. 2011 Jul;34(1):51-8. doi: 10.1111/j.1365-2036.2011.04682.x. Epub 2011 May 3.
2
The safety of infliximab infusions in the community setting.英夫利昔单抗在社区环境中输注的安全性。
Can J Gastroenterol. 2010 May;24(5):307-11. doi: 10.1155/2010/138456.
3
Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis.对5000名日本类风湿性关节炎患者使用英夫利昔单抗安全性的上市后监测。
Ann Rheum Dis. 2008 Feb;67(2):189-94. doi: 10.1136/ard.2007.072967. Epub 2007 Jul 20.
4
Infusion reactions and their management.输液反应及其处理
Gastroenterol Clin North Am. 2006 Dec;35(4):857-66. doi: 10.1016/j.gtc.2006.09.006.
5
Monoclonal antibodies, immunogenicity, and associated infusion reactions.单克隆抗体、免疫原性及相关输注反应。
Mt Sinai J Med. 2005 Jul;72(4):250-6.
6
Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease.克罗恩病维持治疗或间歇性治疗后对英夫利昔单抗抗体反应的发生率及重要性
Clin Gastroenterol Hepatol. 2004 Jul;2(7):542-53. doi: 10.1016/s1542-3565(04)00238-1.
7
The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients.英夫利昔单抗在克罗恩病患者中的安全性概况:梅奥诊所500例患者的经验
Gastroenterology. 2004 Jan;126(1):19-31. doi: 10.1053/j.gastro.2003.10.047.
8
The incidence and management of infusion reactions to infliximab: a large center experience.英夫利昔单抗输注反应的发生率及处理:大型中心经验
Am J Gastroenterol. 2003 Jun;98(6):1315-24. doi: 10.1111/j.1572-0241.2003.07457.x.
9
Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial.静脉注射氢化可的松预处理可降低克罗恩病患者体内针对英夫利昔单抗的抗体:一项随机对照试验。
Gastroenterology. 2003 Apr;124(4):917-24. doi: 10.1053/gast.2003.50145.
10
Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease.免疫原性对英夫利昔单抗治疗克罗恩病长期疗效的影响。
N Engl J Med. 2003 Feb 13;348(7):601-8. doi: 10.1056/NEJMoa020888.

英夫利昔单抗输注的预处理不会影响急性药物不良反应的风险。

Premedications for infliximab infusions do not impact the risk of acute adverse drug reactions.

作者信息

Ducharme James, Pelletier Cindy, Zacharias Ramesh

机构信息

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

AIM Health Group, Mississauga, Ontario, Canada.

出版信息

Frontline Gastroenterol. 2011 Oct;2(4):249-254. doi: 10.1136/flgastro-2011-100030. Epub 2011 Aug 11.

DOI:10.1136/flgastro-2011-100030
PMID:28839619
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5517230/
Abstract

OBJECTIVE

The purpose of this study was to identify the association of premedication with the adverse drug reaction (ADR) rate in infliximab infusions.

DESIGN

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.

SETTING

Community infusion clinics located in Ontario, Canada.

PATIENTS

Patients aged 12-91 years who receive regular infliximab infusions to treat their autoimmune condition, mainly either Crohn's disease or rheumatoid arthritis.

MAIN OUTCOME MEASURES

The number of infusions to the occurrence of an acute ADR by presence of premedication.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

设计

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。

地点

位于加拿大安大略省的社区输注诊所。

患者

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。

主要观察指标

根据是否进行预处理,观察发生急性ADR的输注次数。

结果

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。

结论

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。