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福可定、围手术期过敏反应与欧洲药品管理局:福可定最终在欧盟被下架。

Pholcodine, perioperative anaphylaxis, and the European Medicines Agency: finally the decision to remove pholcodine from the market in the European Union.

机构信息

University of Bergen, Bergen, Norway.

Karolinska Institute, Stockholm, Sweden.

出版信息

Br J Anaesth. 2023 Jul;131(1):11-13. doi: 10.1016/j.bja.2023.03.024. Epub 2023 May 5.

Abstract

Two recent case-control studies, both published in the British Journal of Anaesthesia, have shown that intake of pholcodine-containing cough medicines during the year preceding general anaesthesia significantly increased the risk of anaphylaxis caused by neuromuscular blocking agents. Both a French multicentre study and a single-centre study from Western Australia offer strong support to the pholcodine hypothesis for IgE-sensitisation to neuromuscular blocking agents. The European Medicines Agency, criticised for not taking preventive action at its first assessment of pholcodine in 2011, finally recommended a stop to sales of all pholcodine-containing medicines throughout the EU on December 1, 2022. Time will tell whether this reduces the incidence of perioperative anaphylaxis in the EU, as in Scandinavia.

摘要

最近的两项病例对照研究均发表在《英国麻醉杂志》上,结果表明,在全身麻醉前一年摄入含有福尔可定的咳嗽药会显著增加由神经肌肉阻滞剂引起的过敏反应的风险。法国的一项多中心研究和来自澳大利亚西部的一项单中心研究为神经肌肉阻滞剂的 IgE 致敏与福尔可定假说提供了强有力的支持。欧洲药品管理局在 2011 年首次评估福尔可定时因未能采取预防措施而受到批评,最终建议在 2022 年 12 月 1 日停止在整个欧盟销售所有含有福尔可定的药物。时间将证明这是否会像在斯堪的纳维亚一样降低欧盟围手术期过敏反应的发生率。

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