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对镇咳药福可定的 IgE 致敏性及其从挪威市场撤出的影响。

IgE-sensitization to the cough suppressant pholcodine and the effects of its withdrawal from the Norwegian market.

机构信息

Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway.

出版信息

Allergy. 2011 Jul;66(7):955-60. doi: 10.1111/j.1398-9995.2010.02518.x. Epub 2011 Jan 17.

DOI:10.1111/j.1398-9995.2010.02518.x
PMID:21241314
Abstract

BACKGROUND

IgE-mediated anaphylaxis to neuromuscular blocking agents (NMBA), frequent in Norway, was proposed to be caused by exposure to pholcodine (PHO) carrying the allergenic quarternary ammonium ion epitope. Consequently, the PHO-containing drug was withdrawn from the market in March 2007.

OBJECTIVE

Describe the effects of withdrawal of PHO on IgE, IgE-antibodies and reported frequencies of anaphylaxis to NMBAs.

METHODS

Three hundred sera from supposedly allergic patients sampled yearly through 2006 to 2010 were analysed for IgE antibodies to PHO, suxamethonium (SUX) and morphine (MOR). Furthermore, IgE and preliminary reports from the Norwegian Network for Anaphylaxis under Anaesthesia (NARA) were monitored.

RESULTS

PHO exposure was associated with IgE sensitization to PHO, MOR and SUX. However, after withdrawal, within 1 year, antibody prevalences to PHO and SUX fell significantly from 11.0% to 5.0% and from 3.7% to 0.7%, respectively. At 3 years, SUX had fallen to 0.3%, PHO to 2.7% and MOR to 1.3%. By 2 years, the prevalence of elevated IgE was significantly reduced. After 3 years, the incidence of reported suspected anaesthetic anaphylaxis fell significantly, both the total number, the reactions related to NMBAs and those with IgE antibodies to SUX.

CONCLUSIONS

Withdrawing of PHO lowered significantly within 1-2 years levels of IgE and IgE antibodies to PHO, MOR and SUX, and, within 3 years, the frequency of NMBA suspected anaphylaxis. The results strengthen the PHO hypothesis considerably and equally the need to question the existence of cough depressants containing PHO.

摘要

背景

在挪威,经常发生针对神经肌肉阻滞剂(NMBA)的 IgE 介导的过敏反应,有人提出这种过敏反应是由于接触到含有变应原季铵离子表位的福可定(PHO)引起的。因此,含有 PHO 的药物于 2007 年 3 月退出市场。

目的

描述福可定撤出市场对 IgE、IgE 抗体和报道的 NMBA 过敏反应频率的影响。

方法

2006 年至 2010 年,每年从疑似过敏患者中抽取 300 份血清,分析对 PHO、琥珀胆碱(SUX)和吗啡(MOR)的 IgE 抗体。此外,还监测了挪威麻醉过敏反应网络(NARA)的 IgE 和初步报告。

结果

PHO 暴露与 PHO、MOR 和 SUX 的 IgE 致敏有关。然而,撤出后 1 年内,PHO 和 SUX 的抗体阳性率分别从 11.0%降至 5.0%和从 3.7%降至 0.7%。3 年后,SUX 降至 0.3%,PHO 降至 2.7%,MOR 降至 1.3%。2 年后,升高的 IgE 阳性率显著降低。3 年后,报告的疑似麻醉过敏反应的发生率显著下降,包括 NMBA 相关反应、SUX 抗体阳性的反应。

结论

PHO 撤出后,1-2 年内 PHO、MOR 和 SUX 的 IgE 和 IgE 抗体水平显著降低,3 年内 NMBA 疑似过敏反应的频率也显著降低。结果大大加强了 PHO 假说,同样需要质疑含有 PHO 的镇咳药的存在。

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