对咳嗽抑制剂福尔可定的IgE致敏及其在挪威市场撤药后的结果
2011/03/28
摘要
背景：IgE介导的对神经肌肉阻断剂(NMBA)的过敏反应在挪威较为常见，这可能与福尔可定(PHO)暴露有关，因为后者具有过敏性季铵离子表面抗原。因此，含PHO的药物自2007年起下市。
目的：描述PHO撤药对IgE、IgE抗体和对NMBAs过敏反应发生率的影响。
方法：收集2006～2010年300名过敏症可疑患者的血清，检测PHO、琥珀胆碱(SUX)和吗啡(MOR)特异性IgE抗体。此外，对IgE和挪威麻醉状态过敏性反应监测网络(NARA)的初期报道进行监测。
结果：PHO暴露与针对PHO、MOR和SUX的IgE致敏相关。然而，撤药后1年内，针对PHO和SUX的抗体水平显著降低，分别从11%降至5%和从3.7%降至0.7%。3年后，针对SUX的抗体降至0.3%，针对PHO的抗体降至2.7%，针对MOR的抗体降至1.3%。2年后，存在IgE增加的患者比例显著降低。3年后，报道的可疑麻醉状态过敏反应的患者比例也显著下降，包括在总体数量、针对NMBAs的反应和针对SUX的IgE抗体均下降。
结论：PHO撤药后1~2年，针对PHO、MOR和SUX的IgE和IgE抗体水平显著下降，3年内，可疑NMBA过敏的发生率显著降低。我们的结果也支持，需质疑含PHO的咳嗽抑制剂的使用。
（林江涛 审校）
Allergy. 2011 Jan 17. doi: 10.1111/j.1398-9995.2010.02518.x. [Epub ahead of print]
IgE-sensitization to the cough suppressant pholcodine and the effects of its withdrawal from the Norwegian market.
Florvaag E, Johansson SG, Irgens A, de Pater GH.
Laboratory of Clinical Biochemistry Department of Occupational Medicine, Haukeland University Hospital Institute of Medicine, University of Bergen, Bergen, Norway Department of Medicine, Clinical Immunology and Allergy Unit, Karolinska Institute, Stockholm, Sweden Department of Anaesthesiology and Intensive Care, Haukeland University Hospital, Bergen, Norway.
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 Consequently, the PHO-containing drug was withdrawn from the market in March 2007.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
Allergy. 2011 Jan 17. doi: 10.1111/j.1398-9995.2010.02518.x. [Epub ahead of print]
背景：IgE介导的对神经肌肉阻断剂(NMBA)的过敏反应在挪威较为常见，这可能与福尔可定(PHO)暴露有关，因为后者具有过敏性季铵离子表面抗原。因此，含PHO的药物自2007年起下市。
目的：描述PHO撤药对IgE、IgE抗体和对NMBAs过敏反应发生率的影响。
方法：收集2006～2010年300名过敏症可疑患者的血清，检测PHO、琥珀胆碱(SUX)和吗啡(MOR)特异性IgE抗体。此外，对IgE和挪威麻醉状态过敏性反应监测网络(NARA)的初期报道进行监测。
结果：PHO暴露与针对PHO、MOR和SUX的IgE致敏相关。然而，撤药后1年内，针对PHO和SUX的抗体水平显著降低，分别从11%降至5%和从3.7%降至0.7%。3年后，针对SUX的抗体降至0.3%，针对PHO的抗体降至2.7%，针对MOR的抗体降至1.3%。2年后，存在IgE增加的患者比例显著降低。3年后，报道的可疑麻醉状态过敏反应的患者比例也显著下降，包括在总体数量、针对NMBAs的反应和针对SUX的IgE抗体均下降。
结论：PHO撤药后1~2年，针对PHO、MOR和SUX的IgE和IgE抗体水平显著下降，3年内，可疑NMBA过敏的发生率显著降低。我们的结果也支持，需质疑含PHO的咳嗽抑制剂的使用。
（林江涛 审校）
Allergy. 2011 Jan 17. doi: 10.1111/j.1398-9995.2010.02518.x. [Epub ahead of print]
IgE-sensitization to the cough suppressant pholcodine and the effects of its withdrawal from the Norwegian market.
Florvaag E, Johansson SG, Irgens A, de Pater GH.
Laboratory of Clinical Biochemistry Department of Occupational Medicine, Haukeland University Hospital Institute of Medicine, University of Bergen, Bergen, Norway Department of Medicine, Clinical Immunology and Allergy Unit, Karolinska Institute, Stockholm, Sweden Department of Anaesthesiology and Intensive Care, Haukeland University Hospital, Bergen, Norway.
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
Allergy. 2011 Jan 17. doi: 10.1111/j.1398-9995.2010.02518.x. [Epub ahead of print]
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