Gonzalo Garijo M A, Durán Quintana J A, Bobadilla González P, Máiquez Asuero P
University Hospital Infanta Cristina, Badajoz, Spain.
Ann Pharmacother. 1996 Jan;30(1):37-40. doi: 10.1177/106002809603000107.
To report a patient with an anaphylactic reaction related to povidone administration.
A 37-year-old man with a history of allergic rhinitis presented with urticaria, dyspnea, wheezing, rhinorrhea, and dysphonia 20 minutes after the intraarticular administration of mepivacaine hydrochloride and paramethasone acetate in his right knee. Two months after this episode, he was admitted for controlled provocation tests. Tests on mepivacaine were negative. The preparation of paramethasone contained the excipients benzalkonium chloride, polysorbate 80, and povidone. In vitro tests and provocation were negative with polysorbate 80 and benzalkonium chloride, but positive with povidone.
Povidone, a mixture of synthetic polymers, is commonly used as an excipient in pharmaceutical products, an additive in food products, and a dispersant and stabilizer in hairsprays. Although it is well tolerated when used topically or parenterally, local and systemic effects have been reported. Furthermore, multiorgan involvement resulting from accumulation of the drug in the reticuloendothelial system has been described. The immunologic properties of povidone have not been explored in humans, but have been in animals. In fact, the capacity of povidone to release histamine and its immunogenicity are proportional to its molecular weight. An immunoglobulin (Ig) E-mediated hypersensitivity reaction in asthma has been reported. In our case, povidone was responsible for the syndrome. However, we cannot determine the exact mechanism. An unspecific histamine release and/or an IgE-mediated hypersensitivity could be involved.
Povidone was responsible for a severe anaphylactic reaction in our patient. The possibility of an iatrogenic adverse effect caused by the excipient but not by the active ingredient should be considered in patients exhibiting similar symptoms. We believe that the excipients used in the preparation of all medicines should be disclosed.
报告一例与聚维酮给药相关的过敏反应患者。
一名有过敏性鼻炎病史的37岁男性，在右膝关节腔内注射盐酸甲哌卡因和醋酸倍他米松20分钟后，出现荨麻疹、呼吸困难、喘息、流涕和声音嘶哑。此次发作两个月后，他因可控激发试验入院。对甲哌卡因的试验为阴性。倍他米松制剂含有辅料苯扎氯铵、聚山梨酯80和聚维酮。聚山梨酯80和苯扎氯铵的体外试验和激发试验为阴性，但聚维酮为阳性。
聚维酮是一种合成聚合物混合物，常用作药品辅料、食品添加剂以及发胶中的分散剂和稳定剂。虽然局部或胃肠外使用时耐受性良好，但也有局部和全身作用的报道。此外，还描述了药物在网状内皮系统中蓄积导致的多器官受累情况。聚维酮的免疫特性尚未在人体中进行研究，但在动物中已有研究。事实上，聚维酮释放组胺的能力及其免疫原性与其分子量成正比。已有报道在哮喘中发生免疫球蛋白（Ig）E介导的超敏反应。在我们的病例中，聚维酮是该综合征的病因。然而，我们无法确定确切机制。可能涉及非特异性组胺释放和/或IgE介导的超敏反应。
聚维酮是我们患者严重过敏反应的病因。对于出现类似症状的患者，应考虑由辅料而非活性成分引起医源性不良反应的可能性。我们认为所有药物制剂中使用的辅料都应予以披露。
