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[药品不良反应监测局对疑似不良反应的登记;1993年的研究活动]

[Registration of suspected adverse effects by the Bureau Adverse Effects Drugs; research activities in 1993].

作者信息

Stricker B H, Ottervanger J P, van der Klauw M M

机构信息

Bureau Bijwerkingen Geneesmiddelen, Rijswijk.

出版信息

Ned Tijdschr Geneeskd. 1994 Oct 15;138(42):2110-3.

PMID:7969579
Abstract

In 1993, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 1585 reports of suspected adverse reactions. The most important reports concerned myocardial infarction due to sumatriptan, cholestatic hepatitis due to itraconazole, agranulocytosis due to trazodone and bleeding due to fluoxetine and fluvoxamine. Other published reports concerned cholestatic hepatitis due to amoxicillin/clavulanic acid, hair loss due to beta-blockers, muscle necrosis due to diclofenac, bronchospasm, apnoea and cardiac arrest due to dipyridamole perfusion scintigraphy, interaction of fluvoxamine/fluoxetine and coumarins, liver enzyme elevations due to heparin, skin reactions due to Imedeen, deafness due to neomycin, addiction to nicotine chewing gum, atrial fibrillation and skin reactions due to nicotine patches, interaction between oral contraceptives and terbinafine, neonatal problems caused by psychopharmacological agents, parapemphigus caused by sulfasalazine, taste loss due to terbinafine en intracranial bleeding after use of tranylcypromine and beer. Pharmacoepidemiological studies were performed concerning methods for record linkage, the communication process with respect to the acitretin alert and the adverse events due to sumatriptan.

摘要

1993年,荷兰药物不良反应监测中心收到1585份疑似不良反应报告。最重要的报告涉及舒马曲坦所致心肌梗死、伊曲康唑所致胆汁淤积性肝炎、曲唑酮所致粒细胞缺乏症以及氟西汀和氟伏沙明所致出血。其他已发表的报告涉及阿莫西林/克拉维酸所致胆汁淤积性肝炎、β受体阻滞剂所致脱发、双氯芬酸所致肌肉坏死、双嘧达莫灌注闪烁显像所致支气管痉挛、呼吸暂停和心脏骤停、氟伏沙明/氟西汀与香豆素的相互作用、肝素所致肝酶升高、伊美婷所致皮肤反应、新霉素所致耳聋、尼古丁口香糖成瘾、尼古丁贴片所致心房颤动和皮肤反应、口服避孕药与特比萘芬的相互作用、精神药物所致新生儿问题、柳氮磺胺吡啶所致副肿瘤性天疱疮、特比萘芬所致味觉丧失以及使用反苯环丙胺和啤酒后颅内出血。开展了药物流行病学研究,内容涉及记录链接方法、关于阿维A警示的沟通流程以及舒马曲坦所致不良事件。

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