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五种新型抗抑郁药的不良反应。

Adverse reactions to five new antidepressants.

作者信息

Hayes P E, Kristoff C A

出版信息

Clin Pharm. 1986 Jun;5(6):471-80.

PMID:3087684
Abstract

Postmarketing adverse drug reaction reports for amoxapine, maprotiline hydrochloride, and trazodone hydrochloride and premarketing adverse drug reaction data for bupropion hydrochloride and nomifensine maleate are reviewed, and the role of the new agents in the management of depressive illness is discussed. Nomifensine was withdrawn from markets worldwide because of reports of serious hypersensitivity reactions, especially hemolytic anemia, and marketing of bupropion in the United States was delayed after seizures occurred in bulimic patients in clinical trials. Amoxapine and maprotiline, when taken in overdose attempts, are more toxic and cause more serious central nervous system reactions than the standard tricyclics. Acute renal failure and an increased mortality rate are associated with amoxapine overdose. Amoxapine causes several acute and chronic untoward neurologic and endocrine reactions not commonly associated with the standard tricyclics. For maprotiline and bupropion, maximum doses have been established because of dose-related seizures. Trazodone has minimal effect on cardiac conduction; its main cardiovascular effects are hypotension, orthostasis, and dizziness. The trazodone package insert has been revised to warn of priapism; patients with prolonged or inappropriate penile erections are instructed to discontinue the drug and notify the physician. Serious cardiovascular and neurologic toxicities are rare with trazodone overdose. Of the newly marketed antidepressants, only trazodone offers some advantages over the tricyclic and tetracyclic agents in the areas of side effects and toxicities. The number and type of patients exposed to a new drug during clinical trials is too small for detection of rare but potentially serious adverse effects.

摘要

对阿莫沙平、盐酸马普替林和盐酸曲唑酮的上市后药物不良反应报告以及盐酸安非他酮和马来酸诺米芬辛的上市前药物不良反应数据进行了审查,并讨论了这些新药在抑郁症治疗中的作用。由于有严重过敏反应的报告,尤其是溶血性贫血,诺米芬辛已在全球范围内退市,并且在临床试验中贪食症患者出现癫痫发作后,安非他酮在美国的上市被推迟。与标准三环类药物相比,阿莫沙平和马普替林在过量服用时毒性更大,会引起更严重的中枢神经系统反应。急性肾衰竭和死亡率增加与阿莫沙平过量有关。阿莫沙平会引起一些急性和慢性不良神经及内分泌反应,而这些反应通常与标准三环类药物无关。由于与剂量相关的癫痫发作,已确定了马普替林和安非他酮的最大剂量。曲唑酮对心脏传导影响极小;其主要心血管作用是低血压、直立性低血压和头晕。曲唑酮的药品说明书已修订,以警告阴茎异常勃起;阴茎持续勃起或勃起不当的患者应停药并通知医生。曲唑酮过量很少出现严重的心血管和神经毒性。在新上市的抗抑郁药中,只有曲唑酮在副作用和毒性方面比三环类和四环类药物具有一些优势。在临床试验期间接触新药的患者数量和类型太少,无法检测到罕见但可能严重的不良反应。

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