Overview of postmarketing experience with ofloxacin in Germany.
Overview of postmarketing experience with ofloxacin in Germany.
复制标题
德国氧氟沙星上市后经验概述。
DOI：
10.1093/jac/22.supplement_c.167
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发表时间：
1988
期刊：
影响因子：
--
通讯作者：
Rüdiger Mohr
中科院分区：
文献类型：
--
作者：
Günther Jüngst;Rüdiger Mohr
氧氟沙星的临床试验表明，接受治疗的患者中发生药物不良事件（ADE）的比例在2.4%（II期）和3.1-7.3%（IV期）之间，并且大多是轻度的。与任何其他药物一样，只有在上市后才能充分了解罕见事件的真实谱。自1985年6月氧氟沙星上市以来，在德国，根据平均每日剂量400 mg氧氟沙星和平均治疗持续时间7天计算，约有350万患者接受了治疗。在这2.5年中，获得了985份自发性ADE国家报告，包括临床试验中未观察到的罕见不良事件（例如幻觉、精神病反应和休克）。显示并讨论了上市后监测结果的现状。氧氟沙星有利的总体风险：获益比似乎没有变化。
Clinical trials with ofloxacin have shown that adverse drug events (ADEs) occurred in between 2.4% (Phase II) and 3.1-7.3% (Phase IV) of patients treated and were mostly mild. As with any other drug the true spectrum of rare events can only be fully appreciated after marketing. Since the launch of ofloxacin in June 1985 about 3.5 million patients have been treated in Germany, calculated on the basis of a mean daily dose of 400 mg ofloxacin and a mean duration of treatment of seven days. During these 2.5 years 985 spontaneous national reports of ADEs have been obtained and include rare adverse events (e.g. hallucination, psychotic reaction and shock), not seen in clinical trials. The present status of results from postmarketing surveillance is shown and discussed. The favourable overall risk:benefit ratio of ofloxacin appears unchanged.