Fluoroquinolone-associated anaphylaxis in spontaneous adverse drug reaction reports in Germany - Differences in reporting rates between individual fluoroquinolones and occurrence after first-ever use
Fluoroquinolone-associated anaphylaxis in spontaneous adverse drug reaction reports in Germany - Differences in reporting rates between individual fluoroquinolones and occurrence after first-ever use
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DOI：
10.2165/00002018-200629110-00008
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发表时间：
2006-01-01
期刊：
影响因子：
4.2
通讯作者：
Erdmann, Stephan
中科院分区：
文献类型：
--
作者：
Sachs, Bernhardt;Riegel, Stefan;Erdmann, Stephan
工作背景：根据自发性报告，氟喹诺酮类相关速发型过敏反应的发生率估计为1.8-23/1000万治疗日。尚不清楚各氟喹诺酮类药物过敏反应的报告率之间是否存在差异。根据病理生理学，过敏反应可能是免疫介导的（过敏性）或非免疫介导的（类过敏性）。目的：分析德国联邦药物和医疗器械研究所药物不良反应数据库中氟喹诺酮类药物相关过敏反应的自发报告，比较不同氟喹诺酮类药物之间的报告率差异、既往摄入量和反应发生时间。方法：对1993年1月1日至2004年12月31日期间自发报告给联邦药品和医疗器械研究所的所有氟喹诺酮类相关速发过敏反应、速发过敏反应性休克和速发过敏反应/类速发过敏反应病例进行了识别，并评估了速发过敏反应诊断的正确性、与药物的因果关系、结果：在确定的204例病例中，有166例被诊断为过敏反应，并被认为至少可能与药物存在因果关系。莫西沙星90例（54%），左氧氟沙星25例（15%），环丙沙星21例（13%），氧氟沙星16例（10%）。根据暴露量的粗略估计值，每100万个限定日剂量的相应报告率分别为3.3、0.6、0.2和0.2，分别为利福沙星、左氧氟沙星、环丙沙星和氧氟沙星。166例病例中有71例（43%）报告了首次给药后或前3天内发生速发过敏反应，但这些报告未提供关于既往暴露于本品或任何其他氟喹诺酮类药物的信息。在21 166例（13%），反应发生在前3天内，它是说，特定的氟喹诺酮类药物从来没有采取before.Conclusions：过敏反应似乎与氟喹诺酮类抗菌药物。应进一步调查观察到的报告率差异。氟喹诺酮类药物相关过敏反应可能发生在首次摄入该药物后。
Background: The frequency of fluoroquinolone-associated anaphylaxis has been estimated to be 1.8-23 per 10 million days of treatment based on spontaneous reports. It is unknown whether there are differences between the reporting rates of anaphylaxis with individual fluoroquinolones. According to pathophysiology, anaphylaxis may be immune mediated (anaphylactic) or not (anaphylactoid). The latter may occur after first-ever intake since no sensitisation phase is necessary.Objective: To analyse spontaneous reports of fluoroquinolone-associated anaphylaxis contained in the spontaneous adverse drug reaction database of the Federal Institute for Drugs and Medical Devices in Germany with regard to differences in reporting rates between various fluoroquinolones, the previous intake and the time to onset of the reaction.Methods: All fluoroquinolone-associated cases of anaphylaxis, anaphylactic shock, and anaphylactic/anaphylactoid reaction spontaneously reported to the Federal Institute for Drugs and Medical Devices between I January 1993 and 31 December 2004 were identified and assessed with regard to the correctness of the diagnosis of anaphylaxis, the causal relationship with the drug, the previous intake of fluoroquinolones and the time to onset of the reaction.Results: In 166 of 204 cases identified, the diagnosis of anaphylaxis and a causal relationship with the drug were considered at least possible. Moxifloxacin, levofloxacin, ciprofloxacin and ofloxacin accounted for 90 (54%), 25 (15%), 21 (13%) and 16 (10%) of the 166 cases, respectively. The corresponding reporting rates per I million defined daily doses based on crude estimates of exposure were 3.3, 0.6, 0.2 and 0.2 for moxifloxacin, levofloxacin, ciprofloxacin and ofloxacin, respectively. The occurrence of anaphylaxis after the first dose or within the first three days was reported in 71 of 166 (43%) cases, but no information on prior exposure with this or any other fluoroquinolone was provided with these reports. In 21 of 166 (13%) cases, the reaction occurred within the first 3 days and it was stated that the particular fluoroquinolone had never been taken before.Conclusions: Anaphylaxis appears to be associated with the fluoroquinolone, class of antibacterials. Observed differences in reporting rates should be further investigated. Fluoroquinolone-associated anaphylaxis may occur after first-ever intake of the agent.