血栓栓塞后不良事件使用重组人凝血因子VIIa。

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奥康奈尔KA、木材JJ、明智的RP, Lozier约,布劳恩毫米

血栓栓塞后不良事件使用重组人凝血因子VIIa。

《美国医学协会杂志》上。2006年1月18日,295 (3):293 - 8。

PubMed ID

16418464 (在PubMed

]

文摘

背景:美国食品和药物管理局(FDA)批准重组人凝血因子VIIa (rFVIIa) 3月25日,1999年,血友病患者的出血或B和抑制剂因素第八和第九。在没有血友病患者使用许可以来一直在增加。目的:评估血栓栓塞的严重不良事件(AEs)据报道,FDA不良事件报告系统(aer)。数据库设计、设置和病人:爱尔兰了从3月25日,1999年,在2004年12月31日,血栓栓塞用rFVIIa AE报道。爱尔兰数据库包括美国和非美国自发AE报告从批准(血友病患者特定的适应症)和标记使用。它还包括严重的AEs的病人参加postlicensure接受rFVIIa临床试验。制造商向FDA报告是强制性的,但主要从临床医生和其他通知FDA或制造商是自愿自发报告;因此,爱尔兰——实际的事件发生。主要结果测量:血栓栓塞事件报道发生在病人rFVIIa管理。结果:共有431个AE报告rFVIIa被发现,其中168报道描述185血栓栓塞事件。 Seventeen events occurred in patients with hemophilia and 59 occurred in patients enrolled in postlicensure trials. Unlabeled indications accounted for 151 of the reports, most with active bleeding (n = 115). Reported AEs were thromboembolic cerebrovascular accident (n = 39), acute myocardial infarction (n = 34), other arterial thromboses (n = 26), pulmonary embolism (n = 32), other venous thromboses (including deep vein thrombosis) (n = 42), and clotted devices (n = 10). In 36 (72%) of 50 reported deaths, the probable cause of death was the thromboembolic event. In 144 patients with timing information, 73 events (52%) occurred in the first 24 hours after the last dose (30 events within 2 hours). Sixty-four reports (38%) noted concomitant use of hemostatic agents. Most reports lacked sufficient information to evaluate potential dosage associations. CONCLUSIONS: Most reported thromboembolic AEs followed the use of rFVIIa for unlabeled indications and occurred in arterial and venous systems, often resulting in serious morbidity and mortality. Analysis of the relationship between AEs and rFVIIa is hindered by concomitant medications, preexisting medical conditions, confounding by indication, and inherent limitations of passive surveillance. Randomized controlled trials are needed to establish the safety and efficacy of rFVIIa in patients without hemophilia.

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凝血因子VIIa重组人类