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Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting System.

机译:外用牛凝血酶:向FDA不良事件报告系统提交的外用牛凝血酶自发病例安全性报告为期21年。

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PURPOSE: To review topical bovine thrombin spontaneous adverse event (AE) reports that were forwarded to the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) between January 1986 and December 2006. METHODS: Forty-one spontaneous AE reports were summarized for reported AE profile and chronological reporting patterns. Each AE report was adjudicated by a hematologist for the topical bovine thrombin product that was given and the AE(s) that were reported. AEs were grouped as allergic, coagulopathy/bleeding, and all other AEs combined. Grouped AE serial analyses were carried out using successive 3-year time increments between 1986 (the year an AE report was first noted for a bovine thrombin product) and 2006 (the first full year that was available at the time of initiation of the data summary). MAIN OUTCOME MEASURES: The primary outcome measures were every 3-year trend lines for all-AE reports, all reporters, and topical bovine thrombin brand mentions for 2 AE groups of interest (allergic events and coagulopathy/bleeding events). RESULTS: The all-AE spontaneous reporter trend showed a downward appearance for AE reporting activity that started in 1995-1998 and continued through 2004-2006. The all-AE reports trend showed two potential safety signals that could be identified serially: (1) a prominent 1989-1991 peak that was attributable to allergic events (in particular, anaphylaxis), and (2) a small 1995-2000 broad peak that was attributable in part to coagulopathy/bleeding events. Allergic events were predominantly reported with products approved prior to 1995, were not temporally associated with prior medical literature case reports, and continued to be forwarded to the FDA at low levels up to the end of this study in 2006. Coagulopathy/bleeding events were reported only with products approved prior to 1995, were temporally associated with medical literature case reports, and were not forwarded to the FDA after 2000. CONCLUSIONS: Overall, spontaneous AE reporting for topical bovine thrombin occurs at very low levels, and appears to have been decreasing since 1995. The serial reporting patterns for topical bovine thrombin are best explained as a strong safety signal for allergic events with ongoing, low level reporting, and a weak safety signal for coagulopathy/bleeding events that ceased on or before 2000. Although this descriptive trend analysis cannot measure associations or causation, the coagulopathy/bleeding signal may have been prompted by multiple, antecedent published case reports. The subsequent diminishment of signal attributed to thrombin likewise may coincide with lack of such reporting in larger follow-up clinical trials or, alternatively, in the introduction and growing market share of thrombin brands of greater purity. Currently marketed topical bovine thrombin formulations are rarely volunteered as possible causes of adverse events.
机译:目的:回顾局部牛凝血酶自发不良事件(AE)的报告,该报告在1986年1月至2006年12月之间转发给美国食品和药物管理局(FDA)不良事件报告系统(AERS)。方法:共发表了41篇自发性AE报告。总结了报告的AE资料和按时间顺序排列的报告模式。血液病专家对每份AE报告均作出裁决,以给予的局部牛凝血酶产品和所报告的AE。不良事件分为过敏性,凝血病/出血和所有其他不良事件合并。使用1986年(首次记录牛凝血酶产品的AE报告)和2006年(数据摘要开始时的第一个完整年度)之间连续3年的时间增量进行分组AE系列分析)。主要观察指标:主要结局指标是对所有AE组,感兴趣的2个AE组(过敏事件和凝血病/出血事件)进行全AE报告,所有报告者以及每单位提及牛凝血酶品牌的每3年趋势线。结果:从1995年至1998年一直持续到2004年至2006年,全AE自发的报告者趋势显示出AE报告活动呈下降趋势。所有AE报告的趋势表明,可以依次识别出两个潜在的安全信号:(1)归因于过敏事件(特别是过敏反应)的1989-1991高峰,以及(2)1995-2000的小高峰这部分归因于凝血病/出血事件。过敏事件主要报道于1995年之前批准的产品上,暂时与先前的医学文献中的病例报告无关,直到2006年该研究结束时仍以低水平转发给FDA。据报道有凝血功能障碍/出血事件仅在1995年之前批准的产品上,暂时与医学文献中的病例报告相关联,在2000年后未转发给FDA。结论:总体而言,局部牛凝血酶的自发AE报告发生率很低,并且似乎一直在下降自1995年以来。局部牛凝血酶的系列报告模式被最好地解释为对过敏事件的强安全信号,持续,低水平的报告,以及对凝血病/出血事件的弱安全信号,该信号在2000年或之前停止。尽管是描述性趋势分析无法测量关联或因果关系,可能是由于多个edent已发布病例报告。随后由于凝血酶引起的信号减弱也可能与在较大的后续临床试验中缺乏此类报道相吻合,或者在更高纯度的凝血酶品牌的引入和市场占有率上升的同时。当前市售的局部牛凝血酶制剂很少被自愿作为不良事件的可能原因。

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