凝血因子 XIII 浓缩剂的安全性：20 多年药物警戒数据的分析
Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data.
作者信息
Solomon Cristina, Korte Wolfgang, Fries Dietmar, Pendrak Inna, Joch Christine, Gröner Albrecht, Birschmann Ingvild
机构信息
Medical Affairs Acquired Bleeding Disorders, CSL Behring, Marburg, Germany.
Hemostasis and Hemophilia Center; and Center for Laboratory Medicine, St. Gallen, Switzerland.
出版信息
Transfus Med Hemother. 2016 Sep;43(5):365-373. doi: 10.1159/000446813. Epub 2016 Aug 3.
BACKGROUND
Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data.
METHODS
Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed.
RESULTS
Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile.
CONCLUSION
Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile.
背景
血浆源性凝血因子 XIII（FXIII）浓缩剂是治疗 FXIII 缺乏症的有效药物。我们描述了在对 Fibrogammin®/Corifact®进行药物警戒监测期间报告的药物不良反应（ADR），并回顾已发表的安全性数据。
方法
分析了 CSL Behring 在 1993 年 6 月至 2013 年 9 月期间记录的上市后安全性报告。同时也回顾了同一时期发表的临床研究。
结果
商业数据表明，在审查期间共分发了 1,653,450,333 IU 的 FXIII 浓缩剂，相当于为一名 70 公斤患者提供 1,181,036 剂。共报告了 75 例（每 15,700 标准剂量或 22,046,000 IU 中有 1 例）。特别值得关注的报告包括 12 例可能的过敏反应（每 98,400 剂量或 137,787,500 IU 中有 1 例）、7 例可能的血栓栓塞事件（每 168,700 剂量或 236,207,200 IU 中有 1 例）、5 例可能的抑制剂形成（每 236,200 剂量或 330,690,100 IU 中有 1 例）以及 20 例可能的病原体传播（每 59,100 剂量或 82,672,500 IU 中有 1 例）。19 例病原体传播病例涉及病毒感染；4 例因数据不足无法分析，但对所有其他病例而言，评估认为与该产品存在因果关系的可能性不大。对已发表文献的回顾显示了类似的安全性概况。
结论
对药物不良反应的评估表明，FXIII 浓缩剂在各种临床情况下发生药物不良反应的风险较低，提示其安全性良好。
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