Department for Anaesthesiology and Intensive Care Medicine, Franziskus Hospital Bielefeld, Bielefeld, Germany.
Department for Anaesthesiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany.
Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241254106. doi: 10.1177/10760296241254106.
Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP/Haemocomplettan P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986-June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.
纤维蛋白原浓缩物治疗推荐用于先天性和获得性纤维蛋白原缺乏的成人和儿科患者的急性出血发作。先前的研究报告了纤维蛋白原浓缩物使用的血栓栓塞事件 (TEE) 风险低；然而，治疗后的 TEE 风险仍然令人关注。对 RiaSTAP/Haemocomplettan P（CSL Behring，马尔堡，德国）上市后数据进行了回顾性评估（1986 年 1 月至 2022 年 6 月），并结合已发表研究的文献复习进行补充。在审查期间，约使用了 745 万克纤维蛋白原浓缩物。在 337 名患者中报告了药物不良反应 (ADR)，其中 81 名（24.0%）患者发生了可能的 TEE，包括 14/81 名（17.3%）患者发生了致命结局。大多数情况下存在风险因素和其他凝血产品的使用，提供了替代解释。文献复习确定了 52 项涉及各种临床领域的纤维蛋白原浓缩物的高排名研究，包括 26 项随机对照试验。总体而言，与报告组间更高比率或无差异的研究相比，更多的比较研究显示纤维蛋白原组的 ADR 发生率和/或 TEE 发生率较低。上市后数据和临床研究表明，纤维蛋白原浓缩物治疗的不良反应发生率低，包括 TEE。这些发现表明纤维蛋白原浓缩物具有良好的安全性，使其成为治疗术中止血性出血的一线治疗方法之一。
