二十年的四因子前列红素复杂缩物Octaplex/Balfaxar:一个叙述性回顾
Keyvan Karkouti1, Michelle Gareis2, Chenxi Li3
1Department of Anesthesia and Pain Management, University Health Network, Sinai Health System, Women's College Hospital, Toronto, Ontario, Canada; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada.
概括
四因子前激素复合缩物 (4F-PCC) 有效逆转维生素K对抗剂 (VKA) 抗凝作用,并越来越多地用于紧急出血情况. 安全性和有效性数据支持其既定和新兴的临床应用.
科学领域:
- 血液学 血液学 血液学
- 药理学 药理学 是一个学科.
背景情况:
- 血栓复合物缩剂 (PCC) 增强血栓生成,用于治疗出血障碍.
- 四因子PCC (4F-PCC) 含有凝血因子II,VII,IX和X,提供缩的静血潜力.
- 4F-PCC包括抗凝固蛋白C和S,可能平衡血静并降低血栓形成风险.
研究的目的:
- 审查一个特定的4F-PCC (Octaplex/Balfaxar) 的疗效和安全性.
- 总结其已知的临床用途,并探索潜在的新应用.
- 为各种出血情景整合4F-PCC的证据.
主要方法:
- 发表的疗效和安全性数据的叙述性审查.
- 对VKA逆转中的4F-PCC临床试验数据的分析.
- 对非标签用途的指导方针和新出现的证据的审查.
主要成果:
- 在444名成年人中进行的5项试验证实了4F-PCC在VKA逆转中的有效性,显著降低了INR.
- 在VKA逆转试验中,仅报告了两个可能与治疗相关的血栓发作事件.
- 新出现的证据表明,固定剂量可能是用于逆转VKA的基于体重的剂量替代方案.
结论:
- 4F-PCC在VKA逆转和因子缺乏症等已批准的适用症中是有效的,并且一般安全.
- 目前的指导方针支持其用于直接口服抗凝剂相关出血,心脏手术和创伤.
- 需要进一步的研究,才能在更广泛的临床环境中充分确定疗效和安全性.
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