Federal State-Funded Institution "National Research Center for Hematology" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.
Division of Coagulation, Hemophilia and Thrombosis Comprehensive Treatment Center, Georgetown University Medical Center, Washington, DC, USA.
Haemophilia. 2018 Jan;24(1):70-76. doi: 10.1111/hae.13351. Epub 2017 Oct 19.
Haemophilia A patients are at a high risk of excess bleeding during surgeries. The aim of haemostatic therapy during the perioperative period is to normalize FVIII level perioperatively and postoperatively to maintain normal haemostasis until wound healing is complete.
AIMS/METHODS: To examine the efficacy of Nuwiq (simoctocog alfa, human-cl rhFVIII), a 4 generation recombinant FVIII produced in a human cell line, for surgical prophylaxis in patients with severe haemophilia A. This analysis assessed the efficacy of Nuwiq during surgical procedures and in the postoperative period in seven clinical studies of previously treated patients (PTPs) with severe haemophilia A.
Thirty-six patients, aged 3-55 years, received surgical prophylaxis with Nuwiq for 60 surgeries (28 major and 32 minor). Efficacy was evaluated for 52 surgeries (25 major and 27 minor). The success rate of Nuwiq treatment was 98.1% (51 of 52 evaluated surgeries); haemostatic efficacy was assessed as "excellent" or "good" in all but one major surgery (assessed as "moderate"). The number of infusions ranged from 1 to 19 for minor surgeries and from 3 to 76 for major surgeries. The median (range) daily doses were 42.0 (28.2-100.9) IU kg for minor surgeries and 69.3 (43.3-135.6) IU kg for major surgeries. There were no serious treatment-related adverse events, and none of the patients developed FVIII inhibitors.
The results of this pooled analysis show that Nuwiq was efficacious in maintaining haemostasis during and after major and minor surgical procedures in PTPs with severe haemophilia A.
甲型血友病患者在手术期间有过度出血的高风险。围手术期止血治疗的目的是使 FVIII 水平在围手术期和术后正常化，以维持正常止血，直到伤口愈合完成。
目的/方法：检查 Nuwiq（重组人凝血因子 VIII，四聚体，人源化，rhFVIII）在严重甲型血友病患者手术预防中的疗效。这项分析评估了 Nuwiq 在先前接受治疗的严重甲型血友病患者（PTP）的 7 项临床研究中手术过程中和术后期间的疗效。
36 名年龄 3-55 岁的患者接受了 Nuwiq 用于 60 次手术（28 次大手术和 32 次小手术）的预防治疗。对 52 次手术（25 次大手术和 27 次小手术）进行了疗效评估。Nuwiq 治疗的成功率为 98.1%（52 次评估手术中的 51 次）；除一次大手术（评估为“中度”）外，所有手术的止血效果均为“优秀”或“良好”。小手术的输注次数为 1-19 次，大手术的输注次数为 3-76 次。小手术的中位数（范围）每日剂量为 42.0（28.2-100.9）IU/kg，大手术的中位数（范围）每日剂量为 69.3（43.3-135.6）IU/kg。无严重治疗相关不良事件，也未发现患者产生 FVIII 抑制剂。
这项汇总分析的结果表明，Nuwiq 在严重甲型血友病 PTP 的大手术和小手术期间和之后维持止血方面是有效的。
