Abstract：
Turoctocog alfa is a recombinant Factor VIII used in patients with hemophilia A. The aim is to assess the real-life evidence of turoctocog alfa in surgery.
Data were extracted from a national database.
Turoctocog alfa was used for 86 surgeries (49 major and 37 minor) in 56 patients. The results are expressed as medians (interquartile range). Six (10.7%) patients had severe hemophilia A, four (7.1%) moderate, and 46 (82.2%) mild. For patients who underwent major surgeries, basal plasma FVIII coagulant activity (FVIII:C) levels were 15 IU.dL-1 (8-22). Eight (5-14) infusions were given, at a preoperative loading dose of 40.0 (35.0-45.5) IU.kg-1 and a total dose of 253.3 (125.0-507.0) IU.kg-1 . In patients who underwent minor surgeries, basal FVIII:C levels were 18 IU.dL-1 (9-31). Two (1-3) infusions were required, at a preoperative loading dose of 34.0 (28.8-38.5) IU.kg-1 and a total dose of 73.7 (37.6-122.1) IU.kg-1 . The overall clinical efficacy was judged excellent/good in 77 procedures (89.5%) and fair/poor in nine (10.5%). The fair/poor efficacy concerned seven patients (six mild hemophilia and one severe), for four urological surgeries, two dermatological procedures, one heart surgery, one ear-nose-throat procedure, and one dental avulsion in the patient with severe hemophilia. Three out of those seven patients received antiplatelet therapy. No thromboembolic events, anti-FVIII antibodies, or adverse events were reported.
The efficacy and safety of turoctocog alfa were confirmed for the management of surgery in patients with hemophilia A. No adverse events were observed and overall efficacy was good.
Data were extracted from a national database.
Turoctocog alfa was used for 86 surgeries (49 major and 37 minor) in 56 patients. The results are expressed as medians (interquartile range). Six (10.7%) patients had severe hemophilia A, four (7.1%) moderate, and 46 (82.2%) mild. For patients who underwent major surgeries, basal plasma FVIII coagulant activity (FVIII:C) levels were 15 IU.dL-1 (8-22). Eight (5-14) infusions were given, at a preoperative loading dose of 40.0 (35.0-45.5) IU.kg-1 and a total dose of 253.3 (125.0-507.0) IU.kg-1 . In patients who underwent minor surgeries, basal FVIII:C levels were 18 IU.dL-1 (9-31). Two (1-3) infusions were required, at a preoperative loading dose of 34.0 (28.8-38.5) IU.kg-1 and a total dose of 73.7 (37.6-122.1) IU.kg-1 . The overall clinical efficacy was judged excellent/good in 77 procedures (89.5%) and fair/poor in nine (10.5%). The fair/poor efficacy concerned seven patients (six mild hemophilia and one severe), for four urological surgeries, two dermatological procedures, one heart surgery, one ear-nose-throat procedure, and one dental avulsion in the patient with severe hemophilia. Three out of those seven patients received antiplatelet therapy. No thromboembolic events, anti-FVIII antibodies, or adverse events were reported.
The efficacy and safety of turoctocog alfa were confirmed for the management of surgery in patients with hemophilia A. No adverse events were observed and overall efficacy was good.
摘要：
背景：Turoctococogalfa是一种用于血友病A患者的重组因子VIII。目的是评估手术中turoctocogalfa的真实证据。
方法：数据从国家数据库中提取。
结果：Turoctocogalfa用于56例患者的86例手术（49大和37小）。结果表示为中值(四分位间距)。6名(10.7%)患者患有严重血友病A,四个(7.1%)中等，和46（82.2％）轻度。对于接受大手术的患者，基础血浆FVIII凝血活性（FVIII：C）水平为15IU。dL-1(8-22).8次（5-14次）输液，术前负荷剂量为40.0（35.0-45.5）IU。kg-1和253.3（125.0-507.0）IU的总剂量。kg-1.在接受小手术的患者中，基础FVIII：C水平为18IU。dL-1(9-31).需要两次（1-3）输液，术前负荷剂量为34.0（28.8-38.5）IU。kg-1和73.7（37.6-122.1）IU的总剂量。kg-1.总体临床疗效在77例（89.5％）中被判断为优秀/良好，在9例（10.5％）中被判断为一般/差。疗效一般/较差涉及七名患者(六名轻度血友病及一名重度血友病)，四次泌尿外科手术，两个皮肤病学程序，一次心脏手术,一个耳鼻喉手术，严重血友病患者的牙齿撕脱伤。这7名患者中有3名接受了抗血小板治疗。无血栓栓塞事件,抗FVIII抗体，或报告不良事件.
结论：对血友病A患者进行手术治疗的有效性和安全性得到证实。未观察到不良事件，总体疗效良好。
方法：数据从国家数据库中提取。
结果：Turoctocogalfa用于56例患者的86例手术（49大和37小）。结果表示为中值(四分位间距)。6名(10.7%)患者患有严重血友病A,四个(7.1%)中等，和46（82.2％）轻度。对于接受大手术的患者，基础血浆FVIII凝血活性（FVIII：C）水平为15IU。dL-1(8-22).8次（5-14次）输液，术前负荷剂量为40.0（35.0-45.5）IU。kg-1和253.3（125.0-507.0）IU的总剂量。kg-1.在接受小手术的患者中，基础FVIII：C水平为18IU。dL-1(9-31).需要两次（1-3）输液，术前负荷剂量为34.0（28.8-38.5）IU。kg-1和73.7（37.6-122.1）IU的总剂量。kg-1.总体临床疗效在77例（89.5％）中被判断为优秀/良好，在9例（10.5％）中被判断为一般/差。疗效一般/较差涉及七名患者(六名轻度血友病及一名重度血友病)，四次泌尿外科手术，两个皮肤病学程序，一次心脏手术,一个耳鼻喉手术，严重血友病患者的牙齿撕脱伤。这7名患者中有3名接受了抗血小板治疗。无血栓栓塞事件,抗FVIII抗体，或报告不良事件.
结论：对血友病A患者进行手术治疗的有效性和安全性得到证实。未观察到不良事件，总体疗效良好。
