Shapiro A D, Gilchrist G S, Hoots W K, Cooper H A, Gastineau D A
Indiana University Medical Center, Hemophilia Center, Indianapolis 46260, USA.
Thromb Haemost. 1998 Nov;80(5):773-8.
Recombinant factor VIIa (rFVIIa: NovoSeven; Novo Nordisk) has proven efficacy in the treatment of haemophilic patients with inhibitors. This prospective, double-blind study compared rFVIIa (35 vs. 90 microg/kg) in the initiation and maintenance of haemostasis during and after elective surgery. Patients with inhibitors (FVIII, n = 26; FIX, n = 3) received rFVIIa immediately prior to incision; intraoperatively as needed; every 2 h for the first 48 h; and every 2-6 h for the following 3 days. Haemostasis was evaluated during surgery, at 0, 8, 24 and 48 h and 3, 4 and 5 days after wound closure. After day 5, open-label rFVIIa (90 microg/kg) was available for maintenance. Intraoperative haemostasis was achieved in 28/29 patients. All high-dose patients and 12/15 low dose patients had satisfactory haemostasis during the first 48 h. Twenty-three patients (13/14 high dose) successfully completed the study. Although the 35 microg/kg dose is probably sub-optimal for post-operative management, at least in major procedures, rFVIIa 90 microg/kg is an effective first-line option in surgery for patients with inhibitors.
重组凝血因子VIIa（rFVIIa：诺其；诺和诺德公司）已被证实在治疗有抑制物的血友病患者中有效。这项前瞻性、双盲研究比较了rFVIIa（35微克/千克与90微克/千克）在择期手术期间及术后启动和维持止血的效果。有抑制物的患者（FVIII缺乏，n = 26；FIX缺乏，n = 3）在切口前即刻接受rFVIIa；术中按需给药；在最初48小时内每2小时给药一次；在接下来3天每2 - 6小时给药一次。在手术期间、伤口闭合后0、8、24和48小时以及3、4和5天评估止血情况。5天后，可使用开放标签的rFVIIa（90微克/千克）进行维持治疗。29例患者中有28例术中实现了止血。所有高剂量患者和15例低剂量患者中的12例在最初48小时内止血情况令人满意。23例患者（14例高剂量患者中的13例）成功完成了研究。尽管35微克/千克的剂量对于术后管理可能并非最佳，至少在大手术中如此，但90微克/千克的rFVIIa对于有抑制物的患者在手术中是一种有效的一线选择。
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