Prospective, Randomised Trial of Two Doses of rFVIIa (NovoSeven) in Haemophilia Patients with Inhibitors Undergoing Surgery
Prospective, Randomised Trial of Two Doses of rFVIIa (NovoSeven) in Haemophilia Patients with Inhibitors Undergoing Surgery
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在使用抑制剂接受手术的血友病患者中进行两剂 rFVIIa (NovoSeven) 的前瞻性随机试验
DOI：
10.1055/s-0037-1615357
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发表时间：
1998
影响因子：
6.7
通讯作者：
A. Shapiro
中科院分区：
文献类型：
--
作者：
G. Gilchrist;W. Hoots;Herbert Cooper;D. Gastineau;A. Shapiro
摘要重组因子VIIa(rFVIIa；NovoSeven®；Novo Nordisk)已被证明在使用抑制剂治疗血友病患者方面有效。这项前瞻性双盲研究比较了rFVIIa(35和90μg/kg)在择期手术期间和术后开始和维持止血的作用。使用抑制剂的患者(FVIII，n=26；FIX，n=3)在切开前立即接受rFVIIa治疗；术中根据需要接受rFVIIa治疗；前48h每2 h一次；随后3天每2-6 h一次。分别于术中、缝合后0、8、24、48h、3、4、5d观察止血效果。第5天后，开放标记rFVIIa(90μg/kg)可用于维护。29例术中止血28例。所有大剂量患者和12/15例低剂量患者在最初的48h内止血效果满意，23例患者(13/14例高剂量)成功完成研究。尽管35μg/kg剂量可能不适合术后处理，但至少在大手术中，rFVIIa 90μg/kg对于使用抑制剂的患者来说是一种有效的一线选择。
Summary 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 μg/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 μg/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 μg/kg dose is probably sub-optimal for post-operative management, at least in major procedures, rFVIIa 90 μg/kg is an effective first-line option in surgery for patients with inhibitors.
DOI：
10.1073/pnas.85.18.6687
发表时间：
1988-09-01
影响因子：
11.1
作者：
RAO, LVM;RAPAPORT, SI
通讯作者：
RAPAPORT, SI