Research Institute of Internal Medicine Institute of Clinical Medicine, University of Oslo Department of Haematology Department of Orthopedics, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
Haemophilia. 2011 Sep;17(5):764-70. doi: 10.1111/j.1365-2516.2011.02596.x. Epub 2011 Jun 26.
The use of recombinant FVIIa (rFVIIa) to control bleed in individuals with FVII deficiency has been proven to be effective. The main problems associated with its use are that it requires frequent bolus injections to counteract its short half-life and high cost. Our study aimed to evaluate whether any advantage could be gained by providing rFVIIa by continuous infusion during surgery with regard to haemostatic efficacy, safety and cost. The prospective study included 10 patients with severe FVII deficiency, who underwent 25 surgical procedures (13 major and 12 minor procedures) and were treated with rFVIIa administered by continuous infusion. Tranexamic acid was given concomitantly every 8 h. Prothrombin time, FVII:C assay and thrombin generation assay were used to monitor the treatment. The mean total dose given was 10 mg during a major surgery and 4.4 mg during a minor surgery for a mean treatment duration of 7.5 and 4.0 days respectively. This corresponds to a reduction of 70-90% in drug usage and medication cost compared with bolus injections. Except for one major perioperative bleeding, excellent haemostasis was achieved in all procedures. One patient developed a transient inhibitory activity. None of these events affected the postoperative course or prolonged the hospital stay. Our study demonstrated that continuous infusion of rFVIIa during surgery is safe, effective and highly cost effective.
使用重组 FVIIa（rFVIIa）控制 FVII 缺乏症个体的出血已被证明是有效的。其使用的主要问题是半衰期短且费用高，需要频繁推注以抵消半衰期短的问题。我们的研究旨在评估在手术期间持续输注 rFVIIa 是否在止血效果、安全性和成本方面具有优势。这项前瞻性研究纳入了 10 名严重 FVII 缺乏症患者，他们进行了 25 次手术（13 次大手术和 12 次小手术），并接受了持续输注 rFVIIa 的治疗。同时每 8 小时给予氨甲环酸。使用凝血酶原时间、FVII:C 测定和凝血酶生成试验来监测治疗。大手术时的平均总剂量为 10 毫克，小手术时为 4.4 毫克，平均治疗时间分别为 7.5 天和 4.0 天。这相当于与推注相比，药物使用量和药物费用减少了 70-90%。除了一次大手术围手术期出血外，所有手术均实现了极好的止血效果。有 1 名患者出现短暂的抑制性活性。这些事件均未影响术后病程或延长住院时间。我们的研究表明，手术期间持续输注 rFVIIa 是安全、有效且极具成本效益的。
