Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
Acta Anaesthesiol Scand. 2012 May;56(5):539-48. doi: 10.1111/j.1399-6576.2011.02586.x. Epub 2011 Dec 12.
A sufficient plasma level of fibrinogen is critical for the formation of a fibrin clot and haemostasis in both the perioperative setting and in massive haemorrhage. We assessed the efficacy and safety of fibrinogen concentrate substitution in the perioperative setting and in massive haemorrhage.
We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 1985 to 2010. In addition, we screened several web sites for assessments on fibrinogen concentrate substitution and conducted a hand search using Scopus. In terms of efficacy, we included all prospective, controlled studies. Concerning safety, we included all prospective studies.
We identified two randomised controlled trials and two non-randomised controlled studies, which included a total of 74 patients. The studies indicate that the administration of fibrinogen concentrate is associated with improved clot firmness and reduction in the substitution of other blood products such as red blood cells, fresh frozen plasma and platelet concentrates, as well as decreased post-operative bleeding and drainage volume. In addition, fibrinogen concentrate administration has been reported to be safe with regard to thrombosis and thromboembolic complications, as well as mortality. However, the studies identified were of poor quality.
In conclusion, the results of the available controlled trials suggest that the administration of fibrinogen concentrate was effective and safe. However, because all studies identified were of inadequate quality, these findings need to be confirmed by randomised controlled trials of sufficient size and long-term follow-up.
在围手术期和大出血的情况下，纤维蛋白原的血浆水平充足对于纤维蛋白凝块的形成和止血至关重要。我们评估了纤维蛋白原浓缩物替代在围手术期和大出血中的疗效和安全性。
我们对 1985 年至 2010 年期间在英语或德语发表的关于人类的研究进行了系统的文献检索，并在几个数据库中进行了筛选。此外，我们还对纤维蛋白原浓缩物替代的评估进行了多个网站的筛选，并使用 Scopus 进行了手工搜索。关于疗效，我们包括了所有前瞻性、对照研究。关于安全性，我们包括了所有前瞻性研究。
我们确定了两项随机对照试验和两项非随机对照研究，共纳入了 74 名患者。这些研究表明，纤维蛋白原浓缩物的给药与改善凝块硬度以及减少红细胞、新鲜冷冻血浆和血小板浓缩物等其他血液制品的替代有关，同时还减少了术后出血和引流量。此外，纤维蛋白原浓缩物的给药在血栓形成和血栓栓塞并发症以及死亡率方面被认为是安全的。然而，所确定的研究质量较差。
总之，现有对照试验的结果表明，纤维蛋白原浓缩物的给药是有效和安全的。然而，由于所有确定的研究质量都不足，这些发现需要通过足够大小和长期随访的随机对照试验来证实。
