Négrier C, Ducloy-Bouthors A-S, Piriou V, De Maistre E, Stieltjes N, Borel-Derlon A, Colson P, Picard J, Lambert T, Claeyssens S, Boileau S, Bertrand A, André M-H, Fourrier F, Ozier Y, Sié P, Gruel Y, Tellier Z
Edouard Herriot Hospital, Lyon, France.
University Hospital, Lille, France.
Vox Sang. 2018 Feb;113(2):120-127. doi: 10.1111/vox.12624. Epub 2017 Dec 13.
A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact in acquired fibrinogen deficiency in real-life medical practice in France.
One hundred and fifty patients were planned for 28 days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed.
One hundred and fifty-six patients (16-87 years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18·9 ± 12·3 days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73·6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4·4%).
The Clottafact safety profile observed during the study matched the known profile of fibrinogen during use.
2009年至2012年间开展了一项上市后安全性研究，以描述法国实际医疗实践中克洛塔法克（Clottafact）在获得性纤维蛋白原缺乏症中的应用情况。
计划对150例患者在输注后进行28天的前瞻性随访。本观察性研究的分析具有描述性，并根据治疗类型（治疗性或预防性）和出血来源进行。
13个中心纳入了156例患者（16 - 87岁），并在五种不同的医疗出血情况下进行治疗：产后（59例）、其他妇科/产科（6例）、创伤（34例）、肝脏（13例）、心血管（23例）和其他各种出血情况（21例）。平均随访时间为18.9±12.3天。两名患者出现药物不良反应：一例为肺栓塞，另一例为四处静脉血栓栓塞事件。所有均为严重不良反应，与研究治疗的因果关系存疑。疗效数据作为次要目标收集。在150例接受治疗性治疗的患者中，159次输注中有117次（73.6%）被研究人员认为成功，35次为中等效果（22%），7次无反应（4.4%）。
研究期间观察到的克洛塔法克安全性特征与已知的纤维蛋白原使用特征相符。
