【罂粟摘要】预防性应用纤维蛋白原浓缩液治疗小儿颅缝早闭：一项双盲安慰剂对照试验
预防性应用纤维蛋白原浓缩液治疗小儿颅缝早闭：一项双盲安慰剂对照试验
贵州医科大学 高鸿教授课题组
翻译：佟睿 编辑：佟睿 审校：曹莹
儿童颅缝早闭的外科修复效果与大量失血输血有关。纤维蛋白原浓缩液号称在减少失血和输血需求方面是具有作用的。
我们旨在于研究在儿童颅面外科手术中预防性使用纤维蛋白原浓缩液能否减少失血和输血需求。
随机、安慰剂对照、双盲临床试验。
大学医疗中心。
共纳入114名月龄在25个月以下的婴儿和儿童(月龄中位数为10个月)。
每例患者均接受了颅骨重建术修复颅骨融合畸形。患者被随机分成两组，分别接受平均剂量为79 mg·kg-1的预防性纤维蛋白原浓缩剂(血液完全素P)或安慰剂。
主要观察指标是输入血制品的量。次要观察指标包括围手术期出血量、手术时间、儿科ICU住院时间、住院时间、术后并发症和纤维蛋白原浓缩液输注的不良反应。
主要观察指标是输入血制品的量。次要观察指标包括围手术期出血量、手术时间、儿科ICU住院时间、住院时间、术后并发症和纤维蛋白原浓缩液输注的不良反应。
干预组与安慰剂组在输血量(中位数29ml·kg-1 vs. 29ml·kg-1)、术中估计出血量(45ml·kg-1 vs. 46ml·kg-1)、计算失血量量(57ml·kg-1 vs. 53ml·kg-1)、术后出血量(24ml·kg-1 vs. 24ml·kg-1)等方面均无显著性差异(P>0.05)。此外，两组在手术时间、儿科ICU住院时间、住院时间和并发症方面没有显著差异。
在小儿颅缝融合手术修复过程中，预防性应用大剂量纤维蛋白原浓缩液并不能减少输血量或减少围手术期失血量。
Andreas Machotta, Elise J. Huisman, Inge M. Appel, et al. Prophylactic fibrinogen concentrate administration in surgical correction of paediatric craniosynostosis: A double-blind placebo-controlled trial. [J]Eur J Anaesthesiol 2021; 38:908–915.
Prophylactic fibrinogen concentrate administration in surgical correction of paediatric craniosynostosis: A double-blind placebo-controlled trial
BACKGROUND: Surgical craniosynostosis repair in children is associated with massive blood loss and significant transfusion of blood products. Fibrinogen concentrate is claimed to be useful in reducing blood loss and transfusion requirements.
OBJECTIVE: We investigated whether prophylactic administration of fibrinogen concentrate will reduce blood loss and transfusion requirements during paediatric craniofacial surgery.
DESIGN: Randomised, placebo-controlled, double-blind clinical trial.
SETTING: University medical centre.
PATIENTS: A total of 114 infants and children up to 25 months of age (median age 10 months).
INTERVENTION: Surgical craniosynostosis repair by calvarial remodelling was performed in each patient. Patients were randomised to receive prophylactic fibrinogen concentrate (Haemocomplettan P) at a mean dose of 79 ml·kg-1 body weight or placebo.
MAIN OUTCOME MEASURES: Primary outcome was the volume of transfused blood products. Secondary outcomes were peri-operative blood loss, duration of surgery, length of stay in the paediatric ICU, length of hospital stay, postoperative complications and adverse effects of fibrinogen concentrate infusion.
RESULTS: No significant differences (P<0.05) were found in the volume of transfused blood products (median 29 ml·kg-1 body weight vs. 29 ml·kg-1 body weight), intraoperative estimated blood loss (45 vs. 46 ml·kg-1), calculated blood loss (57 vs. 53 ml·kg-1), or postoperative blood loss (24 vs. 24 ml·kg-1 between the intervention and placebo groups. In addition, duration of surgery, length of stay in the paediatric ICU, hospital stay and complications were not significantly different between the two groups.
CONCLUSION: During surgical craniosynostosis repair in young children, prophylactic administration of high-dose fibrinogen concentrate did not reduce the amount of transfused blood products or decrease peri-operative blood loss.