Hazendonk H C A M, Lock J, Mathôt R A A, Meijer K, Peters M, Laros-van Gorkom B A P, van der Meer F J M, Driessens M H E, Leebeek F W G, Fijnvandraat K, Cnossen M H
Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital Rotterdam, Rotterdam, the Netherlands.
Hospital Pharmacy - Clinical Pharmacology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
J Thromb Haemost. 2016 Mar;14(3):468-78. doi: 10.1111/jth.13242. Epub 2016 Feb 19.
ESSENTIALS: Targeting of factor VIII values is a challenge during perioperative replacement therapy in hemophilia. This study aims to identify the extent and predictors of factor VIII underdosing and overdosing. Blood group O predicts underdosing and is associated with perioperative bleeding. To increase quality of care and cost-effectiveness of treatment, refining of dosing is obligatory.
Perioperative administration of factor VIII (FVIII) concentrate in hemophilia A may result in both underdosing and overdosing, leading to respectively a risk of bleeding complications and unnecessary costs.
This retrospective observational study aims to identify the extent and predictors of underdosing and overdosing in perioperative hemophilia A patients (FVIII levels < 0.05 IU mL(-1)).
One hundred nineteen patients undergoing 198 elective, minor, or major surgical procedures were included (median age 40 years, median body weight 75 kg). Perioperative management was evaluated by quantification of perioperative infusion of FVIII concentrate and achieved FVIII levels. Predictors of underdosing and (excessive) overdosing were analyzed by logistic regression analysis. Excessive overdosing was defined as upper target level plus ≥ 0.20 IU mL(-1).
Depending on postoperative day, 7-45% of achieved FVIII levels were under and 33-75% were above predefined target ranges as stated by national guidelines. A potential reduction of FVIII consumption of 44% would have been attained if FVIII levels had been maintained within target ranges. Blood group O and major surgery were predictive of underdosing (odds ratio [OR] 6.3, 95% confidence interval [CI] 2.7-14.9; OR 3.3, 95% CI 1.4-7.9). Blood group O patients had more bleeding complications in comparison to patients with blood group non-O (OR 2.02, 95% CI 1.00-4.09). Patients with blood group non-O were at higher risk of overdosing (OR 1.5, 95% CI 1.1-1.9). Additionally, patients treated with bolus infusions were at higher risk of excessive overdosing (OR 1.8, 95% CI 1.3-2.4).
Quality of care and cost-effectiveness can be improved by refining of dosing strategies based on individual patient characteristics such as blood group and mode of infusion.
要点:在血友病围手术期替代治疗期间,针对凝血因子 VIII 值进行目标设定是一项挑战。本研究旨在确定凝血因子 VIII 剂量不足和过量的程度及预测因素。O 型血预示剂量不足,并与围手术期出血相关。为提高护理质量和治疗的成本效益,必须优化给药方案。
血友病 A 患者围手术期应用凝血因子 VIII(FVIII)浓缩物可能导致剂量不足和过量,分别导致出血并发症风险和不必要的费用。
这项回顾性观察研究旨在确定围手术期血友病 A 患者(FVIII 水平 < 0.05 IU mL⁻¹)剂量不足和过量的程度及预测因素。
纳入 119 例接受 198 例择期、小型或大型外科手术的患者(中位年龄 40 岁,中位体重 75 kg)。通过量化围手术期 FVIII 浓缩物输注量和所达到的 FVIII 水平来评估围手术期管理。通过逻辑回归分析分析剂量不足和(过度)过量的预测因素。过度过量定义为高于目标上限水平加≥ 0.20 IU mL⁻¹。
根据术后天数,所达到的 FVIII 水平有 7 - 45%低于国家指南规定的预定义目标范围,33 - 75%高于该范围。如果 FVIII 水平维持在目标范围内,FVIII 消耗量可能会降低 44%。O 型血和大型手术是剂量不足的预测因素(优势比 [OR] 6.3,95%置信区间 [CI] 2.7 - 14.9;OR 3.3,95% CI 1.4 - 7.9)。与非 O 型血患者相比,O 型血患者有更多出血并发症(OR 2.02,95% CI 1.00 - 4.09)。非 O 型血患者过量的风险更高(OR 1.5,95% CI 1.1 - 1.9)。此外,接受推注输注治疗的患者过度过量的风险更高(OR 1.8,95% CI 1.3 - 2.4)。
根据血型和输注方式等个体患者特征优化给药策略可提高护理质量和成本效益。