McLeod Lisa M, French Benjamin, Flynn John M, Dormans John P, Keren Ron
*Pediatric Hospital Medicine, Children's Hospital of Colorado, Section of Hospital Medicine, Aurora, CO †Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania ‡Division of Orthopedic Surgery, Children's Hospital of Philadelphia §Department of Orthopedic Surgery, Perelman School of Medicine, University of Pennsylvania ∥Center for Pediatric Clinical Effectiveness, Children's Hospital of Philadelphia ¶Department of General Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
J Spinal Disord Tech. 2015 Oct;28(8):E460-6. doi: 10.1097/BSD.0b013e3182a22a54.
Retrospective cohort study using the Pediatric Health Information Systems database.
To determine the association between antifibrinolytic use and red cell transfusions in spinal fusion operations performed at 37 US Children's Hospitals.
Evidence from randomized clinical trials and systematic reviews suggests that antifibrinolytic therapy can significantly reduce blood loss in children undergoing scoliosis surgery; however, the effectiveness of these agents as used in surgeries performed at US children's has not been studied.
We included children aged 0-18 years with diagnoses indicating adolescent idiopathic scoliosis (AIS) or neuromuscular scoliosis (NMS) for whom a spinal fusion procedure was performed between January 1, 2006 and September 30, 2009. Patients with malignancy, trauma, coagulation disorders, or for whom a cell salvage device was employed were excluded. Multilevel logistic regression was used to determine associations between ε-aminocaproic acid (EACA), tranexamic acid (TXA), and aprotinin (APR) use and blood transfusions, controlling for patient and surgery characteristics.
Cohorts consisted of 2722 AIS and 1547 NMS procedures. Antifibrinolytic use varied across hospitals (AIS 3.3%, interquartile range, 0%-42%; NMS 12 interquartile range, 0%-46%), and was significantly associated with NMS, posterior fusion, number of vertebrae fused. Overall, 15% of children received EACA, 7% TXA, and 2% APR. The median hospital-specific rate of red cell transfusions was 24% for AIS and 43% for NMS. In AIS operations, EACA use, but not TXA use, was associated with significantly lower odds of transfusion (odds ratio, 0.42; P<0.001 vs. odds ratio, 1.0; P=0.8). In NMS operations, neither EACA nor TXA use was associated with a decrease in odds of red cell transfusions.
The effectiveness of antifibrinolytics as used outside of clinical trials is unclear and should continue to be explored. Future prospective research is needed to evaluate which administration protocols will most benefit patients, as well as to determine the comparative effectiveness of these drugs in the context of other blood conservation strategies.
使用儿科健康信息系统数据库进行回顾性队列研究。
确定美国37家儿童医院进行脊柱融合手术时抗纤溶药物使用与红细胞输注之间的关联。
随机临床试验和系统评价的证据表明，抗纤溶治疗可显著减少接受脊柱侧弯手术儿童的失血量；然而，这些药物在美国儿童医院手术中的有效性尚未得到研究。
我们纳入了2006年1月1日至2009年9月30日期间接受脊柱融合手术、诊断为青少年特发性脊柱侧弯（AIS）或神经肌肉型脊柱侧弯（NMS）的0至18岁儿童。排除患有恶性肿瘤、创伤、凝血障碍或使用了细胞回收装置的患者。采用多水平逻辑回归分析来确定使用ε-氨基己酸（EACA）、氨甲环酸（TXA）和抑肽酶（APR）与输血之间的关联，并对患者和手术特征进行控制。
队列包括2722例AIS手术和1547例NMS手术。各医院抗纤溶药物的使用情况各不相同（AIS为3.3%，四分位间距为0% - 42%；NMS为12%，四分位间距为0% - 46%），且与NMS、后路融合、融合椎体数量显著相关。总体而言，15%的儿童使用了EACA，7%使用了TXA，2%使用了APR。AIS手术中红细胞输注的医院特定中位数发生率为24%，NMS手术为43%。在AIS手术中，使用EACA而非TXA与输血几率显著降低相关（比值比为0.42；P < 0.001，而比值比为1.0；P = 0.8）。在NMS手术中，使用EACA和TXA均与红细胞输注几率降低无关。
抗纤溶药物在临床试验之外的有效性尚不清楚，应继续进行探索。未来需要开展前瞻性研究，以评估哪种给药方案对患者最有益，以及确定这些药物在其他血液保护策略背景下的相对有效性。
