Massicotte P, Adams M, Marzinotto V, Brooker L A, Andrew M
Department of Paediatrics, McMaster University, Hamilton, Ontario, Canada.
J Pediatr. 1996 Mar;128(3):313-8. doi: 10.1016/s0022-3476(96)70273-1.
To compare low-molecular-weight preparations of heparin (LMWH) with standard heparin in children requiring anticoagulant treatment for thromboembolic disease.
We treated 25 children who required heparin, but were at significant risk of bleeding, with LMWH (enoxaparin, Rhone-Poulenc Rorer). The median age was 4 years (range, newborn to 17 years), with nine infants less than 2 months of age. Fourteen children had a deep vein thrombosis or pulmonary embolism, nine had thrombotic complications in the central nervous system, and two had complex congenital heart disease, for which they received prophylaxis at a lower dosage (0.5 mg/kg given subcutaneously twice a day). The remaining 23 children received an initial dose of 1 mg/kg, every 12 hours subcutaneously, with subsequent doses adjusted to achieve a 4-hour anti-factor Xa level between 0.5 and 1.0 unit/ml.
Newborn infants had increased dose requirements; an average of 1.60 units/kg was required to achieve therapeutic heparin levels. For the remaining children, the initial dose of 1.0 mg/kg was sufficient. After the initial dose adjustment, LMWH was administered with twice-weekly monitoring. The median duration of therapy with LMWH was 14 days. Two children with previously documented gastrointestinal ulcers bled and required transfusion therapy. Therapy with LMWH was continued without further events. There were no new thrombotic events during the treatment with LMWH. The cost of administering LMWH compared with heparin was reduced by 30% because of decreased laboratory monitoring, blood sampling times, intravenous starts, and nursing time. Needle punctures were reduced with LMWH therapy by the placement of a subcutaneous catheter.
These results provide the basis for a randomized, controlled trial comparing LMWH with standard heparin in pediatric patients.
比较低分子量肝素制剂（LMWH）与标准肝素用于因血栓栓塞性疾病需抗凝治疗的儿童。
我们用LMWH（依诺肝素，罗纳-普朗克-乐安公司生产）治疗了25名需要肝素但有显著出血风险的儿童。中位年龄为4岁（范围从新生儿到17岁），其中9名婴儿小于2个月。14名儿童患有深静脉血栓形成或肺栓塞，9名患有中枢神经系统血栓形成并发症，2名患有复杂先天性心脏病，他们接受较低剂量（0.5mg/kg皮下注射，每日两次）的预防治疗。其余23名儿童初始剂量为1mg/kg，每12小时皮下注射一次，随后调整剂量以使4小时抗Xa因子水平维持在0.5至1.0单位/毫升之间。
新生儿所需剂量增加；平均需要1.60单位/千克才能达到肝素治疗水平。对于其余儿童，1.0mg/kg的初始剂量就足够了。初始剂量调整后，LMWH每两周监测一次进行给药。LMWH治疗的中位持续时间为14天。两名既往有记录的胃肠道溃疡患儿出血并需要输血治疗。LMWH治疗继续进行，未再发生其他事件。LMWH治疗期间未出现新的血栓形成事件。由于实验室监测、采血次数、静脉穿刺次数和护理时间减少，与肝素相比，LMWH的给药成本降低了30%。通过放置皮下导管，LMWH治疗减少了针刺次数。
这些结果为在儿科患者中比较LMWH与标准肝素的随机对照试验提供了依据。
