Ignjatovic Vera, Barnes Chris, Newall Fiona, Hamilton Simone, Burgess Janet, Monagle Paul
Department of Haematology, Royal Children's Hospital, Melbourne, Victoria, Australia.
Thromb Haemost. 2004 Oct;92(4):734-7. doi: 10.1160/TH04-02-0085.
This paper reports the outcome of a research protocol aimed at optimising warfarin monitoring in a tertiary pediatric centre. The Thrombotest INR was the standard monitoring test employed to manage oral anticoagulant therapy in children at the Royal Children's Hospital (RCH), Melbourne. This study compares the results of this standard method to the novel CoaguChek INR monitor and the "gold standard" technique of venous INR sampling. The objectives were to determine 1) if point-of-care techniques of measuring the INR (Thrombotest and CoaguChek) are accurate and reliable compared to INR results obtained from venous sampling, processed in an accredited laboratory, and 2) if INR results generated by POC devices can be safely used to manage oral anticoagulant therapy in children. 18 children (10 females and 8 males) participated in the study. Ages ranged from 9 months to 21 years (Mean 11.9 years; SD 5.03 years). The agreement between CoaguChek and venous INR measurements (r = 0.885) was shown to be higher compared to Thrombotest and venous INR (r = 0.700). Compared to the venous INR, values obtained with Coaguchek and Thrombotest crossed into or out of the therapeutic range in 25% and 36% of cases respectively. In 88% of the CoaguChek cases and 57% Thrombotest cases, the difference from the venous result was less than 0.5. The CoaguChek method of INR monitoring is a more accurate and reliable method compared to Thrombotest, in the pediatric population tested, and can be safely used to manage oral anticoagulant therapy in children.
本文报告了一项研究方案的结果，该方案旨在优化一家三级儿科中心的华法林监测。凝血酶试验国际标准化比值（Thrombotest INR）是墨尔本皇家儿童医院（RCH）用于管理儿童口服抗凝治疗的标准监测测试。本研究将这种标准方法的结果与新型的CoaguChek INR监测仪以及静脉血INR采样的“金标准”技术进行了比较。目标是确定：1）与在认可实验室处理的静脉血采样获得的INR结果相比，即时检测（POC）测量INR的技术（凝血酶试验和CoaguChek）是否准确可靠；2）POC设备生成的INR结果是否可安全用于管理儿童口服抗凝治疗。18名儿童（10名女性和8名男性）参与了该研究。年龄范围为9个月至21岁（平均11.9岁；标准差5.03岁）。结果显示，CoaguChek与静脉血INR测量之间的一致性（r = 0.885）高于凝血酶试验与静脉血INR之间的一致性（r = 0.700）。与静脉血INR相比，使用Coaguchek和凝血酶试验获得的值分别在25%和36%的病例中进入或超出治疗范围。在88%的CoaguChek病例和57%的凝血酶试验病例中，与静脉血结果的差异小于0.5。在测试的儿科人群中，与凝血酶试验相比，CoaguChek法监测INR是一种更准确可靠的方法，可安全用于管理儿童口服抗凝治疗。
