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本文引用的文献

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Intraclass correlations: uses in assessing rater reliability.组内相关系数：在评估评分者可靠性中的应用。
Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
2
Point of care monitoring of oral anticoagulant therapy in children: comparison of CoaguChek Plus and Thrombotest methods with venous international normalised ratio.儿童口服抗凝治疗的床旁监测：CoaguChek Plus和血栓试验方法与静脉国际标准化比值的比较
Thromb Haemost. 2004 Oct;92(4):734-7. doi: 10.1160/TH04-02-0085.
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The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.维生素K拮抗剂的药理学与管理：第七届抗栓与溶栓治疗ACCP会议
Chest. 2004 Sep;126(3 Suppl):204S-233S. doi: 10.1378/chest.126.3_suppl.204S.
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Oral anticoagulant treatment in children based on monitoring at home.基于家庭监测的儿童口服抗凝治疗。
Acta Paediatr. 2004 May;93(5):687-91.
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Accuracy, reproducibility and clinical utility of the CoaguChek S portable international normalized ratio monitor in an outpatient anticoagulation clinic.
Clin Lab Haematol. 2004 Feb;26(1):49-55. doi: 10.1111/j.0141-9854.2003.00578.x.
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Reliability, validity and ease of use of a portable point-of-care coagulation device in a pharmacist-managed anticoagulation clinic.便携式即时检测凝血设备在药剂师管理的抗凝门诊中的可靠性、有效性及易用性
J Thromb Thrombolysis. 2002 Dec;14(3):247-54. doi: 10.1023/a:1025061129122.
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Whole blood international normalization ratio measurements in children using near-patient monitors.使用即时检验仪器对儿童进行全血国际标准化比值测量。
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8
Accuracy and precision of the CoaguChek S versus laboratory INRs in a clinic.
Ann Pharmacother. 2002 May;36(5):769-75. doi: 10.1345/aph.1A310.
9
Accuracy of a portable prothrombin time monitor (Coagucheck) in patients on chronic oral anticoagulant therapy: a prospective multicenter study.慢性口服抗凝治疗患者中便携式凝血酶原时间监测仪（Coagucheck）的准确性：一项前瞻性多中心研究。
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Capillary whole blood monitoring of oral anticoagulants in children in outpatient clinics and the home setting.
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CoaguChek S用于儿科抗凝治疗家庭监测的有效性。

Validity of CoaguChek S for home monitoring of anticoagulant therapy in pediatrics.

作者信息

Hill James, Perreault Sébastien, Dorval Michel

机构信息

Centre Regional de Santé et de Services Sociaux de Rimouski, Rimouski, Canada.

出版信息

Can J Cardiol. 2007 Jan;23(1):47-50. doi: 10.1016/s0828-282x(07)70212-x.

DOI:10.1016/s0828-282x(07)70212-x
PMID:17245482
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2649171/
Abstract

BACKGROUND

CoaguChek S (Roche Diagnostics, Canada) is a portable device designed to monitor international normalized ratio (INR) by capillary puncture. Although the device is used in pediatrics, no study has evaluated its validity in patients of this population.

OBJECTIVE

To evaluate the validity of CoaguChek S as an in-home INR monitor in patients younger than 18 years of age.

METHODS

Data were based on 129 INR pairs collected from nine patients younger than 18 years of age followed up at an anticoagulation clinic between March 1, 2000, and January 19, 2004. The INRs from both the laboratory and CoaguChek S were used to evaluate concordance between the two methods using the intraclass correlation coefficient.

RESULTS

The overall intraclass correlation coefficient between the CoaguChek S and the laboratory was 0.75 (95% CI 0.66 to 0.82). On average, CoaguChek S underestimated INRs by 0.11+/-0.54 units compared with those of the laboratory. INRs of 3.5 units and higher obtained with CoaguChek S were, on average, 0.49+/-1.09 units higher than those obtained in the laboratory.

CONCLUSIONS

CoaguChek S appears to be a valid instrument for in-home INR monitoring for most patients younger than 18 years of age, with INR targets of 2.0 to 3.0 followed up by an anticoagulant therapy clinic's program. However, caution must be used when interpreting INRs higher than 3.5. Parents should perform a second test to confirm all CoaguChek S INR results higher than 4.0.

摘要

背景

CoaguChek S（罗氏诊断公司，加拿大）是一种用于通过毛细血管穿刺监测国际标准化比值（INR）的便携式设备。尽管该设备用于儿科，但尚无研究评估其在该人群患者中的有效性。

目的

评估CoaguChek S作为18岁以下患者家庭INR监测仪的有效性。

方法

数据基于2000年3月1日至2004年1月19日在抗凝门诊随访的9名18岁以下患者收集的129对INR数据。实验室和CoaguChek S的INR值用于使用组内相关系数评估两种方法之间的一致性。

结果

CoaguChek S与实验室之间的总体组内相关系数为0.75（95%CI 0.66至0.82）。平均而言，与实验室相比，CoaguChek S低估INR值0.11±0.54个单位。CoaguChek S测得的3.5及以上的INR值平均比实验室测得的值高0.49±1.09个单位。

结论

对于大多数18岁以下、INR目标值为2.0至3.0且由抗凝治疗门诊项目随访的患者，CoaguChek S似乎是一种有效的家庭INR监测仪。然而，在解释高于3.5的INR值时必须谨慎。对于CoaguChek S测得的高于4.0的所有INR结果，家长应进行第二次检测以确认。