Sobieraj-Teague Magdalena, Daniel Dolly, Farrelly Barbara, Coghlan Douglas, Gallus Alexander
Flinders Medical Centre, Department of Haematology, Bedford Park, South Australia 5042.
Thromb Res. 2009 Apr;123(6):909-13. doi: 10.1016/j.thromres.2008.10.006. Epub 2008 Nov 29.
To assess clinical usefulness of CoaguChek S and XS monitors to measure International Normalised Ratio (INR) when starting warfarin in community patients.
INR in consecutive patients starting warfarin plus enoxaparin was measured in the laboratory and on capillary blood at home using CoaguChek S or XS point of care (POC) devices. INR was measured daily until >2.0 for 2 consecutive readings. Linear regression and Bland Altman plots were derived to compare POC with laboratory INR. Percentages of POC measurements within 0.5 and 0.8 units of laboratory INR <2.0, 2.0-3.5 and >3.5 were calculated. Clinical utility was assessed using previously reported criteria.
200 CoaguChek S and 337 CoaguChek XS results were obtained from 57 and 98 patients respectively and paired with laboratory values. Correlation was acceptable between CoaguChek S and laboratory INRs (r(2)=0.7732), and excellent between CoaguChek XS and laboratory INRs (r(2)=0.9514). Bland-Altman plots showed an increasing difference between laboratory INR above 3.0 for CoaguChek S INRs but no systematic bias with increasing CoaguChek XS INRs. 83.5% of CoaguChek S and 93.5% of CoaguChek XS INRs were within 0.5 units of laboratory INR. 90% of CoaguChek S and 99.4% of the CoaguChek XS INRs were within 0.8 units of laboratory INR. Clinical agreement occurred in 89% and 99.7% of cases by expanded criteria and 82% and 99.4% of cases by narrow criteria when using CoaguChek S and CoaguChek XS respectively.
The CoaguChek XS is suitable for outpatient INR monitoring when starting warfarin.
评估在社区患者开始使用华法林时，CoaguChek S和XS监测仪测量国际标准化比值（INR）的临床实用性。
对连续使用华法林加依诺肝素的患者，在实验室测定INR，并使用CoaguChek S或XS即时检验（POC）设备在家中采集毛细血管血测定INR。每天测量INR，直至连续两次读数>2.0。采用线性回归和布兰德-奥特曼图比较POC与实验室INR。计算实验室INR<2.0、2.0 - 3.5和>3.5时，POC测量值在实验室INR的0.5和0.8单位范围内的百分比。使用先前报告的标准评估临床实用性。
分别从57例和98例患者中获得了200个CoaguChek S和337个CoaguChek XS的结果，并与实验室值配对。CoaguChek S与实验室INR之间的相关性尚可（r(2)=0.7732），CoaguChek XS与实验室INR之间的相关性良好（r(2)=0.9514）。布兰德-奥特曼图显示，CoaguChek S的INR在实验室INR高于3.0时差异增大，但CoaguChek XS的INR升高时无系统偏差。83.5%的CoaguChek S和93.5%的CoaguChek XS的INR在实验室INR的0.5单位范围内。90%的CoaguChek S和99.4%的CoaguChek XS的INR在实验室INR的0.8单位范围内。使用CoaguChek S和CoaguChek XS时，根据扩展标准，临床一致性分别出现在89%和99.7%的病例中；根据严格标准，分别出现在82%和99.4%的病例中。
开始使用华法林时，CoaguChek XS适用于门诊患者INR监测
