외래 항응고 치료 환자에서 자가 프로트롬빈 시간 측정기 CoaguChek XS와 중앙 검사실 기기와의 비교 평가 = Comparison between the Portable Prothrombin Time Self Monitor CoaguChek XS and a Standard Laboratory Method, Sysmex CA-1500 forMonitoring Anticoagulant Therapy of Outpatients

다국어 초록 (Multilingual Abstract)

Background and Objectives：Patients on oral anticoagulation therapy (OAT) require regular monitoring of theprothrombin time (PT) and dosage adjustment to prevent thromboembolic diseases without the risk of hemorrhage.Portable self PT monitors have been recently developed because the standard PT measurements are complicatedand take considerable time. This study compared the International normalized ratio (INR) results that were obtainedwith using the CoaguChek XS device (Roche Diagnostic, Mannheim, Germany) with those obtained usinga standard laboratory method Sysmex CA-1500 (Sysmex Corporation, Kobe, Japan) in the patients on OAT andalso a healthy control group. Subjects and Methods：100 outpatients on OAT and 20 healthy controls wereenrolled on a volunteer basis after providing informed consent at the Dong-A University Hospital. The outpatientsand the healthy control group provided us the INR measurements with using both the CoaguChek XS and theSysmex CA-1500. Results：The coefficients of variation for CoaguChek XS and Sysmex CA-1500 were lessthan 10%. The PT (INR) results of CoaguChek XS and Sysmex CA-1500 were 2.0±0.7 and 2.2±0.7, respectively(p<0.001). There was a good correlation between CoaguChek XS and Sysmex CA-1500 (r=0.974, p<0.001). Onthe regression analysis, the slope of the regression line was 0.9197 and the y-intercept was 0.0058. On the Bland-Altman analysis, the INR mean difference (bias) between the two methods (CoaguChek XS INR-Sysmex CA-1500 INR) was -0.2 and the limit of agreement was +0.168~-0.568. Conclusion：The measurement with usingCoaguChek XS has high repeatability, rapid availability and good accuracy that are comparable to the standardlaboratory method. Therefore, CoaguChek XS can be a valuable tool for the self-monitoring of patients on OAT.(Korean Circulation J 2007;37:216-220)

국문 초록 (Abstract)

배경 및 목적：경구 항응고제 복용시 출혈성 합병증 위험없이 혈전색전성 질환을 예방하기 위해서는 PT를 측정하고 그 결과에 따220·Korean Circulation J 2007;37:216-220라 용량 조절이 필요하다. 기존의 PT 측정법은 절차가 복잡하고 소요시간이 길어 최근 자가 PT 측정기가 개발되었다.
결 과：
CoaguChek XS의 변이계수는 정상인(0.0%)과 고지혈증 환
자(6.1%) 모두에서 변이계수가 10% 미만이었다. CoaguChek
XS의 PT(INR)은 2.0±0.7이었고, Sysmex CA-1500의 PT
(INR)은 2.2±0.7로 CoaguChek XS가 Sysmex CA-1500
보다 낮게 측정되었고, 통계적으로 유의한 차이를 보였다(p<
0.001). Sysmex CA-1500 PT(INR)과 CoaguChek XS PT
(INR)에 대한 회귀분석에서 상관계수 0.974로 나타나 우수
한 상관관계를 보였고, 기울기가 0.9197, y절편이 0.0058이
었다. Bland-Altman 분석에서는 CoaguChek XS PT(INR)
과 Sysmex CA-1500 PT(INR) 결과와의 차이의 평균값(mean
bias)은 -0.20였고, 일치의 한계범위는 +0.168~-0.568였다.
결 론：
CoaguChek XS는 간편하고 정밀도가 높으며, 기존의 검사법과도 우수한 상관관계를 보여, 항응고 치료 중인 외래환자에서 PT감시(monitoring)에 임상적으로 정확하고 유용한 도구라 생각한다.

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