Chapman D C, Stephens M A, Hamann G L, Bailey L E, Dorko C S
The Regional Medical Center at Memphis, TN 38103, USA.
Ann Pharmacother. 1999 Jul-Aug;33(7-8):775-80. doi: 10.1345/aph.18317.
To evaluate the accuracy, clinical correlation, ease of use, and patient acceptance of the Coaguchek and the ProTime Microcoagulation System as compared with standard laboratory methods for prothrombin time determination.
A total of 30 prothrombin times, expressed as international normalized ratios (INRs), were determined by each handheld device for comparison with standard laboratory testing. Accuracy was evaluated by calculating the absolute difference for each pair of INR values. Clinical correlation was defined as an INR obtained by the handheld monitor that would have resulted in the same therapeutic decision as the INR obtained by the standard laboratory method. Subjects were surveyed to determine which method of INR determination they preferred and their reasons for that preference.
Accuracy was superior with the Coaguchek monitor. The absolute difference (mean +/- SD) in the laboratory and Coaguchek INRs was 0.28+/-0.23 (p = 0.96). The absolute difference (mean +/- SD) in the laboratory and the ProTime Microcoagulation System INRs was 0.56+/-0.34 (p < 0.001). For clinical correlation, two out of 24 (8.3%) INRs with the Coaguchek were sufficiently different from the laboratory INR to have resulted in a different therapeutic decision, compared with 12 out of 24 (50%) with the ProTime Microcoagulation System (p < 0.005). Of subjects surveyed, 77.8% preferred the finger stick method.
The Coaguchek was superior to the ProTime Microcoagulation System in accuracy, clinical correlation, and ease of use. The study also showed that patients preferred capillary blood sampling by finger puncture over venipuncture for INR monitoring.
与用于凝血酶原时间测定的标准实验室方法相比，评估Coaguchek和ProTime微量凝血系统的准确性、临床相关性、易用性及患者接受度。
每种手持设备测定30次凝血酶原时间，以国际标准化比值（INR）表示，用于与标准实验室检测进行比较。通过计算每对INR值的绝对差值来评估准确性。临床相关性定义为手持监测仪获得的INR与标准实验室方法获得的INR会导致相同治疗决策的情况。对受试者进行调查，以确定他们更喜欢哪种INR测定方法及其偏好的原因。
Coaguchek监测仪的准确性更高。实验室INR与Coaguchek INR的绝对差值（均值±标准差）为0.28±0.23（p = 0.96）。实验室INR与ProTime微量凝血系统INR的绝对差值（均值±标准差）为0.56±0.34（p < 0.001）。对于临床相关性，Coaguchek的24个INR中有2个（8.3%）与实验室INR差异足够大，导致治疗决策不同，而ProTime微量凝血系统的24个INR中有12个（50%）出现这种情况（p < 0.005）。在接受调查的受试者中，77.8%更喜欢手指采血法。
Coaguchek在准确性、临床相关性和易用性方面优于ProTime微量凝血系统。该研究还表明，患者在进行INR监测时，更喜欢通过手指穿刺采集毛细血管血而非静脉穿刺采血。
