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七种凝血酶原时间试剂的比较——评估策略的制定

A comparison of seven prothrombin time reagents--development of an evaluation strategy.

作者信息

Carter C J, Griswold D J, Louis R A, Hershler R, Wadsworth L D

机构信息

Department of Pathology, University of British Columbia, Canada.

出版信息

Mod Pathol. 1988 Jul;1(4):284-7.

PMID:3237706
Abstract

The control of p.o. anticoagulant therapy by the use of prothrombin times or ratios is one of the major functions of a clinical coagulation laboratory. European prothrombin reagents tend to be more sensitive to the effects of p.o. anticoagulants than traditional North American rabbit brain thromboplastin reagents. The clinical importance of this in vitro observation has been emphasized by the results of two recent clinical trials which both suggested that the less intense anticoagulation therapy that results from the use of a European-type prothrombin reagent may be safer. To minimize the clinical effects of differences in prothrombin time reagent formulation, a global correction factor has been developed--the international normalized ratio (INR). Despite this advance in international standardization, individual laboratories need a rapid and efficient method to help select the most appropriate prothrombin reagent for the clinical management of their local patient population. This study has examined the response of a variety of commercially available prothrombin time reagents to normal plasmas and those from anticoagulated patients. Using both classical sampling theory and multiple range testing, it was demonstrated that as few as 20 estimations on normal plasmas and 50 on anticoagulated specimens will permit a clinical laboratory to select a suitable prothrombin time reagent for anticoagulant control of their specific local patient population.

摘要

利用凝血酶原时间或比值来控制口服抗凝治疗是临床凝血实验室的主要功能之一。与传统的北美兔脑凝血活酶试剂相比,欧洲的凝血酶原试剂往往对口服抗凝剂的作用更为敏感。两项近期临床试验的结果强调了这一体外观察结果的临床重要性,这两项试验均表明,使用欧洲型凝血酶原试剂导致的抗凝治疗强度较低可能更安全。为了尽量减少凝血酶原时间试剂配方差异的临床影响,已制定了一个全球校正因子——国际标准化比值(INR)。尽管在国际标准化方面取得了这一进展,但各个实验室仍需要一种快速有效的方法,以帮助为当地患者群体的临床管理选择最合适的凝血酶原试剂。本研究检测了多种市售凝血酶原时间试剂对正常血浆和抗凝患者血浆的反应。使用经典抽样理论和多重极差检验表明,对正常血浆进行少至20次测定,对抗凝标本进行50次测定,就能使临床实验室为其特定的当地患者群体选择合适的凝血酶原时间试剂用于抗凝控制。

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