凝血活酶的世界卫生组织国际参考制剂的选择对国际标准化比值的影响。
Effect of the choice of WHO International Reference Preparation for thromboplastin on International Normalised Ratios.
作者信息
Poller L, Taberner D A, Thomson J M, Morris J, Mibashan R S, Shinton N K
机构信息
UK Reference Laboratory for Anticoagulant Reagents and Control, Withington Hospital, Manchester.
出版信息
J Clin Pathol. 1993 Jan;46(1):64-6. doi: 10.1136/jcp.46.1.64.
AIMS
To compare the International Normalised Ratio (INR) obtained directly with the two types of WHO plain International Reference Preparation for thromboplastin in patients treated with coumarin.
METHODS
Prothrombin times were performed in parallel at four centres using WHO human plain IRP (BCT/253) and rabbit plain IRP (RBT/79). Sixty patients and 20 normal controls were tested at each centre. Differences in INR among the centres were assessed by one factor, analysis of variance. The bias for each centre was assessed by the t test.
RESULTS
At all four centres higher INRs were consistently found with the rabbit plain reagent. Two of the centres showed significantly greater bias.
CONCLUSIONS
There was a small but significant difference in INR results obtained directly with these two reference reagents at all four centres (mean 7.35%). This in part may result from the different responsiveness of the two IRP to the coumarin defect or to imprecision of the original ISI calibrations of the two plain WHO IRP. The findings support the adoption of a single master IRP, in accord with WHO recommendations, which would resolve the present anomalous situation.
目的
比较在接受香豆素治疗的患者中，使用两种世界卫生组织（WHO）组织凝血活酶普通国际参考制剂直接测得的国际标准化比值（INR）。
方法
在四个中心同时使用WHO人组织凝血活酶普通国际参考制剂（BCT/253）和兔组织凝血活酶普通国际参考制剂（RBT/79）进行凝血酶原时间检测。每个中心检测60例患者和20例正常对照。通过单因素方差分析评估各中心之间INR的差异。通过t检验评估每个中心的偏差。
结果
在所有四个中心，始终发现兔组织凝血活酶普通试剂测得的INR更高。其中两个中心显示出明显更大的偏差。
结论
在所有四个中心，使用这两种参考试剂直接测得的INR结果存在微小但显著的差异（平均7.35%）。这部分可能是由于两种国际参考制剂对香豆素缺陷的反应性不同，或者是由于两种WHO普通国际参考制剂原始国际敏感度指数（ISI）校准的不精确性。这些发现支持按照WHO的建议采用单一的主国际参考制剂，这将解决当前的异常情况。
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