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目的:评价单剂量口服华法林钠后血药浓度与凝血指标的相关性。方法:22名健康男性受试者单剂量口服华法林钠片剂5 mg进行试验,服药后采集血样,用高效液相色谱-荧光检测法测定血浆华法林浓度,同时测量凝血指标,进行相关性分析。结果:平均血药浓度与平均国际标准比值、平均凝血酶原时间、峰值国际标准比值、峰值凝血酶原时间的相关系数分别为0.532(P=0.011);0.502(P=0.017);0.431(P=0.045);0.317(P=0.151)。血药浓度-时间曲线下面积与平均国际标准比值、平均凝血酶原时间、峰值国际标准比值、峰值凝血酶原时间的相关系数分别为0.497(P=0.019); 0.441(P=0.040);0.490(P=0.021);0.346(P=0.114)。国际标准比值、凝血酶原时间和凝血酶原活动度随血药浓度的变化而变化,但反应滞后。结论:健康中国人单次口服华法林后凝血指标与血药浓度有相关性。
Objective: To evaluate the correlation between blood concentration and blood coagulation index after oral administration of warfarin sodium. Methods: Twenty-two healthy male subjects were given a single oral dose of 5 mg warfarin sodium for testing. Blood samples were taken after taking the drug and the plasma warfarin concentration was measured by high performance liquid chromatography-fluorescence detection. The coagulation indexes were also measured Correlation analysis. Results: The correlation coefficients of mean plasma concentration and average international standard, average prothrombin time, peak international standard and peak prothrombin time were 0.532 (P = 0.011), 0.502 (P = 0.017), 0.431 (P = 0.045); 0.317 (P = 0.151). The correlation coefficient between the area under the plasma concentration - time curve and the average international standard ratio, the average prothrombin time, the peak international standard ratio and the peak prothrombin time were 0.497 (P = 0.019), 0.441 (P = 0.040), 0.490 (P = 0.021); 0.346 (P = 0.114). International standard ratio, prothrombin time and prothrombin activity with plasma concentration changes, but the response lag. Conclusion: There is a correlation between blood coagulation index and blood concentration in healthy Chinese single oral warfarin.