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三种统计学方法在建立妊娠期凝血功能指标参考区间中的应用

The application of three statistical methods for reference intervals establishment of coagulation assays during pregnancy

摘要:

目的:比较三种统计学方法在间接法建立参考区间中的实用价值。方法:方法学评价。调取2017年1月至2019年12月在北京大学第一医院门诊进行产前检查的妊娠期妇女凝血指标,共收集32 401例孕妇数据,其中早孕组11 151例,中孕组4 872例,晚孕组16 378例。对凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)、D-二聚体(D-D)和纤维蛋白(原)降解产物(FDP)的检测结果进行分析,判断各孕龄组内是否需要根据年龄进行参考区间分组。PT和APTT在三个孕期均需要根据年龄进行分组,FIB和TT在晚孕期、D-D在早孕期需要根据年龄分组。采用非参数法、Hoffmann法和Q-Q图法计算各指标的参考区间。于2019年10月至2020年1月在北京大学第一医院妇儿门诊招募健康孕妇42例作为参考人群,验证建立的参考区间并比较参考人群检测结果在3种方法计算得出的参考区间外的百分比。结果:35岁以下早孕期PT、APTT、FIB、TT的参考范围分别为(10.44~13.11)s、(25.29~35.88)s、(2.61~4.64)g/L和(11.53~15.58)s6项指标水平随孕期进展产生显著差异,PT和APTT在3个孕期内均需要根据年龄进行分组,FIB和TT在晚孕期、D-D在早孕期需要根据年龄分组。数据量较大时,Hoffmann法所建立的参考区间和非参数法较接近,Q-Q图法建立的参考区间略宽于Hoffmann法。数据量较小时,应用Hoffmann法和Q-Q图法计算的参考区间更为可靠。应用Hoffmann法计算的。结论:妊娠期凝血功能指标需要根据孕期及年龄分组,基于Hoffmann法的间接法可以作为直接法的替代方法。

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abstracts:

Objective:To compare the practical value of three statistical methods in establishing reference intervals by the indirect method.Methods:This is a methodological evaluation study. The data of coagulation parameters were obtained from laboratory information system, which were from pregnant women who had done prenatal examination in Peking University First Hospital from January 2017 to December 2019. The test results from 32 401 pregnant women were collected. Those healthy pregnant women were divided into three groups: early pregnancy group(n=11 151), middle pregnancy group(n=4 872) and late pregnancy group(n=16 378). Statistical analysis was performed for the result of PT, APTT, FIB, TT, D-D and FDP, and the necessity of stratification based on age in different periods of pregnancy was analyzed. Stratification based on age was necessary in three pregnancy groups for PT and APTT, in late pregnancy group for FIB and TT, and in early pregnancy group for D-D. The reference intervals of coagulation parameters were calculated by three statistical methods: non-parametric method, Hoffmann method and Q-Q plot method. Forty-two healthy pregnant women from October 2019 to January 2020 were enrolled as reference individuals for the validation of the reference intervals.The proportions of test results outside the reference intervals in the reference population calculated and compared.Results:The levels of the six coagulation assays vary significantly during the three periods of pregnancy, stratification based on age was necessary in three pregnancy groups for PT and APTT, in late pregnancy group for FIB and TT, and in early pregnancy group for D-D. If the number of test results was large, non-parametric and Hoffmann method provided more similar results, while the reference intervals calculated with Q-Q plot method was slightly wider than Hoffmann method. If the number of test results was small, reference intervals calculated with Hoffmann and Q-Q plot method were more reliable. For pregnant women during early pregnancy under the age of 35, the reference intervals of PT, APTT, FIB and TT calculated by this method were (10.44-13.11)s, (25.29-35.88)s, (2.61-4.64)g/L and (11.53-15.58)s.Conclusion:When establishing the reference interval, stratification according to pregnancy period and age was needed. Hoffmann method can be used as an alternative to the direct method.

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作者: 赵婧晨 [1] 杨文双 [1] 蒋世菊 [1] 邢莹 [1] 苗林子 [1] 屈晨雪 [1]
期刊: 《中华检验医学杂志》2020年43卷8期 823-830页 ISTICPKUCSCDCA
栏目名称: 论著
DOI: 10.3760/cma.j.cn114452-20200309-00207
发布时间: 2020-09-15
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