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美国儿童和青少年人群中 4 种高敏肌钙蛋白检测方法的心肌损伤界值。

Myocardial Injury Thresholds for 4 High-Sensitivity Troponin Assays in a Population-Based Sample of US Children and Adolescents.

机构信息

Division of Cardiology and National Institute for Prevention & Cardiovascular Health, University of Galway, Ireland (J.W.M.).

Department of Epidemiology and the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (J.W.M. D.W., C.E.N., J.C., E.S.).

出版信息

Circulation. 2023 Jul 4;148(1):7-16. doi: 10.1161/CIRCULATIONAHA.122.063281. Epub 2023 Apr 20.

Abstract

BACKGROUND

Myocardial injury is an important pediatric diagnosis. Establishing normative data from a representative pediatric sample is vital to provide accurate upper reference limits (URLs) for defining myocardial injury using high-sensitivity cardiac troponin.

METHODS

Among participants 1 to 18 years of age in the 1999-2004 National Health and Nutrition Examination Survey, we measured high-sensitivity troponin T using one assay (Roche) and high-sensitivity troponin I using 3 assays (Abbott, Siemens, and Ortho). In a strictly defined healthy subgroup, we estimated 97.5th and 99th percentile URLs for each assay using the recommended nonparametric method.

RESULTS

Of 5695 pediatric participants, 4029 met criteria for the healthy subgroup (50% males; mean age 12.6 years). Our 99th percentile URL estimates for all 4 high-sensitivity troponin assays among children and adolescents were lower than the manufacturer-reported URLs (derived from adults). The 99th percentile URLs (95% CI) were 15 ng/L (95% CI, 12-17) for high-sensitivity troponin T, 16 ng/L (95% CI, 12-19) for high-sensitivity troponin I with the Abbott assay, 38 ng/L (95% CI, 25-46) for high-sensitivity troponin I with the Siemens assay, and 7 ng/L (95% CI, 5, 12) for high-sensitivity troponin I with the Ortho assay. The 95% CIs for age-, sex-, and race and ethnicity-specific 99th percentile URLs overlapped. However, the 97.5th percentile URL for each assay was measured with superior statistical precision (ie, tighter 95% CIs) and demonstrated differences by sex. For male compared with female children and adolescents, 97.5th percentile URLs were 11 ng/L (95% CI, 10-12) versus 6 ng/L (95% CI, 6-7) for high-sensitivity troponin T, 9 ng/L (95% CI, 7-10) versus 5 ng/L (95% CI, 4-6) for high-sensitivity troponin I with the Abbott assay, 21 ng/L (95% CI, 18-25) versus 11 ng/L (95% CI, 9-13) for high-sensitivity troponin I with the Siemens assay, and 4 ng/L (95% CI, 3-5) versus 2 ng/L (95% CI, 1-3) for high-sensitivity troponin I with the Ortho assay. In contrast to the 99th percentiles, the point estimates of 97.5th percentile pediatric URLs for high-sensitivity troponin were also much more stable to differences in the analytic approaches taken to estimate URLs.

CONCLUSIONS

Because myocardial infarction is rare in children and adolescents, the use of statistically more precise and reliable sex-specific 97.5th percentile high-sensitivity troponin URLs might be considered to define pediatric myocardial injury.

摘要

背景

心肌损伤是儿科的一个重要诊断。从具有代表性的儿科样本中建立规范数据对于使用高敏心肌肌钙蛋白定义心肌损伤非常重要,因为这可以提供准确的上限参考值(URL)。

方法

在 1999-2004 年全国健康与营养调查中年龄在 1 至 18 岁的参与者中,我们使用一种检测方法(罗氏)测量高敏肌钙蛋白 T,使用 3 种检测方法(雅培、西门子和奥森)测量高敏肌钙蛋白 I。在严格定义的健康亚组中,我们使用推荐的非参数方法估计了每种检测方法的第 97.5 百分位数和第 99 百分位数 URL。

结果

在 5695 名儿科参与者中,有 4029 名符合健康亚组标准(50%为男性;平均年龄 12.6 岁)。我们所有 4 种高敏肌钙蛋白检测方法的儿童和青少年第 99 百分位数 URL 估计值均低于制造商报告的 URL(源自成人)。第 99 百分位数 URL(95%CI)分别为:高敏肌钙蛋白 T 为 15ng/L(95%CI,12-17),雅培检测的高敏肌钙蛋白 I 为 16ng/L(95%CI,12-19),西门子检测的高敏肌钙蛋白 I 为 38ng/L(95%CI,25-46),奥森检测的高敏肌钙蛋白 I 为 7ng/L(95%CI,5,12)。基于年龄、性别和种族/民族的特定第 99 百分位数 URL 的 95%CI 重叠。然而,每种检测方法的第 97.5 百分位数 URL 的测量具有更高的统计精度(即更窄的 95%CI),并表现出性别差异。与女性儿童和青少年相比,男性儿童和青少年的第 97.5 百分位数 URL 分别为:高敏肌钙蛋白 T 为 11ng/L(95%CI,10-12)和 6ng/L(95%CI,6-7),雅培检测的高敏肌钙蛋白 I 为 9ng/L(95%CI,7-10)和 5ng/L(95%CI,4-6),西门子检测的高敏肌钙蛋白 I 为 21ng/L(95%CI,18-25)和 11ng/L(95%CI,9-13),奥森检测的高敏肌钙蛋白 I 为 4ng/L(95%CI,3-5)和 2ng/L(95%CI,1-3)。与第 99 百分位数不同,高敏肌钙蛋白的第 97.5 百分位数儿科 URL 的点估计值在采用不同方法估计 URL 时也更加稳定。

结论

由于儿童和青少年中心肌梗死很少见,因此使用统计学上更精确和可靠的性别特异性第 97.5 百分位数高敏肌钙蛋白 URL 来定义儿科心肌损伤可能是合适的。

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