[A multicenter study of reference intervals for 15 laboratory parameters in Chinese children].
[A multicenter study of reference intervals for 15 laboratory parameters in Chinese children].
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DOI：
10.3760/cma.j.issn.0578-1310.2018.11.009
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发表时间：
2018-11-02
期刊：
影响因子：
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通讯作者：
Dong, C Y
中科院分区：
文献类型：
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作者：
Zhong, X H;Ding, J;Dong, C Y
目的：建立适合中国儿童的综合实验室参考区间。方法：这是一项横断面多中心研究。从2013年6月至2014年12月，在知情同意的情况下，从20家医疗中心招募了符合条件的6个月至17岁的健康儿童。通过体格检查、问卷调查和腹部超声检查评估合格性。采集空腹血样并送至中心实验室。测定雌二醇（E2）、睾酮（T）、黄体生成素（LH）、促卵泡激素（FSH）、丙氨酸转氨酶（ALT）、血清肌酐（Scr）、胱抑素C（Cystatin C）、免疫球蛋白A（伊加）、免疫球蛋白G（IgG）、免疫球蛋白M（IgM）、补体（C3、C4）、碱性磷酸酶（ALP）、尿酸（UA）、肌酸激酶（CK）等15项临床实验室指标。根据参考人群的中心95%置信区间确定参考区间，按年龄和性别分层。结果：共纳入2 259例儿童。最终，1648名儿童符合本研究的条件，包括830名男孩和818名女孩，平均年龄为7.4岁。已为参数建立了年龄和性别特异性参考区间。性激素的参考区间随年龄增长而逐渐增大。ALT、Cystatin C、ALP和CK浓度在2岁以下儿童较高。青春期血清性激素、肌酐、免疫球蛋白、肌酸激酶、碱性磷酸酶和尿素水平迅速升高，性别差异显著。此外，参考区间因测定方法而异。含5 ′-磷酸吡哆醛（PLP）的试剂检测ALT浓度高于不含PLP的试剂。与酶法相比，Jaffe法测定血清肌酐的结果总是偏高，尤其是在9岁以下的儿童。结论：本研究建立了年龄和性别特异性的参考区间，15个临床实验室参数的基础上定义的健康儿童。
Objective: To establish comprehensive laboratory reference intervals for Chinese children. Methods: This was a cross-sectional multicenter study. From June 2013 to December 2014, eligible healthy children aged from 6-month to 17-year were enrolled from 20 medical centers with informed consent. They were assessed by physical examination, questionnaire survey and abdominal ultrasound for eligibility. Fasting blood samples were collected and delivered to central laboratory. Measurements of 15 clinical laboratory parameters were performed, including estradiol (E2), testosterone(T), luteinizing hormone(LH), follicle-stimulating hormone(FSH), alanine transaminase(ALT), serum creatinine(Scr), cystatin C, immunoglobulin A(IgA), immunoglobulin G(IgG), immunoglobulin M(IgM), complement (C3, C4), alkaline phosphatase(ALP), uric acid(UA) and creatine kinase(CK). Reference intervals were established according to central 95% confidence intervals for reference population, stratified by age and sex. Results: In total, 2 259 children were enrolled. Finally, 1 648 children were eligible for this study, including 830 boys and 818 girls, at a mean age of 7.4 years. Age- and sex- specific reference intervals have been established for the parameters. Reference intervals of sex hormones increased gradually with age. Concentrations of ALT, cystatin C, ALP and CK were higher in children under 2 years old. Serum levels of sex hormones, creatinine, immunoglobin, CK, ALP and urea increased rapidly in adolescence, with significant sex difference. In addition, reference intervals were variable depending on assay methods. Concentrations of ALT detected by reagents with pyridoxal 5'-phosphate(PLP) were higher than those detected by reagents without PLP. Compared with enzymatic method, Jaffe assay always got higher results of serum creatinine, especially in children younger than 9 years old. Conclusion: This study established age- and sex- specific reference intervals, for 15 clinical laboratory parameters based on defined healthy children.