Abstract：
OBJECTIVE: Reference intervals for plasma P1NP and β-CTX in children and adolescents from several studies have recently been published. The aim of this study was to combine the available data into a set of reference intervals for use in clinical laboratories.
METHODS: A systematic literature search for primary studies reporting reference intervals for plasma P1NP and β-CTX in infants, children and adolescents using the Roche methods was carried out. Reference limits were extracted. For each year of age, mean upper and lower reference limits were calculated, weighted by the number of subjects in each study, and were plotted against age. Proposed reference limits were developed from the weighted mean data with age partitions determined pragmatically.
RESULTS: Reference limits for clinical use for females to 25 years and males to 18 years, based on the weighted mean reference data, are presented. Ten studies contributed to the pooled analysis. The proposed reference limits are identical for males and females <9 years age, prior to the pubertal growth spurt. For β-CTX, the weighted mean reference limits showed relatively constant values during the pre-pubertal years but a marked increase during puberty before a rapid decline towards adult values. Those for P1NP showed high values declining rapidly in the first 2 years of life, followed by a modest increase during early puberty. Limited published information for late adolescent and young adult subjects was noted.
CONCLUSIONS: The proposed reference intervals may be useful for clinical laboratories reporting these bone turnover markers measured by the Roche assays.
METHODS: A systematic literature search for primary studies reporting reference intervals for plasma P1NP and β-CTX in infants, children and adolescents using the Roche methods was carried out. Reference limits were extracted. For each year of age, mean upper and lower reference limits were calculated, weighted by the number of subjects in each study, and were plotted against age. Proposed reference limits were developed from the weighted mean data with age partitions determined pragmatically.
RESULTS: Reference limits for clinical use for females to 25 years and males to 18 years, based on the weighted mean reference data, are presented. Ten studies contributed to the pooled analysis. The proposed reference limits are identical for males and females <9 years age, prior to the pubertal growth spurt. For β-CTX, the weighted mean reference limits showed relatively constant values during the pre-pubertal years but a marked increase during puberty before a rapid decline towards adult values. Those for P1NP showed high values declining rapidly in the first 2 years of life, followed by a modest increase during early puberty. Limited published information for late adolescent and young adult subjects was noted.
CONCLUSIONS: The proposed reference intervals may be useful for clinical laboratories reporting these bone turnover markers measured by the Roche assays.
摘要：
目的：最近发表了几项研究中儿童和青少年血浆P1NP和β-CTX的参考区间。这项研究的目的是将可用数据组合成一组参考间隔，以供临床实验室使用。
方法：对报告婴儿血浆P1NP和β-CTX参考区间的主要研究进行系统文献检索，儿童和青少年使用罗氏方法进行。提取了参考限值。每一年的年龄,计算了平均参考上限和下限，根据每个研究中的受试者数量加权，并与年龄作对。建议的参考限值是从加权平均值数据中得出的，年龄划分是实用的。
结果：女性至25岁，男性至18岁的临床使用参考限值，基于加权平均参考数据，被呈现。十项研究为汇总分析做出了贡献。对于9岁以下的男性和女性，建议的参考限值相同，在青春期生长突增之前。对于β-CTX，加权平均参考限值在青春期前显示相对恒定的值,但在青春期期间显著增加,然后快速下降至成人值.P1NP的那些在生命的前2年表现出快速下降的高值，随后在青春期早期适度增加。注意到晚期青少年和年轻成人受试者的发布信息有限。
结论：建议的参考区间可能对临床实验室报告这些通过罗氏试验测量的骨转换标志物有用。
方法：对报告婴儿血浆P1NP和β-CTX参考区间的主要研究进行系统文献检索，儿童和青少年使用罗氏方法进行。提取了参考限值。每一年的年龄,计算了平均参考上限和下限，根据每个研究中的受试者数量加权，并与年龄作对。建议的参考限值是从加权平均值数据中得出的，年龄划分是实用的。
结果：女性至25岁，男性至18岁的临床使用参考限值，基于加权平均参考数据，被呈现。十项研究为汇总分析做出了贡献。对于9岁以下的男性和女性，建议的参考限值相同，在青春期生长突增之前。对于β-CTX，加权平均参考限值在青春期前显示相对恒定的值,但在青春期期间显著增加,然后快速下降至成人值.P1NP的那些在生命的前2年表现出快速下降的高值，随后在青春期早期适度增加。注意到晚期青少年和年轻成人受试者的发布信息有限。
结论：建议的参考区间可能对临床实验室报告这些通过罗氏试验测量的骨转换标志物有用。
