北京地区健康绝经期前女性骨转换标志物P1NP 和β⁃CTX 的参考区间分析
Reference interval analysis of procollagen type 1 N⁃terminal propeptide and β cross⁃linked C⁃telopeptide of type 1 collagen for healthy premenopausal women in Beijing
  
DOI:10.3969/j.issn.1006-7108.2018.06.013
中文关键词:  骨转换标志物  血清I 型原胶原氨基端肽  血清I 型胶原羧基端肽交联  参考区间  健康绝经期前女性
英文关键词:Bone turnover marker  Procollagen type 1 N⁃terminal propeptide  β Cross⁃linked C⁃telopeptide of type 1 collagen  Reference interval  Healthy premenopausal women
基金项目:首都临床特色应用研究“吴阶平” 基金项目( Z141107006614002);国家中医临床研究基地业务建设第二批科研专项 (JDZX2015076)
作者单位
张然星1△ 李汉莲1△ 魏戌1∗ 高景华1 谢雁鸣2 韩艳1 史颖红1 游珂1 1. 中国中医科学院望京医院北京100102 2. 中国中医科学院中医临床基础医学研究所北京100700 
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中文摘要:
      目的 分析北京地区健康绝经期前女性不同年龄阶段血清I 型原胶原氨基端肽(procollagen type 1 N?terminal propeptide, P1NP)和I 型胶原羧基端肽交联(β cross?linked C?telopeptide of type 1 collagen, β?CTX)水平的分布趋势差异并初 步建立两者的参考区间。方法 以北京地区健康绝经期前女性作为研究对象,应用罗氏电化学发光免疫分析技术,对符合入 组标准的272 名30 ~54 岁女性血清P1NP 和β?CTX 水平进行检测。以5 岁为一年龄段进行分组:30 ~34 岁,35 ~39 岁,40 ~ 44 岁,45 ~49 岁,50 ~54 岁;运用局部加权回归散点平滑法和Kolmogorov?Smirnov Z 检验比较不同年龄段两者的组间分布趋势 差异,确定参考人群的特异年龄段,并应用非参数方法建立参考区间。结果 272 名入组受试者的平均年龄为(39?? 51 ±5?? 85) 岁,总体P1NP 与β?CTX 水平呈非正态分布。35 ~39 岁与40 ~44 岁的血清P1NP 与β?CTX 水平分布趋势比较差异无统计学 意义(P >0?? 05);进一步将30 ~34 岁及45 ~49 岁水平分别与35 ~44 岁水平的分布趋势比较,差异有统计学意义(P <0?? 05)。 因此将35 ~44 岁年龄段的健康绝经期前女性作为参考人群,由此所建立的血清P1NP 参考区间为: 17?? 95 ~ 65?? 60 ng/ mL,血 清β?CTX 参考区间为0?? 10 ~ 0?? 49 ng/ mL。结论 北京地区35 ~ 44 岁健康绝经期前女性血清骨转换标志物P1NP 和β?CTX 水平分布趋势相对平稳,受变异因素影响最小,两者在此年龄段人群的测定结果适宜作为建立参考区间的参考值。
英文摘要:
      Objective To analyze the difference in the distribution of procollagen type 1 N?terminal propeptide (P1NP) and β cross?linked C?telopeptide of type 1 collagen (β?CTX) levels in different age groups of healthy premenopausal women in Beijing and to establish a reference interval of P1NP and β?CTX. Methods The healthy premenopausal women in Beijing were recruited. The levels of serum P1NP and β?CTX in 272 eligible women aged from 30 to 54 years were measured with Roche electro? chemiluminescence immunoassay. The participants were divided into 30 - 34, 35 - 39, 40 - 44, 45 - 49, and 50 - 54 age groups based on a five?year?old stage. The locally weighted scatterplot smoothing method and the Kolmogorov?Smirnov Z test were used to compare the differences among the distribution and to determine the specific age groups of the reference population. The nonparametric method was used to establish the reference interval. Results The average age of 272 subjects was 39?? 51 ± 5?? 85 years old, and the overall P1NP and β?CTX levels were non?normal distributed. There was no significant difference in the distribution of P1NP and β?CTX levels between 35 -39 years old group and 40 -44 years old group (P >0?? 05). Further research showed that the distribution trend of the 35 -44 years old group had a significant difference when compared with the 30 -34 yearsgroup or the 45 -49 years group (P <0?? 05). Therefore, the healthy menopausal women aged 35 -44 years could be considered as reference population. The serum P1NP reference interval was 17?? 95 -65?? 60 ng / mL, and the reference range of serum β?CTX was 0?? 10 -0?? 49 ng / mL in the healthy menopausal women aged 35 -44 years. Conclusion The trend of distribution of P1NP and β? CTX levels in healthy 35 -44 years old premenopausal women in Beijing is relatively stable with minimal impact. The test result of the two age stages are suitable for establishing reference interval value.
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