湖北武汉地区健康人群骨转换标志物参考区间的建立

梁涛; 吴苏源; 刘凤; 张德太; 胡丽华; 王琳

doi:10.13201/j.issn.1004-2806.2022.10.003

湖北武汉地区健康人群骨转换标志物参考区间的建立

- 华中科技大学同济医学院附属协和医院检验科(武汉，430022)
基金项目:
湖北省自然科学基金(No：2021CFB579)

详细信息

通讯作者: 王琳，E-mail：lin_wang@hust.edu.cn

中图分类号: R681

收稿日期: 2021-09-05

修回日期: 2021-11-25

刊出日期: 2022-10-01

Establishment of reference intervals for bone turnover markers among healthy people in Wuhan, Hubei

- Department of Clinical Laboratory, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China

More Information

Corresponding author: WANG Lin, E-mail: lin_wang@hust.edu.cn

Received Date: 05 September 2021

Revised Date: 25 November 2021

Publish Date: 01 October 2022

摘要

摘要: 目的建立湖北武汉地区健康成人骨转换相关标志物Ⅰ型前胶原N末端前肽(PINP)、Ⅰ型胶原羧基末端肽(CTx)和骨钙素(Oc)的年龄及性别相关性参考区间。方法收集2020年1月至2021年6月于华中科技大学同济医学院附属协和医院体检中心进行体检的健康人群1480例，按年龄及性别进行分组。所有研究对象均采集清晨空腹血，采用IDS-iSYS全自动生化免疫分析仪检测PINP、CTx、Oc血清水平。结果湖北武汉地区1480例健康体检人群，按性别、不同年龄段分组后显示，女性组血清CTx水平显著性低于男性组，而Oc水平显著高于男性组(P < 0.05)，PINP水平在二者间差异无统计学意义。在50岁前，随着年龄的增长，血清PINP、CTx及Oc水平呈下降的趋势。在50岁后，血清PINP、CTx及Oc水平有回升的趋势，可达到21~30岁组的水平。在60岁后，除Oc水平无显著改变外，PINP、CTx的水平又出现下降趋势。根据试剂盒说明书参考区间进行分组显示，体检人群中CTx和Oc的参考区间显著低于试剂盒设定的相应参考区间。对不同性别的健康体检人群进行年龄分组，结果显示男性随着年龄的增加，血清PINP、CTx及Oc水平呈逐渐下降的趋势。在40岁前，女性血清PINP、CTx及Oc水平呈下降的趋势，但在40岁后，上述骨转换标志物水平有所回升，而50岁后，血清PINP、CTx及Oc水平均急剧升高。因此，按性别并对不同年龄段进行分组，建立相应的参考区间。结论湖北武汉地区健康人群骨转换生物标志物PINP、CTx及Oc水平在性别和年龄分布上差异有统计学意义，且与试剂厂家提供的参考区间不同，建议各地区、各实验室建立各自的年龄和性别相关的参考区间。
- Ⅰ型前胶原N末端前肽 /
- Ⅰ型胶原羧基末端肽 /
- 骨钙素 /
- 参考区间 /
- 骨转换标志物
Abstract: Objective To establish age- and gender-specific reference intervals for total procollagen type ⅠN-terminal propeptide(PINP), type Ⅰ collagen carboxy-terminal peptide(CTx) and osteocalcin(Oc) among healthy adults in Wuhan, Hubei.Methods A total of 1480 healthy people who underwent physical examination in Union Hospital of Tongji Medical College of Huazhong University of Science and Technology were collected from January 2020 to June 2021, and were grouped by age and gender. All study subjects took blood on an empty stomach in the early morning. The IDS-iSYS automatic biochemical immunoassay analyzer was used to detect the serum levels of PINP, CTx, and Oc.Results After 1480 healthy physical examination populations in Wuhan, Hubei, were grouped by gender and different ages, the results showed that the serum CTx level of the female group was significantly lower than that of the male group, while the Oc level was significantly higher than that of the male group(P < 0.05). However, there was no significant difference in PINP level between the two groups. Before the age of 50, with the increase of age, the serum PINP, CTx and Oc levels showed a downward trend. After the age of 50, serum PINP, CTx and Oc levels had a tendency to rise, reaching the level of the 21-30 year-old group. After 60 years of old, in addition to no significant changes in Oc levels, the levels of PINP and CTx had a downward trend. Grouping according to the reference interval of the kit instructions showed that the reference intervals of CTx and Oc in the physical examination population were significantly lower than the corresponding reference intervals set by the kit. The healthy examination population with different genders were grouped by the age, and the results showed that the serum PINP, CTx and Oc levels of male gradually decreased with the increase of age. Before the age of 40, female's serum PINP, CTx and Oc levels showed a downward trend, but after the age of 40, the levels of the above-mentioned bone turnover markers rebounded. After the age of 50, the levels of serum PINP, CTx and Oc increased sharply. Therefore, we grouped by gender and different ages, and established corresponding reference intervals.Conclusion The levels of PINP, CTx, and Oc of healthy people in Wuhan, Hubei were different in gender and age distribution, and were also different from the reference interval provided by reagent manufacturers. Therefore, it was recommended that each region and each laboratory should establish their own age and gender-related reference intervals.
- PINP /
- CTx /
- osteocalcin /
- reference intervals /
- bone turnover markers

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表 1 湖北武汉地区人群PINP、CTx及Oc分布情况 μg/L，M(P₂₅，P₇₅)

组别	例数	年龄/岁	PINP	CTx	Oc
总例数	1480	46(33，57)	56.37(43.65，73.17)	0.218(0.137，0.330)	11.4(8.8，15.0)
21~30岁组	300	27(25，29)	61.23(48.85，80.62)	0.243(0.166，0.356)	12.9(10.6，17.1)
31~40岁组	300	36(33，38)	52.92(41.79，66.92)	0.178(0.109，0.271)	10.3(8.6，13.2)
41~50岁组	300	46(44，49)	50.97(41.65，66.35)	0.182(0.123，0.280)	10.0(8.1，12.4)
51~60岁组	300	55(52，57)	61.01(45.81，80.02)	0.265(0.165，0.364)	12.3(8.8，30.7)
≥61岁组	280	65(62，68)	56.16(42.40，72.89)	0.221(0.135，0.349)	11.8(9.0，16.8)
男性组	740	46(33，57)	55.75(43.71，72.52)	0.232(0.146，0.343)	11.2(8.6，14.1)
女性组	740	46(33，57)	57.00(43.30，74.00)	0.205(0.124，0.319)	11.6(8.9，16.1)

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表 2 湖北武汉地区人群按试剂盒年龄分组PINP、CTx及Oc参考区间比较 μg/L，P_2.5~P_97.5

组别	例数	试剂盒			体检人群
组别	例数	CTx	PINP	Oc	CTx	PINP	Oc
成人男性	740	0.115~0.748	—	—	0.070~0.672	—	—
女性绝经前	450	0.112~0.738	—	—	0.063~0.548	—	—
女性绝经后	290	0.142~1.351	—	—	0.081~0.760	—	—
总例数	1480	—	27.700~127.600	10.400~45.600	—	27.400~125.200	5.600~27.700

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表 3 男性不同年龄组PINP、CTx及Oc的水平比较 μg/L, M(P₂₅，P₇₅)

组别	例数	PINP	CTx	Oc
21~30岁组	150	69.18(55.49，89.02)	0.312(0.218，0.448)	13.6(11.3，17.9)
31~40岁组	150	60.78(46.71，75.53)	0.241(0.164，0.346)	11.2(9.3，14.2)
41~50岁组	150	52.31(43.77，68.30)	0.228(0.142，0.334)	10.5(8.2，13.4)
51~60岁组	150	51.89(40.00，65.80)	0.230(0.131，0.323)	10.4(7.8，12.9)
≥61岁组	140	46.55(36.20，61.17)	0.168(0.112，0.245)	10.0(7.8，12.3)

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表 4 女性不同年龄组PINP、CTx及Oc水平比较 μg/L，M(P₂₅，P₇₅)

组别	例数	PINP	CTx	Oc
21~30岁组	150	56.00(43.17，70.32)	0.182(0.128，0.285)	11.9(9.5，15.8)
31~40岁组	150	47.35(36.46，57.46)	0.131(0.084，0.208)	9.6(7.6，12.0)
41~50岁组	150	49.72(40.57，65.50)	0.156(0.106，0.228)	9.4(8.0，11.5)
51~60岁组	150	69.71(57.73，94.11)	0.305(0.213，0.407)	14.6(11.5，19.9)
≥61岁组	140	66.43(52.10，83.58)	0.309(0.202，0.422)	14.6(11.1，19.1)

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表 5 湖北武汉地区不同年龄、性别PINP、CTx及Oc参考区间的建立 μg/L，P_2.5~P_97.5

组别	例数	PINP		CTx		Oc
组别	例数	男	女	男	女	男	女
21~30岁组	150	33.13~151.24	27.89~132.35	0.115~0.776	0.071~0.694	6.8~27.1	6.9~30.9
31~40岁组	150	31.69~132.14	24.85~95.12	0.064~0.633	0.054~0.390	6.8~28.9	5.5~19.6
41~50岁组	150	29.82~109.54	29.56~111.11	0.076~0.715	0.066~0.565	5.6~22.4	5.3~21.4
51~60岁组	150	24.53~92.44	27.38~160.89	0.068~0.592	0.095~0.777	4.8~20.2	5.1~32.5
≥61岁组	140	24.09~100.32	26.24~137.97	0.056~0.654	0.075~0.805	4.8~23.6	6.1~29.2

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