陕西铜川地区<18岁健康人群血清CK,CK-MB,LDH参考区间的建立与验证

Establishment and Verification of Reference Interval of Serum CK,CK-MB and LDH in Healthy Population Under 18 Years Old in Tongchuan Area of Shaanxi

目的建立和验证陕西铜川地区<18岁健康人群血清肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)及乳酸脱氢酶(LDH)参考区间。方法选取2019年1月~2021年12月在铜川市人民医院进行健康体检的<18岁健康儿童及青少年1606例作为研究对象,其中男性804例,女性802例。按年龄分为5组,其中1~12月龄组325例,1~3岁组328例,4~6岁组322例,7~12岁组326例,13~18岁组305例。采用日立7600全自动生化分析仪检测血清CK,CK-MB和LDH水平,通过计算相邻两组间Z和Z^(*),进一步比较不同性别和不同年龄组间是否可以合并。合并后各组采用百分位数法确定其参考区间。根据合并后各组特征,每组于2022年1~2月随机选取健康体检的20例样本验证已建立的血清CK,CK-MB和LDH的参考区间。结果①陕西铜川地区<18岁健康人群血清CK,CK-MB和LDH活性与年龄呈负相关(r=-0.407,-0.946,-0.968,均P<0.05)。②按性别分组:血清CK在13~18岁组男、女检测值Z>Z^(*)(7.81>3.38),不可合并,三个项目其他各年龄组男、女检测值均为Z<Z^(*),可合并。按年龄分组:血清CK-MB(Z和Z^(*))在1~3岁组与4~6岁组为9.10>4.94,7~12岁与13~18岁组为8.38>4.87;血清LDH(Z和Z^(*))在1~3岁组与4~6岁组为7.84>4.94,4~6岁组与7~12岁组为9.13>4.93,7~12岁组与13~18岁组为10.64>4.87,均为Z>Z^(*),不可合并。其他各组间检测值均为Z<Z^(*),可合并。③血清CK参考区间值(U/L):1月龄~12岁36~288U/L,13~18岁男性49~276U/L,13~18岁女性35~197U/L。血清CK-MB参考区间值(U/L):1月龄~3岁12~39U/L,4~12岁8~35U/L,13~18岁6~30U/L。血清LDH参考区间值(U/L):1月龄~3岁198~384U/L,4~6岁173~373U/L,7~12岁148~327U/L,13~18岁123~331U/L。三个项目各组所建立的参考区间全部通过验证。结论铜川地区<18岁健康儿童及青少年血清CK,CK-MB和LDH活性存在性别和年龄差异,建立不同性别和年龄的参考区间很有必要。

Objective To establish and verify the reference interval of serum creatine kinase(CK),creatine kinase isoenzyme(CK-MB)and lactate dehydrogenase(LDH)for healthy children and adolescents aged 1 month to 18 years in Tongchuan area.Methods 1606 healthy children and adolescents aged 1 month to 18 years old who underwent physical examination in Tongchuan People’s Hospital from January 2019 to December 2021 were selected as the research objects,including 804 males and 802 females.They were divided into 5 groups according to age,including 325 cases in the 1~12-month-old group,328 cases in the 1~3-year-old group,322 cases in the 4~6-year-old group,and 326 cases in the 7~12-year-old group,305 cases in 13~18 years old group.To detect serum CK,CK-MB and LDH levels by using Hitachi 7600 automatic biochemical analyzer,calculate Z and Z^(*)between two adjacent groups,and compare whether there was combination between different genders and different age groups.After the combination,each group uses the percentile method to determine its reference interval.According to the characteristics of each group after the combination,each group selected 20 samples of physical examination to verify the established reference interval of CK,CK-MB and LDH from January 2022 to February 2021.Results①CK,CKMB and LDH activity were negatively correlated with age(r=-0.407,-0.946,-0.968,all P<0.05).②According to gender grouping CK in 13~18 years old group male and female test value Z>Z^(*)(7.81>3.38),could not be combined.Three items other age groups male,female test values were Z>Z^(*),which can be combined.According to age group Z and Z^(*)in CK-MB group of 1~3 years old and group of 4~6 years old(9.10>4.94),the group aged 7~12 years old and 13~18 years old was(8.38>4.87),LDH was(7.84>4.94)in the group aged 1~3 years old and the group aged 4~6 years old,the groups aged 4~6 years old and 7~12 years old were 9.13>4.93,and the groups aged 7~12 years old and 13~18 years old were 10.64>4.87.All were Z>Z^(*)and cannot be merged.The detection values among other groups were Z<Z^(*),which could be merged.③CK reference interval value(U/L):1-month-old~12-year-old 36~288U/L,13~18-year-old male 49~276U/L,women aged 13~18U/L,35~197U/L.CK-MB reference interval value(U/L):1 month to 3 years old 12~39,4~12 years old 8~35U/L,13~18 years old 6~30U/L.Reference interval value of LDH(U/L):1 month to 3 years old 198~384U/L,4~6 years old 173~373U/L,7~12 years old 148~327U/L,123~331U/L years old from 13 to 18 years old.All the reference intervals established by the three projects had passed the verification.Conclusion There are gender and age differences in serum CK,CK-MB and LDH activities among healthy children and adolescents aged 1 month to 18 years old in Tongchuan area.It is necessary to establish reference intervals of different genders and ages.