苏州地区健康成人胃蛋白酶原与胃泌素-17参考区间的建立与验证  

The Establishment and Validation of Reference Intervals for SerumPepsinogens and Gastrin-17 Among Healthy Adults in Suzhou Area

作　　者：石燕[1] 李淑湘[1] 郑维玲[1] 魏衍财[1] SHI Yan;LI Shuxiang;ZHENG Weiling;WEI Yancai(Laboratory Medicine Center,Suzhou Hospital Affiliated to Nanjing Medical University,Suzhou Municipal Hospital,Suzhou 215000,China)

机构地区：[1]南京医科大学附属苏州医院/苏州市立医院检验医学中心,江苏苏州215000

出　　处：《标记免疫分析与临床》2024年第11期2093-2098,共6页Labeled Immunoassays and Clinical Medicine

基　　金：南京医科大学科技发展基金一般项目(编号:NMUB20220184)。

摘　　要：目的建立苏州地区健康成人血清中胃蛋白酶原(PG)I、PG II及胃泌素-17(G-17)的参考区间。方法回顾性分析苏州地区34719名表观健康人群,采用酶联免疫法检测PG I、PG II及G-17水平,计算PG I/PG II比值(PGR),根据CLSI C28-A3文件,按照性别及年龄对受试者进行分组,根据统计学方法评估各组间差异是否有统计学意义,采用百分位数法计算PG I、PG II、PGR和G-1795%分布范围,并建立参考区间,计算建立的参考区间与厂商声明的参考区间的差异,评估是否采用新建立的参考区间。结果34719名表观健康人PG I、PG II、PGR及G-17水平均呈偏态分布,采用百分位数法建立参考区间。Spearman相关分析显示,PG I、PG II、G-17与年龄呈正相关(r值分别为0.083、0.087、0.032,均P<0.05),PGR与年龄呈负相关(r值为-0.037,P<0.05)。男性组血清PG I、PG II和PGR水平均高于女性组(均P<0.05),而血清G-17水平低于女性组(P<0.05),需分别按照性别建立参考区间。同性别各年龄组PG I和PG II水平差异均有统计学意义(P<0.05),同性别≥60岁组分别与18~44岁组、45~59岁组PGR水平差异均有统计学意义(P<0.05),女性各年龄组G-17差异均有统计学意义(P<0.05),需进一步按照年龄建立参考区间(PG I:18~44岁男、女性分别为42.87~147.30、41.55~133.34μg/L,45~59岁男、女性分别为43.29~153.90、41.86~131.34μg/L,≥60岁男、女性分别为44.48~155.28、42.16~139.72μg/L;PG II:18~44岁男、女性分别为≤17.56、≤17.29μg/L,45~59岁男、女性分别为≤17.85、≤18.64μg/L,≥60岁男、女性分别为≤18.90、≤18.85μg/L;PGR:18~59岁男、女性分别为≥4.85、≥4.47,≥60岁男、女性分别为≥4.67、≥4.50;女性G-17:18~44岁为0.6~13.96pmol/L、45~59岁为0.6~14.14pmol/L、≥60岁为0.63~14.12pmol/L);男性各年龄组G-17差异无统计学意义,可建立统一参考区间(男性G-17:≥18岁为0.56~13.79pmol/L)。建立的参考区间验证通过。结论初步建立了适合本地�Objective To establish the reference intervals of serum pepsinogen(PG)I,PG II and gastrin-17(G-17)in healthy adults from Suzhou area.Methods A retrospective analysis was conducted among 34-719 apparently healthy individuals in Suzhou area.The levels of PG I,PG II,and G-17 were detected using ELISA method,and the PG I/PG II ratio(PGR)was calculated.According to the CLSI C28-A3 document,all subjects were grouped according to gender and age distributions.The statistical methods were applied to evaluate whether the differences between the groups were statistically significant.The percentile method was used to calculate the 95%distribution range of PG I,PG II,PGR and G-17,and the reference interval was established.The difference between the established reference interval and the reference interval declared by the manufacturer was calculated to evaluate whether the newly established reference interval should be adopted.Results The levels of PG I,PG II,PGR,and G-17 in 34719 apparently healthy people showed skewed distributions,and the reference intervals were established using the percentile method.Spearman correlation analysis showed that PG I,PG II,and G-17 were significantly positively correlated with age(r values were 0.083,0.087,and 0.032,respectively,all P<0.05),while PGR was significantly negatively correlated with age(r value was-0.037,P<0.05).The serum levels of PG I,PGII and PGR in the male group were significantly higher than those in the female group(all P<0.05),while serum G-17 levels were significantly lower than those in female group(P<0.05),suggesting that reference intervals should be established according to different gender groups.There were significant differences in PG I and PG II levels in the same gender and age groups(P<0.05);The PGR levels of the group aged≥60 years were significantly different from those of the group aged 18-44 years and the group aged 45-59 years in the same gender groups(P<0.05);There were statistically significant differences in G-17 in all female age groups,suggesting tha

关 键 词：胃蛋白酶原 胃泌素-17 健康人群 参考区间 

分 类 号：R446.1[医药卫生—诊断学]