血清蛋白电泳筛查单克隆丙种球蛋白533989例结果分析  

Retrospective analysis of serum protein electrophoresis screening for monoclonal gammopathy in 533989 cases

作　　者：沈若坚 邵文琦 朱晶 沈逸枫 潘柏申 王蓓丽 郭玮 Shen Ruojian;Shao Wenqi;Zhu Jing;Shen Yifeng;Pan Baishen;Wang Beili;Guo Wei(Department of Laboratory Medicine,Zhongshan Hospital,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属中山医院检验科,上海200032

出　　处：《中华检验医学杂志》2024年第1期65-71,共7页Chinese Journal of Laboratory Medicine

基　　金：复旦大学附属中山医院临床研究专项(2020ZSLC54);复旦大学附属中山医院科技创新基金(2021ZSCX12);上海市临床重点专科建设项目(shslczdzk03302)。

摘　　要：目的比较不同性别、年龄人群间血清蛋白电泳(SPE)各区带分布差异,探讨血清蛋白电泳筛查单克隆丙种球蛋白(M蛋白)的临床应用。方法回顾性分析复旦大学附属中山医院2018年1月至2019年12月533989例SPE结果,其中住院患者435479例,为血液内科、肾病科、脊柱外科、内分泌科及风湿免疫科患者;表观健康人群98510名,为体检健康人群。比较不同性别和年龄段(≤20、21~30、31~40、41~50、51~60、61~70、71~80、81~90、≥91岁)人群的白蛋白、α1球蛋白、α2球蛋白、β1球蛋白、β2球蛋白及γ球蛋白区带差异分布。筛选出10014例同时完成SPE和免疫固定电泳(IFE)检测的标本,分析SPE各区带及IFE不同条带类型的阳性检出率,以IFE为金标准,评价SPE方法的敏感度和特异度。结果不同性别人群的SPE各区带占比差异均无统计学意义(P均>0.05)。表观健康人群、住院患者不同年龄段白蛋白区带占比差异均有统计学意义(表观健康人群:F=5.12,P<0.05;住院患者:F=4.18,P<0.05),且均随年龄的增长而下降;γ球蛋白区带占比随年龄的增长而上升(表观健康人群:F=1.34,P<0.05;住院患者:F=1.24,P<0.05)。SPE检测M蛋白的敏感度为69%(2098/3051),特异度97%(6721/6963),与IFE法比较,M蛋白阳性检出率差异有统计学意义(χ^(2)=5049.94,P<0.05);γ球蛋白区M蛋白阳性检出率(21.11%,2114/10014)高于β球蛋白区(3.28%,328/10014)(χ^(2)=90.74,P<0.05)和β-γ球蛋白区(1.63%,163/10014)(χ^(2)=44.34,P<0.05);γ球蛋白区常见IgG及IgM型条带,其中IgG-κ型占94.1%(995/1058)、IgG-λ型占94.8%(690/728)、IgM-κ型占89.2%(222/249)、IgM-λ型占83.8%(62/74);β球蛋白区常见IgA型条带,其中IgA-κ型占49.8%(103/207)、IgA-λ型占51.6%(149/289);IgG-κ型在IFE各条带类型中M蛋白的阳性检出率[10.57%(1058/10014)]最高,IgM-λ型M蛋白的阳性检出率[0.74%(74/10014)]最低。结论随着年龄增长,SPE的白蛋白区带占比下降,γ球蛋白区带占比上升。IObjective To compare the distribution differences of serum protein electrophoresis(SPE)among different gender and age individuals,and to explore the clinical application of SPE screening monoclonal gammopathy.Methods A retrospective analysis was conducted based on the SPE results obtained from 533989 cases enrolled from January 2018 to December 2019 at Zhongshan Hospital Affiliated to Fudan University.Among these patients,435479 inpatients were from departments of hematology,nephrology,spinal surgery,endocrinology,and rheumatology and immunology;and 98510 were apparently healthy individuals.The distributions of albumin,α1 globulin,α2 globulin,β1 globulin,β2 globulin andγglobulin in different gender and age groups(≤20,21-30,31-40,41-50,51-60,61-70,71-80,81-90,≥91 years old)were compared.A total of 10014 cases were selected by immunofixation electrophoresis(IFE).The positive detection rates of different SPE bands and IFE bands were analyzed.The sensitivity and specificity of SPE methods were determined according to IFE results as the gold standard.Results No significant difference was examined in the proportion of SPE bands between different genders(P>0.05).There were statistically significant differences in the proportion of albumin bands between apparently healthy individuals and hospitalized patients at different ages(apparently healthy individuals:F=5.12,P<0.05,inpatients:F=4.18,P<0.05),and all of them decreased with the increase of age.The proportion ofγglobulin bands increased with age(apparently healthy individuals:F=1.34,P<0.05;inpatients:F=1.24,P<0.05).The sensitivity of SPE was 69%(2098/3051),and the specificity was 97%(6721/6963).Compared with IFE method,the positive detection rate of monoclonal gammopathy was significantly different(χ^(2)=5049.94,P<0.05).The positive rate of monoclonal gammopathy inγglobulin region(21.11%,2114/10014)was higher than that inβglobulin region(3.28%,328/10014)(χ^(2)=90.74,P<0.05)andβ-γglobulin region(1.63%,163/10014)(χ^(2)=44.34,P<0.05).IgG and IgM bands are

关 键 词：血蛋白电泳 免疫电泳 单克隆丙种球蛋白 

分 类 号：R446.6[医药卫生—诊断学]