查看更多>>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533 989例SPE结果，其中住院患者435 479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98 510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10 014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%（2 098/3 051），特异度97%（6 721/6 963），与IFE法比较，M蛋白阳性检出率差异有统计学意义（χ²=5 049.94，P<0.05）；γ球蛋白区M蛋白阳性检出率（21.11%，2 114/10 014）高于β球蛋白区（3.28%，328/10 014）（χ²=90.74，P<0.05）和β-γ球蛋白区（1.63%，163/10 014）（χ²=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%（995/1 058）、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%（1 058/10 014）］最高，IgM-λ型M蛋白的阳性检出率［0.74%（74/10 014）］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。IgG、IgM型M蛋白大多聚集于γ球蛋白区带，其中IgG型M蛋白阳性检出率较高，IgA型大多聚集于β球蛋白区带，阳性检出率较低。 Objective 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 533 989 cases enrolled from January 2018 to December 2019 at Zhongshan Hospital Affiliated to Fudan University. Among these patients, 435 479 inpatients were from departments of hematology, nephrology, spinal surgery, endocrinology, and rheumatology and immunology and 98 510 were apparently healthy individuals. The distributions of albumin, α1 globulin, α2 globulin, β1 globulin, β2 globulin and γ globulin 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 10 014 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 of γ globulin 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% (2 098/3 051), and the specificity was 97% (6 721/6 963). Compared with IFE method, the positive detection rate of monoclonal gammopathy was significantly different (χ²=5 049.94,P<0.05). The positive rate of monoclonal gammopathy in γ globulin region (21.11%, 2 114/10 014) was higher than that in β globulin region (3.28%, 328/10 014) (χ²=90.74,P<0.05) and β-γ globulin region (1.63%, 163/10 014) (χ²=44.34,P<0.05). IgG and IgM bands are common in γ globulin region. Among them, IgG-κ type accounted for 94.1% (995/1 058), IgG-λ type accounted for 94.8% (690/728), IgM-κ type accounted for 89.2% (222/249), IgM-λ accounted for 83.8% (62/74). IgA bands are common in β region, of which IgA-κ accounted for 49.8% (103/207) and IgA-λ accounted for 51.6% (149/289). The positive rate of monoclonal gammopathy of IgG-κ type was the highest (10.57%, 1 058/10 014), and the positive rate of monoclonal gammopathy of IgM-λ type was the lowest (0.74%, 74/10 014). Conclusions With increasing age, the proportion of albumin band in SPE decreased and the proportion of γ globulin band increased. IgG and IgM type monoclonal gammopathy is mostly found in the gamma region, with a higher detection rate in IgG type. IgA type monoclonal gammopathy is mostly found in the β region, with a lower detection rate.
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