摘要目的 探讨胃癌HER2蛋白表达的免疫组织化学检测结果的影响因素.方法 比较南京大学医学院附属鼓楼医院2007至2009年间(G1组)和2012至2013年间(G2组)两个时间段内1 471例胃癌根治标本中HER2的免疫组织化学(IHC)检测结果,并分析可能影响胃癌中HER2阳性表达的相关因素.结果 G1组胃癌根治标本957例,采用手工方法进行IHC检测,HER2一抗购自Dako公司(克隆号为A0485),标本采用4％甲醛液固定,所有病例由不同医师评判；结果显示HER23+者占9.5％ (91/957),HER2 3+或HER2 2+者占21.7％(208/957).G2组胃癌根治标本514例,采用Roche公司自动化染色系统进行IHC检测,一抗购自Roche公司(克隆号为4B5),检测标本均经4％中性缓冲甲醛液固定,所有病例均由专门小组共同评判；结果显示HER2 3+者占14.4％(74/514),HER2 3+或HER2 2+者占27.2％ (140/514).G2组胃癌HER2 3+者和HER2 3 +/2+者均显著高于G1组(P＜0.05).结论 胃癌HER2规范化IHC检测可能与标本固定液类型、HER2抗体选择、IHC检测方法以及染色结果评估经验等有关,对上述方面条件的优化能够明显提高HER2阳性胃癌的检出率.

abstractsObjective To study the potential factors in influencing the performance of immunohistochemical testing for HER2 protein in gastric cancers.Methods The HER2 protein expression status of 1 471 surgically resected archival gastric cancer cases in Drum Tower Hospital collected during two different periods was retrospectively analyzed.The materials included 957 cases tested during the period from 2007 to 2009 (group 1) and 514 cases from 2012 to 2013 (group 2).The test procedures and results observed during these two periods were compared.Results The percentages of score 3 HER2 protein expression (14.4％,74/514 versus 9.5％,91/957) and score 2 or score 3 HER2 protein expression (27.2％,140/514 versus 21.7％,208/957) were both higher in group 2 than in group 1 (P ＜ 0.05).In group 1,the cancer tissue was fixed in 10％ formalin,stained manually with HER2 antibody A0485 (Dako)and assessed by different pathologists.In group 2,the tissue was fixed in 10％ neutral buffered formalin (pH 7.2),stained using automated immunostaining system (Roche Benchmark XT) with HER2 antibody 4B5 (Ventana) and assessed by a specialized team of pathologists.Conclusion The results of HER2 immunostaining in gastric cancer are influenced by a number of factors including type of fixative,clone number of primary antibody,staining methods and experience of pathologists.