Abstract
背景与目的已有的研究表明：表皮生长因子受体（epidermal growth factor receptor, EGFR）基因突变是非小细胞肺癌（non-small cell lung cancer, NSCLC）患者应用表皮生长因子受体酪氨酸激酶抑制剂（EGFR tyrosine kinase inhibitor, EGFR-TKI）治疗疗效的最重要的预测因子。EGFR基因突变的患者对于使用TKIs分子靶向药物治疗疗效更敏感。其突变检测对肺癌一线靶向治疗选择尤为关键。研究分析特异性抗体免疫组化法（immunohistochemistry, IHC）检测EGFR突变与DNA测序法比较的敏感度与特异度，明确该方法准确性及临床应用价值。方法通过Pubmed数据库检索所有符合检索条件的文献，末次检索日期2013年3月26日，根据纳入和排除标准进行进一步筛选，采用诊断试验meta分析方法，分析特异性抗体免疫组化方法与DNA直接测序法对比的敏感度与特异度。结果10篇文献纳入meta分析，L858R 1, 679例，E746-A750del 1, 041例，诊断比值比（diagnositic odds ratio, DOR）分别为225.17（95%CI: 55.67-910.69）和267.16（95%CI: 132.45-538.88）；SROC曲线AUC分别为0.948, 4（SEAUC=0.014, 4）和0.981, 3（SEAUC=0.009, 9），Q*统计量分别为0.888, 3（SEQ*=0.019, 2）和0.9397（SEQ*=0.019, 1）。结论以上两种特异性抗体IHC鉴别EGFR突变的特异度高，灵敏度较高，作为筛查突变方法可行性高，具有一定的临床应用价值。
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