Sari Aslani Fatemeh, Safaei Akbar, Pourjabali Masoumeh, Momtahan Mozhdeh
Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran;
Iran J Med Sci. 2013 Mar;38(1):15-21.
Cervical intraepithelial neoplasia (CIN) is a premalignant lesion capable of progressing to cervical cancer. Despite the existing well-defined criteria, the histomorphologic diagnosis is subject to high rates of discordance among pathologists. The aim of this study was to evaluate Ki-67 (MIB-1), CK17 and p16 (INK4a) (p16) markers by immunohistochemical methods in differentiating CIN from benign cervical lesions.
The present study reviewed and re-classified 77 cervical biopsies, originally diagnosed as 31 non-CIN, and 46 CIN, as 54 non-CIN, and 23 CIN based on at least two similar diagnoses. Immunostaining by Ki67, p16 and CK17 markers was performed on all cases and the results were compared with pervious and consensus diagnosis.
The overall agreement between pervious and consensus diagnosis was 67.5% (Kappa=0.39, P<0.001). The sensitivity and specificity of Ki67 immunostaining were 95.6% and 85.1% respectively, while for p16 the corresponding values were 91.3% and 98.1%. The overall agreement, for both p16 and Ki67, with consensus diagnosis were significant (P<0.001). The sensitivity and specificity of CK17 negative staining in CIN detection were 39.1% and 40.7% respectively.
Ki67 and p16 markers are recommended as complementary tests for differentiating between dysplastic and non-dysplastic lesions. CK17 does not discriminate between immature metaplasia with and without dysplasia.
宫颈上皮内瘤变（CIN）是一种可发展为宫颈癌的癌前病变。尽管已有明确的诊断标准，但病理学家之间的组织形态学诊断存在较高的不一致率。本研究旨在通过免疫组化方法评估Ki-67（MIB-1）、CK17和p16（INK4a）（p16）标记物在鉴别CIN与良性宫颈病变中的作用。
本研究对77例宫颈活检标本进行回顾性重新分类，最初诊断为31例非CIN和46例CIN，基于至少两种相似诊断重新分类为54例非CIN和23例CIN。对所有病例进行Ki67、p16和CK17标记物的免疫染色，并将结果与先前诊断和共识诊断进行比较。
先前诊断与共识诊断之间的总体一致性为67.5%（Kappa=0.39，P<0.001）。Ki67免疫染色的敏感性和特异性分别为95.6%和85.1%，而p16的相应值分别为91.3%和98.1%。p16和Ki67与共识诊断的总体一致性均具有显著性（P<0.001）。CK17阴性染色在CIN检测中的敏感性和特异性分别为39.1%和40.7%。
推荐将Ki67和p16标记物作为鉴别发育异常和非发育异常病变的补充检查。CK17不能区分有无发育异常的未成熟化生。
