目的 探讨p16/Ki67双染检测在分流宫颈低度鳞状上皮内病变/高度鳞状上皮内病变 (LSIL/HSIL) 及预测LSIL转归中的临床意义.方法 收集2015年2月至2016年5月廉江市人民医院与湛江中心人民医院组织学证实为宫颈炎、LSIL、HSIL和宫颈癌的4组标本 (分别是102例、75例、68例、59例) 为研究对象, 回顾性分析前期细胞学标本的p16/Ki67双染检测结果, 观察4组研究对象的细胞学、组织学诊断结果中p16/Ki67双染结果的差异, 统计分析p16/Ki67双染检测诊断HSIL及以上 (简称HSIL+, 包括HSIL和宫颈癌) 的效能.并对确诊的75例LSIL患者随访2年, 分析p16/Ki67双染检测结果与LSIL转归的关系.结果 (1) 宫颈细胞学结果为未见上皮内瘤变及恶性病变 (NILM) 、意义不明的非典型鳞状细胞 (ASCUS) 、LSIL、ASU-H+ (包括ASU-H、高级别鳞状上皮内瘤变、鳞状细胞癌) 组的p16/Ki67双染阳性率分别为8.79％、41.67％、58.57％、91.57％, 总体差异有统计学意义 (P<0.05) .除ASCUS组与LSIL组之间p16/Ki67双染阳性率差异无统计学意义 (P>0.008) 外, 其余组两两之间比较, p16/Ki67双染阳性率差异均有统计学意义 (P<0.008) . (2) 宫颈组织学结果为宫颈炎、LSIL、HSIL、宫颈癌组p16/Ki67双染阳性率分别为7.84％、30.67％、88.24％、94.92％, 总体差异有统计学意义 (P<0.05) .除HSIL组与宫颈癌组之间p16/Ki67双染阳性率差异无统计学意义 (P>0.008) 外, 其余组两两之间比较, p16/Ki67双染阳性率差异均有统计学意义 (P<0.008) . (3) p16/Ki67双染检测诊断HSIL+病变的灵敏度、特异度、符合率、阳性预测值和阴性预测值分别是91.34％、82.49％、86.18％、78.91％、92.99％. (4) p16/Ki67双染阳性的LSIL患者病变进展率是p16/Ki67双染阴性的5.28倍, 两者比较差异有统计学意义 (P<0.05) .结论 p16/Ki67双染阳性率随着宫颈疾病的诊断结果加重而不断增加.p16/Ki67检测在诊断HSIL+病变、分流LSIL/HSIL、预测LSIL的转归具有一定的意义, 值得在临床推广使用.%Objective To investigate the clinical significance of p16/Ki67 double staining in shunting low/high squamous intraepithelial lesion (LSIL/HSIL) and predicting LSIL outcome.Methods The four groups of cervicitis, LSIL, HSIL and cervical cancer specimens (102, 75, 68, 59 cases respectively) were collected from the Lianjiang Municipal People′s Hospital and Zhanjiang Municipal Central People′s Hospital as the study objects.The p16/Ki67 double staining detection results of preclinical cytology specimens were retrospectively observed.The relationship between p16/Ki67 double staining and the outcome of LSIL was observed.The efficiency of p16/Ki67 double staining for diagnosing HSIL and more (HSIL+, including HSIL and cervical cancer) was statistically analyzed.Seventy-five cases of definitely diagnosed LSIL conducted the follow up 2 years after diagnosis.The relationship between p16/Ki67 double staining detection results with LSIL outcome was analyzed.Results (1) The positive rates of p16/Ki67 double staining in NILM, ASCUS, LSIL and ASU-H+groups (including ASU-H, high grade squamous intraepithelial neoplasia, squamous cell carcinoma) were8.79％, 41.67％, 58.57％ and 91.57％ respectively.The overall difference was statistically significant (P<0.05) .There was no significant difference in the positive rate of p16/Ki67 between ASCUS group and LSIL group (P>0.008) , but there was statistically significant difference in the positive rate of p16/Ki67 between the other two groups (P<0.008) . (2) The positive rates of p16/Ki67 double staining in cervicitis, LSIL, HSIL and cervical cancer groups were 7.84％, 30.67％, 88.24％and 94.92％respectively.The overall difference was statistically significant (P<0.05) .There was no significant difference in the positive rate of p16/Ki67 between HSIL group and cervical cancer group (P>0.008) , but there was significant difference in the positive rate of p16/Ki67 between the other two groups (P<0.008) . (3) The sensitivity, specificity, coincidence rate, positive predictive value and negative predictive value of p16/Ki67 for diagnosing HSIL+ lesion were91.34％, 82.49％, 86.18％, 78.91％ and 92.99％ respectively. (4) The lesion progression rate of LSIL patients with p16/Ki67 double staining positive was 5.28 times higher than that of LSIL patients with p16/Ki67 double staining negative, the difference between them was statistically significant (P<0.05) .Conclusion The positive rate of p16/Ki67 double staining is constantly increased with the aggravation of cervical disease diagnostic results.The detection of p16/Ki67 has a certain significance in diagnosing HSIL+ lesions, shunting LSIL/HSIL and predicting the outcome of LSIL, which is worthy of being clinically promoted and applied.
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