摘要
目的研究p16基因(P16^INK4A)、Ki⁃67共表达检测在宫颈上皮内瘤样病变(CIN)鉴别诊断中的临床和经济价值。方法选取上海市长宁区妇幼保健院2016年12月至2018年8月收诊的液基细胞学(LCT)诊断为≥意义不明的不典型鳞状细胞(ASCUS)女性病人431例,其中因细胞量不足、细胞学不满意无法行P16/Ki⁃67双染剔除21例,最终有效标本数量为410例,均经采取P16^INK4A、Ki⁃67单染及P16/Ki⁃67双染检测,以阴道镜活检作为金标准,分析P16^INK4A、Ki⁃67对CIN的诊断价值(诊断准确性、敏感性、特异性)及其与人乳头状瘤病毒(HPV)感染的关联性。结果(1)P16^INK4A、Ki⁃67与HPV感染关联性:经Spearman相关性分析,P16^INK4A、Ki⁃67与HPV感染呈正相关(r1=0.572,P1=0.005;r2=0.554,P2=0.011);(2)阴道镜活检结果:经阴道镜活检,410例LCT诊断为≥ASCUS女性病人中,132例为阳性病人,占32.20%,阴性病人278例,占67.80%;(3)P16^INK4A、Ki⁃67诊断结果:P16^INK4A单染检查,阳性144例,阴性266例;Ki⁃67单染检查,阳性143例,阴性267例;P16/Ki⁃67双染检查,阳性168例,阴性242例;(4)诊断价值:P16/Ki⁃67双染诊断准确性90.27%、敏感性98.48%高于P16^INK4A、Ki⁃67单染(85.37%、84.15%)、(81.82%、79.55%)(P<0.05);P16/Ki⁃67双染诊断特异性86.33%与P16^INK4A单染87.05%、Ki⁃67单染86.33%相比,差异无统计学意义(P>0.05)。结论P16^INK4A、Ki⁃67应用于CIN鉴别诊断中,与HPV感染具有正相关关系,可显著提高诊断准确性、敏感性,为临床判断CIN病情程度、制定治疗方案等提供有力参考依据。但P16^INK4A、Ki⁃67及P16/Ki⁃67双染检测经济费用较高,致使临床应用受限。
Objective To study the clinical and economic value of P16^INK4A and Ki⁃67 co⁃expression detection in the differential diagnosis of cervical intraepithelial neoplasia(CIN).Methods From December 2016 to August 2018,431 female patients with≥atypical squamous cell(ASCUS)of unknown significance diagnosed by liquid⁃based cytology(LCT)were selected in our hospital.Among them,21 cases of P16/Ki⁃67 double staining were eliminated due to insufficient cell volume and cytological dissatisfaction.The number of valid specimens was 410 cases.By using P16^INK4A,Ki⁃67 single staining and P16/Ki⁃67 double staining,colposcopic biopsy as gold standard,the diagnostic value of P16^INK4Aand Ki⁃67 for CIN(diagnostic accuracy,sensitivity,specificity)and its association with human papillomavirus(HPV)infection were analyzed.Results(1)Association of P16^INK4A,Ki⁃67 with HPV infection:Spearman correlation analysis showed that P16^INK4Aand Ki⁃67 were positively correlated with HPV infection(r1=0.572,P1=0.005;r2=0.554,P2=0.011).(2)Colposcopic biopsy results:Among 410 women diagnosed with≥ASCUS by LCT,132 cases were positive,accounting for 32.20%,278 cases of negative patients,accounting for 67.80%;(3)P16INK4A and Ki⁃67 diagnostic results:P16INK4A single stain test was positive in 144 cases and negative in 266 cases;Ki⁃67 single stain test showed positive in 143 cases and negative in 267 cases;P16/Ki⁃67 double staining showed positive in 168 cases and negative in 242 cases.(4)Diagnostic value:The diagnostic accuracy and sensitivity of P16/Ki⁃67 double staining were 90.27%and 98.48% respectively,which were higher than those of P16^INK4A and Ki⁃67 single staining(85.37% and 84.15%),(81.82% and 79.55%)(P<0.05).The specificity of P16/Ki⁃67 double staining diagnosis was 86.33% compared with P16^INK4A single staining 87.05%and Ki⁃67 single staining 86.33%,the difference was not statistically significant(P>0.05).Conclusions P16^INK4A and Ki⁃67 are used in the differential diagnosis of CIN and have positive correlation with HPV infection.It can significantly improve the diagnostic accuracy and sensitivity,and provide a strong reference for clinical judgment of CIN and formulation of treatment programs.However,the high cost of P16^INK4A,Ki⁃67 and P16/Ki⁃67 double staining tests result in limited clinical application.
作者
尹璐
郑磊贞
赵学军
YIN Lu;ZHENG Leizhen;ZHAO Xuejun(Department of Oncology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China;Department of Obstetrics and Gynecology,Changning Maternity and Child Healthcare Hospital of Shanghai,Shanghai 200051,China;Department of Pathology,Changning Maternity and Child Healthcare Hospital of Shanghai,Shanghai 200051,China)
出处
《安徽医药》
CAS
2020年第3期459-462,I0004,共5页
Anhui Medical and Pharmaceutical Journal
基金
上海市长宁区科学技术委员会项目(CNKW2016Y12)