细胞学p16^(INK4a)检测在宫颈癌初筛与早期诊断中的意义

Significance of cytological p16 adetection in screening and early diagnosis of cervical cancer

目的探讨细胞学p16^(INK4a)检测在宫颈癌初筛与早期诊断中的意义。方法于2019年2月至2019年12月招募湖北十堰地区1927例女性作为研究对象。所有受检者均签署知情同意书,并接受宫颈HR-HPV检测、TCT、p16^(INK4a)检查。筛查时任意一项目结果阳性即需接受阴道镜下宫颈管搔刮加四象限定点加随机活检(POI)方案活检。所有细胞学样本均由两位阅片医师判读。结果完成筛查人群共计1927例,任一筛查项目为阳性者比率为13.91%(268/1927),其中p16^(INK4a)、TCT、HR-HPV阳性率分别为7.06%(136/1927)、4.77%(92/1927)和8.46%(163/1927)。首筛阳性人群中回叫应答率为83.21%(223/268),病理诊断结果176例为非宫颈上皮内瘤变(CIN),27例为CIN1期病变,11例为CIN2期病变以及9例CIN3期病变。对p16^(INK4a)结果判读的阴性一致率、阳性一致率和整体一致性均明显高于TCT(P<0.01)。而诊断效能方面,p16^(INK4a)与HR-HPV的灵敏度均明显大于TCT(P<0.05),但二者间无明显差异(P>0.05),而p16^(INK4a)与TCT的特异度明显大于HR-HPV(P<0.05),但二者间无明显差异(P>0.05)。结论p16^(INK4a)染色作为新一代宫颈细胞检查技术,染色简捷快速、成本较低,其结果易判读,可重复,客观性强,具有较高敏感度与特异度,有望成为大范围人群普查筛选的技术。

Objective To explore the significance of cytological p16^(INK4a)detection in screening and early diagnosis of cervical cancer.Methods From February 2019 to December 2019,1927 women were recruited as research subjects.All subjects signed informed consent,and received cervical HR-HPV test,TCT and p16^(INK4a)examination.When the screening result is positive,it is necessary to call back to accept the colposcopy curettage+four images limited point+random biopsy(POI)scheme.All cytological samples were interpreted by two film readers.Results A total of 1927 people were screened,and the positive rate of any screening item was 13.91%(268/1927),among which the positive rates of p16^(INK4a),TCT and HR-HPV were 7.06%(136/1927),4.77%(92/1927)and 8.46%(163/1927),respectively.The callback response rate of the first screening positive population was 83.21%(223/268),and the pathological diagnosis results were 176 non-CIN cases,27 CIN stage 1 lesions,11 CIN stage 2 lesions and 9 CIN stage 3 lesions.The negative consistent rate,positive consistent rate and overall consistent rate of p16^(INK4a)interpretation were significantly higher than those of TCT(P<0.01).In terms of diagnostic efficiency,the sensitivity of p16^(INK4a)and HR-HPV was significantly higher than that of TCT(P<0.05),but the specificity of p16^(INK4a)and TCT was significantly higher than that of HRHPV(P<0.05),but there was no significant difference between them(P>0.05).Conclusion p16^(INK4a)staining,as a new generation of cervical cytology examination technology,is simple,rapid and low cost,has the advantages of easy interpretation,repeatability,strong objectivity,high specificity and high sensitivity,and has the potential to become the optimal technology for screening and accurate referral of large-scale population.