TCT联合p16^(INK4a)蛋白检测进行子宫颈癌筛查的临床效果研究

Clinical effect of TCT combined with p16^(INK4a)protein detection for cervical cancer screening

目的探究子宫颈薄层液基细胞学(ThinPrep cytologic test,TCT)联合细胞学p16^(INK4a)蛋白检测在宫颈癌筛查中的应用效果和价值。方法募集2021年10月至2022年3月在本院进行子宫颈癌筛查的3986例有性生活的非妊娠期女性作为研究对象,均行TCT和细胞学p16^(INK4a)蛋白检测,任一结果为阳性均召回行阴道镜检查。结果(1)3986例女性中,TCT阳性[≥低级别鳞状上皮内病变(LSIL)]627例(15.73%),p16^(INK4a)蛋白阳性642例(16.11%),阴道镜下活检,组织病理学诊断共发现249例(6.25%)子宫颈上皮内病变(CIN)2+患者、105例(2.63%)CIN3+患者。(2)p16^(INK4a)蛋白检测作为CIN2+初筛方案的灵敏度、特异度、阳性预测值和阴性预测值分别为89.56%(95%CI:84.91%~92.94%)、88.79%(95%CI:87.72%~89.77%)、34.74%(95%CI:31.08%~38.58%)和99.22%(95%CI:98.84%~99.48%),其灵敏度和阳性预测值显著高于TCT(P<0.05)。(3)将p16^(INK4a)作为ASCUS分流方案,对CIN2+的灵敏度、特异度、阳性预测值和阴性预测值分别为95.18%(95%CI:91.52%~97.37%)、88.04%(95%CI:86.94%~89.05%)、34.65%(95%CI:31.11%~38.37%)和99.64%(95%CI:99.35%~99.80%);对CIN3+的灵敏度、特异度、阳性预测值和阴性预测值分别为98.10%(95%CI:92.62%~99.67%)、85.03%(95%CI:83.86%~86.13%)、15.06%(95%CI:12.51%~18.01%)和99.94%(95%CI:99.76%~99.99%)。结论p16^(INK4a)蛋白作为初筛方案或者作为ASCUS分流方案,对于CIN2+的筛查效果均优于TCT初筛方案,且该技术操作简单、容易判读,可在宫颈癌筛查中发挥重要作用。

Objective To explore the application effect and value of ThinPrep cytologic test(TCT)combined with p16^(INK4a)protein detection in cervical cancer screening and diagnosis.Methods 3986 sexually active non-pregnant women who were screened for cervical cancer in our hospital from October 2021 to March 2022 were recruited as the research objects.They were tested for TCT and p16^(INK4a)protein.If any result was positive,they were recalled for colposcopy.Results(1)Among the 3986 patients,627(15.73%)were TCT positive and 642(16.11%)were p16^(INK4a)protein positive.Colposcopic biopsy showed 249(6.25%)CIN2+patients and 105(2.63%)CIN3+patients.(2)The sensitivity,specificity,positive predictive value and negative predictive value of p16^(INK4a)protein as the primary screening scheme were 89.56%(95%CI:84.91%~92.94%),88.79%(95%CI:87.72%~89.77%),34.74%(95%CI:31.08%~38.58%)and 99.22%(95%CI:98.84%~99.48%)respectively.The sensitivity and positive predictive value of p16^(INK4a)protein were significantly higher than that of TCT(P<0.05).(3)Using p16^(INK4a)as triage for ASCUS,the sensitivity,specificity,positive predictive value and negative predictive value of CIN2+were 95.18%(95%CI:91.52%~97.37%),88.04%(95%CI:86.94%~89.05%),34.65%(95%CI:31.11%~38.37%)and 99.64%(95%CI:99.35%~99.80%)respectively;The sensitivity,specificity,positive predictive value and negative predictive value of CIN3+were 98.10%(95%CI:92.62%~99.67%),85.03%(95%CI:83.86%~86.13%),15.06%(95%CI:12.51%~18.01%)and 99.94%(95%CI:99.76%~99.99%)respectively.Conclusions p16^(INK4a)protein as a primary screening scheme or triage of ASCUS,the screening effect of CIN2+is better than that of TCT as primary screening,and this technology is simple to operate and easy to interpret,and can play an important role in cervical cancer screening.