P16/Ki67双染检测在宫颈病变筛查中的诊断价值

Diagnostic value of P16/Ki67 double staining in cervical screening

目的探讨P16/Ki67双染检测在宫颈病变筛查中的诊断价值。方法选取2018年10月至2020年3月于南昌市洪都中医院行宫颈细胞学检查的400例患者作为研究对象,包括113例不典型鳞状细胞(ASCUS)患者、140例低度鳞状上皮内病变(LSIL)患者、147例高级别鳞状上皮内瘤变及鳞状细胞癌患者,分别作为ASCUS组、LSIL组、HSIL+组。以宫颈活检结果作为诊断“金标准”,分析P16/Ki67双染检测在ASCUS、LSIL、HSIL+组的阳性检出率;另分析P16/Ki67双染检测在HSIL+中的诊断效能。结果三组患者的P16/Ki67双染检测阳性率比较,差异有统计学意义(P<0.05)。采用Bonferroni方法校正,进一步两两比较,结果显示,LSIL组、HSIL+组患者的P16/Ki67双染检测阳性率均高于ASCUS组,差异有统计学意义(P<0.017);LSIL组与HSIL+组患者的P16/Ki67双染检测阳性率比较,差异无统计学意义(P>0.017)。P16/Ki67双染检测在HSIL+组患者中的诊断灵敏度为84.35%,特异度为98.81%,准确度为93.50%,阳性预测值为97.64%,阴性预测值为91.58%。Kappa检验显示,P16/Ki67双染检测与宫颈活检的一致性良好(Kappa值=0.853,P<0.001)。结论P16/Ki67双染检测在HSIL+患者中具有较高的临床诊断价值,有助于提高HSIL+阳性检出率。

Objective To investigate the diagnostic value of P16/Ki67 double staining in cervical screening.Methods A total of 400 patients who underwent cervical cytology in Hongdu Hospital of Traditional Chinese Medicine of Nanchang City from October 2018 to March 2020 were selected as the research objects,including 113 cases of atypical squamous cells(ASCUS),140 cases of low grade squamous intraepithelial lesion(LSIL),147 cases of high-grade squamous intraepithelial lesion and squamous cell carcinoma.They were divided into ASCUS group,LSIL group and HSIL+group.Cervical biopsy results were used as the diagnostic"gold standard"to analyze the positive detection rate of P16/Ki67 double staining in ASCUS,LSIL and HSIL+groups.The diagnostic efficacy of P16/Ki67 double staining in HSIL+was also analyzed.Results The positive rate of P16/Ki67 double staining was compared among the three groups,and the difference was statistically significant(P<0.05).Bonferroni method was used for correction and further pairwise comparison.The results showed that the positive rates of P16/Ki67 double staining in LSIL group and HSIL+group were higher than that in ASCUS group,and the differences were statistically significant(P<0.017).There was no significant difference in the positive rate of P16/Ki67 double staining between LSIL and HSIL+groups(P>0.017).The diagnostic sensitivity,specificity,accuracy,positive predictive value and negative predictive value of P16/Ki67 double staining in HSIL+were 84.35%,98.81%,93.50%,97.64%and 91.58%,respectively.Kappa test showed good consistency between P16/Ki67 double staining and cervical biopsy(Kappa=0.853,P<0.001).Conclusion P16/Ki67 double staining has a high clinical diagnostic value in HSIL+patients,which is helpful to improve the positive detection rate of HSIL+.