Evaluation of the clinical performance of p16/Ki-67 dual-staining cytology for cervical lesion detection in premenopausal and postmenopausal Chinese women
Evaluation of the clinical performance of p16/Ki-67 dual-staining cytology for cervical lesion detection in premenopausal and postmenopausal Chinese women
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DOI：
10.1007/s00432-023-04938-1
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发表时间：
2023-06
影响因子：
3.6
通讯作者：
Yu-xin Dai;Tingting Chen;Xin-Ye Li;Changning Zhang;Ting-yuan Li;Yuqian Zhao;Yakun Wang;Simiao Chen;Lu-lu Yu;M. Jiang;Zeni Wu;Jinghong Yang;Wen Chen
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文献类型：
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作者：
Yu-xin Dai;Tingting Chen;Xin-Ye Li;Changning Zhang;Ting-yuan Li;Yuqian Zhao;Yakun Wang;Simiao Chen;Lu-lu Yu;M. Jiang;Zeni Wu;Jinghong Yang;Wen Chen
研究背景p16/Ki-67双重染色在诊断绝经后宫颈病变中的临床应用研究有限。方法入选4364例符合条件的妇女，其中542例为癌，217例为CIN2/3。分析不同病理分级、不同年龄组p16、Ki-67单染和p16/Ki-67双染阳性率。结果P16/Ki-67双染阳性率在绝经前和绝经后妇女中随组织学严重程度增加而增加(P<； )，而绝经后妇女P16/Ki-67单染和p16单染表达无明显增加趋势。P16/Ki-67对CIN2/3的阳性预测值(88.09%vs.81.91%，P<； 0.001)和阳性预测值(33.8%vs.13.18%，P<； 0.001)高于绝经后组(89.97%vs.82.61%，P= 0.012)；在对HR-HPV+人群进行分类以确定CIN2/3方面，p16/Ki-67在绝经前妇女中的表现与淋巴细胞相似，且绝经前妇女的PPV(51.14%比23.08%，P<； 0.001)高于绝经后妇女。P16/Ki-67在绝经前和绝经后妇女中的SPE高于HR-HPV，而阴道镜检查转诊率低于HR-HPV。结论p16/Ki-67双重染色在绝经前和绝经后妇女中的表达不同。P16/Ki-67对绝经前妇女宫颈病变的检出效果较好。对于分型，p16/Ki-67适合于HR-HPV阳性妇女，特别是绝经前妇女，以识别CIN2/3和ASC-US/LsIL。
BackgroundStudies on the clinical performance of p16/Ki-67 dual-staining in detecting cervical lesions by menopausal status were limited.Methods4364 eligible women were enrolled with valid p16/Ki-67, HR-HPV, and LBC test results, including 542 cancer and 217 CIN2/3 cases. The positivity rates of p16 and Ki-67 single staining and p16/ Ki-67 dual-staining were analyzed by different pathological grades and age groups. The sensitivity (SEN), specificity (SPE), positive predictive value (PPV), and negative predictive value (NPV) of each test in different subgroups were calculated and compared.ResultsP16/Ki-67 dual-staining positivity increased with histopathological severity in premenopausal and postmenopausal women (P< 0.05), while no increasing trends of individual expression of p16 single staining and Ki-67 single staining were observed in postmenopausal women. P16/Ki-67 showed higher SPE (88.09% vs. 81.91%,P< 0.001) and PPV (33.8% vs. 13.18%,P< 0.001) in detecting CIN2/3, and higher SEN (89.97% vs. 82.61%,P= 0.012) and SPE (83.22% vs. 79.89%,P= 0.011) in detecting cancer in premenopausal women than postmenopausal women. For triaging the HR-HPV+ population to identify CIN2/3, p16/Ki-67 performed comparably to LBC in the premenopausal women, and showed higher PPV (51.14% vs. 23.08%,P< 0.001) in premenopausal than postmenopausal women. For triaging ASC-US/LSIL population, p16/Ki-67 demonstrated higher SPE and lower colposcopy referral rate than HR-HPV in both premenopausal and postmenopausal women.ConclusionsExpressions of p16/Ki-67 dual-staining between premenopausal and postmenopausal women are varied. P16/Ki-67 performs better in detecting cervical lesions in premenopausal women. For triaging, p16/Ki-67 is suitable for HR-HPV+ women, especially premenopausal women, to identify CIN2/3 and women with ASC-US/LSIL.