Abstract：
To evaluate the clinical utility of p16/Ki67 dual-stain (DS) compared with cytology for detecting cervical intraepithelial lesion grade two or worse (CIN2+) in women with a transformation zone type 3 (TZ3).
Cross-sectional study.
Colposcopy clinics in Central Denmark Region.
Women aged 45 years or older referred for colposcopy because of an abnormal screening test.
All women had a cervical sample collected for cytology and DS testing and underwent large-loop excision of the transformation zone (LLETZ).
Sensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology.
Of 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4-70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty-two women (55.9%) were DS-positive, 29 (55.8%) of whom had CIN2+ detected. Twenty-seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC-US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p = 0.021) and NPV (97.6% versus 86.4%, p = 0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p = 0.001) were lower for DS compared with cytology.
Dual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS-negative women.
Cross-sectional study.
Colposcopy clinics in Central Denmark Region.
Women aged 45 years or older referred for colposcopy because of an abnormal screening test.
All women had a cervical sample collected for cytology and DS testing and underwent large-loop excision of the transformation zone (LLETZ).
Sensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology.
Of 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4-70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty-two women (55.9%) were DS-positive, 29 (55.8%) of whom had CIN2+ detected. Twenty-seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC-US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p = 0.021) and NPV (97.6% versus 86.4%, p = 0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p = 0.001) were lower for DS compared with cytology.
Dual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS-negative women.
摘要：
目的：评估p16/Ki67双重染色（DS）与细胞学检查相比，在3型转化区（TZ3）女性中检测宫颈上皮内病变2级或更差（CIN2）的临床实用性。
方法：横断面研究。
方法：位于丹麦中部地区的阴道镜诊所。
方法：45岁或以上的女性因筛查试验异常而进行阴道镜检查。
方法：所有女性都收集了用于细胞学和DS检测的宫颈样本，并对转化区进行了大环切除（LLETZ）。
方法：灵敏度，将DS对CIN2+检测的特异性和阴性（NPV）和阳性（PPV）预测值与细胞学的预测值进行比较。
结果：在166名符合条件的女性中，93（56.0％）包括在最终分析中。中位年龄为68岁（四分位距[IQR]63.4-70.5岁）。大多数妇女是绝经后（95.7％），并根据人乳头瘤病毒筛查试验阳性（86.0％）转诊。52名女性（55.9％）为DS阳性，29人（55.8%）检测到N2+CI。27名（29.0%）女性患有不确定意义或更差的非典型鳞状细胞（ASC-US+），21名女性(77.8%)检测到N2+。DS具有更高的灵敏度（96.7%对70.0%p=0.021）和NPV（97.6%对86.4%，p=0.018）与细胞学检测CIN2+相比。相比之下,特异性(63.5%对90.5%p<0.001)和PPV(55.8%对77.8%，与细胞学相比，DS的p=0.001）较低。
结论：双重染色可能是指导TZ3患者临床治疗的一个有价值的风险标记。DS的高NPV表明，DS阴性女性可以安全地避免诊断性切除。
方法：横断面研究。
方法：位于丹麦中部地区的阴道镜诊所。
方法：45岁或以上的女性因筛查试验异常而进行阴道镜检查。
方法：所有女性都收集了用于细胞学和DS检测的宫颈样本，并对转化区进行了大环切除（LLETZ）。
方法：灵敏度，将DS对CIN2+检测的特异性和阴性（NPV）和阳性（PPV）预测值与细胞学的预测值进行比较。
结果：在166名符合条件的女性中，93（56.0％）包括在最终分析中。中位年龄为68岁（四分位距[IQR]63.4-70.5岁）。大多数妇女是绝经后（95.7％），并根据人乳头瘤病毒筛查试验阳性（86.0％）转诊。52名女性（55.9％）为DS阳性，29人（55.8%）检测到N2+CI。27名（29.0%）女性患有不确定意义或更差的非典型鳞状细胞（ASC-US+），21名女性(77.8%)检测到N2+。DS具有更高的灵敏度（96.7%对70.0%p=0.021）和NPV（97.6%对86.4%，p=0.018）与细胞学检测CIN2+相比。相比之下,特异性(63.5%对90.5%p<0.001)和PPV(55.8%对77.8%，与细胞学相比，DS的p=0.001）较低。
结论：双重染色可能是指导TZ3患者临床治疗的一个有价值的风险标记。DS的高NPV表明，DS阴性女性可以安全地避免诊断性切除。
