| 王 鹏,郭 珍,赵冬梅.高危型人乳头瘤病毒E6/E7 mRNA对未明确意义的非典型鳞状上皮细胞人群分流的意义[J].中国肿瘤,2019,28(11):876-882. |
| 高危型人乳头瘤病毒E6/E7 mRNA对未明确意义的非典型鳞状上皮细胞人群分流的意义 |
| Effects of Human Papilloma Virus E6/E7 mRNA on the Triage of Women with Cytological Atypical Squamous Cells of Undetermined Signification |
| 投稿时间：2019-09-24 |
| DOI：10.11735/j.issn.1004-0242.2019.11.A012 |
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| 中文关键词: 人乳头瘤病毒 mRNA DNA 未明确意义的非典型鳞状上皮细胞 宫颈上皮内瘤样病变 诊断 |
| 英文关键词:human papilloma virus mRNA DNA atypical squamous cells of undetermined signification cervical intraepithelial neoplasia diagnosis |
| 基金项目:国家自然科学基金（81502475)，河南省科技攻关计划项目(172102310067) |
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| 中文摘要: |
| 摘 要：［目的］ 评价人乳头瘤病毒（human papilloma virus，HPV）E6/E7mRNA检测对未明确意义的非典型鳞状上皮细胞（atypical squamous cells of undetermined signification，ASCUS）人群的分流效果。［方法］ 选择在郑州大学第二附属医院妇科就诊的20~65岁且细胞学检测结果为ASCUS的135例妇女作为研究对象，采用 cobas 4800 HPV和APTIMA HPV实验技术分别检测HPV DNA及 HPV E6/E7 mRNA，所有妇女均行阴道镜活检和病理学检查，并以病理学诊断作为金标准，分别计算高危型HPV(HR-HPV）DNA、HPV E6/E7 mRNA和HPV16/18检测的敏感性、特异性、阳性预测值（positive predictive value，PPV）、阴性预测值（negative predictive value，NPV）、转诊率及其95%CI值。 ［结果］ 135例妇女的平均年龄为（46.48±10.19）岁。以CIN2+作为疾病终点指标时，HPV E6/E7 mRNA分流ASCUS人群的敏感性、特异性、PPV、NPV、转诊率分别为：86.4%(19/22，95%CI：66.7%～95.3%)、77.9%(88/113，95%CI：69.4%～84.5%)、43.2%(19/44，95%CI：29.7%～57.8%)、96.7%（88/91，95%CI：90.8%～98.9%)、32.6%(44/135)，与之相比，HR-HPV的敏感性高［95.5%（21/22，95%CI：78.2%～99.2%)］，但特异性很低［68.1%(77/113，95%CI：59.1%～76.0%)］，但差异无统计学意义（P>0.05）。HPV16/18的特异性高［ 92.9%(105/113，95%CI：86.7%～96.4%)］，但敏感性很低［ 59.1%(13/22，95%CI：38.7%～76.7%)］。以CIN3+作为疾病终点指标时，三种筛查方法对ASCUS人群分流的特异性与CIN2+为终点时类似，但敏感性均提高。年龄分层后显示以CIN2+为终点时，HPV E6/E7mRNA 在年龄≥45岁的ASCUS人群中分流效果更好，敏感性、特异性及阳性预测值均高于HR-HPV，但差异无统计学意义（P>0.05）。［结论］从对筛查方法敏感性和特异性应均较高的方面考虑，HPV E6/E7 mRNA 检测用于ASCUS 人群分流，效果可能优于HR-HPV和HPV16/18检测，可以避免不必要的阴道镜转诊，且降低了漏诊率。 |
| 英文摘要: |
| Abstract：［Purpose］ To evaluate the performance of human papilloma virus(HPV) E6/E7 mRNA test for triage of Chinese women with atypical squamous cells of undetermined signification(ASCUS). ［Methods］ A total of 135 women with ASCUS aged 20~79 years were selected from the Second Affiliated Hospital of Zhengzhou University. HPV DNA and HPV E6/E7 mRNA were detected by using cobas 4800 HPV and APTIMA HPV technology，respectively. All women underwent colposcopy biopsy and pathological examination，and pathological diagnosis was used as the gold standard. The sensitivity，specificity，positive predictive value(PPV)，negative predictive value(NPV)，and referral rate with corresponding 95% confidence intervals(CIs) of HPV DNA，HPV E6/E7 mRNA，and HPV16/18 tests were calculated. ［Results］ The mean age of the 135 women was(46.48±10.19) years. In CIN2+ patients，the sensitivity，specificity，PPV，NPV，and referral rate of woman with ASCUS detected by using HPV E6/E7 mRNA test were 86.4%(19/22，95%CI：66.7%~95.3%)，77.9%(88/113，95%CI：69.4%~84.5%)，43.2%(19/44，95%CI：29.7%~57.8%)，96.7%(88/91，95%CI：90.8%~98.9%)，32.6%(44/135). Compared with HPV E6/E7 mRNA test，HR-HPV test had higher sensitivity［95.5%(21/22，95%CI：78.2%~99.2%)］ and lower specificity［36.8%(77/113，95%CI：25.5%~49.8%)］，but the difference was not significant(P>0.05). HPV16/18 test had high specificity［92.9%(105/113，95%CI：86.7%~96.4%)］，but the sensitivity was very low［59.1%(13/22，95%CI：38.7%~76.7%)］. HPV E6/E7 mRNA，HR-HPV，and HPV16/18 tests showed a similar specificity and a higher sensitivity in CIN3+ patients when compared with their performance in CIN2+ patients. After age stratification，HPV E6/E7 mRNA test had a better triage effect in CIN2+ patients with age ≥45，and the sensitivity，specificity，and PPV of HPV E6/E7 mRNA test were all higher than those of HR-HPV test，but the difference was not significant(P>0.05). ［Conclusion］ Considering the sensitivity and specificity of the screening method，HPV E6/E7 mRNA detection is possibly better than HR-HPV and HPV16/18 detection for triaging ASCUS woman，which could avoid unnecessary transvaginal referral and reduce the rate of missed diagnosis. |
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