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Prognostic value of human papillomavirus 16/18 genotyping in low-grade cervical lesions preceded by mildly abnormal cytology

人乳头瘤病毒16/18 分型在细胞学轻度异常的低度宫颈病变中的预测价值

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Abstract

Histological low-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade 1 (LSIL/CIN1) preceded by normal or mildly abnormal cytology is recommended for conservative follow-up, with no separated management. In this study, we assessed the triage value of human papillomavirus (HPV) 16/18 genotyping in 273 patients with LSIL/CIN1. HPV16/18 genotyping was performed at baseline and follow-up was at 6-monthly intervals for up to 2 years. At each follow-up, women positive for cytology or high-risk HPV (hrHPV) were referred for colposcopy. Enrollment cytology, HPV16/18 genotyping, and questionnaire-obtained factors were linked to the 2-year cumulative progression rate. Univariate and multivariate analyses were performed taking into account time-to-event with Cox proportional hazard regression. The results showed that 190 cases (69.6%) regressed, 37 (13.6%) persisted, and 46 (16.8%) progressed. HPV16/18 positivity (hazard ratio (HR), 2.708; 95% confidence interval (CI), 1.432–5.121; P=0.002) is significantly associated with higher 2-year cumulative progression rate. Sub-analysis by enrollment cytology and age restricted the positive association among patients preceded by mildly abnormal cytology and aged 30 years or older. Immediate treatment is a rational recommendation for the high-risk subgroup, when good compliance is not assured.

概要

目的

评估人乳头瘤病毒(HPV)16/18 分型在细胞学正常或轻度异常的低度宫颈病变中的预测价值,为临床分流决策提供依据。

创新点

目前对于细胞学正常或轻度异常的低度宫颈病变患者缺乏有效分流策略。本研究首次探索HPV16/18 分型对这部分患者疾病转归的预测价值。

方法

新招募细胞学正常或轻度异常的低度宫颈病变患者,以6 个月为间隔随访2 年,采用Cox 回归模型对入组HPV16/18 分型结果与疾病转归进行关联分析。

结论

对于HPV16/18 阳性,细胞学轻度异常,且30 岁及以上的低度宫颈病变患者,可以考虑比保守随访更积极的诊疗方案。

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Acknowledgements

We thank all the patients who took part in this study. We thank Dr. Hong-yun WANG (Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China) for assistance with data entry.

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Corresponding authors

Correspondence to Jing Ye or Xiao-dong Cheng.

Additional information

Project supported by the Zhejiang Provincial Natural Science Foundation of China (No. LQ14H160007), the National Natural Science Foundation of China (No. 81402364), the Zhejiang Provincial Medical & Hygienic Science and Technology Project of China (No. 2013KYA104), the Special Fund for Scientific Research in the Public Interest from the National Health and Family Planning Commission of the People’s Republic of China (No. 2015SQ00243), and the National Key Research and Development Program of China (No. 2016YFC1302900)

ORCID: Jing YE, http://orcid.org/0000-0001-5976-7044

Contributors

Jing YE, Xing XIE, Wei-guo LU, and Xiao-dong CHENG conceived and designed the project. Bei CHENG, Yi-fan CHENG, and Ye-li YAO participated in the recruitment and follow-up of patients. Jing YE analyzed the data and wrote the manuscript. Xing XIE, Wei-guo LU, and Xiao-dong CHENG revised the manuscript. All authors agreed to be accountable for all aspects of the work. All authors read and approved the final manuscript.

Compliance with ethics guidelines

Jing YE, Bei CHENG, Yi-fan CHENG, Ye-li YAO, Xing XIE, Wei-guo LU, and Xiao-dong CHENG declare that they have no conflict of interest.

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients for being included in the study.

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Ye, J., Cheng, B., Cheng, Yf. et al. Prognostic value of human papillomavirus 16/18 genotyping in low-grade cervical lesions preceded by mildly abnormal cytology. J. Zhejiang Univ. Sci. B 18, 249–255 (2017). https://doi.org/10.1631/jzus.B1600473

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  • DOI: https://doi.org/10.1631/jzus.B1600473

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