• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

LUO Yan-yan1, DAI Xin-zhen2, LIAO Yan-ting1, LUO Xiao-wan2, FU Li-hua1

DOI: 10.12201/bmr.202410.00056
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Objective: To explore the significance of HPV L1 capsid protein and p16 protein in the clinical outcomes of cervical low-grade squamous intraepithelial lesions with persistent high-risk HPV infection. Method: Immunohistochemical analysis of HPV L1 and p16 was conducted on cervical tissues from 114 patients with persistent high-risk HPV infection and pathologically confirmed LSIL who were treated at the Cervical Disease Center of Zhongshan Boai Hospital from January 2022 to July 2022, and follow-up was conducted. The follow-up results are divided into three categories: progression, persistence, and regression. Results:25 out of 114 LSIL patients progressed to HSIL, with a cumulative progression rate of 21.93% (25/114). Among them, 14 cases (14/37, 37.84%) were positive for HPV16/18 and 11 cases (11/77, 14.29%) were positive for other types, with statistically significant differences between the two (χ2=8.097, p=0.004). The positive rates of HPV L1 and p16 were 25.44% (29/114) and 39.47% (45/114), respectively; In individual testing, HPV L1 (+) expression was highest in the regression group at 68.97%, with statistically significant differences between the progression group and the persistence group (χ2=24.931, p=0.000); there was no statistically significant difference in p16 (+) expression among the three groups.In joint testing, the cumulative regression rates of HPV L1 (+)/p16 (+), HPV L1 (+)/p16 (-), and HPV L1 (-)/p16 (+) expression were 60.00%, 78.57%, and 43.64%, respectively, with statistically significant differences in cumulative progression rate and persistence rate. Stratified analysis revealed that when tested individually, the regression rate of HPV L1(+) expression at 24 months was higher than that of p16(+) expression, with a statistically significant difference ((χ2=4.270, p=0.038). When combined detection was performed, the progression rate of HPV L1 (-)/p16 (+) expression at 6 and 12 months was higher than that of other immunohistochemical groups, and the difference was statistically significant; The regression rate of HPV L1 (+)/p16 (-) expression in the 24th month was higher than that of other immunohistochemical groups, and the difference was statistically significant ((χ2=8.045, p=0.045) .The results of binary Logistic regression analysis showed that HPV16/18 and p16 positive were risk factors for the progression of LSIL, with OR values of 3.242 (95% CI: 1.261-8.336) and 2.714 (95% CI: 1.055-6.980), respectively. Conclusion: The analysis of persistent infection types of high-risk HPV, as well as immunohistochemical detection of HPV L1 capsid protein and p16 protein, have certain clinical value in the clinical outcomes of LSIL patients with persistent infection of high-risk HPV, which can help guide clinical physicians to conduct individualized follow-up and triage management of LSIL patients with persistent infection of high-risk HPV.

    Key words: low-grade squamous intraepithelial lesion of the cervix; human papillomavirus; HPV L1 capsid protein; p16 protein; outcome

    Submit time: 19 October 2024

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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    1 2024-09-28

    10.12201/bmr.202410.00056V1

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DAI Xin-zhen, LIAO Yan-ting, LUO Xiao-wan, FU Li-hua. LUO Yan-yan1, DAI Xin-zhen2, LIAO Yan-ting1, LUO Xiao-wan2, FU Li-hua1. 2024. biomedRxiv.202410.00056

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