Effectiveness and safety of REBACIN as a non-invasive intervention for persistent high-risk human papillomavirus infection: A real-world prospective multicenter cohort study

作者全名："Chen, Fei; Zhang, Guo-Nan; Lei, Wei; Zhou, Shu-Guang; Zhang, Ying; Liu, Lin; Jia, Ying; Xie, Rong-Kai; Tian, Xiu-Fang; Guo, Jie; Yang, Yue-Bo; Wang, Xue-Feng; Wu, Xiao-Mei; Sun, Qi-Jian; Zhou, Xu; Lin, Yang; Zhang, You-Zhong; Ma, Jun-Qi; Liu, Yu-Xiu; Cheng, Yi-Fan; Chen, Jian-Cui; Qu, Quan-Xin; Du, Dong-Mei; Wang, Gui-Yu; Wang, Sheng; Ling, Yu -Li; Wu, Dai-Fei; Zhang, Chun-Fa; Lang, Jing-He"

作者地址："[Chen, Fei; Lang, Jing-He] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Natl Clin Res Ctr Obstet & Gynecol Dis, Beijing, Peoples R China; [Chen, Fei; Lang, Jing-He] Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China; [Zhang, Guo-Nan] Sichuan Canc Hosp & Inst, Chengdu, Peoples R China; [Lei, Wei] Sichuan Univ, West China Univ Hosp 2, Chengdu, Peoples R China; [Zhou, Shu-Guang] Anhui Med Univ, Affiliated Matern & Child Healthcare Hosp, Hefei, Peoples R China; [Zhang, Ying; Liu, Lin] Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China; [Jia, Ying] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Xie, Rong-Kai] Army Med Univ, Xinqiao Hosp, Chongqing, Peoples R China; [Tian, Xiu-Fang] Peking Univ, BinHai Hosp, Tianjin, Peoples R China; [Guo, Jie] Tianjin Univ Tradit Chinese Med, Affiliated Hosp 2, Tianjin, Peoples R China; [Yang, Yue-Bo] Sun Yat Sen Univ, Affiliated Hosp 3, Guangzhou, Peoples R China; [Wang, Xue-Feng] Southern Med Univ, Affiliated Hosp 3, Guangzhou, Peoples R China; [Wu, Xiao-Mei] First Peoples Hosp Yunnan Prov, Kunming, Peoples R China; [Sun, Qi-Jian] Kunming Med Univ, Affiliated Hosp 1, Kunming, Peoples R China; [Zhou, Xu; Lin, Yang] Second Hosp Jilin Univ, Changchun, Peoples R China; [Zhang, You-Zhong] Shandong Univ, Qilu Hosp, Jinan, Peoples R China; [Ma, Jun-Qi] Xinjiang Med Univ, Affiliated Hosp 1, Urumqi, Peoples R China; [Liu, Yu-Xiu] China Mongolia Hosp Ulanqab, Ulanqab, Peoples R China; [Cheng, Yi-Fan] Zhejiang Univ, Womens Hosp, Sch Med, Hangzhou, Peoples R China; [Chen, Jian-Cui] Fujian Prov Maternal & Child Hlth Care Hosp, Fuzhou, Peoples R China; [Qu, Quan-Xin] Tianjin First Cent Hosp, Tianjin, Peoples R China; [Du, Dong-Mei; Wang, Gui-Yu; Wang, Sheng; Ling, Yu -Li] Key Lab Prot Engn & Drug Dev Hainan, Haikou, Peoples R China; [Wu, Dai-Fei; Zhang, Chun-Fa] SR Life Sci Inst, Gaithersburg, MD USA; [Lang, Jing-He] 1 Shuaifuyuan Wangfujing Dongcheng Dist, Beijing 100730, Peoples R China"

通信作者："Lang, JH (通讯作者)，1 Shuaifuyuan Wangfujing Dongcheng Dist, Beijing 100730, Peoples R China."

来源：GYNECOLOGIC ONCOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001079282100001

JCR分区：Q1

影响因子：4.5

年份：2023

卷号：178

期号：　

开始页：8

结束页：13

文献类型：Article

关键词：REBACIN; Human papilloma virus (HPV); Clearance; Cervical cancer; Real-world study

摘要："Background. We previously reported that REBACIN effectively eliminates persistent high-risk human papillomavirus (hrHPV) infection. Here, we conducted a prospective multicenter cohort study to evaluate the safety and effectiveness of REBACIN, taking into account factors such as specific hrHPV subtype and patient's age. Methods. According to inclusion/exclusion criteria and participant willingness, 3252 patients were divided into REBACIN group while 249 patients into control group. Patients in REBACIN group received one course treatment of intravaginal administration of REBACIN while no treatment in control group. After drug withdrawal, participants in both groups were followed up.Results. The clearance rate of persistent hrHPV infection in REBACIN group was 60.64%, compared to 20.08% in control group. Specifically, the clearance rates for single-type infection of HPV16 or HPV18 were 70.62% and 69.23%, respectively, which was higher than that of HPV52 (59.04%) or HPV58 (62.64%). In addition, the single, double, and triple/triple+ infections had a clearance rate of 65.70%, 53.31%, and 38.30%, respectively. Moreover, 1635 patients under 40 years old had a clearance rate of 65.14%, while it was 55.08% for 1447 patients over 40 years old. No serious adverse effects were found.Conclusion. This study confirmed that REBACIN can effectively and safely eliminate persistent hrHPV infection, which the clearance rate of HPV16/18 is higher than that of HPV52/58, the clearance rate of single-type infection is higher than that of multiple-type infections, and the clearance rate in young patients is higher than that in elder patients, providing a guidance for REBACIN application in clearing hrHPV persistent infection in real -world settings.Clinical trial registration. Chinese Clinical Trial Registry Registration Number: ChiCTR1800015617 http://www.chictr.org.cn/showproj.aspx?proj=26529Date of Registration: 2018-04-11 (c) 2023 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/)."

基金机构：Beijing Union Medical College Hospital & Central Higher Hospital Clinical Research Special Fund [2022-PUMCH-D-003]

基金资助正文：<B>Funding</B> This research was supported by the Beijing Union Medical College Hospital & Central Higher Hospital Clinical Research Special Fund (No. 2022-PUMCH-D-003) .