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

Autor: Chen F; National Clinical Research Center for Obstetric & Gynecologic Diseases, and Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China., Zhang GN; Sichuan Cancer Hospital & Institute, Chengdu, China., Lei W; West China Second University Hospital, Sichuan University, Chengdu, China., Zhou SG; Anhui Medical University Affiliated Maternity and Child Healthcare Hospital, Hefei, China., Zhang Y; The First Affiliated Hospital of Anhui Medical University, Hefei, China., Liu L; The First Affiliated Hospital of Anhui Medical University, Hefei, China., Jia Y; The First Affiliated Hospital of Chongqing Medical University, Chongqing, China., Xie RK; Xinqiao Hospital Army Medical University, Chongqing, China., Tian XF; Peking University BinHai Hospital, Tianjin, China., Guo J; The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China., Yang YB; The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China., Wang XF; The Third Affiliated Hospital of Southern Medical University, Guangzhou, China., Wu XM; The First People's Hospital of Yunnan Province, Kunming, China., Sun QJ; First Affiliated Hospital of Kunming Medical University, Kunming, China., Zhou X; The Second Hospital of Jilin University, Changchun, China., Lin Y; The Second Hospital of Jilin University, Changchun, China., Zhang YZ; Qilu Hospital of Shandong University, Jinan, China., Ma JQ; The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China., Liu YX; China-Mongolia Hospital of Ulanqab, Ulanqab, China., Cheng YF; The Women's Hospital School of Medicine Zhejiang University, Hangzhou, China., Chen JC; Fujian Provincial Maternal and Child Health Care Hospital, Fuzhou, China., Qu QX; Tianjin First Central Hospital, Tianjin, China., Du DM; Key Laboratory of Protein Engineering and Drug Development of Hainan, Haikou, China., Wang GY; Key Laboratory of Protein Engineering and Drug Development of Hainan, Haikou, China., Wang S; Key Laboratory of Protein Engineering and Drug Development of Hainan, Haikou, China., Ling YL; Key Laboratory of Protein Engineering and Drug Development of Hainan, Haikou, China., Wu DF; SR Life Sciences Institute, MD, USA., Zhang CF; SR Life Sciences Institute, MD, USA., Lang JH; National Clinical Research Center for Obstetric & Gynecologic Diseases, and Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. Electronic address: lxiehe@163.com.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2023 Nov; Vol. 178, pp. 8-13. Date of Electronic Publication: 2023 Sep 19.
DOI: 10.1016/j.ygyno.2023.09.004
Abstrakt: 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=26529 Date of Registration: 2018-04-11.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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