Efficacy Analysis of Paiteling in Treating Persistent High-Risk Human Papillomavirus after Cervical Cancer Surgery

Summary

This retrospective cohort study evaluates the clinical efficacy of Paiteling, a Traditional Chinese Medicine compound, compared to recombinant human interferon gel in treating persistent high-risk human papillomavirus (HR-HPV) infection following cervical cancer surgery.

Abstract

Persistent infection with high-risk human papillomavirus (HR-HPV) following cervical cancer surgery poses a significant risk for disease recurrence and progression to vaginal intraepithelial neoplasia. This retrospective cohort study evaluated the comparative efficacy of Paiteling, a Traditional Chinese Medicine compound, versus recombinant human interferon gel in treating persistent HR-HPV infection post-hysterectomy. Thirty-six patients with persistent HR-HPV positivity were allocated to either Paiteling (n = 17) or interferon (n = 19) treatment groups. Comprehensive assessment included HPV DNA load, ThinPrep cytologic test results, and colposcopic findings at baseline, 6-month, and 12-month follow-ups. At 6 months, the interferon group demonstrated significantly higher cure rates (68.4% vs 17.6%, ²= 7.646, p = 0.006). However, a remarkable reversal was observed at 12 months, with Paiteling achieving superior clearance rates (94.1% vs 63.2%, ²=4.976, p = 0.044). Multivariable analysis confirmed Paiteling treatment as a strong predictor of HPV clearance (adjusted OR = 9.52, 95% CI: 1.11–220.32, p = 0.039). Subgroup analysis revealed consistent treatment effects across all HPV genotypes. Adverse events were mild and self-limiting, with no significant differences between groups (29.4% vs 10.5%, p. = 0.226). This study demonstrates Paiteling’s superior long-term efficacy for persistent postoperative HR-HPV infection, characterized by a unique delayed-but-sustained response pattern. The multi-targeted mechanism, favorable safety profile, and sustained viral clearance support Paiteling’s potential as an effective therapeutic option in postoperative management, though validation through larger prospective trials is warranted.

Introduction

Cervical cancer remains a significant global health burden, with persistent infection by high-risk human papillomavirus (HR-HPV) established as its primary cause¹. While surgical intervention is a cornerstone treatment for early-stage disease, persistent or re-emergent HR-HPV infection post-surgery poses a serious risk for cancer recurrence and the development of vaginal intraepithelial neoplasia (VAIN)². The key to ensuring long-term surgical success and improving patient survival lies in the effective clearance of residual HPV. The clinical challenge is substantial; studies indicate that a significant proportion of pat....

Protocol

This retrospective cohort study was conducted at Shengjing Hospital of China Medical University and approved by the Institutional Medical Ethics Review Committee (2023PS846K). The research adhered to the principles of the Declaration of Helsinki, and written informed consent was obtained from all participants before study enrollment. The reagents and the equipment used are listed in the Table of Materials.

1. Patient selection

A total of 36 patients who underwent hysterectomy for cervical malignancy were enrolled based on predefined criteria. Inclusion criteria comprised: age 32....

Results

The final analytical cohort comprised 36 patients with persistent high-risk HPV infection following cervical cancer surgery, while baseline characteristics demonstrated general comparability between treatment groups (Table 1), a statistically significant age difference was noted (Interferon group: 56.0 ± 5.6 years vs. Paiteling group: 50.0 ± 5.0 years; p. = 0.005). As illustrated in Figure 2, participants were allocated to either Paiteling (n = 17) or interferon (n .......

Discussion

This study provides compelling evidence supporting the superior long-term efficacy of Paiteling compared to interferon in managing persistent HR-HPV infection following cervical cancer surgery. Paiteling is proposed as an effective, conservative local therapy specifically tailored for the unique postoperative microenvironment, an area that currently lacks standardized treatment guidelines. The findings reveal a remarkable temporal pattern: while interferon demonstrated better initial response rates at 6 months, Paiteling.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
5% Acetic Acid	Chemical reagent	Shenzhen Andoff High-Tech Co., Ltd.	Shenzhen
Disposable Cervical Sampling Brush	Medical device	Hangzhou Aipeng Medical Instruments Co., Ltd.	Hangzhou
High-Risk HPV Nucleic Acid Detection Kit	Diagnostic reagent	Chaozhou Hybribio Biochemistry Co., Ltd.	Chaozhou
Lugol's Iodine Solution	Chemical reagent	Shenzhen Andoff High-Tech Co., Ltd.	Shenzhen
Opto-electronic Colposcope	Laboratory equipment	Leica Microsystems	Wetzlar
Paiteling Solution	Herbal preparation	Beijing Paiteling Biotechnology Co., Ltd.	Beijing
R Software (version 4.5.1)	Statistical software	R Foundation for Statistical Computing	Vienna
Recombinant Human Interferon $\alpha$-2b Gel	Pharmaceutical preparation	Zhaoke Pharmaceutical Co., Ltd.	Hefei
Sea Buckthorn Oil	Herbal preparation	Shengjing Hospital Pharmacy	Shenyang
ThinPrep® System (JY-8000B)	Laboratory equipment	Beijing Beidou Xinghang Biotechnology Co., Ltd.	Beijing