Objectives: Persistent infection with high-risk human papillomavirus (HR-HPV) is a major cause of cervical precancerous lesions and cervical cancer. This study aimed to evaluate the effectiveness of Qingdu Suppository (QDS) in promoting HPV clearance and to identify predictors of treatment response.
Methods: This was a prospective observational cohort with retrospective analysis. A total of 60 patients with persistent HR-HPV infection were included (30 QDS and 30 non-QDS). The primary endpoint was HPV clearance, defined as 2 consecutive negative PCR results ≥6 months apart. Intention-to-treat (ITT, n=66, with lost-to-follow-up treated as persistent infection) and per-protocol (PP, n=60) analyses were performed. Inverse probability of treatment weighting (IPTW) was applied, and robust (sandwich) variance estimators were used to obtain valid confidence intervals.
Results: In the IPTW-weighted analysis, QDS was associated with higher HPV clearance than non-QDS (55.2% vs. 3.4%, p<.001). HPV clearance was significantly higher in the QDS group than in the non-QDS group (55.2% vs. 3.4%, p<.001). QDS remained an independent predictor of clearance (adjusted OR=33.1, 95% CI: 4.5-243.6, p=.001), with consistent benefits across subgroups.
Conclusions: Using a strict endpoint of 2 consecutive negatives, QDS was associated with higher HPV clearance. Results were consistent across analytic approaches but should be interpreted with caution, given the limited sample size and nonrandomized design. QDS may represent a promising adjunctive therapy, but its efficacy and long-term benefits require confirmation in larger multicenter randomized controlled trials.
Keywords: Qingdu suppository; influencing factors; persistent HR-HPV; retrospective cohort study; traditional Chinese medicine.
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