温阳散寒祛湿方治疗宫颈高危型人乳头瘤病毒持续感染的有效性研究OA

Objective This study aimed to evaluate the efficacy and safety of Wenyang Sanhan Qushi Formula(Yang-Warming,Cold-Dissipating,and Dampness-Dispelling Formula,WYSHQSF)for persistent HR-HPV infection manifesting yang deficiency with cold-damp obstruction pattern.Methods In this prospective,randomized,open-label,parallel-group clinical trial conducted at Beijing Anzhen Hospital between May and November 2024,we enrolled 126 women aged 24-77 years with persistent HR-HPV infection lasting≥12 months,characterized by the yang deficiency with cold-damp obstruction pattern.Participants were randomly assigned 1∶1 to receive either WYSHQSF combined with lifestyle intervention alone(n=63)or lifestyle intervention alone(n=63).The primary outcome was overall HPV clearance efficacy rate at 6 months,defined as complete viral clearance or significant reduction in detectable subtypes.Secondary outcomes included subtype-specific clearance rates across 12 HR-HPV genotypes,cytological normalization among participants with abnormal baseline TCT result,and comprehensive safety monitoring.Results Among 106 participants completing the study(54 in the treatment group,52 in the control group),baseline characteristics were well-balanced.The treatment group demonstrated significantly superior overall efficacy compared to controls(77.8%vs.42.3%;P=0.000 4),with markedly higher complete viral clearance rates(66.7%vs.32.7%).TCT normalization rates among participants with abnormal baseline cytology were significantly higher in the treatment group(42.3%vs.11.5%,P=0.026 6).Moreover,subtype-specific analyses revealed consistently higher clearance rates across most HR-HPV genotypes,with complete clearance achieved for HPV 39,58,and 66.No serious adverse events were reported in either group.Conclusion WYSHQSF achieved significantly superior HPV clearance efficacy compared to lifestyle intervention alone,with excellent safety profiles.These findings provide alternatives for women seeking non-invasive options.