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

Efficacy of Wenyang Sanhan Qushi Formula for persistent high-risk human papillomavirus infection in women

摘要

目的 本研究旨在评价温阳散寒祛湿方在治疗阳虚寒湿型高危型人乳头瘤病毒（high-risk human papillomavirus，HR-HPV）持续感染女性患者中的有效性及安全性。方法 本研究为前瞻性、随机、开放标签、平行对照临床试验，于2024年5月至11月在首都医科大学附属北京安贞医院开展，纳入126名年龄24～77岁、HR-HPV持续感染≥12个月且中医辨证为阳虚寒湿证的女性患者，按1∶1随机分为治疗组（n=63）和对照组（n=63）。治疗组给予温阳散寒祛湿方剂，同时给予生活方式指导；对照组仅给予生活方式指导。主要终点为治疗后6个月HPV清除有效率（原有HPV型别完全转阴和/或亚型显著减少），次要终点包括HPV亚型的完全转阴率、TCT异常者的细胞学完全转阴率及安全性。结果 共106名受试者完成研究（治疗组54例，对照组52例），基线特征均衡。治疗组总有效率显著优于对照组（77.8% vs. 42.3%，P=0.0004），完全转阴率更高（66.7% vs. 32.7%）。基线TCT异常者中，治疗组细胞学转阴率显著高于对照组（42.3% vs. 11.5%，P=0.0266）。部分HR-HPV亚型转阴率较高，HPV 39、58、66型实现完全清除。安全性方面，两组均无严重不良事件。结论 温阳散寒祛湿方治疗阳虚寒湿证HR-HPV持续感染的有效性显著优于单纯生活方式干预，且安全性良好，为HR-HPV持续感染提供了新的非侵入性治疗选择。

Abstract

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=0.0004), 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=0.0266). 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.

关键词

人乳头瘤病毒 / 持续感染 / 中药 / 阳虚寒湿证 / 随机对照试验

Key words

human papillomavirus / persistent infection / Traditional Chinese Medicine / herbal medicine / randomized controlled trial

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基金资助

湖北省生殖医学临床医学研究中心开放课题基金(2025RMOF018)