人民卫生出版社系列期刊
ISSN 2096-2738 CN 11-9370/R

中国科技核心期刊(中国科技论文统计源期刊)
中国科学引文数据库(CSCD)来源期刊
《中国学术期刊影响因子年报》统计源期刊
美国化学文摘社(CAS)数据库收录期刊
日本科学技术振兴机构(JST)数据库收录期刊

新发传染病电子杂志 ›› 2025, Vol. 10 ›› Issue (3): 53-57.doi: 10.19871/j.cnki.xfcrbzz.2025.03.009

• 论著 • 上一篇    下一篇

芩苓子阴道灌注液与人干扰素α2b阴道泡腾片治疗高危型人乳头瘤病毒感染的疗效对比研究

宋清霞1, 孙凤丹1, 徐丹1, 张乐梅1, 高银艳2, 玄振玉3   

  1. 1.苏州市中医医院/妇科,江苏 苏州 215000;
    2.苏州玉森新药开发有限公司医学中心,江苏 苏州 215123;
    3.苏州大学药学院 江苏 苏州 215123
  • 收稿日期:2024-10-12 出版日期:2025-06-30 发布日期:2025-07-24
  • 通讯作者: 玄振玉,Email:xuanzhenyu@ys6919.wecom.work
  • 基金资助:
    2024年度江苏省中医流派研究院开放课题(JSZYLP2024009)

A comparative study of the efficacy of Qinlingzi vaginal infusion and human interferon α2b vaginal effervescent tablets in the treatment of high-risk human papilloma virus infection

Song Qingxia1, Sun Fengdan1, Xu Dan1, Zhang Lemei1, Gao Yinyan2, Xuan Zhenyu3   

  1. 1. Department of Gynecology, Suzhou Hospital of Traditional Chinese Medicine, Jiangsu Suzhou 215000, China;
    2. Department of Medical Center, Suzhou Yusen Drug Development Co., LTD., Jiangsu Suzhou 215123, China;
    3. College of Pharmaceutical Sciences, Soochow University, Jiangsu Suzhou 215123, China
  • Received:2024-10-12 Online:2025-06-30 Published:2025-07-24

摘要: 目的 评估芩苓子阴道灌注液与人干扰素α2b阴道泡腾片在治疗高危型人乳头瘤病毒(human papilloma virus,HPV)感染中的疗效和安全性。方法 选择苏州市中医医院2022年10月至2023年8月高危型HPV 16或18感染患者作为研究对象。共纳入180例患者,按随机数字表法分为两组,其中90例对照组给予人干扰素α2b阴道泡腾片治疗,90例研究组给予芩苓子阴道灌注液治疗。比较两组用药3个月、6个月后HPV转阴率、中医证候积分、不良反应发生情况。结果 对照组HPV转阴的总有效率3个月为20.00%,6个月为33.33%,均显著低于研究组3个月55.56%和6个月71.11%的总有效率,差异有统计学意义(P<0.05)。治疗后,研究组的中医证候积分显著低于对照组(P<0.05)。对比两组患者不同年龄段用药3个月和6个月后HPV转阴率,对照组中,治疗3个月以及治疗6个月,均以19~30岁患者疗效最佳(88.89%、100.00%);研究组中,治疗3个月以及治疗6个月,均以19~30岁患者疗效最佳(100.00%、100.00%);组间对比,治疗3个月,研究组19~30岁、>30~40岁、>40岁患者疗效均优于对照组,但仅有>30~40岁、>40岁组间对比差异有统计学意义(均P<0.05);治疗6个月,研究组>30~40岁、>40岁患者疗效均优于对照组,但仅有>30~40岁组间对比差异有统计学意义(P<0.05);两组患者炎症因子水平对比,治疗前转化生长因子-β1(transforming growth factor-β1,TGF-β1)、白介素-6(interleukin-6,IL-6)水平均无差异(P>0.05);治疗3个月、6个月,两组TGF-β1水平均下降,IL-6水平均上升,研究组TGF-β1水平均低于对照组,IL-6水平均高于对照组(均P<0.05)。两组中医证候积分及不良反应发生率无显著差异。结论 芩苓子阴道灌注液治疗高危型HPV的疗效优于人干扰素α2b阴道泡腾片,能显著改善临床症状,安全性良好。

关键词: 芩苓子, 人干扰素α2b阴道泡腾片, 高危型人乳头瘤病毒, 宫颈病变, 中医证候积分

Abstract: Objective To evaluate the efficacy and safety of Qinlingzi vaginal infusion and human interferon α2b vaginal effervescent tablets in treating high-risk human papillomavirus (HPV) infection, and to explore the potential advantages of Qinlingzi vaginal infusion in clinical applications. Method Patients with high-risk HPV infection from Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine between October 2022 and August 2023 were selected as research subjects. A total of 180 patients were included, with 90 patients in the control group receiving interferon α2b vaginal effervescent tablets and 90 patients in the study group received Qinlingzi vaginal infusion treatment. The HPV clearance rates, traditional Chinese medicine (TCM) syndrome scores, and adverse reactions were compared between the two groups after 3 and 6 menstrual cycles of treatment. Result The overall effective rate of HPV clearance in the control group was 20.00% at 3 months and 33.33% at 6 months, both significantly lower than that in the study group, which was 55.56% at 3 months and 71.11% at 6 months, with statistically significant differences (P<0.05). After treatment, the TCM syndrome score in the study group was significantly lower than that in the control group (P<0.05). The HPV clearance rates at 3 months and 6 months post-treatment were compared across different age groups in both groups. In the control group, the best efficacy was observed in the 19-30 age group, with rates of 88.89% at 3 months and 100.00% at 6 months. In the study group, the 19-30 age group also showed the best efficacy, with 100.00% clearance rates at both 3 and 6 months. When comparing the two groups, at 3 months, the efficacy in the 19-30, >31-40, and >40 age groups was better in the study group than in the control group, but significant differences were only found in the >31-40 and >40 age groups (P<0.05). At 6 months, the efficacy in the >31-40 and >40 age groups was better in the study group, with a significant difference only in the >31-40 age group (P<0.05). Regarding inflammatory factor levels, there were no significant differences in the levels of Transforming Growth Factor-β1 (TGF-β1) and Interleukin-6 (IL-6) between the two groups before treatment (P>0.05). After 3 and 6 months of treatment, TGF-β1 levels decreased and IL-6 levels increased in both groups. However, the study group had significantly lower TGF-β1 and higher IL-6 levels compared to the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups. Conclusion The therapeutic effect of Qinlingzi vaginal lavage solution on high-risk HPV is superior to that of interferon α2b vaginal effervescent tablets. It can significantly improve clinical symptoms and has good safety.

Key words: Qinlingzi, Human interferon alpha 2b vaginal effervescent tablets, High-risk human papillom avirus, Cervical lesions, Traditional Chinese Medicine syndrome integral

中图分类号: