预防性四价 HPV 疫苗可否用于 CIN 妇女的治疗？一项随机试验。
Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial.
机构信息
Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Shahid Sadoughi University of Medical Science, Yazd, Iran.
出版信息
BMC Public Health. 2020 Feb 27;20(1):274. doi: 10.1186/s12889-020-8371-z.
BACKGROUND
Human papillomavirus (HPV) is one of the most significant risk factors for cervical cancer. The HPV vaccine has a very significant impact on the incidence of cervical cancer. The present study aimed to investigate the impact of prophylactic quadrivalent HPV vaccine in the treatment of women with cervical intraepithelial neoplasia (CIN 1-3).
METHODS
This randomized controlled trial was conducted in the Shahid Sadoughi University of Medical Sciences (SSUMS), Yazd, Iran, from October 2011 to November 2015 in women with histologically confirmed residual/recurrent CIN 1 or high-grade CIN (CIN 2-3). Eligible women were assigned randomly to an intervention and a control group. Women in the intervention group were given HPV vaccinations while those in the control group were not. Participants were followed up for 24 months. Primary and secondary outcomes, and adverse effects of the treatment in the two groups were compared using Student's t test, the chi-square test, or Fisher's exact test. P values < 0.05 or less were considered statistically significant.
RESULTS
Three-hundred and twelve women were randomized to the two groups; the data of 138 in the intervention group and 104 in the control group were analyzed. The mean age of the women was 32.59 ± 4.85 years. Differences in age, marital status, and grades of CIN weren't significant between the two groups. At the end of the two-year follow-up period, the number of women with CIN 2-3 in the intervention and control groups was reduced by 75% (from 93 to 23) versus 40% (from 69 to 41). The efficacy of the HPV vaccine in women with CIN 1-3 was 58.7% (p = 0.018). No serious adverse effects related to the vaccines were reported.
CONCLUSIONS
The prophylactic quadrivalent HPV vaccine after treatment may have a therapeutic effect in women with residual/recurrent CIN 1 or high-grade CIN (CIN 2-3).
TRIAL REGISTRATION
Iranian Registry of Clinical Trials, IRCT20190603043801N1. Registered 24 July 2019 - Retrospectively registered, http://www.irct.ir/user/trial/40017/view.
背景
人乳头瘤病毒（HPV）是宫颈癌的最重要危险因素之一。HPV 疫苗对宫颈癌的发病率有非常显著的影响。本研究旨在探讨预防性四价 HPV 疫苗在治疗宫颈上皮内瘤变（CIN 1-3）女性中的作用。
方法
这是一项随机对照试验，于 2011 年 10 月至 2015 年 11 月在伊朗萨迪戈德沙希德大学医学科学（SSUMS）进行，纳入经组织学证实的残留/复发 CIN 1 或高级别 CIN（CIN 2-3）的女性。符合条件的女性被随机分配到干预组和对照组。干预组女性接种 HPV 疫苗，而对照组女性未接种。两组均随访 24 个月。采用 Student's t 检验、卡方检验或 Fisher 精确检验比较两组的主要和次要结局以及治疗的不良反应。P 值<0.05 或更小被认为具有统计学意义。
结果
312 名女性被随机分为两组；干预组 138 名和对照组 104 名女性的数据进行了分析。女性的平均年龄为 32.59±4.85 岁。两组间的年龄、婚姻状况和 CIN 分级无显著差异。在 2 年的随访期结束时，干预组和对照组的 CIN 2-3 女性数量分别减少了 75%（从 93 例降至 23 例）和 40%（从 69 例降至 41 例）。HPV 疫苗在 CIN 1-3 女性中的疗效为 58.7%（p=0.018）。未报告与疫苗相关的严重不良反应。
结论
治疗后预防性四价 HPV 疫苗可能对残留/复发 CIN 1 或高级别 CIN（CIN 2-3）女性具有治疗作用。
试验注册
伊朗临床试验注册中心，IRCT20190603043801N1。于 2019 年 7 月 24 日注册-回顾性注册，http://www.irct.ir/user/trial/40017/view.
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