Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial
Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial
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预防性四价HPV疫苗可以作为CIN女性的治疗剂吗？一项随机试验
DOI：
10.1186/s12889-020-8371-z
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发表时间：
2020-02-27
影响因子：
4.5
通讯作者：
Alkatout, Ibrahim
中科院分区：
文献类型：
--
作者：
Karimi-Zarchi, Mojgan;Allahqoli, Leila;Alkatout, Ibrahim
研究背景人乳头瘤病毒（HPV）是宫颈癌最重要的危险因素之一。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）妇女中的作用。方法这项随机对照试验于2011年10月至2015年11月在伊朗亚兹德的Shahid Sadoughi医科大学（SSUMS）进行，研究对象为经组织学证实的残留/复发性CIN 1或高度CIN（CIN 2-3）的女性。符合条件的妇女被随机分配到干预组和对照组。干预组的妇女接受了HPV疫苗接种，而对照组的妇女则没有。参与者被随访了24个月。采用Student 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显著性。结果将312例妇女随机分为两组，干预组138例，对照组104例。女性的平均年龄为32.59 ± 4.85岁。两组患者的年龄、婚姻状况、CIN分级差异无统计学意义。在两年随访期结束时，干预组和对照组中CIN 2-3的妇女人数减少了75%（从93人减少到23人），而对照组减少了40%（从69人减少到41人）。HPV疫苗在CIN 1-3女性中的有效性为58.7%（p = 0.018）。未报告与疫苗相关的严重不良反应。结论四价HPV疫苗治疗后对残留/复发的CIN 1或高度CIN（CIN 2-3）患者可能有治疗作用。
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).