Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Blvd, Rockville, MD 20852, USA.
BMJ. 2010 Mar 2;340:c712. doi: 10.1136/bmj.c712.
To assess whether vaccination against human papillomavirus (HPV) increases the risk of miscarriage.
Pooled analysis of two multicentre, phase three masked randomised controlled trials
Multicentre trials in several continents and in Costa Rica.
26 130 women aged 15-25 at enrolment; 3599 pregnancies eligible for analysis.
Participants were randomly assigned to receive three doses of bivalent HPV 16/18 VLP vaccine with AS04 adjuvant (n=13 075) or hepatitis A vaccine as control (n=13 055) over six months.
Miscarriage and other pregnancy outcomes.
The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination.
There is no evidence overall for an association between HPV vaccination and risk of miscarriage.
Clinical Trials NCT00128661 and NCT00122681.
评估人乳头瘤病毒（HPV）疫苗接种是否会增加流产的风险。
两项多中心、三阶段、双盲随机对照试验的汇总分析。
多个大洲和哥斯达黎加的多中心试验。
26130 名年龄在 15-25 岁的女性在入组时；3599 例符合分析条件的妊娠。
参与者被随机分配接受三剂二价 HPV 16/18 VLP 疫苗加 AS04 佐剂（n=13075）或甲型肝炎疫苗作为对照（n=13055），共 6 个月。
流产和其他妊娠结局。
HPV 组妊娠流产率估计为 11.5%，对照组为 10.2%。主要分析的单侧 P 值为 0.16；因此，总体而言，HPV 疫苗组的流产率没有显著增加。在二次描述性分析中，在最近接种后三个月内开始的妊娠中，HPV 疫苗组的流产率为 14.7%，对照组为 9.1%。
总体而言，没有证据表明 HPV 疫苗接种与流产风险之间存在关联。
临床试验 NCT00128661 和 NCT00122681。
Zotero 插件