Martín-Merino Elisa, Llorente-García Ana, Castillo Cano Belén, Montero Corominas Dolores, Huerta-Álvarez Consuelo
Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Calle Campezo nº 1, Edificio 8, 28022, Madrid, Spain.
Pharmaceut Med. 2019 Dec;33(6):519-530. doi: 10.1007/s40290-019-00309-9.
In Spain, girls are vaccinated against human papillomavirus (HPV) in the primary care setting, according to a national vaccination programme. Vaccination is voluntary and is covered by the public health system.
The aim of the study was to estimate the incidence and patterns of HPV vaccination amongst girls in primary care in Spain.
A cohort study was performed using the information recorded in the Spanish Primary Care Database for Pharmacoepidemiological Research (BIFAP) from 7.9 million patients from seven Spanish regions, between 2001 and 2016 (56.6% of the regional population). Data available in BIFAP include patient age, sex, life-style factors, clinical events, specialist referrals, prescriptions, and vaccinations as recorded by the primary care physician (PCP) or administering nurse. The study cohort comprised all girls aged 9-18 years registered in BIFAP between 1st January of 2007 and 31st December of 2016 who had at least 1 year of clinical record information with their PCP (inclusion criteria). The date the inclusion criteria were met was designated as the start date to the study cohort contribution. In order to estimate the incidence of HPV vaccination (initiation of vaccination schedule), girls with an HPV vaccination recorded before the start date or without vaccination date were excluded. Girls forming the study cohort were followed from start date until there was a recorded HPV vaccination, they reached 19 years of age or died, end of available information, or 31st December 2016. The person-time of all patients forming the study cohort was reckoned in the incidence estimations. The follow-up was replicated yearly from 2007 to 2016. The cumulative incidence (CuIn) of vaccination by birth cohort, year and region, was estimated using life tables (proportion of vaccination by intervals in which the denominator is the initial population corrected for losses).
Of 388,690 girls forming the study population, 154,211 initiated the vaccination during 2007-2016. Ages ranged from 12 to 14 years at first dose in 84.5% of vaccinated girls, 42.79% received a quadrivalent vaccine, 21.86% a bivalent vaccine, and 35.35% an unknown type. Of the vaccinated population, 48.0% were completely vaccinated with a three-dose schedule and 28.9% with a two-dose schedule, 20.2% received one dose and 3.0% two doses in a three-dose schedule, at a maximum of 10 years of follow-up. The CuIn was highest among girls aged either 13 or 14 years over all regions (reaching 92.8% and 89.7%, respectively), and aged 12 in some regions/years (up to 89.8%). Girls aged 15 years were also vaccinated (although showing lower yearly incidence, i.e. < 69.1%) in two regions. The coverage was broadened to younger girls (11 years) during the last years of the study period in some regions.
According to BIFAP primary care data, a high incidence of vaccination among girls aged 13-14 years was observed. Vaccination among younger and older girls were less common, although they reached high incidence in some regions and/or years. Most vaccination patterns adjusted to a complete vaccination regimen, as recommended posology.
在西班牙,根据国家疫苗接种计划,女孩在初级保健机构接种人乳头瘤病毒(HPV)疫苗。接种是自愿的,且由公共卫生系统提供。
本研究旨在评估西班牙初级保健机构中女孩HPV疫苗接种的发生率和模式。
采用队列研究,利用西班牙初级保健药物流行病学研究数据库(BIFAP)中记录的2001年至2016年期间来自西班牙七个地区790万患者的信息(占地区人口的56.6%)。BIFAP中的可用数据包括患者年龄、性别、生活方式因素、临床事件、专科转诊、处方以及初级保健医生(PCP)或执行护士记录的疫苗接种情况。研究队列包括2007年1月1日至2016年12月31日期间在BIFAP中登记的所有9至18岁女孩,这些女孩与她们的PCP至少有1年的临床记录信息(纳入标准)。满足纳入标准的日期被指定为研究队列贡献的开始日期。为了评估HPV疫苗接种的发生率(疫苗接种计划的起始),排除在开始日期之前有HPV疫苗接种记录或没有接种日期的女孩。组成研究队列的女孩从开始日期开始随访,直到有记录的HPV疫苗接种、达到19岁、死亡、可用信息结束或2016年12月31日。在发生率估计中计算组成研究队列的所有患者的人时。从2007年到2016年每年重复随访。使用生命表估计按出生队列、年份和地区划分的疫苗接种累积发生率(CuIn)(按间隔计算的疫苗接种比例,其中分母是针对损失校正的初始人群)。
在组成研究人群的388,690名女孩中,154,211名在2007 - 2016年期间开始接种疫苗。84.5%接种疫苗的女孩首次接种时年龄在12至14岁之间,42.79%接种四价疫苗,21.86%接种二价疫苗,35.35%接种类型不明。在接种人群中,48.0%按照三剂次接种计划完成接种,28.9%按照两剂次接种计划完成接种,20.2%接种一剂次,3.0%在三剂次接种计划中接种两剂次,最长随访10年。在所有地区,13岁或14岁女孩的CuIn最高(分别达到92.8%和89.7%),在某些地区/年份12岁女孩的CuIn也较高(高达89.8%)。在两个地区,15岁女孩也接种了疫苗(尽管年发生率较低,即<69.1%)。在研究期的最后几年,一些地区将接种范围扩大到了年龄更小的女孩(11岁)。
根据BIFAP初级保健数据,观察到13 - 14岁女孩的疫苗接种发生率较高。年龄更小和更大的女孩接种情况较少见,尽管在某些地区和/或年份达到了较高的发生率。大多数接种模式符合推荐的完整接种方案。