Gonçalves Ana Katherine, Cobucci Ricardo Ney, Rodrigues Hugo Marcus, de Melo Amanda Gosson, Giraldo Paulo César
Postgraduate Program in Health Sciences, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.
Postgraduate Program in Health Sciences, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil.
Braz J Infect Dis. 2014 Nov-Dec;18(6):651-9. doi: 10.1016/j.bjid.2014.02.005. Epub 2014 Apr 27.
Recently, many studies have evaluated HPV vaccine safety and adverse effects. Two vaccines have been recently evaluated in randomized controlled trials: the bivalent vaccine for HPV 16 and 18 (Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium) and the quadrivalent vaccine for HPV 6, 11, 16, and 18 (Gardasil, Merck and Co., Inc., Whitehouse Station, NJ). We have performed a systematic review of all randomized controlled trials in which HPV vaccines were compared with placebo regarding safety, tolerability and adverse effects. Studies were searched up to March 2013 in the databases: Pubmed, Embase, Scielo and Cancerlit. Odds Ratios (OR) of most incident adverse effects were obtained. Twelve reports, involving 29,540 subjects, were included. In the HPV 16/18 group, the most frequently reported events related to the vaccine were pain (OR 3.29; 95% CI: 3.00-3.60), swelling (OR 3.14; 95% CI: 2.79-3.53) and redness (OR 2.41; 95% CI: 2.17-2.68). For the HPV 6/11/16/18 group the events were pain (OR 2.88; 95% CI: 2.42-3.43) and swelling (OR 2.65; 95% CI: 2.0-3.44). Concerning the HPV 16/18 vaccine, pain was the most common outcome detected. These effects can be due to a possible VLP-related inflammation process. Fatigue was the most relevant general effect observed followed by fever, gastrointestinal symptoms, and headache. In the HPV 6/11/16/18 group, only general symptoms, pain and swelling were observed. Pain and swelling were the most frequent. Comparing HPV 16/18 to HPV 6/11/16/18 vaccines, the former presented more adverse effects, perhaps because there are many more trials evaluating the bivalent vaccine. Other studies are needed to clarify this issue.
最近，许多研究评估了人乳头瘤病毒（HPV）疫苗的安全性和不良反应。最近在随机对照试验中评估了两种疫苗：针对HPV 16和18型的二价疫苗（希瑞适，葛兰素史克生物制品公司，比利时里克森萨特）以及针对HPV 6、11、16和18型的四价疫苗（加卫苗，默克公司，美国新泽西州怀特豪斯站）。我们对所有将HPV疫苗与安慰剂在安全性、耐受性和不良反应方面进行比较的随机对照试验进行了系统评价。截至2013年3月，在以下数据库中检索了相关研究：PubMed、Embase、Scielo和Cancerlit。获得了大多数新发不良反应的比值比（OR）。纳入了12份报告，涉及29540名受试者。在HPV 16/18组中，与疫苗相关的最常报告事件为疼痛（OR 3.29；95%置信区间：3.00 - 3.60）、肿胀（OR 3.14；95%置信区间：2.79 - 3.53）和发红（OR 2.41；95%置信区间：2.17 - 2.68）。对于HPV 6/11/16/18组，这些事件为疼痛（OR 2.88；95%置信区间：2.42 - 3.43）和肿胀（OR 2.65；95%置信区间：2.0 - 3.44）。关于HPV 16/18疫苗，疼痛是检测到的最常见结果。这些效应可能归因于可能的病毒样颗粒（VLP）相关炎症过程。疲劳是观察到的最相关的全身效应，其次是发热、胃肠道症状和头痛。在HPV 6/11/16/18组中，仅观察到全身症状、疼痛和肿胀。疼痛和肿胀最为常见。将HPV 16/18疫苗与HPV 6/11/16/18疫苗进行比较，前者出现的不良反应更多，可能是因为评估二价疫苗的试验更多。需要其他研究来阐明这个问题。
