ABSTRACT
Recently, many studies have evaluated HPV vaccine safety and adverse effects. Two vaccine shave 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.
Subject(s)
Female , Humans , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/immunology , Uterine Cervical Neoplasms/prevention & control , Papillomavirus Infections/complications , Papillomavirus Infections/immunology , Papillomavirus Vaccines/administration & dosage , Papillomavirus Vaccines/adverse effects , Randomized Controlled Trials as Topic , Uterine Cervical Neoplasms/virologyABSTRACT
Treating sexual partners of women with vaginal candidiasis and bacterial vaginosis is a discussed topic. Despite the recommendations of international guidelines, doctors are still known to treat asymptomatic partners. Objective: To evaluate the influence of asymptomatic partner treatment inthe cure and recurrence of vulvovaginitis in women. Methods: The following databases were searched using Mesh terms: PubMed, Embase, SciELO and CINAHAL. The selection criteria included randomized clinical trials published from 1982 to 2012. Studies involving pregnant women were excluded.Methodological quality was assessed using Jadads scale. Review Manager 5.1 was used for statistical analysis. Results: Eight randomized clinical trials were included based on the chosen criteria: 1,088 women were enrolled. For bacterial vaginosis, the relative risk for cure was 1.00 (95%CI 0.95-1.05,p=0.13), and for recurrence 0.84 (95%CI 0.62-1.14, p=0.34). Vaginal candidiasis had a RR of 1.03 (95%CI 0.94-1.14, p=0.48) for cure, and 1.02 (95% CI0.77-1.33, p=0.91) for recurrence. Conclusion: Treatment of asymptomatic sexual partners of women with vaginal candidiasis or bacterial vaginosis does not affect the cure or recurrence rates and may increase the risk of side effects and unnecessary financial costs.
O tratamento de parceiros sexuais de mulheres com candidíase vaginal e vaginose bacteriana é um assunto muito abordado. Apesar das recomendações estabelecidas nos manuais internacionais, este tópico ainda é muito questionado por um grande número de médicos que prosseguem desobedecendo estes manuais. Objetivo: Avaliar a influência do tratamento de parceiros assintomáticos na cura e recorrência de vulvovaginite em mulheres. Métodos: Foi realizada busca com descritores específicos nas seguintes bases de dados: PubMed, Embase, SciELO e CINAHAL. No critério de seleção foram incluídos ensaios clínicos randomizados publicados no período de 1982 a 2012. Estudos envolvendo mulheres grávidas foram excluídos. Na avaliação qualitativa, utilizou-se a Escala de Jadad. A análise dos dados foi realizada por meio do programa estatístico Review Manager 5.1. Resultados:Oito ensaios clínicos randomizados foram selecionados: 1.088 mulheres foram escolhidas. Na vaginose bacteriana, o risco relativo para cura foi de 1,00(IC95% 0,95-1,05, p=0,13) e para recorrência foi de 0,84 (IC95% 0,62-1,14, p=0,34). A candidíase vaginal apresentou risco relativo de 1,03 (IC95% 0,94-1,14, p=0,48) para cura e de 1,02 (IC95% 0,77-1,33, p=0,91) para recorrência. Conclusão: O tratamento do parceiro sexual assintomático de mulheres com candidíase vaginal e vaginose bacteriana não afetaria as suas taxas de cura e recorrência, como também poderia causar efeitos colaterais e custos desnecessários.