| アブストラクト | AIMS: Human papilloma virus (HPV) is 1 of the most common sexually transmitted infection responsible for different types of cancer: cervical, penile, vulvar, anal and oropharyngeal. It can affect both males and females. Our aim was to enrich the knowledge on the safety profiles of HPV vaccines in the male population. METHODS: We reviewed all the reports of adverse events following immunization (AEFI) present in the US Vaccine Adverse Event Reporting System from 1 January 2006 to 30 September 2018. Statistical data mining was performed using the reporting odds ratio with 95% confidence interval in order to detect disproportionality in reporting. RESULTS: A total of 5493 reports of AEFI were retrieved. The events most reported and that proportionally occurred more frequently with HPV vaccines than with others in males were: syncope (n = 701, reporting odds ratio = 2.85, 95% confidence interval [1.41-5.76p), loss of consciousness (n = 425, 2.79 [1.36-5.72]) and fall (n = 272, 3.54 [2.00-6.26]). CONCLUSION: Most of the AEFIs were already reported in premarketing clinical trials and acknowledged for the corresponding vaccines. A disproportionate reporting was found for some of these events including syncope. The HPV vaccines are generally well tolerated in males, although limitations own of spontaneous reporting should be considered. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2020/11/5 |
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| 投稿者 | Bonaldo, Giulia; Montanaro, Nicola; Vaccheri, Alberto; Motola, Domenico |
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| 組織名 | Unit of Pharmacology, Department of Medical and Surgical Sciences, University of;Bologna, Bologna, Italy.;Former Professor of Pharmacology, University of Bologna, Bologna, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33145777/ |
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