University of Florence, Florence, Italy.
Vaccine. 2010 Jul 5;28(30):4719-30. doi: 10.1016/j.vaccine.2010.04.070. Epub 2010 May 6.
GARDASIL has been shown to reduce the incidence of pre-cancerous cervical, vulvar, and vaginal lesions, and external genital warts causally related to HPV6/11/16/18. Because of its expected public health benefit on reduction of cervical cancer and other HPV-related diseases, this vaccine has been rapidly implemented in the routine vaccination programs of several countries. It is therefore essential to assess its impact and safety through post-licensure surveillance programs. Here, we present a summary of 16 post-licensure safety and impact studies across 20 countries. These studies address general safety, including autoimmune disorders, long-term effectiveness, and type replacement. A summary of the surveillance efforts of the Unites States Centers for Disease Control and Prevention can be found in the accompanying article by Markowitz et al.
加德西已被证实能降低 HPV6/11/16/18 型所致宫颈癌前病变、外阴和阴道病变和外生殖器疣的发生率。由于其预期能减少宫颈癌和其他 HPV 相关疾病，该疫苗已在多个国家的常规免疫规划中迅速实施。因此，通过上市后监测项目评估其影响和安全性至关重要。在此，我们总结了 20 个国家的 16 项上市后安全性和影响研究。这些研究涉及一般安全性，包括自身免疫性疾病、长期有效性和型别替换。美国疾病预防控制中心的监测工作概述见马克维茨等人的相关文章。
