Monteiro Sandra Aparecida Moreira Gomes, Takano Olga Akiko, Waldman Eliseu Alves
Instituto de Saúde Coletiva, Universidade Federal de Mato Grosso, Cuiabá, MT, Brasil.
Rev Bras Epidemiol. 2011 Sep;14(3):361-71. doi: 10.1590/s1415-790x2011000300002.
To describe and evaluate the Brazilian system of passive surveillance of adverse events following immunization (PSAEFI).
The description and evaluation of PSAEFI were undertaken using the reported cases of adverse events following immunization with DTwP-Hib vaccine (AEFI-T), during the period from 2002 to 2005, using the Centers for Disease Control methodology.
The PSAEFI system, which provides national coverage, is designed to standardize practices in cases of adverse events following immunization (AEFI) and to identify highly reactogenic lots of vaccine. The PSAEFI system proved its usefulness, simplicity and flexibility; despite low sensitivity, overestimate the proportion of sever events, but it consistently described AEFI-T, identifying fever, convulsions and hypotonic-hyporesponsive episodes as the most common events. It showed that 49.7% of AEFI-T occur after the first dose, and that 72.8% occur within the first six hours after vaccination. It facilitates public health decisions and epidemiological investigations. It is timely, 46.1% of all AEFI-T being reported within 10 days after vaccination and its completeness ranges from 70 to 90%, depending on the item evaluated.
The PSAEFI system proved useful for monitoring DTwP-Hib vaccine safety. We recommended the incorporation of new methodologies, such the use of sentinel cities/hospitals and computerized immunization registries in order to increase its sensitivity.
描述和评估巴西免疫后不良事件被动监测系统（PSAEFI）。
采用疾病控制中心的方法，对2002年至2005年期间白喉破伤风无细胞百日咳b型流感嗜血杆菌结合疫苗（DTwP-Hib疫苗）免疫后不良事件（AEFI-T）的报告病例进行PSAEFI的描述和评估。
PSAEFI系统覆盖全国，旨在规范免疫后不良事件（AEFI）的处理流程，并识别高反应原性的疫苗批次。PSAEFI系统证明了其有用性、简易性和灵活性；尽管敏感性较低，且高估了严重事件的比例，但它持续描述了AEFI-T，确定发热、惊厥和低张力-低反应性发作是最常见的事件。结果显示，49.7%的AEFI-T发生在首剂接种后，72.8%发生在接种后的前6小时内。它有助于公共卫生决策和流行病学调查。报告及时，46.1%的AEFI-T在接种后10天内报告，其完整性根据评估项目的不同在70%至90%之间。
PSAEFI系统被证明对监测DTwP-Hib疫苗安全性有用。我们建议采用新方法，如使用哨点城市/医院和计算机化免疫登记系统，以提高其敏感性。
