Fantinato Francieli Fontana Sutile Tardetti, Vargas Alexander, Carvalho Sandra Maria Deotti, Domingues Carla Magda Allan Santos, Barreto Gisele, Fialho Arieli Schiessl, Silva Roselita Heinen da, Saad Eduardo, Agredo Ivonne Natalia Solarte
Ministério da Saúde, Brasília, Brasil.
Secretaria de Estado da Saúde de Santa Catarina, Florianópolis, Brasil.
Cad Saude Publica. 2018 Mar 12;34(3):e00043617. doi: 10.1590/0102-311X00043617.
The study aimed to describe cases and verify the frequency of anaphylaxis related to measles, mumps, and rubella (MMR) vaccine produced by manufacturer A and to assess associated risk factors. This was a case-control study (1:4) in Santa Catarina State, Brazil, from July 14, 2014, to January 12, 2015, in children from one year to less than five years of age, vaccinated with MMR and reported with anaphylaxis, while the controls were without anaphylaxis. The measure of association was odds ratio (OR) with 95% confidence interval (95%CI), using the chi-square and Fisher's exact tests. Anaphylaxis rates were calculated per doses distributed/administered. Fifteen cases and 60 controls were interviewed in 12 municipalities (counties). Anaphylaxis rates were 2.46 and 5.05 cases per 100,000 doses distributed and administered, respectively. Among the cases of anaphylaxis, eight (53.4%) were males, and among the controls, 36 (60%), with p = 0.64. The bivariate analysis of anaphylaxis and cow's milk protein allergy (CMPA) showed OR = 51.62, with p = 0.00002 and 95%CI: 5.59-476.11. The variables family food allergy, breastfeeding, previous post-vaccine adverse event (PVAE), and simultaneous vaccination were not statistically significant (p = 0.48; p = 1.00; p = 0.49; p = 0.61). Anaphylaxis rates per doses distributed/administered exceeded 1/100,000 doses administered (expected rate). Anaphylaxis and CMPA showed a statistically significant association. No statistically significant associations were found with simultaneous vaccination, breastfeeding, family food allergy, or history of PVAE.
the manufacturer should specify the product's components in the package insert, and children with a history of CMPA should not be vaccinated with this vaccine.
本研究旨在描述病例并核实与制造商A生产的麻疹、腮腺炎和风疹(MMR)疫苗相关的过敏反应发生率,并评估相关危险因素。这是一项病例对照研究(1:4),于2014年7月14日至2015年1月12日在巴西圣卡塔琳娜州开展,研究对象为1至5岁以下接种MMR疫苗并报告有过敏反应的儿童,对照组为无过敏反应的儿童。关联度量为比值比(OR)及95%置信区间(95%CI),采用卡方检验和费舍尔精确检验。按分发/接种的剂量计算过敏反应发生率。在12个市(县)对15例病例和60例对照进行了访谈。分发和接种的每10万剂中过敏反应发生率分别为2.46例和5.05例。在过敏反应病例中,8例(53.4%)为男性,在对照组中,36例(60%)为男性,p = 0.64。过敏反应与牛奶蛋白过敏(CMPA)的二元分析显示OR = 51.62,p = 0.00002,95%CI:5.59 - 476.11。家庭食物过敏、母乳喂养、既往疫苗接种后不良事件(PVAE)和同时接种等变量无统计学意义(p = 0.48;p = 1.00;p = 0.49;p = 0.61)。分发/接种的每剂过敏反应发生率超过了1/100,000剂(预期发生率)。过敏反应与CMPA显示出统计学显著关联。未发现与同时接种、母乳喂养、家庭食物过敏或PVAE病史有统计学显著关联。
制造商应在包装说明书中明确产品成分,有CMPA病史的儿童不应接种该疫苗。