BMJ ：流感疫苗对胎儿死亡风险无影响

ipsvirus

近日，Karolinska医学院的一项新研究表明，怀孕期间的母亲接种了H1N1流感疫苗后或可降低胎儿和新生儿死亡的风险，该研究结果发表在《英国医学杂志》(BMJ)上。

Karolinska医学院流行病学和生物统计学博士，儿科医生及医学教授Jonas F. Ludvigsson与他的同事们对有关问题进行了调查研究，研究目的用来观察孕妇接种流感疫苗后是否会影响胎儿或新生儿的死亡率。

在2009 - 2010年间，当流感疫情爆发时，很大一部分瑞典人接种了新型H1N1流感疫苗(也称为猪流感)。从那时起，特别是通过研究已经表明这种疫苗会增加儿童和青少年以及年轻的成年人嗜睡症的风险后，科学家们围绕流感疫苗这一问题一直争论不休。

      2013年在欧洲流行病学杂志上发表的一项研究表明，经研究显示，假设胎儿或新生儿出生时低体重，发育不良或发生早产的风险增加，然而女性在怀孕期间接种流感疫苗也不会增加胎儿和新生儿死亡率的风险。

没有更高的风险

研究人员总共分析了275,500名怀孕的母亲，其中41,183名孕妇接种了流感疫苗。在随访期间，共有1172名孕妇死产，有380个新生儿死亡(出生后0-6天)，706个婴儿死亡(出生后7天到4.6年间)。

研究人员说，这意味着妇女在怀孕期间接种疫苗引起胎儿和新生儿死亡的风险较低。同样的结果被发现在接种疫苗的胎儿与其未接种疫苗的兄弟姐妹之间。

来源：生物谷

ipsvirus

Maternal vaccination against H1N1 influenza and offspring mortality: population based cohort study and sibling design.

Ludvigsson JF1, Ström P2, Lundholm C2, Cnattingius S3, Ekbom A3, Örtqvist Å4, Feltelius N5, Granath F3, Stephansson O6.

Abstract

STUDY QUESTION:
What is the mortality in offspring of mothers who had influenza A(H1N1)pdm09 vaccination during pregnancy?

METHODS:
This was a prospective population based cohort study in seven healthcare regions in Sweden based on vaccinations taking place between 2 October 2009 and 26 November 2010. H1N1 vaccination data were linked with pregnancy and birth characteristics and offspring mortality data in 275 500 births (of which 1203 were stillbirths) from 137 886 mothers. Of these offspring, 41 183 had been exposed to vaccination with Pandemrix, a monovalent AS03 adjuvanted H1N1 influenza vaccine, during fetal life. A primary comparison group consisted of pregnancies of women who were not vaccinated during the same calendar period. In a second comparison, non-exposed siblings of infants prenatally exposed to vaccination were used as controls. Cox regression was used to estimate hazard ratios for stillbirth, early neonatal mortality (days 0-6 after birth), and subsequent mortality (beginning on day 7) in vaccinated versus non-vaccinated women, adjusting for mother's age at delivery, body mass index, parity, smoking, country of birth, and disposable income and for sex of offspring.

STUDY ANSWER AND LIMITATIONS:
The results of this study suggest that AS03 adjuvanted H1N1 vaccination during pregnancy does not affect the risk of stillbirth, early neonatal death, or later mortality in the offspring. During follow-up, 1172 stillbirths, 380 early neonatal deaths, and 706 deaths thereafter occurred. Compared with general population controls, this corresponded to adjusted hazard ratios of 0.83 (95% confidence interval 0.65 to 1.04) for stillbirth, 0.71 (0.44 to 1.14) for early neonatal death, and 0.97 (0.69 to 1.36) for later death. When siblings were used as controls, adjusted hazard ratios were 0.88 (0.59 to 1.30) for stillbirth, 0.82 (0.46 to 1.49) for early neonatal death, and 0.78 (0.52 to 1.19) for later death. Limitations of the study include lack of data on miscarriage before gestational week 22, inability to ascertain which mothers had pandemic flu during pregnancy, and lack of data on factors influencing the decision to vaccinate during pregnancy.

WHAT THIS STUDY ADDS:
H1N1 vaccination during pregnancy is not associated with adverse fetal outcome or offspring mortality, including when familial factors are taken into account.

FUNDING, COMPETING INTERESTS, DATA SHARING:
This project was supported by grants from the Swedish Research Council and the Swedish Council for Working Life and Social Research. NF was employed at the Swedish Medical Product Agency at the time of the study.

http://www.ncbi.nlm.nih.gov/pubmed/26572546