Faldella Giacomo, Galletti Silvia, Corvaglia Luigi, Ancora Gina, Alessandroni Rosina
Istituto di Pediatria Preventiva e Neonatologia, S. Orsola-Malpighi Hospital, University of Bologna, Via Massarenti 11, 40138 Bologna, Italy.
Vaccine. 2007 Jan 22;25(6):1036-42. doi: 10.1016/j.vaccine.2006.09.065. Epub 2006 Oct 6.
To assess the clinical safety of DTaP-IPV-HIb-HBV hexavalent immunization in very premature infants and to verify if the first administration of vaccine is by itself a reason for close monitoring hospitalized VLBW infants born at less than 31 weeks' gestation.
Eighty-one preterm newborns less than 31 weeks' gestational age, admitted in the NICU, were eligible to be immunized with hexavalent vaccine under close monitoring, including pre-and post-immunization continuous monitoring of heart rate, oxygen saturation, respiratory rate, resistance index at the anterior cerebral artery and ECG cQT interval.
Of the 81 eligible premature newborns, 36 were graduated from the NICU before the least date for immunization, at 7 weeks of age. The other 45 were vaccinated in the NICU and entered the study. Twenty-three of them were under medical treatment for chronic disease at the time of the immunization while 22 were healthy and stable. Five infants (11%) had apnoea/bradycardia/desaturation, related to vaccine administration and required medical support. All five infants were in the group of newborns with chronic disease (21.7% prevalence of adverse reactions in this group). No significant variation of cQT or RI before and after the immunization was observed either in the whole groups of patients or in the five infants who showed cardio-respiratory events related to vaccination.
Hexavalent DTaP-IPV-HIb-HBV immunization is not associated with cardiac electric activity and cerebral blood flow variations in both stable and unstable very premature infants. However, it can cause apnoea/bradycardia/desaturation in premature babies with chronic disease. Therefore, if the baby is in the NICU for chronic diseases at 2 months post-birth, it should be monitored for apnoea, bradycardia and desaturation in association with vaccination. Hospitalized healthy preterm infants without chronic disease and therapy seem to be less vulnerable to cardio-respiratory adverse reactions. Nevertheless, it is advisable to immunize and monitor them at 8 weeks before discharge instead of possibly delaying immunization for several weeks and not monitor them.
评估无细胞百白破-脊髓灰质炎灭活疫苗- b型流感嗜血杆菌结合疫苗-乙肝六联疫苗在极早产儿中的临床安全性，并验证疫苗首次接种本身是否是密切监测胎龄小于31周的住院极低出生体重儿的一个原因。
81例胎龄小于31周的早产新生儿入住新生儿重症监护病房（NICU），在密切监测下有资格接种六联疫苗，包括免疫接种前后持续监测心率、血氧饱和度、呼吸频率、大脑前动脉阻力指数和心电图cQT间期。
81例符合条件的早产新生儿中，36例在免疫接种的最晚日期前，即7周龄时从NICU出院。其他45例在NICU接种疫苗并进入研究。其中23例在免疫接种时正在接受慢性病治疗，22例健康且状况稳定。5例婴儿（11%）出现与疫苗接种相关的呼吸暂停/心动过缓/血氧饱和度下降，需要医疗支持。所有5例婴儿均在患有慢性病的新生儿组中（该组不良反应发生率为21.7%）。在整个患者组或5例出现与疫苗接种相关的心肺事件的婴儿中，均未观察到免疫接种前后cQT或RI有显著变化。
无细胞百白破-脊髓灰质炎灭活疫苗- b型流感嗜血杆菌结合疫苗-乙肝六联疫苗接种与稳定和不稳定的极早产儿的心脏电活动及脑血流变化无关。然而，它可导致患有慢性病的早产儿出现呼吸暂停/心动过缓/血氧饱和度下降。因此，如果婴儿出生后2个月因慢性病入住NICU，应在接种疫苗时监测其呼吸暂停、心动过缓及血氧饱和度下降情况。住院的无慢性病且未接受治疗的健康早产儿似乎对心肺不良反应的易感性较低。尽管如此，建议在出院前8周为他们接种疫苗并进行监测，而不是可能推迟数周接种疫苗且不进行监测。
