Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials
Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials
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DOI：
10.1016/s0140-6736(09)61208-3
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发表时间：
2009-10-17
期刊：
影响因子：
168.9
通讯作者：
Schuerman, Lode
中科院分区：
文献类型：
--
作者：
Prymula, Roman;Siegrist, Claire-Anne;Schuerman, Lode
虽然发热是免疫后正常炎症过程的一部分，但有时建议预防性使用解热药物以减轻高热和热性惊厥的担忧。我们评估了对乙酰氨基酚在接种疫苗对婴儿发热反应率和疫苗responses.Methods的预防性管理的效果在两个连续的（主要和助推器）随机，对照，开放标签的疫苗接种研究，459名健康的婴儿从10个中心在捷克共和国。使用计算机生成的随机化列表将婴儿随机分配，在每次接种10价肺炎球菌不可分型流感嗜血杆菌蛋白D-结合疫苗（PHiD-CV）和6价白喉-破伤风-3组分无细胞百日咳-B型肝炎疫苗后的前24小时内每6-8小时接受3次预防性扑热息痛给药（n=226）或不接受预防性扑热息痛给药（n=233）。灭活脊髓灰质炎病毒1型、2型和3型-H流感B型（DTPa-HBV-IPV/HiB）和口服人轮状病毒疫苗。两项研究的主要目的是在总接种队列中降低38.0 ℃或更高的发热反应。第二个目的是评估符合方案队列的免疫原性。这些研究在ClinicalTrials.gov上注册，编号为NCT 00370318和NCT 00496015。
Background Although fever is part of the normal inflammatory process after immunisation, prophylactic antipyretic drugs are sometimes recommended to allay concerns of high fever and febrile convulsion. We assessed the effect of prophylactic administration of paracetamol at vaccination on infant febrile reaction rates and vaccine responses.Methods In two consecutive (primary and booster) randomised, controlled, open-label vaccination studies, 459 healthy infants were enrolled from ten centres in the Czech Republic. Infants were randomly assigned with a computer-generated randomisation list to receive three prophylactic paracetamol doses every 6-8 h in the first 24 h (n=226) or no prophylactic paracetamol (n=233) after each vaccination with a ten-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with the hexavalent diphtheria-tetanus-3-component acellular pertussis-hepatitis B-inactivated poliovirus types 1, 2, and 3-H influenzae type b (DTPa-HBV-IPV/Hib) and oral human rotavirus vaccines. The primary objective in both studies was the reduction in febrile reactions of 38.0 degrees C or greater in the total vaccinated cohort. The second objective was assessment of immunogenicity in the according-to-protocol cohort. These studies are registered with ClinicalTrials.gov, numbers NCT00370318 and NCT00496015.Findings Fever greater than 39.5 degrees C was uncommon in both groups (after primary: one of 226 participants [