Phuong Linny Kimly, Bonetto Caterina, Buttery Jim, Pernus Yolanda Brauchli, Chandler Rebecca, Felicetti Patrizia, Goldenthal Karen L, Kucuku Merita, Monaco Giuseppe, Pahud Barbara, Shulman Stanford T, Top Karina A, Trotta Francesco, Ulloa-Gutierrez Rolando, Varricchio Frederick, de Ferranti Sarah, Newburger Jane W, Dahdah Nagib, Singh Surjit, Bonhoeffer Jan, Burgner David
Monash Children's Hospital, Clayton, Melbourne, Australia; Royal Children's Hospital, Parkville, Victoria, Australia.
Italian Medicines Agency (AIFA), Rome, Italy.
Vaccine. 2017 Mar 27;35(14):1770-1779. doi: 10.1016/j.vaccine.2016.09.033. Epub 2017 Mar 2.
Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation.
We conducted a systematic literature review using various reference sources to review the available evidence published in the literature.
We identified twenty seven publications reporting a temporal association between immunisation and Kawasaki disease. We present a systematic review of data drawn from randomised controlled trials, observational studies, case series and reports, and reviews. Overall there was a lack of standardised case definitions, making data interpretation and comparability challenging.
Although a temporal relationship between immunisation and Kawasaki disease is suggested, evidence for an increased risk or a causal association is lacking. Implementation of a standardised Kawasaki disease case definition would increase confidence in the findings and add value to future studies of pre- or post-licensure vaccine safety studies.
川崎病是一种复杂且可能严重的病症。已观察到其与免疫接种存在时间关联。
我们使用多种参考文献来源进行了系统的文献综述，以回顾文献中已发表的现有证据。
我们确定了27篇报告免疫接种与川崎病之间存在时间关联的出版物。我们对来自随机对照试验、观察性研究、病例系列和报告以及综述的数据进行了系统综述。总体而言，缺乏标准化的病例定义，使得数据解读和可比性具有挑战性。
尽管提示免疫接种与川崎病之间存在时间关系，但缺乏风险增加或因果关联的证据。实施标准化的川崎病病例定义将增强对研究结果的信心，并为许可前或许可后疫苗安全性研究的未来研究增添价值。
