Oseltamivir use and severe abnormal behavior in Japanese children and adolescents with influenza: Is a self-controlled case series study applicable?
Oseltamivir use and severe abnormal behavior in Japanese children and adolescents with influenza: Is a self-controlled case series study applicable?
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DOI：
10.1016/j.vaccine.2017.07.007
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发表时间：
2017-08-24
期刊：
影响因子：
5.5
通讯作者：
Hirota, Yoshio
中科院分区：
文献类型：
--
作者：
Fukushima, Wakaba;Ozasa, Kotaro;Hirota, Yoshio
目的：自20世纪90年代以来，包括自身对照病例系列(SCCS)研究在内的自身对照设计偶尔被用于药物或疫苗的上市后安全性评价。一项SCCS研究被试探性地应用于评估流感患者使用奥司他韦与A型异常行为(可能导致事故或伤害他人的严重异常行为)之间的关系。方法：来自最初对大约10,000名日本流感儿童和青少年(老年)进行的前瞻性队列研究
Objective: Since the 1990s, self-controlled designs including self-controlled case series (SCCS) studies have been occasionally used in post-marketing evaluation of drug or vaccine safety. An SCCS study was tentatively applied to evaluate the relationship between oseltamivir use and abnormal behavior Type A (serious abnormal behavior potentially leading to an accident or harm to another person) in influenza patients.Methods: From the original prospective cohort study with approximately 10,000 Japanese children and adolescents with influenza (aged