Oseltamivir use and severe abnormal behavior in Japanese children and adolescents with influenza: Is a self-controlled case series study applicable?

被引：9

作者：

Fukushima, Wakaba ^{[1
,2
]}

Ozasa, Kotaro ^{[3
,13
]}

Okumura, Akihisa ^{[4
,14
]}

Mori, Masaaki ^{[5
,15
]}

Hosoya, Mitsuaki ^{[6
]}

Nakano, Takashi ^{[7
,16
]}

Tanabe, Takuya ^{[8
,17
]}

Yamaguchi, Naoto ^{[9
]}

Suzuki, Hiroshi ^{[10
,18
]}

Mori, Mitsuru ^{[11
]}

Hatayama, Hideaki ^{[1
,19
]}

Ochiai, Hirotaka ^{[1
,20
]}

Kondo, Kyoko ^{[1
,2
]}

Ito, Kazuya ^{[1
,2
]}

Ohfuji, Satoko ^{[1
,2
]}

Nakamura, Yosikazu ^{[12
]}

Hirota, Yoshio ^{[1
,21
,22
]}

机构：

[1] Osaka City Univ, Grad Sch Med, Dept Publ Hlth, Osaka, Japan

[2] Osaka City Univ, Grad Sch Med, Res Ctr Infect Dis Sci, Osaka, Japan

[3] Kyoto Prefectural Univ Med, Grad Sch Med Sci, Dept Epidemiol Community Hlth & Med, Kyoto, Japan

[4] Juntendo Univ, Sch Med, Dept Pediat, Tokyo, Japan

[5] Yokohama City Univ, Dept Pediat, Med Ctr, Yokohama, Kanagawa, Japan

[6] Fukushima Med Univ, Sch Med, Dept Pediat, Fukushima, Japan

[7] Mie Natl Hosp, Dept Int Hlth & Pediat, Tsu, Mie, Japan

[8] Hirakata City Hosp, Dept Pediat, Osaka, Japan

[9] Tokyo Womens Med Univ, Sch Med, Dept Publ Hlth, Tokyo, Japan

[10] Niigata Univ, Grad Sch Med & Dent Sci, Dept Infect Dis Control & Int Med, Niigata, Japan

[11] Sapporo Med Univ, Sch Med, Dept Publ Hlth, Sapporo, Hokkaido, Japan

[12] Jichi Med Univ, Dept Publ Hlth, Shimotsuke, Japan

[13] Radiat Effects Res Fdn, Dept Epidemiol, Hiroshima, Japan

[14] Aichi Med Univ, Dept Pediat, Nagakute, Aichi, Japan

[15] Tokyo Med & Dent Univ, Grad Sch Med & Dent Sci, Dept Pharmacovigilance, Tokyo, Japan

[16] Kawasaki Med Sch, Dept Pediat, Okayama, Japan

[17] Tanabe Childrens Clin, Dept Pediat Neurol, Osaka, Japan

[18] Niigata Seiryo Univ, Sch Nursing, Niigata, Japan

[19] Osaka Prefectural Govt, Dept Publ Hlth & Med Affairs, Osaka, Japan

[20] Showa Univ, Dept Publ Hlth, Sch Med, Tokyo, Japan

[21] Coll Healthcare Management, Miyama, Japan

[22] Med Co LTA, Clin Epidemiol Res Ctr, Fukuoka, Japan

来源：

VACCINE | 2017年 / 35卷 / 36期

关键词：

Self-controlled case series study; Oseltamivir; Abnormal behavior; Influenza; ADVERSE EVENTS; RISK; VACCINATION; DESIGNS;

D O I：

10.1016/j.vaccine.2017.07.007

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 <18 years), 28 subjects (mean age: 7.3 years) who developed abnormal behavior Type A after the first visit to the collaborating hospitals/clinics were analyzed. We hypothesized four combination patterns of the effect period (i.e., the period that effect of oseltamivir on occurrence of abnormal behavior Type A is likely) and the control period. Mantel-Haenszel rate ratio (M-H RR) and its 95% confidence interval (CI) were calculated as the relative risk estimate. Results: Among 28 subjects in the SCCS study, 24 subjects (86%) were administered oseltamivir and 4 subjects (14%) were not. Abnormal behavior Type A was more likely to occur in the effect period than the control period in every pattern (M-H RR: 1.90-29.1). We observed the highest estimate when the effect period was set between the initial intake of oseltamivir and T-max (M-H RR: 29.1, 95% CI: 4.21-201). Conclusion: Abnormal behavior Type A was more likely to develop up to approximately 30 times during the period between the initial intake of oseltamivir and T-max. However, this period overlapped with the early period of influenza where high fever was observed. Since useful approaches to control the influence of the natural disease course of influenza were not available in this study, we could not deny the possibility that abnormal behavior was induced by influenza itself. The SCCS study was not an optimal method to evaluate the relationship between oseltamivir use and abnormal behavior. (C) 2017 Elsevier Ltd. All rights reserved.

引用

页码：4817 / 4824

页数：8

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