論文

2018年

有害事象自発報告データベース(JADER)を用いた一般用医薬品の総合感冒剤による有害事象プロファイルの検討

薬学雑誌. 乙号
  • 笹岡 沙也加
  • ,
  • 上田 夏実
  • ,
  • 平出 耕石
  • ,
  • 井口 和弘
  • ,
  • 中村 光浩
  • ,
  • 畠平 春奈
  • ,
  • 長谷川 栞
  • ,
  • 元岡 佑美
  • ,
  • 福田 昌穂
  • ,
  • 長沼 美紗
  • ,
  • 梅津 亮冴
  • ,
  • 中尾 智史
  • ,
  • 島内 あかり

138
1
開始ページ
123
終了ページ
134
記述言語
日本語
掲載種別
DOI
10.1248/yakushi.17-00172
出版者・発行元
公益社団法人 日本薬学会

&emsp;OTC combination cold remedies are widely used in Japan. In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database. The JADER database contained 430587 reports between April 2004 and November 2016. 1084 adverse events associated with the use of OTC combination cold remedy were reported. Reporting odds ratio (ROR) was used to detect safety signals. The ROR values for &ldquo;skin and subcutaneous tissue disorders&rdquo;, &ldquo;hepatobiliary disorders&rdquo;, and &ldquo;immune system disorders&rdquo; stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 9.82 (8.71-11.06), 2.63 (2.25-3.07), and 3.13 (2.63-3.74), respectively. OTC combination cold remedy containing acetaminophen exhibited a significantly higher reporting ratio for &ldquo;hepatobiliary disorders&rdquo; than OTC combination cold remedy without acetaminophen. We demonstrated the potential risk of OTC combination cold remedy in a real-life setting. Our results suggested that the monitoring of individuals using OTC combination cold remedy is important.<br>

Web of Science ® 被引用回数 : 1

リンク情報
DOI
https://doi.org/10.1248/yakushi.17-00172
CiNii Articles
http://ci.nii.ac.jp/naid/130006300839
CiNii Books
http://ci.nii.ac.jp/ncid/AN00284903
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29311458
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000419662800016&DestApp=WOS_CPL
URL
http://id.ndl.go.jp/bib/028775425
Jamas Url
http://search.jamas.or.jp/link/ui/2018302827

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