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安全性シグナル指標を用いた経口非ステロイド抗炎症薬の既知の有害事象である消化器障害のリスク評価とその注意点
https://gifu-pu.repo.nii.ac.jp/records/13386
https://gifu-pu.repo.nii.ac.jp/records/13386147c3b20-297e-41a3-b296-f2cb633003df
| Item type | 研究室原著論文(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2018-12-27 | |||||
| タイトル | ||||||
| タイトル | 安全性シグナル指標を用いた経口非ステロイド抗炎症薬の既知の有害事象である消化器障害のリスク評価とその注意点 | |||||
| タイトル | ||||||
| タイトル | The Problems of Assessment Using Signal Detection of Gastrointestinal Tract Injury Known as Adverse Event Associated with the Oral Non-Steroidal Anti-Inflammatory Drugs | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| アクセス権 | ||||||
| アクセス権 | metadata only access | |||||
| アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
| 抄録 | ||||||
| 値 | Objective: Gastrointestinal tract injury associated with non-steroidal anti-inflammatory drugs (NSAIDs) remains a clinically significant problem. Therefore, evaluate using the signal detection that is also used clinically and report attention concerning the assessment of known adverse drug events. Methods: In this study, we analyzed data on the serious adverse event gastrointestinal tract injury collected from 2004 to 2013 using Japanese Adverse Drug Event Report (JADER). The indicated drugs were classified into 12 NSAIDs based on COX selectivity. Results: In the usual analysis, several COX-1 selective NSAIDs were detected, but the signals of aspirin and the COX-2-selective NSAIDs etodolac and meloxicam associated with gastrointestinal tract injury were detected using ad hoc analysis. Conclusion: Since the signal value is calculated from the data obtained from the spontaneous reporting system, it is influenced by the clinical use situation at the time of investigation. Therefore, the signal value decreases if the risk, for which a countermeasure has been established, is high. This result does not indicate that COX-1 selective NSAIDs are pharmacologically less risk of gastrointestinal tract injury than COX-2 selective NSAIDs. There is a need to focus risk on emphasis on NSAIDs signal detected by ad hoc analysis. |
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| 書誌情報 |
医薬品情報学 巻 19, 号 3, p. 127-132, 発行日 2017-12 |
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| DOI | ||||||
| 値 | 10.11256/jjdi.19.127 | |||||
