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有害事象自発報告データベースを用いたOTC医薬品の解熱鎮痛消炎剤の有害事象発現傾向の調査
https://gifu-pu.repo.nii.ac.jp/records/13376
https://gifu-pu.repo.nii.ac.jp/records/13376276f36ae-46c5-4ba7-aee9-61eba6cca7a2
| Item type | 研究室原著論文(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2018-07-30 | |||||
| タイトル | ||||||
| タイトル | 有害事象自発報告データベースを用いたOTC医薬品の解熱鎮痛消炎剤の有害事象発現傾向の調査 | |||||
| タイトル | ||||||
| タイトル | Adverse Event Trends Associated with OTC Analgesic and Antipyretic Drug: Data Mining of the Japanese Adverse Drug Event Report Database | |||||
| 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 | OTC drugs play an important role in self-medication. OTC analgesic and antipyretic drugs are widely used in Japan. The present study aimed to survey the components of OTC drug package inserts for analgesic and antipyretic drugs and to evaluate the adverse event profiles using the Japanese Adverse Drug Event Report database (JADER). The JADER contains 430587 reports from between April 2004 and November 2016; a total of 750 reports of adverse events resulted from the use of OTC analgesic and antipyretic drugs. The safety signals were detected by the reporting odds ratio (ROR). The ROR values for "Skin & subcutaneous tissue disorders", "Immune system disorders", and "Hepatobiliary disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 7.58 (6.56-8.76), 4.25 (3.51-5.14), and 2.35 (1.93-2.85), respectively. OTC analgesic and antipyretic drugs containing allylisopropylacetylurea (AIAU) exhibited a significantly high reporting ratio of "Skin & subcutaneous tissue disorders" compared with the drugs without AIAU. No difference in the reported incidence of "Hepatobiliary disorders" was found between the drugs with or without acetaminophen. Our results suggested that it was important to monitor patients who use OTC analgesic and antipyretic drug containing AIAU; in particular, careful attention should be paid to skin and subcutaneous tissue disorders. | |||||
| 書誌情報 |
薬学雑誌 en : YAKUGAKU ZASSHI 巻 137, 号 10, p. 1301-1311, 発行日 2017-10 |
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| DOI | ||||||
| 値 | 10.1248/yakushi.17-00120 | |||||
