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Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases.
https://gifu-pu.repo.nii.ac.jp/records/13159
https://gifu-pu.repo.nii.ac.jp/records/13159d882db4a-3d85-43de-a196-a04baaabaec8
Item type | 研究室原著論文(1) | |||||
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公開日 | 2018-06-14 | |||||
タイトル | ||||||
タイトル | Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases. | |||||
言語 | en | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | Association rule mining technique | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | Drug-induced gingival hyperplasia (DIGH) | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | FAERS | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | JADER | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | Spontaneous reporting system | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | Time-to-onset analysis | |||||
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 | BACKGROUND: Drug-induced gingival hyperplasia (DIGH) causes problems with chewing, aesthetics, and pronunciation, and leads to the deterioration of the patient's quality of life (QOL). Thus, the aim of this study was to evaluate the incidence of DIGH using spontaneous reporting system (SRS) databases. METHODS: We analyzed reports of DIGH from SRS databases and calculated the reporting odds ratios (RORs) of suspected drugs (immunosuppressants, calcium channel blockers, and anticonvulsants). The SRS databases used were the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) database. With the data, we evaluated the time-to-onset profile and the hazard type using the Weibull shape parameter (WSP). Furthermore, we used the association rule mining technique to discover undetected relationships such as possible risk factors. RESULTS: The FAERS contained 5,821,716 reports. The RORs (95% confidence interval: CI) for cyclosporine, everolimus, sirolimus, mycophenolate mofetil, amlodipine, nifedipine, carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, and valproic acid, were 39.4 (95% CI: 30.3-51.2), 4.2 (1.7-10.0), 6.6 (2.5-17.7), 13.1 (7.2-23.2), 94.8 (80.0-112.9), 57.9 (35.7-94.0), 15.1 (10.3-22.3), 65.4 (33.8-126.7), 6.5 (3.6-11.8), 19.7 (8.8-44.0), 65.4 (52.4-82.9), 56.5 (21.1-151.7), 2.9 (1.1-7.7), and 17.5 (12.6-24.4), respectively. The JADER database contained 430,587 reports. The median time-to-onset of gingival hyperplasia values for immunosuppressants, calcium channel blockers, and anticonvulsants use were 71, 262, and 37 days, respectively. Furthermore, the 95% CI of the WSP β for anticonvulsants was over and excluded 1, which meant that they were wear-out failure type. CONCLUSIONS: Our results suggest that DIGH monitoring of patients administered immunosuppressants, calcium channel blockers, or anticonvulsants is important. We demonstrated the potential risk of DIGH following the long-term use of calcium channel blocker over approximately 260 days. Based on the results of the association rule mining approach, patients with intellectual disability who are administered phenytoin should be monitored carefully. We recommend that patients who experience symptoms related to DIGH should be closely monitored. |
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書誌情報 |
en : Journal of pharmaceutical health care and sciences 巻 3, p. 19, 発行日 2017-06 |
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DOI | ||||||
値 | 10.1186/s40780-017-0088-5 |