| アブストラクト | 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 beta 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. |
|---|
| 投稿者 | Hatahira, Haruna; Abe, Junko; Hane, Yuuki; Matsui, Toshinobu; Sasaoka, Sayaka; Motooka, Yumi; Hasegawa, Shiori; Fukuda, Akiho; Naganuma, Misa; Ohmori, Tomofumi; Kinosada, Yasutomi; Nakamura, Mitsuhiro |
|---|
| 組織名 | Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4;Daigaku-nishi, Gifu, 501-1196 Japan.0000 0000 9242 8418grid.411697.c;Medical Database Co., Ltd, 3-11-10 Higashi, Shibuya-ku, Tokyo, 150-0011 Japan.;Ace Pharmacy, Seiyou Trading Co., Ltd, 1343 Funatsuke Nakashiro, Yoro-cho, Gifu,;503-1382 Japan.;United Graduate School of Drug Discovery and Medical Information Sciences, Gifu;University, 1-1 Yanagido, Gifu, 501-1194 Japan.0000 0004 0370 4927grid.256342.4 |
|---|
