2021 Fiscal Year Final Research Report
Quantitative Assessment of Adverse Effects of Neuroleptics and Multiple Drug Interactions in the Elderly
Project/Area Number |
19K20736
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Research Category |
Grant-in-Aid for Early-Career Scientists
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Allocation Type | Multi-year Fund |
Review Section |
Basic Section 90140:Medical technology assessment-related
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Research Institution | Musashino University |
Principal Investigator |
Okada Akira 武蔵野大学, 薬学部, 助教 (50825320)
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Project Period (FY) |
2019-04-01 – 2022-03-31
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Keywords | データベース / 薬物動態 |
Outline of Final Research Achievements |
We analyzed information collected in the PMDA's database on adverse drug reactions and screened for adverse drug reactions, focusing on symptoms of geriatric syndrome. Triazolam (TZR) was taken up as a typical drug to be taken care of in the elderly from the viewpoints of aging and polypharmacy. From a report by Greenblatt et al. (NEJM, 1991), we extracted the blood concentration of TZR and the changes in sedation and cognitive functions, and constructed a PK/PD model. When TRZ was administered to the elderly (69 years old), it was estimated that 0.156 mg of TRZ was required to lower the blood concentration below 0.44 ug/mL 5.95 hours after administration.
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Free Research Field |
臨床薬理学
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Academic Significance and Societal Importance of the Research Achievements |
本邦の医薬品副作用データベース (JADER) を用いた解析は, 本邦におけるリアルワールドデータとして非常に有用であり, 近年多くの報告がなされている. 一方で,有害事象の定性的評価は可能であるものの, 定量的評価の実施は難しい. 本研究では, 治験では得ることが難しい高齢者における長期間の薬物使用状況と薬物有害事象の傾向の把握及び薬物の生体内運命の数理的モデル解析による包括的な評価を行った. このような研究は現時点で少なく, 本研究が先駆的な位置づけである.
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