| Project/Area Number |
22K06695
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Review Section |
Basic Section 47060:Clinical pharmacy-related
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| Research Institution | Niigata University |
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Principal Investigator |
Saiki Takuro 新潟大学, 医歯学系, 助教 (90865057)
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| Co-Investigator(Kenkyū-buntansha) |
西條 康夫 新潟大学, 医歯学系, 教授 (10270828)
日比野 浩 大阪大学, 大学院医学系研究科, 教授 (70314317)
緒方 元気 慶應義塾大学, 理工学部(矢上), 特任准教授 (80452829)
栄長 泰明 慶應義塾大学, 理工学部(矢上), 教授 (00322066)
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| Project Period (FY) |
2022-04-01 – 2025-03-31
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| Project Status |
Completed (Fiscal Year 2024)
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| Budget Amount *help |
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2024: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2023: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2022: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Keywords | ダイヤモンド電極 / 電気化学測定 / 血中薬物濃度 / TDM / 分子標的薬 / パゾパニブ / 血中薬物濃度測定 |
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| Outline of Research at the Start |
現在，血漿サンプル量: ~100 µL，測定時間: ~35秒，簡単なボタン操作のみで測定可能な系を確立した．今後，動物血漿検体を用い，迅速性，簡便性，測定感度のさらなる向上を目指し，電極装置，サンプル処理法などの最適化を進める．
また，実臨床で薬剤を服用予定の患者に，文書による同意を得た上で採血を行い，本手法による血中薬物濃度測定が可能であるか，測定結果が妥当であるか，検証を行う．
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| Outline of Final Research Achievements |
This study aimed to develop an electrochemical measurement system using diamond electrodes for the rapid, simple, and inexpensive determination of blood drug concentrations of molecular-targeted anti-cancer drugs. We used pazopanib as a test drug. The measurement system was capable of quantifying plasma drug concentrations in the range of 0-150 micromolar, which covers the optimal therapeutic concentration range. This method demonstrated several advantages: a short measurement time (~35 seconds per measurement and ~10 minutes including sample processing), a small blood sample volume (~40 microliters of whole blood per measurement), no complex modification or manipulation, and a low cost (approximately $5 per measurement). The validity of the assay system was confirmed by comparison with the conventional method using samples from rats administered orally and clinical human patients undergoing treatment.
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| Academic Significance and Societal Importance of the Research Achievements |
臨床ヒト患者サンプルにおいて，電気化学測定によるがん分子標的薬の血漿中薬物濃度測定の妥当性を示した，初めての研究である．実臨床への応用に向けては取り組むべき課題が残っているが，本手法を用いて，TDMの活用，薬物投与法の個別化・最適化による治療成績の向上，Point-of-care testing, On-site monitoringに貢献できる可能性が示唆された.
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