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附属病院 薬剤部 |
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Yumiko Akamine, Miyuki Matsushita, Satoru Morikawa, Masatomo Miura
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan ( 公益社団法人 日本薬学会 ) 143 ( 4 ) 377 - 383 2023年
研究論文（学術雑誌）
Plasma concentrations of mycophenolic acid (MPA), an immunosuppressive agent, have been measured in clinical settings using immunoassay methods or HPLC. However, immunoassay methods show cross-reactivity with metabolites of MPA glucuronide. Recently, the LM1010 high-performance liquid chromatography instrument was approved as a new general medical device. In this study, we compared the results of MPA plasma concentrations analyzed using the LM1010 method and the previously described HPLC method. Plasma samples obtained from 100 renal transplant patients (32 women and 68 men) were evaluated using both HPLC instruments. Deming regression analyses showed a very high correlation between the two instruments, with a slope of 0.9892 and an intercept of 0.0235 µg/mL (r2=0.982). Bland-Altman analysis showed an average of -0.0012 µg/mL between the LM1010 method and the previously described HPLC method. For the LM1010 method, the total run time for MPA analysis was 7 min, and the analytical time was short; however, the extraction recovery when using a spin column was extremely low for frozen plasma samples stored at -20°C for 1 month, and the volume required for the assay (150 µL) could not be collected. Thus, for the LM1010 method, analysis using fresh plasma samples was optimal. Overall, our findings showed that the LM1010 method was a rapid, accurate HPLC assay for MPA analysis and could be used in clinical practice for routine monitoring of MPA in fresh plasma samples.
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Comparison electrochemiluminescence immunoassay and latex agglutination turbidimetric immunoassay for evaluation of everolimus blood concentrations in renal transplant patients.
Akamine Y, Sato S, Kagaya H, Ohkubo T, Satoh S, Miura M.
Journal of Clinical Pharmacy and Therapeutics 2018年04月 [査読有り]
研究論文（学術雑誌） 国内共著
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An update on the clinical pharmacokinetics of fexofenadine enantiomers.
Akamine Y and Miura M.
Expert Opinion on Drug Metabolism & Toxicology ( Taylor and Francis Group ) 2018年04月
総説・解説（学術雑誌） 国内共著
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Yayoi Fukushi, Yumiko Akamine, Maiko Abumiya, Nagi Tozawa, Takaya Yamashita, Miho Nara, Yoshihiro Kameoka, Naoto Takahashi, Masatomo Miura
British journal of clinical pharmacology ( British Journal of Clinical Pharmacology ) 2022年12月
The effects of polymorphisms of ABCB1 and ABCG2 on the dose-adjusted plasma trough concentrations and cerebrospinal fluid (CSF)-to-plasma ratios of ponatinib were evaluated. Blood (C4 ) and CSF (CSF4 ) concentrations at 4 h after administration were determined. The median (95% confidence interval) CSF4 -to-C4 ratio of ponatinib in subjects homozygous for ABCB1 variants 1236T/T, 2677T/T + T/A or 3435T/T were significantly higher than that in a group of subjects with other genotypes (P = .026, .012 and .015, respectively). The median (95% confidence interval) CSF4 -to-C4 ratio of ponatinib in 4 patients with the combination of ABCB1 variants 1236T/T-2677T/T + T/A-3435T/T was 2.62% (1.42-3.42%); this ratio was significantly higher than that in subjects with other genotypes (1.08% [0.89-1.47%]; P = .006). The brain distribution of ponatinib was affected by ABCB1 polymorphisms and therefore seems to be modulated by P-glycoprotein at the blood-brain and blood-CSF barriers.
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Natsuki Fukuda, Takahiro Kobayashi, Honami Sato, Yumiko Akamine, Naoto Takahashi, Masatomo Miura
Journal of Chromatographic Science ( Oxford University Press (OUP) ) 2022年10月
Abstract
A simple, highly sensitive and specific method based on high-performance liquid chromatography (HPLC) with ultraviolet detection was developed for the measurement of venetoclax concentrations in plasma samples. The chromatographic method employed a mobile phase of acetonitrile: 0.5% KH2PO4 (pH 3.5) (80/20, v/v) on a CAPCELL PAK C18 UG120 column at a flow rate of 0.5 mL/min. The quantitative method was validated based on standards described in “Bioanalytical Method Validation: Guidance for Industry” published by the US Food and Drug Administration. The separation of venetoclax and the internal standard R051012 was satisfactory, and the chromatograms were free of interfering peaks from the biological matrix. The intra- and inter-day coefficients of variation for venetoclax assays were <12.9%, whereas intra- and inter-day accuracies were within 13.6%. Only 100 μL of human plasma was required to detect a lower limit of quantification of 10 ng/mL for venetoclax. The recoveries of venetoclax extracted with an Oasis HLB cartridge were between 81 and 85%. The developed HPLC method was successfully applied to the determination of venetoclax concentrations in plasma of acute myeloid leukemia patients taking venetoclax. The degree of drug interactions between venetoclax and CYP3A4 inhibitors can be determined by this HPLC assay. -
Fukuda N.
Cancer Chemotherapy and Pharmacology ( Cancer Chemotherapy and Pharmacology ) 89 ( 5 ) 609 - 616 2022年05月
PURPOSE: We evaluated the plasma exposure and response relationships of nilotinib for patients with newly diagnosed chronic myeloid leukemia (CML) in real-world practice. METHODS: For the 26 patients enrolled in this study, at 3, 6, 12, and 24 months after nilotinib administration, the trough plasma concentrations (Ctrough) of nilotinib were analyzed. The relationships between nilotinib Ctrough and the molecular response to nilotinib treatment at each point (each n = 26) were evaluated. RESULTS: Median nilotinib Ctrough values were significantly higher in patients with a major molecular response (MMR) at 3 months than in patients without an MMR (809 and 420 ng/mL, respectively; P = 0.046). Based on the area under the receiver-operating characteristic curve, the threshold value of the nilotinib Ctrough at 3 months for predicting MMR achievement was 619 ng/mL at the best sensitivity (71.4%) and specificity (77.8%). Patients with a nilotinib Ctrough of above 619 ng/mL had a significantly shorter time to achievement of a deep molecular response (DMR; 9.0 and 18.0 months, respectively; P = 0.020) and higher rates of DMR by 2 years in Kaplan-Meier plots (P = 0.025) compared with that in patients with a nilotinib Ctrough of less than 619 ng/mL. CONCLUSION: For patients with newly diagnosed CML, the nilotinib dose may be adjusted using a Ctrough of above 619 ng/mL as the minimum effective concentration, i.e., the lowest concentration required for MMR or DMR achievement within a shorter time, during early stages after beginning therapy to obtain faster and deeper clinical responses.
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クロザピン又はその誘導体の血中薬剤濃度上昇リスク判定方法及び薬剤投与量判定方法
特許
特願 特願2016-092152 特開 特開2017-195862 特許 特許第6807094号
出願日： 2016年04月29日
公開日： 2017年11月02日
赤嶺 由美子, 三浦 昌朋
学術関係受賞 【 表示 ／ 非表示 】
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日本医療薬学会奨励賞
2022年09月24日 一般社団法人日本医療薬学会 精神科領域における個別化薬物療法の開発
受賞者： 赤嶺由美子 -
女性研究者支援コンソーシアムあきた賞
2020年11月26日 秋田県 患者血液中マーカーを用いた 精神科領域の個別化薬物療法の確立
受賞者： 赤嶺由美子 -
秋田県病院薬剤師会臨床薬学賞
2020年06月06日 一般社団法人秋田県病院薬剤師会 精神科領域における 個別化薬物療法の確立
受賞者： 赤嶺由美子 -
第27回日本医療薬学会年会 優秀演題賞
2017年11月04日 一般社団法人日本医療薬学会 ACMIA, CLIA, ECLIA, LTIA法によるタクロリムス血中濃度測定値へのCYP3A5遺伝子多型の影響
受賞者： 赤嶺由美子,加賀谷英彰, 佐藤滋, 三浦 昌朋 -
日本薬学会九州支部 学術奨励賞
2013年12月07日 日本薬学会九州支部 フェキソフェナジンの立体選択的体内動態とその規定因子の解析
受賞者： 赤嶺由美子
科研費（文科省・学振）獲得実績 【 表示 ／ 非表示 】
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抗精神病薬誘発性代謝異常に関するメカニズム研究
基盤研究(C)
研究期間: 2021年04月 - 2024年03月 代表者: 赤嶺由美子
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腎薬物トランスポータ遺伝子多型に基づいた炭酸リチウム副作用発現予測
奨励研究
研究期間: 2016年04月 - 2017年03月 代表者: 赤嶺由美子
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薬物トランスポータ遺伝子多型に基づくクロザピンの副作用発現予測
奨励研究
研究期間: 2015年04月 - 2016年03月 代表者: 赤嶺由美子
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UGT1A4の遺伝子多型からみたラモトリギンの副作用発現予測
奨励研究
研究期間: 2011年04月 - 2012年03月 代表者: 赤嶺由美子
その他競争的資金獲得実績 【 表示 ／ 非表示 】
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クロザピン活性代謝物血中濃度測定の臨床的意義に関する研究
提供機関: 民間財団等 先進医薬研究振興財団
研究期間： 2018年12月 - 2019年11月 代表者: 赤嶺由美子
資金支給機関区分：民間財団等
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PK-PD-PGx に基づいたクロザピン個別化療法の確立
提供機関: 民間財団等 薬学研究奨励財団
研究期間： 2016年04月 - 2019年03月 代表者: 赤嶺由美子
資金支給機関区分：民間財団等
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クロザピンの個別化治療の確立
提供機関: 民間財団等 臨床薬理研究振興財団
研究期間： 2016年04月 - 2017年10月 代表者: 赤嶺由美子
資金支給機関区分：民間財団等