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Affiliation |
Hospital Department of Pharmacy |
Graduating School 【 display / non-display 】
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-2002.03
Tohoku Pharmaceutical University Faculty of Pharmaceutical Science Graduated
Graduate School 【 display / non-display 】
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-2010.03
Tohoku Pharmaceutical University Graduate School, Division of Pharmaceutical Sciences Doctor's Course Completed
Campus Career 【 display / non-display 】
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2023.12-Now
Akita University Hospital Department of Pharmacy Professor
Research Areas 【 display / non-display 】
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Life Science / Clinical pharmacy
Research Achievements 【 display / non-display 】
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Relevance of plasma lenvatinib concentrations and endogenous urinary cytochrome P450 3A activity biomarkers in clinical practice.
Masaki Kumondai, Reika Ogawa, Nagomi Hayashi, Yurika Ishida, Hanae Oshikiri, Yuji Sato, Masafumi Kikuchi, Yu Sato, Toshihiro Sato, Masamitsu Maekawa, Nariyasu Mano
Pharmacology research & perspectives 12 ( 4 ) e1241 2024.08
Research paper (journal)
Lenvatinib (LEN), a multitarget tyrosine kinase inhibitor used in various cancer treatments, is mainly metabolized by cytochrome P450 3A (CYP3A) enzymes. The importance of therapeutic drug monitoring (TDM) in patients administered LEN has been proposed. Although some biomarkers of endogenous CYP3A activity have been reported, their utility in dosage adjustments has not been well evaluated. This study investigated the correlation between plasma LEN concentrations and endogenous urinary CYP3A biomarkers in clinical practice. Concentrations of plasma LEN (N = 225) and CYP3A biomarkers (cortisol, 6β-hydroxycortisol, deoxycholic acid, and 1β-hydroxydeoxycholic acid) in urine (N = 214) from 20 patients (hepatocellular carcinoma, N = 6; thyroid cancer, N = 3; endometrial cancer, N = 8; and renal cell carcinoma, N = 3) collected for consultation for up to 1 year were evaluated using liquid chromatography-tandem mass spectrometry. Moreover, plasma trough LEN concentrations were predicted using a three-compartment model with linear elimination for outpatients administered LEN before sample collection. Moderate correlations were observed between the quantified actual concentrations and the predicted trough concentrations of LEN, whereas there was no correlation with endogenous urinary CYP3A biomarkers. The utility of endogenous urinary CYP3A biomarkers could not be determined. However, TDM for outpatients administered orally available medicines may be predicted using a nonlinear mixed effect model (NONMEM). This study investigated the utility of endogenous urinary CYP3A biomarkers for personalized medicine and NONMEM for predicting plasma trough drug concentrations. These findings will provide important information for further clinical investigation and detailed TDM.
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Naldemedine-induced perforation of a diverticulum in the sigmoid colon of a patient with opioid-related constipation: a case report.
Hayato Yokota, Yumiko Akamine, Mizuki Kobayashi, Takuro Kitabayashi, Misato Horie, Tentaro Endo, Takechiyo Yamada, Masafumi Kikuchi
Journal of pharmaceutical health care and sciences 10 ( 1 ) 50 - 50 2024.08 [Refereed]
Research paper (journal)
BACKGROUND: Naldemedine is an orally available peripherally acting μ-opioid receptor antagonist approved to treat opioid-induced constipation (OIC). It is contraindicated for patients with known or suspected gastrointestinal obstruction to protect against naldemedine-induced perforation. Here, we report a clinical case of suspected perforation of a diverticulum in the sigmoid colon associated with naldemedine. CASE PRESENTATION: The patient was a 65-year-old man with a history of oral cancer who had been prescribed oxycodone (20 mg/day) for cancer pain. On day 0, the patient started naldemedine 0.2 mg once daily before bedtime for OIC. The dose of oxycodone was increased for pain control up to 60 mg/day. On day 35 of naldemedine treatment, the patient developed fever and abdominal pain, and his frequency of defecation had decreased. Initial laboratory results showed a C-reactive protein (CRP) level of 28.5 mg/dL and white blood cell (WBC) count of 13,500/µL. On day 37, the patient still had tenderness in his lower abdomen. Abdominal computed tomography revealed free air in the abdominal cavity suggesting an intestinal perforation. A Hartmann procedure was performed. Histopathological findings showed numerous diverticula in the sigmoid colon, some of which were perforated. CONCLUSIONS: These results suggest that the effects of OIC may have compressed the intestinal tract, which was followed by naldemedine-activation of peristalsis, which led to the onset of intestinal perforation. In patients with pre-existing diverticular disease, we should monitor for increased WBC counts and CRP levels after the initiation of treatment with naldemedine, and consider performing appropriate tests early in the event of abdominal complaints.
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Development of a simultaneous LC-MS/MS analytical method for plasma: 16 antipsychotics approved in Japan and 4 drug metabolites.
Masamitsu Maekawa, Maki Yokota, Toshihiro Sato, Yu Sato, Masaki Kumondai, Yuji Sato, Masato Suzuka, Daisuke Kobayashi, Kotaro Sakamoto, Masaki Matsuura, Masafumi Kikuchi, Hiroshi Komatsu, Kumiko Fujii, Yuji Ozeki, Hiroaki Tomita, Nariyasu Mano
Analytical sciences : the international journal of the Japan Society for Analytical Chemistry 2024.06
Research paper (journal)
The increased risk of adverse drug reactions due to the concomitant use of antipsychotics is problematic in the treatment of schizophrenia. Therefore, the simultaneous analysis of their plasma concentrations is required. In this study, we developed a simultaneous liquid chromatography/tandem mass spectrometry (LC-MS/MS) method for analyzing plasma antipsychotics approved in Japan for therapeutic drug monitoring (TDM) applications. First, we counted the prescriptions for 16 antipsychotics and concomitant drugs used at the Tohoku University Hospital. LC-MS/MS was used for the simultaneous analysis of 16 antipsychotics and four drug metabolites. This analysis was conducted using a combination of selected reaction monitoring mode and reversed-phase chromatography. Following the examination of the MS/MS and LC conditions, an analytical method validation test was conducted. The developed method was used to analyze plasma antipsychotic levels in patients with schizophrenia. One-third of the patients received treatment with multiple antipsychotics. Under LC-MS/MS conditions, LC separation was performed using a combination of a C18 column and ammonium formate-based mobile phases with a gradient flow. The calibration curves were optimized by adjusting the ion abundance, and 11 compounds met the criteria for intra- and inter-day reproducibility tests. Some stability test results did not meet these criteria; therefore, further investigation is required. The developed method permitted the measurement of all the plasma parameters, including concentrations above the therapeutic range. Therefore, this method may be useful in the daily TDM practice of antipsychotics.
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Association of the modified Glasgow prognostic score and prognostic nutritional index with duration of oral anamorelin administration in patients with cancer cachexia: a retrospective cohort study.
Kazuma Fujita, Yumiko Akamine, Haruka Igarashi, Yayoi Fukushi, Katsuya Sasaki, Koji Fukuda, Masafumi Kikuchi, Hiroyuki Shibata
Japanese journal of clinical oncology 2024.06 [Refereed]
Research paper (journal)
BACKGROUND: The modified Glasgow Prognostic Score (mGPS) and Prognostic Nutritional Index (PNI) are indicators of nutritional status in cancer patients; however, the effects of baseline mGPS and PNI on the duration of administration of the ghrelin receptor agonist anamorelin, which is used to treat cachexia in patients with cancer, are unclear. This study aimed to clarify the association of mGPS and PNI with the duration of oral anamorelin administration for patients who did not have beneficial effects from anamorelin. METHODS: The attending physician determined the duration of oral anamorelin administration based on discontinuation due to cancer progression, poor efficacy, adverse events, or death. RESULTS: The 12-week continuation rate of oral anamorelin was 30.4%. Univariate analysis revealed that an Eastern Cooperative Oncology Group performance status (ECOG-PS) of ≥2 (P < .001), concurrent chemotherapy (P = .002), albumin level (P = .005), C-reactive protein level (P = .013), and a mGPS of 2 (P = .014) were statistically significant predictors of the 12-week continuation rate of oral anamorelin. In the multivariate analysis, a mGPS of 2 remained a significant risk factor, and the ECOG-PS and concurrent chemotherapy had no effect on the association between the mGPS and 12-week continuation rate of oral anamorelin. CONCLUSION: Patients with a mGPS of 2, compared with mGPS of 0 or 1, are less likely to maintain oral anamorelin therapy, regardless of the ECOG-PS or concurrent chemotherapy. Therefore, it is necessary to consider initiating anamorelin administration at mGPS 0 or 1.
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Case report of QT interval prolongation induced by anamorelin in an obese patient with non-small cell lung cancer.
Hayato Yokota, Ruriko Asahi, Yumiko Akamine, Mizuki Kobayashi, Hiyu Wakabayashi, Sho Sakamoto, Yuji Okuda, Kazuhiro Sato, Katsutoshi Nakayama, Masafumi Kikuchi
Journal of pharmaceutical health care and sciences 10 ( 1 ) 33 - 33 2024.06 [Refereed]
Research paper (journal)
BACKGROUND: Anamorelin, a drug to treat cancer cachexia, binds to ghrelin receptors and improves body weight and appetite. In clinical trials in Japan, patients experienced a 10.7% frequency of stimulant conduction system depression as a severe side effect. Although rare, anamorelin sometimes causes fatal arrhythmias. Because patients with cancer cachexia are often underweight, data on the safety of anamorelin in obese patients are lacking. We report a case of QT interval prolongation after anamorelin administration to an obese patient with non-small cell lung cancer. CASE PRESENTATION: A female patient with a body mass index of 30 kg/m2 underwent immunotherapy for lung adenocarcinoma. She presented with severe weight loss, anorexia, and fatigue. She had no history of heart disease. On day 12, after administration of anamorelin 100 mg once daily, the patient developed nausea, diarrhea, and anorexia, which were considered cancer immunotherapy-induced immune-related adverse events, and she was admitted to the hospital. An electrocardiogram (ECG) on admission showed a QTc interval of 502 ms. On admission, her hepatic function was Child-Pugh class B, and anamorelin was discontinued the next day. On day 3 after anamorelin discontinuation, the QTc interval was prolonged by up to 557 ms, then decreased to 490 ms on day 6, and improved to 450 ms on day 16. Re-administration of anamorelin was avoided. CONCLUSIONS: When administering anamorelin to obese patients, we should be aware of the potential for stimulatory conduction system depression, as in underweight patients. Therefore, we should monitor patients by ECG from the early stages of anamorelin administration. Anamorelin is lipophilic, and its volume of distribution is increased in obese patients. Consequently, obese patients may continue to have QT interval prolongation after discontinuation of anamorelin, requiring long-term side-effect monitoring.
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Simultaneous analysis of remdesivir, favipiravir, and etoposide used to treat COVID-19 infection using liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring
高崎新也, 佐藤稔之, 鈴木博也, 青柳哲史, 青柳哲史, 森下啓, 千葉僚, 佐藤裕, 佐藤紀宏, 菊地正史, 大島謙吾, 徳田浩一, 前川正充, 眞野成康
JSBMS Letters 46 ( Supplement ) 2021
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Fundamental study for the development of LC/ESI-MS/MS method for simultaneous quantification of oral molecular targeted drugs and their metabolites
平澤天晴, 菊地正史, 菊地正史, 高崎新也, 公文代將希, 佐藤裕, 佐藤紀宏, 前川正充, 前川正充, 眞野成康, 眞野成康
JSBMS Letters 46 ( Supplement ) 2021
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インソースCIDを利用したLC/ESI‐MS/MSによる薬物一斉定量法構築への取り組み
菊地正史, 前川正充, 塚本多矩, 眞野成康, 眞野成康
臨床化学 48 ( Suppl.1 ) 162 - 162 2019.08
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インソースCIDを利用したLC/ESI‐MS/MSによる抗がん薬の同時測定法の構築に向けた基礎的検討
平澤天晴, 重田健介, 前川正充, 小倉次郎, 菊地正史, 菊地正史, 眞野成康, 眞野成康
臨床化学 ( (一社)日本臨床化学会 ) 48 ( Suppl.1 ) 251 - 251 2019.08
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第2回病院薬剤師が実践するリバーストランスレーショナルリサーチの最前線〜分子標的探索と個別化医療への挑戦〜 経口分子標的薬の個別化投与設計に向けて
山口 浩明, 高崎 新也, 菊地 正史, 川崎 芳英, 荒井 陽一, 眞野 成康
薬学雑誌 ( (公社)日本薬学会 ) 139 ( 6 ) 911 - 915 2019.06
異なるチロシンキナーゼ阻害薬を服用している腎癌患者の血中濃度を,それぞれの最適条件で同時分析することは困難であり,これまでは各薬物を個別に測定する必要があった.チロシンキナーゼ阻害薬一斉測定法を開発したので概説した.さらに,日本人の腎細胞癌患者におけるスニチニブの有効血中濃度域を明らかにするため,総血中濃度と有害事象および治療継続期間の関連性について解析した.
◆Original paper【 display / non-display 】
◆Other【 display / non-display 】
Grant-in-Aid for Scientific Research 【 display / non-display 】
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Grant-in-Aid for Scientific Research(C)
Project Year： 2021.04 - 2024.03
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Grant-in-Aid for Encouragement of Scientists
Project Year： 2014.04 - 2015.03
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Grant-in-Aid for Encouragement of Scientists
Project Year： 2013.04 - 2014.03
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Grant-in-Aid for Encouragement of Scientists
Project Year： 2006 - 2006
Presentations 【 display / non-display 】
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Fundamental study for the development of LC/ESI-MS/MS method for simultaneous quantification of oral molecular targeted drugs and their metabolites
平澤天晴, 菊地正史, 菊地正史, 高崎新也, 公文代將希, 佐藤裕, 佐藤紀宏, 前川正充, 前川正充, 眞野成康, 眞野成康
JSBMS Letters 2021 - 2021
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Simultaneous analysis of remdesivir, favipiravir, and etoposide used to treat COVID-19 infection using liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring
高崎新也, 佐藤稔之, 鈴木博也, 青柳哲史, 青柳哲史, 森下啓, 千葉僚, 佐藤裕, 佐藤紀宏, 菊地正史, 大島謙吾, 徳田浩一, 前川正充, 眞野成康
JSBMS Letters 2021 - 2021
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インソースCIDを利用したLC/ESI‐MS/MSによる抗がん薬の同時測定法の構築に向けた基礎的検討
平澤天晴, 重田健介, 前川正充, 小倉次郎, 菊地正史, 菊地正史, 眞野成康, 眞野成康
臨床化学 2019.08 - 2019.08 (一社)日本臨床化学会
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血中エベロリムス濃度と臨床効果の関連性~腎癌治療における長期追跡調査~
高崎新也, 川崎芳英, 菊地正史, 田中雅樹, 山口浩明, 伊藤明宏, 眞野成康
TDM研究 2019.05 - 2019.05 (一社)日本TDM学会
Academic Activity 【 display / non-display 】
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2024.09-Now
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2024.07-Now
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2024.06-Now
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2024.06-Now
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2024.06-Now