Research activity information

• Mar. 2026 日本薬学会第146年会学生優秀発表賞（ポスター発表の部）, 生理学的薬物動態モデルを用いた高度腎機能低下患者におけるオシメルチニブの薬物動態評価

  川野太郎, 高橋大, 三浦太郎, 丹田雅明, 伊藤雄大, 糸原光太郎, 矢野育子, 山本和宏


• Nov. 2025 2025年度日本医療薬学会論文賞, 抗EGFR抗体薬使用患者における皮膚障害に対する多職種連携による早期介入の有用性

  佐野尚平, 亀位耕平, 伊藤雄大, 栩野有輝, 嶋本めぐみ, 江川英毅, 平岡芹菜, 岸部美和子, 杉本里美, 上中智香子, 山本有紀, 上田弘樹, 須野学, 中川貴之, 松原和夫


• Jun. 2025 第17回日本がん薬剤学会（JSOPP）学術大会優秀発表賞, 膵癌患者に対するアルブミン懸濁型パクリタキセル＋ゲムシタビン療法の継続性を予測する因子の検討

  酒井陽香, 奥田あんり, 伊藤雄大, 江川英毅, 松原和夫, 須野学


• Jun. 2022 日本病院薬剤師会, 第10回江口記念がん優秀論文賞, Safety and Efficacy of Bis-Glyceryl Ascorbate as Prophylaxis for Hand-Foot Skin Reaction: A Single-Arm, Open-Label Phase I/II Study (DGA Study)

  Kazuhiro Yamamoto, Satoshi Nishiyama, Makoto Kunisada, Masashi Iida, Takahiro Ito, Takeshi Ioroi, Hiroo Makimoto, Tomohiro Omura, Kenichi Harada, Masato Fujisawa, Chikako Nishigori, Ikuko Yano


• Oct. 2021 2021年度日本医療薬学会論文賞, 経口抗がん薬治療における情報共有ツールおよびチーム基盤型学習を用いた病診薬連携の有用性の評価

  植田梨沙, 丹田雅明, 伊藤雄大, 榎本彩花, 飯田真之, 水田直美, 山本和宏, 槇本博雄, 大村友博, 矢野育子


• Feb. 2021 第27回日本がんチーム医療研究会優秀演題賞, 抗がん薬調製ロボット導入前後における抗がん薬関連業務の比較

  伊藤雄大, 丹田雅明, 水田直美, 丸上奈穂, 山口由加里, 植田梨沙, 山本和宏, 槇本博雄, 大村友博, 矢野育子


• Nov. 2015 第25回日本医療薬学会年会優秀演題賞, ヒト血漿中および乳汁中のdexmedetomidine濃度測定法の開発とその臨床応用

  中西里佳, 須野学, 伊藤雄大, 国沢卓之, 吉村学, 青木和葉, 黒澤温, 菅原亜美

• Changes in remimazolam plasma concentration associated with the Pringle maneuver during hepatectomy: a pilot study.

  Shunya Ogawa, Hirotsugu Kanda, Takahiro Ito, Manabu Suno, Kazuo Matsubara, Sarah Kyuragi Luthe, Tomoyuki Kawamata

  BACKGROUND: Remimazolam (RMZ) is an ultrashort-acting benzodiazepine used in general anesthesia, metabolized rapidly by carboxylesterase 1, an enzyme primarily located in the liver. The Pringle maneuver (PM), an established technique commonly employed during hepatectomies to reduce bleeding, involves clamping major vessels, potentially affecting drug metabolism and clearance. Therefore, we conducted a study to investigate the changes in plasma concentration (Cp) of RMZ associated with the PM during hepatectomy and the impact on bispectral index (BIS) values. METHODS: This single-center prospective observational pilot study included ten patients undergoing hepatectomy using the PM. RESULTS: Our findings showed that the changes in RMZ Cp immediately following each PM tended to be higher than those before PM in six cases, though this was not observed in others. However, there was no statistically significant difference between the median RMZ Cp after the final PM (1099 [723-1386] ng/mL) and before the initial PM (707 [641-856] ng/mL). Similarly, the median BIS value after the final PM (45 [40-46]) was comparable to the BIS prior to initiation of PM (46 [44-50]). CONCLUSIONS: This study suggested that RMZ may be safely administered during hepatectomies with PM in patients with Child-Pugh classification A. TRIAL REGISTRATION: Clinical trial number: not applicable.

  Jun. 2026, Journal of pharmaceutical health care and sciences, 12(1) (1), 78, English, International magazine

  [Refereed]

  Scientific journal


• 炎症マーカーとPK/PD/PGxの統合解析に基づくトファシチニブの個別化治療法の構築

  伊藤雄大

  Jun. 2026, 臨床薬理の進歩, 47, 219 - 225


• 術後悪心嘔吐発生に対する薬剤師介入の効果に関する後方視的研究

  住吉霞美, 大村友博, 栗村朋子, 山下和彦, 村川亜光, 津田瑞季, 伊藤雄大, 田口真也, 木村丈司, 山本和宏, 小幡典彦, 矢野育子

  Japanese Society of Pharmaceutical Health Care and Sciences, Mar. 2026, Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences), 52(3) (3), 111 - 119, Japanese

  [Refereed]

  Scientific journal


• Impact of continuous hemodiafiltration on serum acyclovir concentrations in a patient with encephalopathy.

  Takahiro Ito, Kotaro Itohara, Sachi Hirata, Takeshi Kimura, Yumi Kitahiro, Tomohiro Omura, Joji Kotani, Ikuko Yano

  Reports on serum acyclovir (ACV) concentrations in patients undergoing continuous hemodiafiltration (CHDF) remain limited. We present a case describing the impact of CHDF on serum ACV levels in a patient with encephalopathy. A Japanese woman in her 70s was prescribed oral valacyclovir (VACV) at a dose of 1000 mg three times daily for herpes zoster ophthalmicus. After 7 days of treatment, she was admitted to a local hospital with fever, dysarthria, altered consciousness, hallucinations, and headache. Her serum creatinine level was elevated at 4.02 mg/dL. Intravenous ACV was initiated under the clinical suspicion of varicella zoster virus (VZV) encephalitis. However, after 3 days of treatment without improvement in consciousness, she was transferred to our hospital. Her serum ACV concentration upon admission was 14.1 μg/mL. Suspecting ACV-induced encephalopathy and renal dysfunction, CHDF was promptly initiated. Following CHDF therapy, serum ACV levels declined rapidly, accompanied by a gradual improvement in consciousness. This case suggests that CHDF may be an effective therapeutic option for managing ACV-associated nephropathy and encephalopathy.

  Dec. 2025, Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 31(12) (12), 102859 - 102859, English, International magazine

  [Refereed]

  Scientific journal


• Effect of Hemodialysis on Total and Free Lenvatinib Concentrations in a Patient With Metastatic Renal Cell Carcinoma.

  Takahiro Ito, Shimpei Yamashita, Manabu Suno, Ayaka Iwata, Yasuo Kohjimoto, Kazuo Matsubara

  INTRODUCTION: Lenvatinib (LEN) concentrations in patients undergoing hemodialysis (HD) have not been examined. Herein, we report the effect of HD on total and free LEN concentrations in a patient with mRCC. CASE PRESENTATION: The hemodialyzed patient was a 55-year-old Japanese male who was treated with 20 mg LEN daily. The area under the plasma concentration-time curve for LEN from 0 to 24 h (AUC0-24) was calculated on Day 8 (off HD) and Day 9 (on HD) after starting administration of LEN. For total LEN on Days 8 and 9, the AUC0-24 was 2553 and 2783 ng × h/mL, respectively. The free LEN concentration just after HD on Day 9 was 40% lower than that at the same time on Day 8 (1.8 vs. 3.0 ng/mL). CONCLUSION: Although the free LEN concentration is reduced just after HD, LEN will have sufficient pharmacological activity on HD days for patients undergoing HD.

  Lead, Nov. 2025, IJU case reports, 8(6) (6), 601 - 603, English, International magazine

  [Refereed]

  Scientific journal


• Changes and Effectiveness of Pharmaceutical Interventions via Tracing Reports Under Enhanced Collaboration Between Hospitals and Community Pharmacies in Outpatient Cancer Pharmacotherapy

  津田瑞季, 丹田雅明, 大村友博, 伊藤雄大, 飯田真之, 丸上奈穂, 山口由加里, 大本暢子, 山本和宏, 矢野育子

  Apr. 2025, 医療薬学, 51(4) (4), 203 - 212, Japanese

  [Refereed]


• Simultaneous Quantification of Filgotinib and Its Active Metabolite in Human Plasma Using Liquid Chromatography-Tandem Mass Spectrometry: Validation and Clinical Application.

  Takahiro Ito, Manabu Suno, Minae Shintani, Ayaka Iwata, Takao Fujii, Kazuo Matsubara

  Filgotinib (FLG) is a Janus kinase 1 inhibitor and is metabolized to an active metabolite, GS-829845. There is no report on the method for simultaneous quantification of FLG and GS-829845 in clinical samples. We developed a liquid chromatography-tandem mass spectrometry method for simultaneous determination of FLG and GS-829845 in patient plasma. FLG and GS-829845 were extracted from an aliquot of 50 μL of human plasma by simple deproteinization using methanol. Chromatographic separation was performed using a Shim-pack Scepter C18-120 column with a combined mobile phase of water and methanol containing 0.1% formic acid and gradient elution at a flow rate of 0.2 mL/min. Detection was performed by positive electrospray ionization using a QTRAP 4500 mass spectrometer. The method was validated in the concentration range of 2.5-50 ng/mL for FLG and 250-5000 ng/mL for GS-829845. Intra- and inter-day assay accuracy and precision were within 11.4% and 13.9%, respectively. Recoveries and matrix effects were consistent and reproducible. This developed and fully validated method is simple, rapid, and cost-effective and was used successfully for therapeutic drug monitoring in a patient with rheumatoid arthritis.

  Lead, Apr. 2025, Biomedical chromatography : BMC, 39(4) (4), e70030, English, International magazine

  [Refereed]

  Scientific journal


• Insight from Lymphocyte-Albumin Scores into Treatment Continuity of Nanoliposomal Irinotecan With 5-Fluorouracil and L-leucovorin in Metastatic Pancreatic Cancer.

  Takahiro Ito, Manabu Suno, Minae Shintani, Ayaka Iwata, Reiko Ashida, Manabu Kawai, Kazuo Matsubara

  BACKGROUND/AIM: Nanoliposomal irinotecan with 5-fluorouracil and L-leucovorin (nal-IRI/FL) is the standard regimen for metastatic pancreatic cancer, but there are no reports on prediction of early discontinuation. In this study, we investigated predictive factors of early discontinuation of nal-IRI/FL. PATIENTS AND METHODS: The study included 36 patients who received nal-IRI/FL at Wakayama Medical University Hospital between June 2021 and May 2022. Those with time-to-treatment failure (TTF) ≤28 days were defined as the early discontinuation group (group ED), and those with TTF >28 days were placed in the continuation group (group C). Laboratory data were collected just before and every 14 days after initiation of nal-IRI/FL treatment. RESULTS: There were six patients (16.7%) in group ED and 30 patients (83.3%) in group C. The lymphocyte×albumin (LA) score before therapy was significantly lower in group ED (p=0.005). In receiver operating characteristic analysis, pre-treatment LA was the best predictor for early discontinuation, with a cutoff value of 4,142 (sensitivity: 1.00, specificity: 0.77, p=0.004). In group C, LA was significantly lower at 28 days before nal-IRI/FL treatment failure compared to the value before the start of therapy [median with range: 3,299 (1,478-6,994) vs. 4,304 (2,085-8,085), p=0.006]. CONCLUSION: The LA score is a useful marker for evaluating treatment continuity, and especially early discontinuation, of nal-IRI/FL in patients with pancreatic cancer.

  Lead, Nov. 2024, In vivo (Athens, Greece), 38(6) (6), 2873 - 2879, English, International magazine

  [Refereed]

  Scientific journal


• 抗EGFR抗体薬使用患者における皮膚障害に対する多職種連携による早期介入の有用性

  佐野 尚平, 亀位 耕平, 伊藤 雄大, 栩野 有輝, 嶋本 めぐみ, 江川 英毅, 平岡 芹菜, 岸部 美和子, 杉本 里実, 上中 智香子, 山本 有紀, 上田 弘樹, 須野 学, 中川 貴之, 松原 和夫

  抗EGFR抗体薬(パニツムマブ、セツキシマブ)使用患者の皮膚障害に対して多職種連携で早期介入を行う体制を構築し、その有効性について検証するとともに、重度皮膚障害のリスク因子について検討した。多職種連携のツールとして、皮膚症状や支持療法へのアドヒアランス等を医師・看護師・薬剤師で情報共有する「治療経過シート」を多職種で協議し作成した。そして同シートを用い、Grade 2の皮膚障害が2週間以上改善しない時点で皮膚科医が介入する体制とした。多職種連携体制構築前(2014年1月～2017年8月)の患者41例と構築後(2017年9月～2022年9月)の患者45例の重度皮膚障害発現率を構築前後で比較すると、構築前19.5%、構築後は4.4%と有意に低下した。重度皮膚障害の発現に影響を及ぼす有意な因子として「多職種連携の構築」と「性別(女性で発現率が高い)」が抽出された。

  (一社)日本医療薬学会, Oct. 2024, 医療薬学, 50(10) (10), 523 - 530, Japanese

  [Refereed]


• Pharmacokinetics of Brexpiprazole, Quetiapine, Risperidone, and Its Active Metabolite Paliperidone in a Postpartum Woman and Her Baby.

  Toru Konishi, Yumi Kitahiro, Naoko Fujiwara, Kazuhiro Yamamoto, Mari Hashimoto, Takahiro Ito, Kotaro Itohara, Kazumichi Fujioka, Hitomi Imafuku, Ikuo Otsuka, Tomohiro Omura, Ikuko Yano

  BACKGROUND: Brexpiprazole is a second-generation antipsychotic approved in Japan in 2018; however, information on placental passage and breast milk transfer remains limited. In this report, the patient, a 30-year-old pregnant woman with schizophrenia, was medicated with brexpiprazole, risperidone, and quetiapine. METHODS: The study used high-performance liquid chromatography-tandem mass spectrometry to determine the concentrations of brexpiprazole, quetiapine, risperidone, and its active metabolite (paliperidone) in maternal and neonatal plasma, cord venous plasma, and breast milk. Maternal plasma samples were obtained approximately 2 and 8 hours after the last administration of antipsychotics on the day of delivery and at the estimated drugs' trough time on days 1, 3, and 5 after delivery. RESULTS: The maternal plasma concentrations of brexpiprazole, quetiapine, and paliperidone increased by approximately 3.5-fold on the fifth day compared with those on the day of delivery, whereas the risperidone concentration remained almost constant. Moreover, the neonatal plasma concentrations of the 4 drugs immediately after birth were indistinguishable from the umbilical cord concentrations and gradually decreased, except for risperidone. Relative infant doses of these compounds were below 1.1%. CONCLUSIONS: Pregnancy status notably alters the pharmacokinetic properties of antipsychotics. Therefore, close and careful monitoring of clinical symptoms should be considered during pregnancy and after delivery. Although brexpiprazole is transferred to neonates through the placenta, breastfeeding is still possible because the relative infant dose value of this drug was much less than 10%.

  Oct. 2024, Therapeutic drug monitoring, 46(5) (5), 687 - 691, English, International magazine

  [Refereed]

  Scientific journal

  Link to Kobe Univ. Repository (Kernel)


• Risk Factors for Adverse Events of Nanoliposomal Irinotecan Plus 5-Fluorouracil and L-leucovorin.

  Takahiro Ito, Manabu Suno, Hideki Egawa, Serina Hiraoka, Kohei Kamei, Shohei Sano, Reiko Ashida, Manabu Kawai, Kazuo Matsubara

  BACKGROUND/AIM: The regimen with nanoliposomal irinotecan plus 5-fluorouracil and L-leucovorin (nal-IRI/FL) is used for metastatic pancreatic cancer. A clinical study has indicated that the uridine diphosphate-glucuronosyltransferase (UGT) 1A1 polymorphism is associated with neutropenia during nal-IRI/FL treatment; however, no studies have reported risk factors for the occurrence of adverse events in the clinical setting. This study aimed to explore the risk factors for adverse events of nal-IRI/FL. PATIENTS AND METHODS: This study included patients with metastatic pancreatic cancer who started nal-IRI/FL treatment. Patient information, including laboratory data before nal-IRI/FL initiation and adverse events during nal-IRI/FL treatment, was retrospectively obtained from medical records. RESULTS: This study consisted of 36 patients, including 16, 16, and 4 with UGT1A1*6 or *28 wild-type (-/-), heterozygous (+/-), and homozygous (+/+), respectively. Patients with UGT1A1*6 or *28 (+/+) exhibited significantly lower nadir counts of white blood cells (p=0.033) and neutrophils (p=0.043). Multiple regression analyses revealed that the decreased white blood cell count was significantly associated with the genotype of UGT1A1*6 or *28 (+/+) (p=0.009), high aspartate aminotransferase (AST) value before the therapy (p=0.019), and pancreatic head cancer (p=0.030). Also, the decreased neutrophil count was significantly related to the genotype of UGT1A1*6 or *28 (+/+) (p=0.017). CONCLUSION: Patients with UGT1A1*6 or *28 (+/+) should be especially concerned about neutropenia and leukopenia during nal-IRI/FL treatment. Additionally, high AST value and pancreatic head cancer may be risk factors for leukopenia during nal-IRI/FL treatment.

  Lead, May 2024, Cancer diagnosis & prognosis, 4(3) (3), 244 - 249, English, International magazine

  [Refereed]

  Scientific journal


• Assessment of Patient Characteristics Influencing the Analgesic Effects of Ibuprofen Gargle After Mandibular Third Molar Extractions.

  Yasumasa Kakei, Takeshi Ioroi, Keiko Miyakoda, Takahiro Ito, Masahiko Kashin, Tatsuya Shirai, Takumi Hasegawa, Toshiyasu Sakane, Ikuko Yano, Masaya Akashi

  Introduction In our previous work, we investigated the analgesic effects of ibuprofen gargle after mandibular third molar extractions. However, a subsequent detailed review of individual patient data revealed variations in postoperative pain reduction among patients. Consequently, the present study was designed to conduct post-hoc subanalyses that identified factors contributing to variation in the analgesic response to ibuprofen gargle after third molar extractions. Materials and methods This study involved thirty-five Japanese patients from a prior randomized, double-blind, placebo-controlled, crossover study, which focused on the analgesic effects of ibuprofen gargle after mandibular third molar extractions. Participants were categorized as responders (n = 13) and non-responders (n = 22) based on the within-subject difference (ibuprofen-placebo, IP) of visual analog scale (VAS) changes. Baseline characteristics were compared, along with variables, such as age, sex, the reason for extraction, extraction site, Pell Gregory (space and depth) classification, Winter's classification, surgeon's experience, and surgery time. Baseline characteristics predicting responder status were examined using multivariate logistic regression. Results In the univariate analysis, variables such as age, sex, and baseline VAS scores with p-values <0.2 were evaluated using a stepwise approach. This analysis identified age (per -10 years) with an odds ratio of 4.163 (95% confidence interval (CI): 1.170-31.952, p = 0.0233) and sex (female) with an odds ratio of 9.977 (95% CI: 1.336-208.256, p = 0.0213) as significant predictors of responder status. Conclusions In young and female patients, ibuprofen gargle decreased postoperative pain after mandibular third molar extractions.

  Apr. 2024, Cureus, 16(4) (4), e57516, English, International magazine

  [Refereed]

  Scientific journal

  Link to Kobe Univ. Repository (Kernel)


• Evaluation of Practice of Community Health Care and Pharmacy for first-year pharmacy students at Wakayama Medical University

  Ito Takahiro, Suno Manabu, Nagata Misa, Matsubara Kazuo, Ohta Shigeru

  In pharmaceutical education, the current practical training program to understand roles of pharmacists in the comprehensive community health care system and the uneven distribution of pharmacists is insufficient. We conducted an original educational program named “Practice of Community Health Care and Pharmacy I”, which included fieldwork, for 15 first-year pharmacy students at Wakayama Medical University aimed at understanding the uneven distribution of pharmacists. The overall satisfaction with the practice (0–100%) was assessed through a satisfaction survey. The usefulness of the practice was evaluated using a questionnaire based on the self-evaluation score (average of six questions, 1–4 points each) asking “Can you explain about community health care and uneven distribution?” The satisfaction was 78.0 ± 8.0% (mean ± standard deviation). After the practice, the self-evaluation scores increased significantly from 1.5 ± 0.3 points to 3.0 ± 0.3 points (mean ± standard deviation). In the students’ practice reports, words such as “pharmacy”, “medical care”, “pharmacist”, and “community” were found to be relevant. The results suggest that practice helps students to understand community health care and uneven distribution of pharmacists. Additionally, a fieldwork may be effective to bring awareness among students about the uneven distribution of pharmacists.

  Lead, Japan Society for Pharmaceutical Education, Mar. 2024, Japanese Journal of Pharmaceutical Education, 8, Japanese

  [Refereed]


• Efficacy and safety of ibuprofen gargle for postoperative pain after mandibular third molar extraction: A phase II, placebo-controlled, double-blind, randomized crossover trial.

  Takeshi Ioroi, Yasumasa Kakei, Takahiro Ito, Tatsuya Shirai, Yutaro Okazaki, Takumi Hasegawa, Masaya Akashi, Ikuko Yano

  OBJECTIVE: This study was designed to evaluate the postoperative efficacy and safety of using an ibuprofen gargle as a pain management strategy for patients who have undergone mandibular third molar extraction. We also ensured that the quality of treatment was not compromised throughout the study. MATERIAL AND METHODS: Patients were randomized in a 1:1 ratio into two groups: the ibuprofen-placebo (IP) group and the placebo-ibuprofen (PI) group. On postoperative Day (POD) 1, the IP group initiated ibuprofen administration, while the PI group started taking placebo. On POD 2, the IP group switched to using placebo, whereas the PI group switched to ibuprofen. From PODs 3-5, both groups were prescribed ibuprofen gargle. The primary endpoint was within-subject visual analog scale (VAS) score before and 5 min after the first use of the ibuprofen or placebo gargle on PODs 1 and 2 (ΔVAS5_ibuprofen  - ΔVAS5_placebo ). The incidence and severity of adverse events were assessed using the Common Terminology Criteria for Adverse Events version 5.0 and a subjective rating scale. RESULTS: This study enrolled 40 patients. The within-subject VAS5 of the IP and PI groups were 1.25 ± 12.0 and -5.26 ± 8.93 mm, respectively. The treatment effect of ibuprofen gargle was -2.01 ± 10.62 mm (p = .246). None of the patients in each group presented with serious adverse events or clinically significant complications (including dry sockets) after extraction. Transient adverse events, such as throat tingling and oral discomfort (grade 1), were observed in each group. CONCLUSION: Ibuprofen gargle was safe but did not provide significant pain relief when used after mandibular third molar extraction.

  Dec. 2023, Clinical and experimental dental research, 9(6) (6), 1058 - 1068, English, International magazine

  [Refereed]

  Scientific journal

  Link to Kobe Univ. Repository (Kernel)


• Physiologically-based pharmacokinetic model to investigate the effect of pregnancy on risperidone and paliperidone pharmacokinetics: Application to a pregnant woman and her neonate.

  Walaa Y B Mahdy, Kazuhiro Yamamoto, Takahiro Ito, Naoko Fujiwara, Kazumichi Fujioka, Tadasu Horai, Ikuo Otsuka, Hitomi Imafuku, Tomohiro Omura, Kazumoto Iijima, Ikuko Yano

  This study aimed to determine the effects of pregnancy and ontogeny on risperidone and paliperidone pharmacokinetics by assessing their serum concentrations in two subjects and constructing a customized physiologically-based pharmacokinetic (PBPK) model. Risperidone and paliperidone serum concentrations were determined in a pregnant woman and her newborn. PBPK models for risperidone and paliperidone in adults, pediatric, and pregnant populations were developed and verified using the Simcyp simulator. These models were then applied to our two subjects, generating their "virtual twins." Effects of pregnancy on both drugs were examined using models with fixed pharmacokinetic parameters. In the neonatal PBPK simulation, 10 different models for estimating the renal function of neonates were evaluated. Risperidone was not detected in the serum of both pregnant woman and her newborn. Maternal and neonatal serum paliperidone concentrations were between 2.05-3.80 and 0.82-1.03 ng/ml, respectively. Developed PBPK models accurately predicted paliperidone's pharmacokinetics, as shown by minimal bias and acceptable precision across populations. The individualized maternal model predicted all observed paliperidone concentrations within the 90% prediction interval. Fixed-parameter simulations showed that CYP2D6 activity largely affects risperidone and paliperidone pharmacokinetics during pregnancy. The Flanders metadata equation showed the lowest absolute bias (mean error: 22.3% ± 6.0%) and the greatest precision (root mean square error: 23.8%) in predicting paliperidone plasma concentration in the neonatal population. Our constructed PBPK model can predict risperidone and paliperidone pharmacokinetics in pregnant and neonatal populations, which could help with precision dosing using the PBPK model-informed approach in special populations.

  Apr. 2023, Clinical and translational science, 16(4) (4), 618 - 630, English, International magazine

  [Refereed]

  Scientific journal

  Link to Kobe Univ. Repository (Kernel)


• 抗がん薬調製ロボット導入前後における薬剤師のがん薬物療法関連業務の比較

  伊藤雄大, 丹田雅明, 水田直美, 丸上奈穂, 山口由加里, 植田梨沙, 梅山遥, 伊藤恵, 山本和宏, 槇本博雄, 大村友博, 矢野育子

  Lead, (一社)日本病院薬剤師会, Jun. 2022, 日本病院薬剤師会雑誌, 58(6) (6), 627 - 632, Japanese

  [Refereed]

  Scientific journal


• Efficacy of Ibuprofen Gargle for Postoperative Pain After Mandibular Third Molar Extraction: Protocol for a Phase II, Placebo-Controlled, Double-Blind, Randomized Crossover Trial.

  Yasumasa Kakei, Takeshi Ioroi, Takahiro Ito, Yutaro Okazaki, Takumi Hasegawa, Ikuko Yano, Masaya Akashi

  BACKGROUND: Extraction of mandibular third molars is one of the most commonly performed oral surgical procedures, and nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management. Oral NSAIDs are associated with adverse events such as gastrointestinal disorders, renal and hepatic dysfunction, and platelet dysfunction. Topical analgesics have been proposed as alternatives to oral and injectable medications to safely improve postoperative pain relief. We will conduct a single-center, placebo-controlled, double-blind, randomized crossover trial to assess the pain-relieving effect of an ibuprofen-containing gargle in patients undergoing extraction of mandibular third molars when compared with a placebo gargle. OBJECTIVE: This will be the first clinical study to compare the efficacy of an ibuprofen gargle with that of a placebo for relieving postoperative pain in addition to loxoprofen after mandibular third molar extraction. METHODS: This study will be performed at Kobe University Hospital. Participants (N=40) will be randomized equally to 1 of 2 groups. The ibuprofen-placebo group will receive an ibuprofen gargle on postoperative day (POD) 1 and a placebo gargle on POD 2. The placebo-ibuprofen group will receive a placebo gargle on POD 1 and an ibuprofen gargle on POD 2. Both groups will receive ibuprofen gargles on PODs 3-5 at least once daily. The primary objective is to estimate the within-subject difference on a visual analog scale (VAS) before and 5 minutes after using the ibuprofen or placebo gargle on PODs 1 and 2. The secondary objectives are to estimate the within-subject differences in ΔVAS before and 15 minutes after using the ibuprofen or placebo gargle on PODs 1 and 2, ΔVAS before and 5 or 15 minutes after using the ibuprofen gargle on PODs 3-5, overall efficacy (self-completion, 5 scales) on PODs 1-5, daily frequency of use (ibuprofen or placebo gargle and analgesics) on PODs 1-7, and the occurrence of adverse events. RESULTS: The Certified Review Board of Kobe University approved the study. The intervention was implemented in May 2021. For the primary analysis, we will calculate the mean and SD of ΔVAS5 on PODs 1 and 2 and the within-study difference in ΔVAS5. The treatment effect will be estimated by dividing the mean ΔVAS5 in the within-subject difference by 2 and calculating the P value using an unpaired t test. For the secondary analysis, we will calculate the mean and SD of ΔVAS15 on PODs 1 and 2 and the within-study difference in ΔVAS15. The treatment effect will be estimated as in the primary analysis. CONCLUSIONS: This trial will provide exploratory evidence of the efficacy and safety of an ibuprofen gargle for pain reduction after mandibular third molar extraction. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCTs051210022; https://tinyurl.com/39ej23zu. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35533.

  May 2022, JMIR research protocols, 11(5) (5), e35533, English, International magazine

  [Refereed]

  Scientific journal


• Safety and Efficacy of Bis-Glyceryl Ascorbate as Prophylaxis for Hand-Foot Skin Reaction: A Single-Arm, Open-Label Phase I/II Study (DGA Study).

  Kazuhiro Yamamoto, Satoshi Nishiyama, Makoto Kunisada, Masashi Iida, Takahiro Ito, Takeshi Ioroi, Hiroo Makimoto, Tomohiro Omura, Kenichi Harada, Masato Fujisawa, Chikako Nishigori, Ikuko Yano

  BACKGROUND: Hand-foot skin reaction (HFSR) induced by multiple tyrosine kinase inhibitors (TKIs) is a serious side effect that can cause treatment interruption or decreased dosing. This study was conducted to evaluate the safety and efficacy of bis-glyceryl ascorbate (Amitose bis(di)-glyceryl ascorbate [DGA])-containing cream (DGA cream) for the prevention of sunitinib-induced HFSR. METHODS: A single-arm, open-label phase I/II study was conducted, targeting patients with metastatic renal cell carcinoma (mRCC) who were receiving sunitinib therapy with a schedule of 2 weeks on/1 week off. The participants applied DGA cream to both palmar and plantar surfaces in combination with a moisturizing agent as standard-of-care prophylaxis during two sunitinib treatment cycles (6 weeks). The primary endpoint in phase I was safety defined as dermatological abnormalities and it was determined in the first five participants. The primary endpoint in phase II was efficacy defined as development of grade 1 or higher HFSR defined by Common Terminology Criteria for Adverse Events within 6 weeks and it was determined on a full analysis set (FAS) defined as the population including all participants who used DGA cream once in the study duration. Efficacy in the per protocol set (PPS) defined as the population excluding seven patients whose study treatment was interrupted was evaluated as a secondary endpoint. RESULTS: Twenty-four patients were enrolled as a FAS. No dermatological abnormalities occurred in the first 5 patients enrolled in the phase I study. Three patients developed HFSR (grade 1: n = 2, grade 2: n = 1) in the observation period. The HFSR incidence rate was 12.5% (3/24; 95% confidence interval [CI]: 2.7%-32.4%) in the FAS, which was significantly lower than the incidence rate predefined as a threshold of 33.3% by a previous report from our hospital (P = .030). The incidence rate in the 17 patients of the PPS was 17.6% (3/17; 95%CI: 3.8%-43.4%). CONCLUSION: DGA cream may be safe and effective in the prophylaxis of HFSR in mRCC patients who receive sunitinib therapy (Trial ID: jRCTs051180051).

  May 2022, The oncologist, 27(5) (5), e384-e392, English, International magazine

  [Refereed]

  Scientific journal


• Association of sunitinib concentration and clinical outcome in patients with metastatic renal cell carcinoma treated with a 2‐week‐on and 1‐week‐off schedule

  Takahiro Ito, Kazuhiro Yamamoto, Junya Furukawa, Kenichi Harada, Masato Fujisawa, Tomohiro Omura, Ikuko Yano

  Lead, Wiley, Jan. 2022, Journal of Clinical Pharmacy and Therapeutics, 47(1) (1), 81 - 88, English

  [Refereed]

  Scientific journal


• がん化学療法誘発性悪心・嘔吐の予防を目的としたオランザピンの投与量と傾眠発現との関連

  穐原裕奈, 山本和宏, 水田直美, 丹田雅明, 伊藤雄大, 大村友博, 坂根稔康, 國正淳一, 矢野育子

  Jan. 2022, 日本病院薬剤師会雑誌, 58(1) (1), 67 - 72, Japanese

  [Refereed]

  Scientific journal


• 移植非適応の成人T細胞白血病リンパ腫患者に化学療法が施行される際のサイトメガロウイルス感染のリスク因子に関する後方視的調査

  吉田裕生, 福石和久, 津曲恭一, 高田正温, 川俣洋生, 牛島知実, 衛藤智章, 斎田翌美, 伊藤雄大, 林稔展

  Dec. 2021, 日本病院薬剤師会雑誌, 57(12) (12), 1391 - 1395, Japanese

  [Refereed]

  Scientific journal


• 薬理遺伝学および薬物動態学的解析に基づくリスペリドンの個別化投与設計法の確立

  伊藤 雄大

  (公財)薬学研究奨励財団, Mar. 2021, 薬学研究の進歩, (37) (37), 63 - 66, Japanese


• 経口抗がん薬治療における情報共有ツールおよびチーム基盤型学習を用いた病診薬連携の有用性の評価

  植田 梨沙, 丹田 雅明, 伊藤 雄大, 榎本 彩花, 飯田 真之, 水田 直美, 山本 和宏, 槇本 博雄, 大村 友博, 矢野 育子

  トレーシングレポート等の情報共有ツールの活用とチーム基盤型学習(TBL)形式の勉強会による連携体制強化が、臨床的に有益な効果すなわち経口抗がん薬治療の質的向上に寄与するか検討した。経口抗がん薬がキードラッグとなる消化器系悪性腫瘍の術後補助化学療法を受ける患者を対象とした。全3回のTBL形式勉強会全てに参加した薬剤師のプレテスト(最高30点)の平均スコアは17.7±5.9点、ポストテストの平均スコアは24.9±2.9点であり、ポストテストで有意に平均スコアの上昇を認めた。プレテストとポストテストの平均スコア変化量は、保険薬局薬剤師7.3±6.0点、病院薬剤師7.0±4.0点であり、両者で有意差は認めなかった。勉強会開催前後各5ヵ月間において、トレーシングレポート枚数は開催前後で有意差は認めなかった。トレーシングレポートの記載内容については、副作用確認指導内容に対する患者理解度の確認投薬時の患者発言に関する記載枚数が勉強会開催後に有意に増加した。連携体制構築前後において、治療開始後3ヵ月間の副作用による治療中止は構築前7名(15.6%)、構築後2名(3.1%)と有意な低下を認めた。また、緊急受診や緊急入院については連携体制構築前後で有意差は認められなかった。

  (一社)日本医療薬学会, Dec. 2020, 医療薬学, 46(12) (12), 681 - 691, Japanese

  [Refereed]


• Model-based assessment of pharmacokinetic changes of sunitinib, tacrolimus, and everolimus in a patient with metastatic renal cell carcinoma after renal transplantation.

  Takahiro Ito, Kazuhiro Yamamoto, Satoshi Ogawa, Junya Furukawa, Kenichi Harada, Masato Fujisawa, Tomohiro Omura, Ikuko Yano

  The safety of the coadministration of sunitinib with tacrolimus and everolimus with regard to therapeutic drug monitoring has not been demonstrated. Here, we report a patient who showed high sunitinib concentrations, in addition to pharmacokinetic changes in tacrolimus and everolimus after sunitinib therapy. A living-donor renal transplant patient treated with tacrolimus and everolimus was diagnosed with pulmonary and pleural metastases of renal cell carcinoma. The patient received sunitinib therapy (37.5 mg/day, 2 weeks on and 1 week off). This patient exhibited a high total sunitinib concentration (sunitinib, 105.8 ng/mL; N-desethyl sunitinib, 27.9 ng/mL) on day 10 postinitiation and experienced grade 3 diarrhea. The observed sunitinib concentrations were a little higher than those reported in the 421C>A polymorphism of the ATP-binding cassette subfamily G member 2 gene carrier. The observed concentrations of both tacrolimus and everolimus gradually decreased compared with the Bayesian-predicted values after the onset of sunitinib therapy, and the doses of tacrolimus and everolimus were increased. Careful therapeutic drug monitoring of sunitinib, tacrolimus, and everolimus concentrations is necessary during combination therapy, especially after episodes of diarrhea.

  Lead, Oct. 2020, Drug metabolism and pharmacokinetics, 35(5) (5), 405 - 409, English, International magazine

  [Refereed]

  Scientific journal


• オピオイド服用患者における酸化マグネシウムの緩下作用に対してプロトンポンプ阻害薬併用が与える影響

  岡田 美咲, 飯田 真之, 伊藤 雄大, 五百蔵 武士, 山本 和宏, 矢野 育子

  (一社)日本病院薬剤師会, Aug. 2019, 日本病院薬剤師会雑誌, 55(8) (8), 964 - 968, Japanese

  [Refereed]


• 薬剤師教育におけるチーム基盤型学習の有用性の検討

  伊藤 雄大, 高田 麻季, 飯田 真之, 宇田 篤史, 住吉 霞美, 秋山 恵里, 丸上 奈穂, 丹田 雅明, 野間 千尋, 山本 和宏, 五百蔵 武士, 木村 丈司, 西岡 達也, 久米 学, 槇本 博雄, 矢野 育子

  薬剤師歴が1〜8年目の薬剤師29名を対象とした。参加者を2群に分け、チーム基盤型学習(TBL)群と講義群に割り当てた。ジャーナルクラブの実施前に行ったプレテストのスコアと薬剤師歴、ジャーナルクラブに参加する前のモチベーションは、講義群とTBL群で有意差は認めなかった。ジャーナルクラブ参加前の予習時間は、TBL群において有意に短かった。主要評価項目であるプレテストとジャーナルクラブ直後のポストテストのスコア差は、講義群とTBL群で有意差は認めなかったが、プレテストのスコアで調整したプレテストとジャーナルクラブ直後のポストテストのスコア差は、TBL群で有意に高かった。ジャーナルクラブ直後のポストテストのスコアはTBL群で有意に高かった。ジャーナルクラブ1ヵ月後のポストテストのスコアは講義群とTBL群で有意差は認めないものの、TBL群においてスコアは高い傾向にあった。アンケートの結果、ジャーナルクラブに対する満足度は講義群とTBL群で有意差は認めなかった。TBLについてジャーナルクラブの満足度に対する顧客満足度分析を行い、重要維持項目は、「司会者の熱意」および「論文内容の解説」であった。

  Lead, (一社)日本医療薬学会, May 2018, 医療薬学, 44(5) (5), 236 - 243, Japanese

  [Refereed]


• Association of CYP2D6 polymorphisms and extrapyramidal symptoms in schizophrenia patients receiving risperidone: a retrospective study.

  Takahiro Ito, Kazuhiro Yamamoto, Fuminori Ohsawa, Ikuo Otsuka, Akitoyo Hishimoto, Ichiro Sora, Midori Hirai, Ikuko Yano

  Background: Risperidone is mainly metabolized by cytochrome P450 (CYP) 2D6 in the liver. The gene encoding CYP2D6 is highly polymorphic. The average steady-state plasma concentration of risperidone active moiety is higher in the CYP2D6 intermediate metabolizers (IMs) compared with that in the extensive metabolizers (EMs). An association between drug-induced extrapyramidal symptoms scale (DIEPSS) score and CYP2D6 polymorphisms has not been reported to date. This study investigates the association of CYP2D6 polymorphisms with the severity of extrapyramidal symptoms in schizophrenia patients receiving risperidone therapy. Methods: Schizophrenia patients undergoing risperidone treatment were recruited for the study in the Kobe University Hospital. We evaluated extrapyramidal symptoms of schizophrenia using the DIEPSS. CYP2D6*10 and CYP2D6*14 were analyzed using TaqMan® assays, and CYP2D6*5 was analyzed using the long-PCR method. Patients with CYP2D6*1/*5, *1/*14, *5/*10, *10/*10, and *10/*14 were classified as IMs, and patients with CYP2D6*1/*1 and *1/*10 were classified as EMs. Patients with CYP2D6*5/*5, *5/*14, and *14/*14 were classified as poor metabolizers (PMs). Results: A total of 22 patients were included in the study. No patients were classified as PMs. The dose of risperidone (mg/day) was not significantly different between EMs (n = 15) and IMs (n = 7) (median with the interquartile range: 4.0 (2.0-6.0) vs. 4.0 (2.0-7.0) mg, p = 0.31). The age and disease duration of schizophrenia were not significantly different between the EMs and IMs. The DIEPSS score in the IMs was significantly higher than that in the EMs (median with the interquartile range: 5.0 (3.5-6.5) vs. 0.0 (0.0-3.0), p < 0.001). The multiple regression analysis showed that CYP2D6 IMs is a significant risk factor for the DIEPSS (p < 0.05). Conclusion: Special attentions should be paid to the onset of extrapyramidal symptoms in schizophrenia patients identified as CYP2D6 IM undergoing risperidone therapy.

  Lead, 2018, Journal of pharmaceutical health care and sciences, 4, 28 - 28, English, International magazine

  [Refereed]

  Scientific journal


• Therapeutic Effect of Sirolimus for Lymphangioleiomyomatosis Remaining in the Abdominopelvic Region After Lung Transplantation: A Case Report

  T. Ito, M. Suno, K. Sakamoto, Y. Yoshizaki, K. Yamamoto, R. Nakanishi, Y. Hirano, M. Irie, T. Kurosaki, S. Otani, M. Yamane, S. Sugimoto, K. Miyoshi, T. Oto

  Lead, Elsevier BV, Jan. 2016, Transplantation Proceedings, 48(1) (1), 271 - 274

  [Refereed]

  Scientific journal


• Correlation of plasma crizotinib trough concentration with adverse events in patients with anaplastic lymphoma kinase positive non-small-cell lung cancer.

  Yasuko Kurata, Narumi Miyauchi, Manabu Suno, Takahiro Ito, Toshiaki Sendo, Katsuyuki Kiura

  BACKGROUND: Crizotinib, an ATP-competitive receptor tyrosine kinase inhibitor of both anaplastic lymphoma kinase (ALK) and the hepatocyte growth factor receptor, commonly causes several adverse events (AEs). The clinical utility of measuring the plasma concentration of crizotinib in patients with non-small-cell lung cancer (NSCLC) has not been fully elucidated. The aim of this study was to evaluate the variability in the crizotinib trough concentration and its relationship with the occurrence of AEs in NSCLC patients. FINDINGS: Plasma samples were collected from 9 ALK fusion gene-positive NSCLC Japanese patients at day 14 after the first administration of crizotinib. We assessed crizotinib-induced AEs on days 7, 14, 21, and 28. The crizotinib trough concentration on day 14 ranged from 243.5 to 847.8 ng/mL, and all of the patients achieved stable disease based on assessment of the tumor response on day 28. The cumulative number of AEs on day 28 in the higher trough concentration group was approximately 3-fold greater than that in the lower trough concentration group. AEs of grade 3 or 4 were observed only in patients in the higher trough concentration group. CONCLUSIONS: The occurrence of several AEs may correlate with the increase in the crizotinib trough concentration. Monitoring of the crizotinib trough concentration could predict the risk of development of several AEs and provide guidance for determining the optimal dose of crizotinib.

  2015, Journal of pharmaceutical health care and sciences, 1, 8 - 8, English, International magazine

  [Refereed]

  Scientific journal

• 学会発表の始め方

  伊藤雄大

  Jan. 2026, 月刊薬事（2026年1月臨時増刊号）, 68(2) (2), 466 - 473


• 消化器障害（IBDなどの消化器内科疾患）のある鉄欠乏性貧血患者に対して鉄剤は，何を選ぶ？

  伊藤雄大

  Oct. 2023, 月刊薬事（2023年10月臨時増刊号）, 65(14) (14), 2859 - 2864


• 高血圧症の過活動膀胱患者に対して薬剤は，何を選ぶ？

  伊藤雄大

  Oct. 2023, 月刊薬事（2023年10月臨時増刊号）, 65(14) (14), 2854 - 2858


• トピックス：リキッドバイオプシーによる薬物代謝活性ならびに排泄能の予測

  伊藤雄大

  Jan. 2023, ファルマシア, 59(1) (1), 73

• 日本臨床薬理学会

  Jul. 2020 - Present


• 日本医療薬学会

  Mar. 2014 - Present


• 日本薬学会

  Oct. 2013 - Present

• 制吐薬ドンペリドンから見出す新たな可能性：抗がん作用メカニズムの新規解明

  松本 准, 別宮 謙介, 伊藤 雄大

  日本学術振興会, 科学研究費助成事業, 基盤研究(C), 岡山大学, 01 Apr. 2026 - 31 Mar. 2029


• 炎症時の薬物動態変動に着目したチロシンキナーゼ阻害薬の個別投与設計と腫瘍制御

  伊藤 雄大

  日本学術振興会, 科学研究費助成事業, 若手研究, 神戸大学, 01 Apr. 2026 - 31 Mar. 2029


• 炎症と薬物動態変動の統合理解に基づくフィルゴチニブの個別化投与設計法の構築

  伊藤 雄大

  日本学術振興会, 科学研究費助成事業, 若手研究, 和歌山県立医科大学, Apr. 2023 - Mar. 2026


• 炎症マーカーとPK/PD/PGxの統合解析に基づく潰瘍性大腸炎におけるトファシチニブの個別化治療法の構築

  伊藤 雄大

  公益財団法人臨床薬理研究振興財団, 2022年度（第47回）研究奨励金, Nov. 2022 - Oct. 2025, Principal investigator


• カボザンチニブの母集団薬物動態モデルを用いた個別化投与設計法の開発

  伊藤 雄大

  日本学術振興会, 科学研究費助成事業, 奨励研究, 神戸大学, Apr. 2021 - Mar. 2022

  腎がんに対してカボザンチニブ治療を新規に開始した患者を対象に、有効かつ安全なカボザンチニブ血中濃度域および薬物動態モデルを構築するための観察研究を開始した。現在、カボザンチニブ血中濃度データの解析中である。 腎がんの分子標的薬スニチニブの2週投与1週休薬スケジュール下において、総スニチニブ血中トラフ濃度を108 ng/mL未満に維持することは重篤な有害事象の発現を回避するために有効で、それに伴う治療継続性の低下は認められないことが明らかとなった。


• 薬理遺伝学および薬物動態学的解析に基づくリスペリドンの個別化投与設計法の確立

  伊藤 雄大

  公益財団法人薬学研究奨励財団, 平成29年度研究助成金, Apr. 2018 - Dec. 2020, Principal investigator