慶應義塾大学 薬学部 薬効解析学講座

Division of Pharmacodynamics / Keio University Faculty of Pharmacy

臨床研究・臨床データ解析

　抗菌薬の最適な投与設計と安全な使用を実現するため、臨床試験や実臨床のデータを解析し、エビデンスに基づく治療指針を創出しています。多角的な臨床データ解析を通じて、患者ごとの個別化医療や薬剤安全性の向上に貢献しています。

主な研究テーマ

母集団薬物動態解析とモンテカルロシミュレーション

　臨床試験や実臨床で得られた血中薬物濃度データを用いて、母集団薬物動態解析を実施しています。患者背景や病態による薬物動態の差異を明らかにし、特殊集団における至適投与法の検討や個別化医療の推進に取り組んでいます。
　さらに、臨床分離株のMIC分布と母集団薬物動態データを組み合わせたモンテカルロシミュレーションにより、抗菌薬の至適投与レジメンを科学的に評価しています。これにより、実臨床における目標PK/PD達成確率を定量的に提示しています。

メタアナリシス

　無作為化比較試験を中心とした臨床試験を統合するメタアナリシスを行い、エビデンスレベルの高い治療選択指標を提示しています。これらの成果は国内の臨床ガイドラインにも引用され、患者ごとの薬剤選択や治療方針の決定に貢献しています。

副作用解析

　日本の医薬品副作用データベース（JADER）や米国FDAの副作用報告システム（FAERS）を用いて、安全性シグナルの検出や副作用発現リスクの評価を行うことで、頻度の少ない副作用の把握や薬剤安全性情報の更新に寄与しています。

主な関連業績

  1. Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system.
    Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto.
    Expert opinion on drug safety, 2025;1-7. DOI
  2. Development and validation of a population pharmacokinetic model of vancomycin for patients of advanced age.
    Keisuke Takada, Masaru Samura, Yuki Igarashi, Ayako Suzuki, Tomoyuki Ishigo, Satoshi Fujii, Yuta Ibe, Hiroaki Yoshida, Hiroaki Tanaka, Fumiya Ebihara, Takumi Maruyama, Yukihiro Hamada, Toshiaki Komatsu, Atsushi Tomizawa, Akitoshi Takuma, Hiroaki Chiba, Yusuke Yagi, Yoshifumi Nishi, Yuki Enoki, Kazuaki Taguchi, Koji Tanikawa, Hiroyuki Kunishima, Kazuaki Matsumoto.
    Journal of pharmaceutical health care and sciences. 2025;11(1):18. DOI
  3. SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database.
    Keisuke Takada, Kazuaki Taguchi, Masaru Samura, Yuki Igarashi, Yuko Okamoto, Yuki Enoki, Koji Tanikawa, Kazuaki Matsumoto.
    Journal of Infection and Chemotherapy, 2024;31(1):102485. DOI
  4. Optimal therapeutic recommendation for Clostridioides difficile infection in pediatric and adolescent populations: a systematic review and meta-analysis.
    Sho Tashiro, Takayuki Mihara, Rikiya Okawa, Yoko Tanaka, Masaru Samura, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto, Yuka Yamagishi.
    European Journal of Pediatrics, 2023;182(6):2673-2681. DOI
  5. Comparison of the efficacy and safety of standard- and high-dose daptomycin: a systematic review and meta-analysis.
    Masaru Samura, Keisuke Takada, Naoki Hirose, Takenori Kurata, Fumio Nagumo, Masaki Uchida, Junki Inoue, Koji Tanikawa, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto, Takashi Ueda, Shigeru Fujimura, Hiroshige Mikamo, Yoshio Takesue, Kotaro Mitsutake.
    British Journal of Clinical Pharmacology, 2023;89(4):1291-1303. DOI
  6. Safety of linezolid in patients with decreased renal function and trough monitoring: a systematic review and meta-analysis.
    Xiaoxi Liu, Mari Aoki, Sumika Osa, Chihiro Ito, Reika Saiki, Tomoya Nagai, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto.
    BMC Pharmacology and Toxicology, 2022;23(1):89. DOI
  7. Efficacy of surgical skin preparation with chlorhexidine in alcohol according to the concentration required to prevent surgical site infection: meta-analysis.
    Tatsuki Hasegawa, Sho Tashiro, Takayuki Mihara, Junya Kon, Kazuki Sakurai, Yoko Tanaka, Takumi Morita, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto, Kazuhiko Nakajima, Yoshio Takesue.
    BJS open, 2022;6(5):zrac111. DOI
  8. Oral fidaxomicin versus vancomycin for the treatment of Clostridioides difficile infection: A systematic review and meta-analysis of randomized controlled trials.
    Sho Tashiro, Takayuki Mihara, Moe Sasaki, Chiaki Shimamura, Rina Shimamura, Shiho Suzuki, Maiko Yoshikawa, Tatsuki Hasegawa, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto, Hiroki Ohge, Hiromichi Suzuki, Atsushi Nakamura, Nobuaki Mori, Yoshitomo Morinaga, Yuka Yamagishi, Sadako Yoshizawa, Katsunori Yanagihara, Hiroshige Mikamo, Hiroyuki Kunishima.
    Journal of Infection and Chemotherapy, 2022;28(11):1536-1545. DOI
  9. Efficacy and Safety of Daptomycin versus Vancomycin for Bacteremia Caused by Methicillin-Resistant Staphylococcus aureus with Vancomycin Minimum Inhibitory Concentration > 1 µg/mL: A Systematic Review and Meta-Analysis.
    Masaru Samura, Yuki Kitahiro, Sho Tashiro, Hiromu Moriyama, Yuna Hamamura, Isamu Takahata, Rina Kawabe, Yuki Enoki, Kazuaki Taguchi, Yoshio Takesue, Kazuaki Matsumoto.
    Pharmaceutics, 2022;14(4):714. DOI
  10. Clinical Practice Guidelines for Therapeutic Drug Monitoring of Vancomycin in the Framework of Model-Informed Precision Dosing: A Consensus Review by the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring.
    Kazuaki Matsumoto, Kazutaka Oda, Kensuke Shoji, Yuki Hanai, Yoshiko Takahashi, Satoshi Fujii, Yukihiro Hamada, Toshimi Kimura, Toshihiko Mayumi, Takashi Ueda, Kazuhiko Nakajima, Yoshio Takesue.
    Pharmaceutics, 2022;14(3):489. DOI
  11. Target Therapeutic Ranges of Anti-MRSA Drugs, Linezolid, Tedizolid and Daptomycin, and the Necessity of TDM.
    Kazuaki Matsumoto, Masaru Samura, Sho Tashiro, Shino Shishido, Reika Saiki, Wataru Takemura, Kana Misawa, Xiaoxi Liu, Yuki Enoki, Kazuaki Taguchi.
    Biological & pharmaceutical bulletin, 2022;45(7):824-833. DOI
  12. Incidence of elevated creatine phosphokinase between daptomycin alone and concomitant daptomycin and statins: a systematic review and meta-analysis.
    Masaru Samura, Keisuke Takada, Naoki Hirose, Takenori Kurata, Fumio Nagumo, Sakura Koshioka, Junichi Ishii, Masaki Uchida, Junki Inoue, Yuki Enoki, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto.
    British Journal of Clinical Pharmacology, 2021;88(5):1985-1998. DOI
  13. Identification of Risk Factors for Daptomycin-Associated Creatine Phosphokinase Elevation and Development of a Risk Prediction Model for Incidence Probability.
    Masaru Samura, Naoki Hirose, Takenori Kurata, Keisuke Takada, Fumio Nagumo, Sakura Koshioka, Junichi Ishii, Masaki Uchida, Junki Inoue, Yuki Enoki, Kazuaki Taguchi, Ryuji Higashita, Norifumi Kunika, Koji Tanikawa, Kazuaki Matsumoto.
    Open Forum Infectious Diseases, 2021;8(12):ofab568. DOI
  14. Population pharmacokinetic analysis and dosing optimization of prophylactic fluconazole in japanese patients with hematological malignancy.
    Yasutaka Sakamoto, Hikaru Isono, Yuki Enoki, Kazuaki Taguchi, Takuya Miyazaki, Hiroyoshi Kunimoto, Hirofumi Koike, Maki Hagihara, Kenji Matsumoto, Hideaki Nakajima, Yukiko Sahashi, Kazuaki Matsumoto.
    Journal of Fungi, 2021;7(11):975. DOI
  15. Species Distribution of Candidemia and Their Susceptibility in a Single Japanese University Hospital: Prior Micafungin Use Affects the Appearance of Candida parapsilosis and Elevation of Micafungin MICs in Non-parapsilosis Candida Species.
    Yasutaka Sakamoto, Kazuhiro Kawabe, Tomoyo Suzuki, Kayoko Sano, Kazuo Ide, Tetsuta Nishigaki, Yuki Enoki, Kazuaki Taguchi, Hirofumi Koike, Hideaki Kato, Yukiko Sahashi, Kazuaki Matsumoto.
    Journal of Fungi, 2021;7(8):596. DOI
  16. Population Pharmacokinetic Analysis and Dosing Optimization Based on Unbound Daptomycin Concentration and Cystatin C in Nonobese Elderly Patients with Hypoalbuminemia and Chronic Kidney Disease.
    Masaru Samura, Keisuke Takada, Risako Yamamoto, Hayato Ito, Fumio Nagumo, Masaki Uchida, Takenori Kurata, Sakura Koshioka, Yuki Enoki, Kazuaki Taguchi, Ryuji Higashita, Norifumi Kunika, Koji Tanikawa, Kazuaki Matsumoto.
    Pharmaceutical Researchi, 2021;38(6):1041-1055. DOI
  17. Retrospective study of the efficacy and safety of metronidazole and vancomycin for Clostridioides difficile infection.
    Kana Misawa, Osamu Iketani, Yuki Enoki, Kazuaki Taguchi, Shunsuke Uno, Yoshifumi Uwamino, Naoki Hasegawa, Kazuaki Matsumoto.
    Journal of Infection and Chemotherapy, 2021;27(10):1407-1412. DOI
  18. The monitoring of vancomycin: a systematic review and meta-analyses of area under the concentration-time curve-guided dosing and trough-guided dosing.
    Moeko Tsutsuura#, Hiromu Moriyama#, Nana Kojima, Yuki Mizukami, Sho Tashiro, Sumika Osa, Yuki Enoki, Kazuaki Taguchi, Kazutaka Oda, Satoshi Fujii, Yoshiko Takahashi, Yukihiro Hamada, Toshimi Kimura, Yoshio Takesue, Kazuaki Matsumoto. #Contributed equally.
    BMC Infectious Diseases, 2021;21(1):153. DOI
  19. Remdesivir for the treatment of coronavirus COVID-19: a meta-analysis of randomised controlled trials.
    Yuki Enoki, Yuki Igarashi, Yuki Watabe, Kyoka Honma, Yuto Suzuki, Yukitaka Hayashi, Kana Hiraoka, Kazuaki Taguchi, Kazuaki Matsumoto.
    Journal of Global Antimicrobial Resistance, 2020;24:81-82. DOI
  20. Azoles versus conventional amphotericin B for the treatment of candidemia: A meta-analysis of randomized controlled trials.
    Sumika Osa, Sho Tashiro, Yuki Igarashi, Yuki Watabe, Xiaoxi Liu, Yuki Enoki, Kazuaki Taguchi, Toshihiko Mayumi, Yoshitsugu Miyazaki, Yoshio Takesue, Kazuaki Matsumoto.
    Journal of Infection and Chemotherapy, 2020;26(11):1232-1236. DOI
  21. Echinocandins versus non-echinocandins for the treatment of invasive candidiasis: A meta-analysis of randomized controlled trials.
    Sho Tashiro, Sumika Osa, Yuki Igarashi, Yuki Watabe, Xiaoxi Liu, Yuki Enoki, Kazuaki Taguchi, Toshihiko Mayumi, Yoshitsugu Miyazaki, Yoshio Takesue, Kazuaki Matsumoto.
    Journal of Infection and Chemotherapy, 2020;26(11):1164-1176. DOI
  22. Factorial Analysis of Clostridioides Difficile Colitis and Pseudomembranous Colitis Using JADER.
    Risako Takaya, Kana Misawa, Sho Tashiro, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto.
    BPB Reports, 2020;3(1):1-6. DOI
  23. Support for fungal infection treatment mediated by pharmacist-led antifungal stewardship activities.
    Masaru Samura, Naoki Hirose, Takenori Kurata, Junichi Ishii, Fumio Nagumo, Keisuke Takada, Sakura Koshioka, Masaki Uchida, Syunya Yamamoto, Junki Inoue, Yuki Enoki, Kazuaki Taguchi, Akira Ishida, Hisakazu Sekine, Norifumi Kunika, Hiroyuki Kunishima, Kazuaki Matsumoto.
    Journal of Infection and Chemotherapy, 2019;26(3):272-279. DOI
  24. Evaluation of the expression time of ganciclovir-induced adverse events using JADER and FAERS.
    Go Ando, Kazuaki Taguchi, Yuki Enoki, Yuta Yokoyama, Junko Kizu, Kazuaki Matsumoto.
    Biological and Pharmaceutical Bulletin, 2019;42(11):1799-1804. DOI
  25. Oral vancomycin versus metronidazole for the treatment of Clostridioides difficile infection: Meta-analysis of randomized controlled trials.
    Yuki Igarashi, Sho Tashiro, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto, Hiroki Ohge, Hiromichi Suzuki, Atsushi Nakamura, Nobuaki Mori, Yoshitomo Morinaga, Yuka Yamagishi, Sadako Yoshizawa, Katsunori Yanagihara, Hiroshige Mikamo, Hiroyuki Kunishima.
    Journal of Infection and Chemotherapy, 2018;24(11):907-914. DOI

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