University of the Ryukyus · Faculty of Medicine · 教授

Research keywords循環器・臨床薬理学・腫瘍循環器・動脈硬化・血管内皮機能・臨床試験

Research fieldsCirculatory organs internal medicine・臨床薬理学

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• Analysis of in-hospital deaths in patients with critical limb ischemia necessitating invasive treatments: based on a Japanese nationwide database2024 · Iwata, K; Nitta, M; Kaneko, M; Fushimi, K; Ueda, S; Shimizu, S
• Agile 3+and Agile 4, noninvasive tests for liver fibrosis, are excellent formulae to predict liver-related events in nonalcoholic fatty liver disease2023 · AIM: The noninvasive tests (NITs) Agile 3+ and Agile 4 effectively identify patients with nonalcoholic fatty liver disease (NAFLD) complicated with advanced fibrosis (F3-4) and cirrhosis (F4), respectively. Little information is available on associations between Agile scores and intra-/extrahepatic events. The aim of this study was to determine the predictive performance of Agile scores for intra-/extrahepatic events in Asian patients with biopsy-proven NAFLD. METHODS: We undertook a retrospective multicenter cohort study to investigate associations between intra-/extrahepatic events and two Agile scores, Agile 3+ and Agile 4. The scores were obtained by combining clinical parameters and liver stiffness measurement using transient elastography. RESULTS: Among 403 enrolled patients, 11 had liver-related events (LREs), including seven with hepatocellular carcinoma (HCC). The incidence of LREs and HCC showed a stepwise increase in the advanced fibrosis group (F3-4), Agile 3+ rule-in (F3-4, highly suspected), and Agile 4 rule-in (F4, highly suspected) groups, compared to their counterparts. Hazard ratios for LREs in the advanced fibrosis group, Agile 3+ rule-in, and Agile 4 rule-in groups were 4.05 (p = 0.03), 23.5 (p = 0.003), and 45.5 (p < 0.001), respectively. The predictive performance results for Agile 3+ and Agile 4 were 0.780 and 0.866, respectively, which were higher than for fibrosis (0.595). Unlike for LREs, Agile scores failed to identify patients with extrahepatic events, including cardiovascular events and extrahepatic cancer. CONCLUSIONS: Agile 3+ and Agile 4 scores are excellent NITs for predicting LREs in patients with NAFLD, possibly without histological assessment.
• Factors associated with carotid intima-media thickness progression in patients with asymptomatic hyperuricemia: insights from the PRIZE study2023 · Saito Y.
• Comparison of the Quality of Phase Ⅲ Non-commercial Clinical Trials in Japan, the United States, and the United Kingdom before the Implementation of the New Japanese Clinical Trials Act2018 · <p>Recent research misconduct, represented by the valsartan scandal, has raised questions about the quality of non-commercial trials not for regulatory approval in Japan. Unlike in the US and Europe, non-commercial clinical trials are not regulated by law in Japan, which was believed to be a reason why quality could not be guaranteed. However, until now, few studies have compared the quality of clinical studies among countries. In this study, the quality of Japanese non-commercial phase Ⅲ trials before the implementation of the Clinical Trials Act (CTA) in 2018 was compared with Western non-commercial trials registered in the database using study design as quality indicators. The study found a lower proportion of randomized, controlled trials (RCTs) (70％ in Japan, 89％ in the US, and 88％ in the UK) and fewer blinded designs (46％ in Japan, 59％ in the US, and 52％ in the UK) in non-commercial trials in Japan. Single-arm trials not for either cancer or rare diseases, which are usually considered low quality because of a lack of fair comparison, were more common in Japan (82％) than in the US (76％) and the UK (50％). In terms of endpoint setting, most non-commercial trials in Japan had surrogate endpoints, with only a few trials using true endpoints (5％) compared to the US (24％) and the UK (40％). A comparison of these quality indicators in Japanese non-commercial trials before and after the CTA implementation showed no increases in the proportion of RCT and blinded designs, but an increase in the proportion of trials using true endpoints and appropriate use of single-arm design. In conclusion, the lack of legal regulation in Japan may have indirectly affected the quality of non-commercial phase Ⅲ trials in Japan at the time. Implementation of the CTA has contributed to some quality improvements, but the effect is limited at present. </p>

• 白血球活性化抑制による動脈硬化治療を目指した臨床薬理学研究2015 · 基盤研究(C)
• 心血管系バイオマーカーとヒト薬効評価実験系に関する臨床薬理学的研究2010 · 基盤研究(C)
• 80歳以上の高齢者を対象とした大腿骨近位部骨折の発生要因を明らかにするための研究2010 · 沖縄県内の老人保健施設において、2010年～14年の間に新規入所した後期高齢者1930例のカルテから大腿骨近位部骨折発生の関連因子を後見的に調査した。骨折発生率は3.4%で、7，8月に発生が多くみられた。介護度の低い介護１および2、障害高齢者の自立度で自立度が高いランクJおよびA、日常生活が比較的自立しているBarthel indexが60以上で骨折リスクが高かった。また認知症高齢者の日常生活自立度では認知症が重度のランク3aおよび３bで骨折リスクが高い傾向があった。対側の大腿骨近位部骨折の既往がある方に骨折発生リスクが高かった。
• 心血管薬の薬効評価システムの開発と臨床試験に向けた代替エンドポイントの評価2004 · 基盤研究(C)

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