| Project/Area Number |
17K09252
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical and hospital managemen
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| Research Institution | Hyogo Medical University |
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Principal Investigator |
OHTA Yoshinori 兵庫医科大学, 医学部, 特任准教授 (10516404)
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| Co-Investigator(Kenkyū-buntansha) |
森本 剛 兵庫医科大学, 医学部, 教授 (30378640)
作間 未織 兵庫医科大学, 医学部, 講師 (60349587)
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| Project Period (FY) |
2017-04-01 – 2023-03-31
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| Project Status |
Completed (Fiscal Year 2022)
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| Budget Amount *help |
¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Fiscal Year 2019: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2018: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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| Keywords | 医療の質 / 臨床疫学研究 / 手術関連有害事象 / 医原性有害事象 / 医療・福祉 |
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| Outline of Final Research Achievements |
To evaluate the epidemiology of Adverse Event in pediatric inpatients, we conducted two multicenter cohort studies; the Japan Adverse Event Study and the Japan Adverse Drug Event (JADE) Study. In the surgical inpatients, the incidents of adverse events (AE) were 83 AEs per 1,000 patient-days and 131 AEs per 100 admissions. Among respiratory symptom of AEs, severity of AEs was 13 life-threatening AEs, which accounted for 62% of the 21 life-threatening AEs, and 33 serious AEs, which accounted for 33% of the 103 serious AEs.
The JADE study enrolled 944 patients, and we identified 480 adverse drug events (ADEs) due to any drugs occurred in 225 patients. The risk of fatal or life-threatening ADEs due to central nervous system (CNS) depressant drugs was significantly higher than other drugs (12% vs. 2%, p<0.001).
The highest risk symptom of AEs was respiratory disorder in surgical inpatients and ADEs due to CNS depressant drugs was especially important in pediatric patients.
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| Academic Significance and Societal Importance of the Research Achievements |
疫学的手法を用いて、成人のみならず小児においても、手術に関連した有害事象は死亡や重症度の高い健康被害に至る症例が多い事を明らかにした。本研究課題で詳細に分析及び検討した結果、医原性有害事象による健康被害が呼吸器系である場合に重症度が高くなることが明らかとなり、鎮静作用を有する薬剤はそうでない薬剤よりも危険であることが判明した。
これらを効果的に阻止する戦略を立てることは医療安全上重要な課題である。有害事象として呼吸器系に影響を及ぼす原因が懸念される医療行為、特に鎮静を行う際にはこれまで以上に慎重に医療を行う必要があり、モニタリング及び介入を含めたさらなる研究が必要である。
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