Tadalafil treatment for Fetus with Early onset growth Restriction
| Project/Area Number |
17K16846
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Obstetrics and gynecology
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| Research Institution | Mie University |
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Principal Investigator |
KANEDA MICHIKO 三重大学, 医学部附属病院, 助教 (10770274)
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| Research Collaborator |
UMEKAWA TAKASHI
TANAKA HIROAKI
TANAKA KAYO
MAKI SHINTARO
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| Project Period (FY) |
2017-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2018: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2017: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
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| Keywords | 胎児発育不全 |
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| Outline of Final Research Achievements |
Fetal growth restriction (FGR) is one of the most important perinatal disorders; it can increase perinatal mortality and morbidity, cause neurological sequelae in infants, and serve as the developmental origin of diseases such as hypertension and diabetes mellitus. There is also no proven fetal therapy to reverse or ameliorate established FGR. We conducted a phase I trial to confirm the safety of tadalafil:a phosphodiesterase 5 inhibitor administration for FGR and no severe adverse event was seen.
As the next step, We started a multicenter phase II trial on the efficacy and safety of tadalafil in fetuses with early-onset growth restriction. tadalafil significantly prolonged pregnancy compared with conventional treatment in cases registered at <32 weeks gestatinal age.
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| Academic Significance and Societal Importance of the Research Achievements |
本邦では、低出生体重児の割合が増加しており、出生体重が漸増している先進諸国の中で、減少を続ける日本の現在の状況は非常に特異的で、かつ重要な問題とされる。未熟児や重症例の増加により、神経学的障害のための在宅医療など退院後の支援が必要な例も増加し、成人期においても生活習慣病の発症リスクが高いことも問題とされる。
本研究により胎児発育不全に対するタダラフィル投与の安全性が確認され、また第Ⅱ相試験により、登録時妊娠週数32週未満の症例において、妊娠期間の延長がみられた。
今後、少子化と医療費の増大が懸念される我が国において、大きく寄与すると考えられる。
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Report
(3 results)
Research Products
(10 results)
