Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial

• Material Type: 博士論文
• Title: Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial
• Author/Editor: Maki, Shintaro
• Author Heading: Maki, Shintaro
• Publication, Distribution, etc.: 三重大学
• Publication Date: 2019-12-18
• Publication Date (W3CDTF): 2019-12-18
• Degree grantor/type: 三重大学
• Date Granted: 2019-12-18
• Date Granted (W3CDTF): 2019-12-18
• Dissertation Number: 甲医学第1990号
• Degree Type: 博士(医学)
• Conferring No. (Dissertation): 甲医学第1990号
• Text Language Code: eng
• Alias of Author: マキ, シンタロウ; 真木, 晋太郎
• Subject Heading: fetal growth restriction; tadalafil; phosphodiesterase 5 inhibitor
• Target Audience: 一般
• Note (General): application/pdf; Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor with a long half-life, high selectivity, and rapid onset of action. Because the safety of using PDE5 inhibitors as therapeutic agents for fetal growth restriction (FGR) has been a problem worldwide, this paper primarily focuses on the safety assessments performed in the Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER) II population. Neonatal and maternal adverse events were analyzed, in addition to fetal, neonatal, and infant death cases, six months after stopping the trial. Eighty-nine pregnant women with FGR were studied between September 2016 and March 2018 (45 and 44 in the tadalafil and conventional treatment groups, respectively). Seven (16%) deaths (four fetal, one neonatal, and two infant) in the control group, whereas only one neonatal death occurred in the tadalafil group. Although headache, facial flushing, and nasal hemorrhage occurred more frequently in the tadalafil group, these symptoms were Grade 1 and transient. In conclusion, this trial showed that tadalafil decreased the fetal and infant deaths associated with FGR. This is thought to be primarily due to pregnancy prolongation. Further studies are warranted to evaluate the efficacy of tadalafil in treating early-onset FGR.; 本文/Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, 2-174 Edobashi,Tsu, Mie 514-8507, Japan; 17p
• DOI: info:doi/10.3390/jcm8060856; https://doi.org/info:doi/10.3390/jcm8060856
• Persistent ID (NDL): info:ndljp/pid/11449754; https://dl.ndl.go.jp/pid/11449754
• Collection: 障害者向け資料
• Collection (Materials For Handicapped People:1): テキストデータ
• Collection (particular): 国立国会図書館デジタルコレクション > デジタル化資料 > 博士論文; https://dl.ndl.go.jp/collections/A00014
• Acquisition Basis: 博士論文（自動収集）
• Date Accepted (W3CDTF): 2020-02-10T02:20:18+09:00
• Date Created (W3CDTF): 2020-02-04
• Format (IMT): application/pdf
• Access Restrictions: 国立国会図書館内限定公開
• Service for the Digitized Contents Transmission Service: 図書館・個人送信対象外
• Availability of remote photoduplication service: 可
• Periodical Title (URI): http://hdl.handle.net/10076/00018949; https://mie-u.repo.nii.ac.jp/records/13330
• Data Provider (Database): 国立国会図書館 : 国立国会図書館デジタルコレクション; https://dl.ndl.go.jp

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