教員業績データベース |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読なし |
表題 | Phase I clinical trial of olprinone in liver surgery |
掲載誌名 | 正式名:Surgery today 略 称:Surg Today ISSNコード:1436-2813(Electronic)0941-1291(Linking) |
掲載区分 | 国外 |
巻・号・頁 | 47(8),pp.918-27 |
著者・共著者 | Fuji Hiroaki, Hatano Etsuro, Iguchi Kohta, Yamanaka Kenya, Yoh Tomoaki, Ikeno Yoshinobu, Seo Satoru, Taura Kojiro, Yasuchika Kentaro, Tanaka Shiro, Ishii Hisanari, Kobayashi Mariko, Ueno Kazuyuki, Uemoto Shinji |
発行年月 | 2017/08 |
概要 | PURPOSE:Post-hepatectomy liver failure is one of the most serious complications liver surgeons must overcome. We previously examined olprinone, a selective phosphodiesterase III inhibitor, and demonstrated its hepatoprotective effects in rats and pigs. We herein report the results of a phase I clinical trial of olprinone in liver surgery (UMIN000004975).METHODS:Twenty-three patients who underwent hepatectomy between 2011 and 2015 were prospectively registered. In the first 6 cases, olprinone (0.1 μg/kg/min) was administered for 24 h from the start of surgery. In the remaining 17 cases, olprinone (0.05 μg/kg/min) was administered from the start of surgery until just before the transection of the liver parenchyma. The primary endpoint was safety, and the secondary endpoint was efficacy. For the evaluation of efficacy, the incidence of post-hepatectomy liver failure in 20 hepatocellular carcinoma patients was externally compared with 20 propensity score-matched patients.RESULTS:No intraoperative side effects were observed, and the morbidity rates in the analyzed cohorts were acceptable. The rate of post-hepatectomy liver failure frequency tended to be lower in the olprinone group.CONCLUSIONS:The safety of olprinone in liver surgery was confirmed. The efficacy of olprinone will be re-evaluated in clinical trials. |
DOI | 10.1007/s00595-016-1461-y |
PMID | 28028637 |