Study on the establishment of palliative care for patients with interstitial pneumonia at the end of life - Interventions for dyspnoea.

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K07388
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 52010:General internal medicine-related
• Research Institution: Hamamatsu University School of Medicine
• Principal Investigator: SUDA TAKAFUMI 浜松医科大学, 医学部, 理事 (30291397)
• Co-Investigator(Kenkyū-buntansha): 森 雅紀 聖隷クリストファー大学, 看護学研究科, 臨床教授 (10771868) ; 藤澤 朋幸 浜松医科大学, 医学部, 助教 (20402357) ; 森田 達也 聖隷クリストファー大学, 看護学研究科, 臨床教授 (70513000)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 間質性肺炎 / 緩和医療 / 呼吸困難 / モルヒネ

Outline of Final Research Achievements

A multicentre, single-arm, open-label, uncontrolled study was planned to generate "evidence for drug therapy for dyspnoea in patients with interstitial pneumonia" and to investigate the tolerability, safety and efficacy of an extended-release morphine preparation. As a physician-led specific clinical study, 24 patients with interstitial pneumonia (target number of cases: 34) have already been enrolled with the cooperation of six centres in Japan, and the results are currently being analysed and the study is continuing to reach the target number of cases. To date, no serious adverse events have occurred that would pose a problem for the continuation of this specific clinical study.

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Free Research Field

呼吸器内科学

Academic Significance and Societal Importance of the Research Achievements

本研究は，いまだ確立していない間質性肺炎患者の緩和ケアにおいて，これらの患者の最も大きな苦しみである呼吸困難に対するモルヒネ徐放製剤の安全性，有効性などについて検証し，第3相試験に進むための基盤となる知見を得ることである．本研究の結果によって，間質性肺炎患者の呼吸困難に対する診療における新たなエビデンスが得られ，これらの患者のより適切な緩和治療の開発，普及につながる可能性を持つ意義のある研究である．