非補償性肝硬変における長期アルブミンの投与 (ANSWER):公開ランダム化試験
Paolo Caraceni1, Oliviero Riggio2, Paolo Angeli3
1Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.
Lancet (London, England)
|June 5, 2018
まとめ
長期にわたるヒトアルブミン (HA) 投与は,不補償性肝硬変患者の生存率を有意に改善しました. この治療は病気の進行を修正し,肝硬変の患者に新しい治療法を提供します.
科学分野:
- ヘパトロジー
- 臨床試験
- 内科 医学
背景:
- 非補償性肝硬変に対するヒトアルブミン (HA) の長期的な有効性に関する証拠は限られている.
- ANSWERの研究は,この知識のギャップを埋めることを目的とした.
研究 の 目的:
- 非補償性肝硬変の患者に長期にわたるヒトアルブミン投与の有効性を評価する.
- HAが全生存期と疾患変異に与える影響を評価する.
主な方法:
- マルチセンターでランダム化され,オープンラベルの実用的な試験で,肝硬変と不合併症の患者440人が参加しました.
- 患者は標準治療 (SMT) またはSMTとヒトアルブミン (HA) を最大18ヶ月間受けた.
- 主なエンドポイントは18ヶ月の死亡率でした.
主要な成果:
- 死亡リスク比率は38%減少した (p=0. 028).
- 肝臓に関係ないグレード3〜4の有害事象の有意な違いは観察されなかった.
結論:
- 長期にわたるヒトアルブミンの投与は,不補償性肝硬変の患者の全生存期間を延長します.
- HAは,この患者集団において,病気を修正する治療として機能する可能性があります.
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