慢性閉塞性肺疾患 (TRILOGY) に対する単一の吸入器のトリプルセラピーと,吸入用コルチコステロイドと長時間作用のβ2アゴニストの治療:二重盲検,並行グループ,ランダム化制御試験
Dave Singh1, Alberto Papi2, Massimo Corradi3
1Centre for Respiratory Medicine and Allergy, University of Manchester, Manchester, UK.
Lancet (London, England)
|September 7, 2016
まとめ
ベクロメタゾン二プロピオネート,フォルモテロールフーマレート,およびグリコピロニウムブロミド (BDP/FF/GB) の三重治療は,中等から重度のCOPD患者における悪化を有意に減少させた. この単一吸入器治療は,二重治療 (BDP/ FF) に比べて肺機能も改善しました.
科学分野:
- 肺科
- 呼吸器医学
- 臨床薬理学
背景:
- 2つの長時間作用する支氣管拡張剤と吸入用コルチコステロイドを使用したCOPDにおけるトリプルセラピーの有効性に関するデータは限られている.
- この研究では,COPD患者における単一吸入器のトリプル療法 (ベクロメタゾン二プロピオネート/フォルモテロールフーマレート/グリコピロニウムブロミド - BDP/FF/GB) を評価した.
研究 の 目的:
- 単発吸入器のBDP/FF/GBの有効性をBDP/FFと比較して評価する.
- 肺機能と悪化率に対するトリプルセラピーの影響を評価する.
主な方法:
- TRILOGY試験: ランダム化され,ダブルブラインドで,アクティブ・コントロールされ,1368人のCOPD患者を対象とした52週間の試験.
- 患者はBDP/ FF/ GBまたはBDP/ FFを1日2回投与された.
- 投与前FEV1,投与後2時間FEV1,トランジション呼吸不全指数 (TDI) を含む.
主要な成果:
- BDP/ FF/ GBは,26週間のBDP/ FFと比較して,投与前のFEV1 (0. 081L) と投与後の2時間のFEV1 (0. 117L) を有意に改善した.
- BDP/ FF/ GB (0. 41) は,BDP/ FF (0. 53) (p=0. 005) と比較して,調整された年間悪化率で23%減少した.
- TDIスコアは,統計的に有意ではないが,BDP/FF/GB (1.71) とBDP/FF (1.50) との数字的な改善を示した (p=0.160).
結論:
- 単発吸入器のトリプルセラピー (BDP/FF/GB) へのステップアップは,COPD患者にとって臨床的な利点をもたらします.
- この治療法はCOPDの悪化を効果的に軽減し,肺機能を改善します.
- この発見は,COPD患者の適切な管理のためにトリプルセラピーの使用を支持する.
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