精神疾患の重症患者の不眠症に対する認可および非承認の薬理学的介入の有効性および受容性: ランダム化試験の体系的レビューとメタ解析
Nina Friis Bak Fuglsang1,2, Nanna Marker Madsen1,2, Søren Lundorff Jacobsen1,2
1Psychosis Research Unit, Aarhus University Hospital-Psychiatry, Aarhus, Denmark.
Acta psychiatrica Scandinavica
|September 3, 2025
まとめ
重度の精神疾患 (SMI) の不眠症に対する薬理学的介入は,プラセボと比較して睡眠の質と総睡眠時間の適度な改善を示しています. しかし,低品質と高異質性の研究は一般化可能性を制限し,厳格な研究の必要性を強調しています.
科学分野:
- 精神科
- 薬理学について
- 睡眠医学
背景:
- 不眠症は,統合失調症,双極性障害 (BD),重度のうつ病 (MDD) を含む重度の精神疾患 (SMI) を有する個人に一般的です.
- この集団における不眠症の治療には 承認された薬も非承認された薬も使用されています
- これらの介入の有効性と安全性に関する既存の証拠は断片化されており,疾患特異的またはトランス診断的アウトカムに関する包括的なレビューがない.
研究 の 目的:
- SMI患者の不眠症に対する薬理学的介入を評価したランダム化対照試験 (RCT) を体系的にレビューし,メタ分析する.
- これらの治療の有効性 (総睡眠時間,睡眠の質) と受容性 (あらゆる原因による中止) を評価する.
- 安全性や耐受性を含む二次的結果を調べる
主な方法:
- 薬理学的不眠症治療とプラセボまたは活性比較剤を比較するRCTの体系的な検索
- 2人のレビュー者による独立したスクリーニング,データ抽出,バイアスのリスク評価 (RoB2を使用).
- ランダム効果メタ解析は,共プライマリーアウトカム (睡眠時間,睡眠品質,受容性) と二次アウトカム (安全性,受容性) で実施された.
主要な成果:
- 25件のRCT (n=2476) が含まれており,そのほとんどがMDD (18件のRCT),続いてBD (4件のRCT) と統合失調症 (3件のRCT) に焦点を当てていた.
- 25件のRCTのうち22件でバイアスの高いリスクが認められた.
- 薬理学的介入は,プラセボと比較して,睡眠の質 (g=0. 24) と総睡眠時間 (MD=30. 82分) のわずかな,しかし有意な改善を示し,同様の受容性 (RR=1. 06) を示した.
結論:
- SMIにおける不眠症に対する多くの薬学的治療法は,堅実な調査が欠けている.
- メタアナリシスは,有効性とプラセボと同様の受容性を示唆しているが,結果は研究異質性と低品質によって制限されている.
- 高品質のRCTは,SMI集団における薬理学的不眠症治療のための信頼性の高いエビデンスベースを確立するために不可欠です.
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