薬剤の有害反応を予防するための12遺伝子製薬パネル:オープンラベル,多センター,制御,クラスターランダム化クロスオーバー実施試験
Jesse J Swen1, Cathelijne H van der Wouden1, Lisanne En Manson1
1Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, Netherlands.
Lancet (London, England)
|February 4, 2023
まとめ
12遺伝子パネルを用いた予防的薬剤遺伝検査は,大規模なヨーロッパ研究で副作用を著しく減少させた. この遺伝子型によるアプローチは様々な医療環境で実行可能であり,薬物療法の安全性を向上させました.
科学分野:
- ファルマゲノミクス
- 臨床薬理学
- 遺伝学
背景:
- 単一遺伝子薬のペアの薬剤遺伝子検査の利点は知られている.
- 予防的なゲノタイプ化パネルの臨床的有用性は,厳格な評価を必要とする.
研究 の 目的:
- 予防的なゲノタイプ化のための12遺伝子製薬パネルの臨床的有用性を評価する.
- 遺伝子型による治療の副作用への影響を評価する.
主な方法:
- 欧州7カ国の18の病院,9の保健センター,28の薬局で実施された,オープンな,多センター,制御された,クラスターランダム化,クロスオーバー研究.
- インデックス薬の初処方を受けた患者における50種の生殖線変異の遺伝子型決定.
- 遺伝子型による治療の比較 (オランダ製薬遺伝学ワーキンググループの実行可能な変種に関する勧告に従って) と標準治療の比較.
- 主要アウトカム: 12週間以内に臨床的に重要な副作用.
主要な成果:
- ゲノタイプによるグループでは3342人,標準治療群では3602人.
- 治療可能な患者では,薬物の副作用は21. 0% (研究) と27. 7% (対照群) (OR 0. 70; p=0. 0075) で発生した.
- すべての患者で発生率は21. 5% (研究) と28. 6% (対照群) であった (OR 0. 70; p < 0. 0001).
結論:
- 12遺伝子製薬パネルによる遺伝子型誘導治療は副作用を大幅に減少させた.
- この戦略は様々な欧州の医療制度で実現可能である.
- 大規模な実施は 薬物療法の安全性を高めることができます
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