ソマトスタチンは,ヘマテメシスとメラエナの治療に用いられる
Lancet (London, England)
|January 19, 1985
まとめ
この研究では,ソマトスタチンの注入が,胃腸出血患者における再出血を有意に減少させなかったことが判明しました. 治療を受けた患者では再出血が少ないが,アウトカムはプラセボと類似しており,以前の利益の主張に疑問を呈している.
科学分野:
- 胃腸内科 胃腸内科
- クリニック・トライアル 臨床試験
- 薬理学 薬理学とは
背景:
- ヘマテメシスとメラーナによって特徴づけられる胃腸出血は,重要な臨床的懸念事項です.
- 以前の小規模な研究では,このような状態の管理においてソマトスタチンの潜在的な利点が示唆されました.
研究 の 目的:
- ヘマテメシスとメラエナを呈する患者でプラセボと比較して,継続的な静脈内ソマトスタチン輸液の有効性を評価する.
- ソマトスタチンの再出血率,手術の必要性,死亡率への影響を評価する.
主な方法:
- ダブルブラインド,ランダム化制御試験で,血熱症とメレーナの患者630人が参加した.
- 患者は,ソマトスタチンまたは同一のプラセボを常時静脈注入で投与するように割り当てられました.
- 再出血エピソード,手術率,死亡率を含むアウトカムが記録され,比較されました.
主要な成果:
- 再出血は,治療を受けた患者315人のうち70人に,対照患者315人のうち89人に発生し,統計的に有意ではない差異がありました.
- ソマトスタチン群 (35人) とプラセボ群 (34人) の手術率は類似した.
- プラセボ群 (25例) に比べて,ソマトスタチン治療群 (31例) で死亡率がわずかに高いことが観察されました.
結論:
- 研究結果は,継続的な静脈内ソマトスタチン注入が,血熱症とメラエナの患者の再出血を減らすのに有意な利点を提供していないことを示唆しています.
- この結果は,前回の有意な有効性に関する報告と矛盾しており,ソマトスタチンによる実質的な利点の主張は正当化されない可能性があることを示しています.
- 特定の個体における利点の完全な排除は不可能ですが,全体的な証拠は,この試験に基づいて広範な使用を支持しません.
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