女性における不耐性急性尿失禁に対するオナボトリヌムトキシンA対サクラル神経調節:ランダム化臨床試験
Cindy L Amundsen1, Holly E Richter2, Shawn A Menefee3
1Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.
JAMA
|October 5, 2016
まとめ
オナボトリヌムトキシンAは,女性におけるサクラル神経調節と比較して,毎日の急性無禁症のエピソードをわずかに減少させました. しかし,それは尿路感染症のリスクを高め,自己キャセテリゼーションの必要性を高めました.
科学分野:
- 泌尿器科
- 女性 骨盤 医学 と 再建 手術
背景:
- 抵抗性尿失禁 (UUI) は女性の生活の質に大きな影響を与えます.
- 現在の治療法はサクラル神経調節 (SNM) とオナボトリン毒素A (BTX-A) が含まれており,比較データは限られている.
研究 の 目的:
- 女性における不耐性尿失禁の治療におけるオナボトリン毒素Aの有効性と安全性の比較
主な方法:
- 381人のUUI耐性女性を対象とした多センター,オープン,ランダム化試験です.
- 参加者はオナボトゥリヌムトキシンA (n=192) またはサクラル神経調節 (n=189) のインジェクションを受けた.
- 結果は6ヶ月間,毎日の日記と検証されたアンケートを使って評価された.
主要な成果:
- オナボトリヌム毒素Aは,SNMと比較して,毎日UUIエピソードを統計的に有意に減少させました (- 3. 9 vs - 3. 3エピソード/ 日).
- 症状の不安,治療の満足度,および承認に関する過活性の膀アンケート (SF) のスコアの改善は,オナボトゥリヌムトキシンAにより大きい.
- しかし,オナボトリン毒素Aは尿路感染症の発生率 (35%対11%) と一時的な自己カテーテル化が必要との関連がありました.
結論:
- SNMと比較して,OnabotulinumtoxinAは統計的に有意であるが,臨床的に有意ではない,UUIエピソードの改善をもたらす.
- 尿路感染症のリスクの増加とオナボトリヌムトキシンAによる自己カテーテリゼーションの必要性は,治療決定に考慮されなければならない.
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