糖尿病の男性における勃起不全の治療のためのシルデナフィル:ランダム化制御試験. シルデナフィルの糖尿病研究グループ
M S Rendell1, J Rajfer, P A Wicker
1Creighton Diabetes Center, Omaha, Neb 68131, USA.
JAMA
|February 10, 1999
まとめ
シルデナフィルは,糖尿病の男性における勃起不全を効果的に治療します. この経口薬は,性交の成功率を向上させ,よく耐えており,頭痛や消化不良などの一般的な副作用がありました.
科学分野:
- 泌尿器科 泌尿器科とは
- エンドクリノロジー エンドクリノロジー
- 薬理学 薬理学とは
背景:
- 勃起不全 (ED) は,糖尿病と診断された男性の一般的な合併症です.
- 糖尿病は,血管および神経学的損傷のために勃起機能を著しく損なう可能性があります.
研究 の 目的:
- 特に糖尿病の男性集団における勃起不全 (ED) の治療における口服用シルデナフィルシトラートの有効性と安全性を評価する.
- 勃起機能の改善におけるシルデナフィルの有効性をプラセボと比較するために.
主な方法:
- 多センター,ランダム化,ダブルブラインド,プラセボ対照,柔軟な用量エスカレーション研究です.
- EDと糖尿病の268人の男性は,ランダムにシルデナフィル (n=136) またはプラセボ (n=132) を12週間に渡って投与されました.
- 効果は,国際勃起機能指数 (International Index of Erectile Function) を使用して勃起を達成し,維持する自己報告の能力によって評価されました.
主要な成果:
- シルデナフィルはプラセボと比較して勃起機能を有意に改善し,患者の56%が10% (P<.001) と比べて勃起を改善したと報告しました.
- シルデナフィル群では,成功した性交の試みは61%,プラセボ群では22%に増加した (P<.001).
- 副作用は,シルデナフィル (16%) がプラセボ (1%) よりも頻繁に発生し,主に頭痛,消化不良,呼吸器系の問題でした. 心血管疾患のイベントは,グループ間で類似していました.
結論:
- 経口用シルデナフィルシトラートは,糖尿病の男性における勃起不全に対する安全で効果的な治療法です.
- この薬は,この患者集団で好ましい耐受性プロファイルを示しています.
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