抄録
(目的)勃起障害(ED)治療の第一選択であるphosphodiesterase type5 (PDE5)阻害剤のシルデナフィルとバルデナフィルの2剤に関して,その有効性と安全性,さらにED以外の付随効果につき,多施設共同研究にて検討した.(対象と方法)勃起障害患者125名(55.9±10.9歳)をシルデナフィル25mgとバルデナフィル5mgまたは50mgと10mgを同数同時に処方して,各剤それぞれ2回以上内服後に,EDに対する効果,副作用,付随効果につき調査を行った.(結果)国際勃起指数(IIEF5)は,治療前8.87±4.10が治療後17.24±6.17と有意に改善した(p<0.0001).EDに対する有効性は2剤ともに81.6%であった.副作用発現率は,シルデナフィル13.6%,バルデナフィル5.6%とシルデナフィルで有意に高かった(p=0.032)が,いずれも軽度であった.患者自身の使用感によると,シルデナフィルがよい40.7%,バルデナフィルがよい45.1%との回答であった.さらにED以外の附随効果では,生活にハリがでた46.5%,若返った感じがする45.1%,パートナーとの関係がより親密になった38.0%,健康に気をつけるようになった28.2%,などが認められた.(結論)シルデナフィルとバルデナフィルによるED治療は,有効性,安全性ともに高く,さらにED以外の附随効果ももたらすものと考えられた.
(Objective) The efficacy and safety of two types of phoshodiestrase type 5 (PDE 5) inhibitors (sildenafil (sil) and vardenafil (var)) were investigated for multi-centric study. (Subjects and methods) One hundred and twenty five patients (55.9±10.9 years old) with erectile dysfunction (ED) were treated by both of sil and var. The patients were administered a pair of 25mg of sil and 5mg of var, or 50mg of sil and 10mg of var. The efficacy for ED and safety of these 2 drugs were evaluated after administration of each drugs at least 2 times. (Results) The results showed that the score of international index of erectile function 5 (IIEF5) were elevated from 8.87±4.10 to 17.24±6.17 after treatments (p<0.0001, Student' s t test). The efficacy rates for ED were 81.6% in sil and 81.6% in var, respectively. The adverse reactions rates such as headache, burning, palpitation, etc. were 13.6% in sil and 5.6% in var, which is significantly higher in sil (p=0.032; χ^2 test). These side effects were not serious at all, and there were no cases that gave up to use PDE5 inhibitors because of adverse reactions. According to individual patients experiences, 40.7% of patients preferred sil, 45.4% choose var. In addition, associated effects for quality of life (QOL) of ED patients treated by PDE5 inhibitors were analyzed. The results revealed that encouraging in life 46.5%, rejuvenation feeling 45.1%, self care for their health 28.2%, improvement of depression 12.7%, improvement of voiding dysfunction 5.6%, intimacy with partner 38.0%, good conversation with partner 18.3%, and so on. (Conclusion) The treatments of ED by sil and var were very effective and safety. Furthermore, associated effects for QOL of ED patients were also improved with these treatments.
