Afif-Abdo João, Teloken Claudio, Damião Ronaldo, Koff Walter, Wroclawski Eric, Yamasaki Rui, Torres Luiz Otávio, Sabaneeff Jorge, Faria Geraldo, Pompeo Antonio Carlos, Cortado Pedro, Glina Sidney
Service of Urology, Hospital Santa Cruz, and Service of Urology, State University of Rio de Janeiro, Sao Paulo, Brazil.
BJU Int. 2008 Sep;102(7):829-34. doi: 10.1111/j.1464-410X.2008.07767.x. Epub 2008 Jun 4.
To compare the effectiveness, safety and tolerability of sildenafil and apomorphine in Brazilian patients with erectile dysfunction (ED) of various causes.
In all, 108 patients (mean age 55 years, sd 11) and documented ED for > or =6 months were included in 12 centres in Brazil. The patients were initially followed for 2 weeks and then randomized to initial treatment with apomorphine or sildenafil, taken before sexual intercourse, no more than once a day. The initial dose (2 mg apomorphine and 50 mg sildenafil) could be adjusted (to 3 mg apomorphine, or to 25 or 100 mg for sildenafil) depending on the effectiveness and tolerability during the first 4 weeks of treatment. The patients were re-evaluated after 8 weeks on treatment and, after a wash-out period of 2 weeks (no treatment), received the other study drug (other than that received in the first phase), and then had the same procedures as in the first phase.
In all, 97 patients were evaluated for therapeutic effectiveness, the overall effectiveness being assessed using two questions; sildenafil had a significantly higher proportion of affirmative answers for both (P < 0.001). Likewise, the estimates for the mean (sd) proportion of successful sexual intercourse, of 83.3 (4.7)% vs 40.3 (4.7)% and the total ED Inventory of Treatment Satisfaction score, of 86.7 (2.9) vs 56.9 (2.9) (P < 0.001) were higher for sildenafil. At the end of the study, 93.8% of the patients randomized to initial therapy with apomorphine declared a preference for sildenafil, and 81.3% of those initially treated with sildenafil declared a preference for that drug. The two drugs were well tolerated, and the main adverse events for apomorphine were nausea, vomiting, headache, taste perversion and dizziness; for sildenafil they were headache, flushing or vasodilatation, abdominal pain or dyspepsia and nasal congestion.
Sildenafil is more effective than apomorphine for treating ED, in the domains of erectile function, satisfaction with sexual intercourse and overall satisfaction, and was the drug preferred by most of the patients.
比较西地那非和阿扑吗啡对巴西各种病因所致勃起功能障碍（ED）患者的有效性、安全性及耐受性。
巴西12个中心共纳入108例患者（平均年龄55岁，标准差11），均有记录显示ED病程≥6个月。患者最初随访2周，然后随机分为接受阿扑吗啡或西地那非初始治疗组，于性交前服用，每日不超过1次。初始剂量（阿扑吗啡2mg，西地那非50mg）可根据治疗前4周的有效性和耐受性进行调整（阿扑吗啡调至3mg，西地那非调至25mg或100mg）。治疗8周后对患者进行重新评估，经过2周的洗脱期（未治疗）后，给予另一种研究药物（与第一阶段所用药不同），然后进行与第一阶段相同的程序。
共97例患者接受了治疗有效性评估，总体有效性通过两个问题进行评估；西地那非对两个问题的肯定回答比例均显著更高（P<0.001）。同样，西地那非成功性交的平均（标准差）比例估计值为83.3（4.7）%，高于阿扑吗啡的40.3（4.7）%；治疗满意度总评分方面，西地那非为86.7（2.9），高于阿扑吗啡的56.9（2.9）（P<0.001）。研究结束时，随机接受阿扑吗啡初始治疗的患者中有93.8%表示更倾向于西地那非，而最初接受西地那非治疗的患者中有81.3%表示更倾向于该药物。两种药物耐受性良好，阿扑吗啡的主要不良事件为恶心、呕吐、头痛、味觉异常和头晕；西地那非的主要不良事件为头痛、潮红或血管扩张、腹痛或消化不良以及鼻塞。
在勃起功能、性交满意度及总体满意度方面，西地那非治疗ED比阿扑吗啡更有效，且是大多数患者更偏爱的药物。
