Ng Chi-Fai, Wong Annie, Cheng Chi-Wai, Chan Eddie Shu-Yin, Wong Hon-Ming, Hou See-Ming
Division of Urology, Department of Surgery, The Chinese University of Hong Kong, Hong Kong SAR, China.
J Urol. 2008 Sep;180(3):1042-6. doi: 10.1016/j.juro.2008.05.052. Epub 2008 Jul 17.
We investigated the effect of the combination of the doxazosin gastrointestinal therapeutic system and 10 mg vardenafil on the hemodynamic status of patients with benign prostatic hyperplasia and erectile dysfunction.
This was a double-blinded, randomized, placebo controlled crossover trial. Patients with benign prostatic hyperplasia and erectile dysfunction treated with the doxazosin gastrointestinal therapeutic system on a regular basis, with no other antihypertensive events, were recruited. Subjects took 10 mg vardenafil or placebo in a randomized crossover fashion with a washout period of at least 7 days between each treatment. The supine and standing blood pressure of the subjects was recorded from 1 hour before to 6 hours after the administration of vardenafil or placebo. The primary outcome of the study was the maximal change in standing systolic blood pressure of the subjects from 1 half hour before to 6 hours after the administration of drugs.
A total of 37 patients, 25 (67.6%) and 12 (32.4%) on the doxazosin gastrointestinal therapeutic system at 4 mg and 8 mg, respectively, completed the trial. The combination drug therapy resulted in a maximal decrease in standing systolic blood pressure of 6.18 mm Hg (95% CI -12.02, -0.33; p = 0.039). Only 1 patient had an asymptomatic standing systolic blood pressure of less than 85 mm Hg. Otherwise no symptomatic hypotension or clinically significant adverse cardiovascular event was observed during the study.
In patients on the doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia a single 10 mg dose of vardenafil had no symptomatic hemodynamic effects.
我们研究了多沙唑嗪胃肠治疗系统与10毫克伐地那非联合应用对良性前列腺增生和勃起功能障碍患者血流动力学状态的影响。
这是一项双盲、随机、安慰剂对照的交叉试验。招募了定期接受多沙唑嗪胃肠治疗系统治疗、无其他降压事件的良性前列腺增生和勃起功能障碍患者。受试者以随机交叉方式服用10毫克伐地那非或安慰剂，每次治疗之间有至少7天的洗脱期。在服用伐地那非或安慰剂前1小时至服用后6小时记录受试者的仰卧位和站立位血压。该研究的主要结局是受试者在服用药物前半小时至服用后6小时站立位收缩压的最大变化。
共有37例患者完成试验，其中分别有25例（67.6%）和12例（32.4%）服用4毫克和8毫克的多沙唑嗪胃肠治疗系统。联合药物治疗使站立位收缩压最大降低6.18毫米汞柱（95%置信区间-12.02，-0.33；p = 0.039）。只有1例患者站立位收缩压无症状性低于85毫米汞柱。在研究期间未观察到其他有症状的低血压或具有临床意义的不良心血管事件。
对于接受多沙唑嗪胃肠治疗系统治疗良性前列腺增生的患者，单次服用10毫克伐地那非对血流动力学无有症状性影响。
