Aranda Pedro, Ruilope Luis M, Calvo Carlos, Luque Manuel, Coca Antonio, Gil de Miguel Angel
Hospital Carlos Haya, Málaga, Spain.
Am J Hypertens. 2004 Feb;17(2):139-45. doi: 10.1016/j.amjhyper.2003.09.006.
The aim of this study was to establish the prevalence of erectile dysfunction (ED) in hypertensive patients in specialized care hypertension units (SCHUs) and to assess the effectiveness and tolerability of sildenafil treatment.
This was a multicenter, prospective, open, observational pharmacoepidemiology study conducted in 25 Spanish SCHUs. A total of 2130 men with essential hypertension under treatment were recruited. In a second phase, 291 subjects with a score < or = 21 in the Sexual Health Inventory for Men (SHIM) received sildenafil (50 mg/day) as required 30 to 60 minutes before sexual activity, and were evaluated by the International Index of Erectile Function (IIEF).
A total of 975 subjects (45.8%) had a score < or = 21 in the SHIM. In the second phase, sildenafil improved the score in the erectile function domain in 232 patients (83.2%). Severity of ED significantly improved (P <.001); severe (22.3% to 7.7%), moderate (23% to 5.6%), and mild impairment (36.3% to 44.8%). The IIEF was normalized in 39.1% of patients who completed post-treatment IIEF. In all, 33 subjects (11.8%) failed to complete the study: two (0.7%) because of lack of efficacy, two (0.7%) intercurrent disease, 10 (3.6%) failure to return to the visits, three (1.1%) fear of therapy, four (1.4%) adverse effects requiring treatment discontinuation, and 12 (4.3%) protocol violations. No statistically significant association was found between the prevalence of adverse effects and antihypertensive treatment with single drug or combination therapy.
A high incidence of ED was found in hypertensive patients from Spanish SCHUs. Sildenafil showed an excellent response and safety profile.
本研究旨在确定高血压专科护理病房（SCHUs）中高血压患者勃起功能障碍（ED）的患病率，并评估西地那非治疗的有效性和耐受性。
这是一项在25个西班牙SCHUs中进行的多中心、前瞻性、开放性观察性药物流行病学研究。共招募了2130名正在接受治疗的原发性高血压男性患者。在第二阶段，291名男性性健康量表（SHIM）得分≤21分的受试者在性活动前30至60分钟按需服用西地那非（50毫克/天），并通过国际勃起功能指数（IIEF）进行评估。
共有975名受试者（45.8%）SHIM得分≤21分。在第二阶段，西地那非使232例患者（83.2%）的勃起功能领域得分得到改善。ED严重程度显著改善（P<.001）；重度（从22.3%降至7.7%）、中度（从23%降至5.6%）和轻度损害（从36.3%降至44.8%）。39.1%完成治疗后IIEF评估的患者IIEF恢复正常。共有33名受试者（11.8%）未完成研究：2名（0.7%）因疗效不佳，2名（0.7%）并发疾病，10名（3.6%）未复诊，3名（1.1%）惧怕治疗，4名（1.4%）因不良反应需停药，12名（4.3%）违反研究方案。未发现不良反应患病率与单药或联合抗高血压治疗之间存在统计学显著关联。
西班牙SCHUs的高血压患者中ED发病率较高。西地那非显示出良好的反应和安全性。
