Sánchez-Chapado M, Guil M, Alfaro V, Badiella L, Fernández-Hernando N
Urology Service, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.
Eur Urol. 2000 Apr;37(4):421-7. doi: 10.1159/000020163.
This general practitioner-run study assess the security as well as the efficacy and impact on health-related quality of life of a sustained-release (SR) form of alfuzosin in Spanish patients suffering from lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
3,095 patients with symptomatic BPH were enrolled into a national, multicentric, open, phase IV observational study. The period of active treatment studied (5 mg, twice daily) was 60 days. Safety was assessed by monitoring blood pressure and spontaneous adverse events. Symptoms were assessed using a validated Spanish International Prostate Symptom Score (I-PSS). Impact of symptoms on health-related quality of life was assessed using the quality of life index (L).
101 adverse events were reported in 82 patients (2.6%). 28 adverse events (2.6%) were classified as severe. 49 patients (1.6%) dropped out of the study due to adverse events but only 17 of these patients (0.5%) showed adverse events related to vasodilation. Incidence of postural events (vertigo, postural hypotension/hypotension, headache and dizziness) was low (55 patients, 1.8%) and effects on sexual function were found not significant: no retrograde ejaculation was reported and only 1 patient (0.03%) showed impotence. Blood pressure or heart rate showed no clinically significant changes. All the I-PSS scores decreased significantly during the treatment with alfuzosin, improvement being excellent in 60% of the patients. Symptomatic improvement was associated with a significant improvement in health-related quality of life.
This large study conducted during general practice on Spanish BPH patients confirms the efficacy on LUTS and good safety profile of SR alfuzosin, especially its low incidence of postural symptoms and no deleterious effect on sexual function.
这项由全科医生开展的研究评估了阿夫唑嗪缓释剂型在患有提示良性前列腺增生（BPH）的下尿路症状（LUTS）的西班牙患者中的安全性、疗效以及对健康相关生活质量的影响。
3095例有症状的BPH患者被纳入一项全国性、多中心、开放性IV期观察性研究。所研究的积极治疗期（5毫克，每日两次）为60天。通过监测血压和自发不良事件来评估安全性。使用经过验证的西班牙国际前列腺症状评分（I-PSS）来评估症状。使用生活质量指数（L）来评估症状对健康相关生活质量的影响。
82例患者（2.6%）报告了101起不良事件。28起不良事件（2.6%）被归类为严重事件。49例患者（1.6%）因不良事件退出研究，但其中只有17例患者（0.5%）出现与血管舒张相关的不良事件。体位性事件（眩晕、体位性低血压/低血压、头痛和头晕）的发生率较低（55例患者，1.8%），并且发现对性功能的影响不显著：未报告逆行射精，只有1例患者（0.03%）出现阳痿。血压或心率未显示出临床上的显著变化。在使用阿夫唑嗪治疗期间，所有I-PSS评分均显著下降，60%的患者改善情况极佳。症状改善与健康相关生活质量的显著改善相关。
这项在西班牙BPH患者的全科医疗实践中进行的大型研究证实了阿夫唑嗪缓释剂型对LUTS的疗效和良好的安全性，尤其是其体位性症状发生率低且对性功能无有害影响。
