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阿夫唑嗪对良性前列腺增生患者生活质量的影响:初步结果。意大利阿夫唑嗪合作组

Effect of alfuzosin on quality of life in benign prostatic hyperplasia patients: preliminary results. Italian Alfuzosin Co-Operative Group.

作者信息

Martelli A, Pacifico P, Casadei G

机构信息

Urology Department, University Bologna, Italy.

出版信息

Eur Urol. 1993;24 Suppl 1:28-33. doi: 10.1159/000474371.

Abstract

Recently urologists have focused their attention not only on classical evaluation parameters for patients suffering from benign prostatic hyperplasia (BPH), such as symptoms and uroflowmetry, but also on the impact of therapy on the patients' quality of life. An observational, open-label, uncontrolled trial was designed to evaluate the impact of a 3-month therapy with alfuzosin (2.5 mg t.i.d.) on the quality of life of patients complaining of BPH-related symptoms for at least 6 months. Nine hundred and ninety patients were enrolled in 86 Italian centers of urology. At baseline and after 84 days of treatment the following assessments were performed: the Maine Medical Assessment Program Symptom Score, a quality of life questionnaire, and at selected centers, uroflowmetry and residual volume measurement. Preliminary results on 498 evaluable patients (who completed the study by March 1992), showed the ability of alfuzosin to improve BPH symptoms significantly (total mean score from 12.02 +/- 0.17 to 7.27 +/- 0.12, -39.5%), mostly in patients with severe symptoms at baseline (-46.8%). All the three indices describing patients' quality of life improved significantly: mental health +2.3% (p < 0.01); general health +4.3% (p < 0.01), and especially, activity +12.9% (p < 0.01). A marked improvement was observed in patients with severe symptoms (activity index +23.8%). Uroflowmetric data obtained from 255 patients showed a significant increase in peak (+4.14 ml/s) and mean (+2.58 ml/s) flows, associated with a marked decrease in residual volume (-34.1 ml, -52.6%). Thirty-three patients experienced one or more adverse medical events, mainly within the first 4 weeks of treatment (20 patients).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

最近,泌尿外科医生不仅关注良性前列腺增生(BPH)患者的传统评估参数,如症状和尿流率,还关注治疗对患者生活质量的影响。一项观察性、开放标签、非对照试验旨在评估阿夫唑嗪(2.5毫克,每日三次)为期3个月的治疗对抱怨BPH相关症状至少6个月的患者生活质量的影响。990名患者在意大利86个泌尿外科中心入组。在基线和治疗84天后进行了以下评估:缅因州医学评估项目症状评分、一份生活质量问卷,以及在选定的中心进行尿流率和残余尿量测量。对498名可评估患者(截至1992年3月完成研究)的初步结果显示,阿夫唑嗪能够显著改善BPH症状(总平均分从12.02±0.17降至7.27±0.12,降低39.5%),主要是基线时症状严重的患者(降低46.8%)。描述患者生活质量的所有三个指标均显著改善:心理健康提高2.3%(p<0.01);总体健康提高4.3%(p<0.01),尤其是活动能力提高12.9%(p<0.01)。症状严重的患者有显著改善(活动指数提高23.8%)。从255名患者获得的尿流率数据显示,峰值流速(+4.14毫升/秒)和平均流速(+2.58毫升/秒)显著增加,同时残余尿量显著减少(-34.1毫升,-52.6%)。33名患者经历了一次或多次不良医疗事件,主要发生在治疗的前4周内(20名患者)。(摘要截选至250字)

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