Lukacs B, Grange J C, Comet D, McCarthy C
Urology Department, Tenon Hospital, Paris, France.
Eur Urol. 2000 Feb;37(2):183-90. doi: 10.1159/000020116.
As we have previously published 4 articles reporting the treatment of 7,093 clinical benign prostatic hyperplasia (BPH) patients treated with alfuzosin in a 3-month open-labelled study which was subsequently extended to 12, 24, and 36 months, the objective of this article is to provide additional data on dropouts, acute urinary retention (AUR), progression to surgery, and safety under the natural conditions of general practice, paying special attention to the predictive factors.
7,093 patients were initially enrolled by 1,812 centers for up to 3 months. Subsequently 1,508, 1,325, and 812 general practitioners agreed to extend the study up to 12, 24, and 36 months, respectively, which corresponds to 4 patient populations.
The baseline symptom profile of patients who completed the study was identical to that of patients who dropped out (because the center resigned or during treatment). In the 4 patient populations, the percentage of patients per month who dropped out, experienced adverse effects, AUR and surgery were 0. 6-1.6, 0.1-0.5, 0.01-0.03, and 0.1-0.3%, respectively. The classes of symptom severity were not predictive for dropouts: 3.5, 12.6, 20, and 14.3% of the severe patients dropped out during treatment versus 4.2, 13.7, 22.9, and 14.0% of the moderate patients who dropped out up to 3, 12, 24, and 36 months, respectively. Safety was satisfactory regarding the number of adverse events and blood pressure measurement. No retrograde ejaculation was reported.
Under the natural conditions of general practice the reasons for dropping out were not correlated with symptom severity.
我们之前发表了4篇文章，报道了在一项为期3个月的开放标签研究中，7093例临床良性前列腺增生（BPH）患者接受阿夫唑嗪治疗的情况，该研究随后延长至12、24和36个月。本文的目的是在一般临床实践的自然条件下，提供关于退出、急性尿潴留（AUR）、手术进展和安全性的更多数据，特别关注预测因素。
1812个中心最初招募了7093例患者，为期3个月。随后，分别有1508、1325和812名全科医生同意将研究延长至12、24和36个月，这相当于4个患者群体。
完成研究的患者的基线症状特征与退出研究的患者（因中心退出或在治疗期间）相同。在这4个患者群体中，每月退出、出现不良反应、发生AUR和接受手术的患者百分比分别为0.6 - 1.6%、0.1 - 0.5%、0.01 - 0.03%和0.1 - 0.3%。症状严重程度类别对退出无预测性：重度患者在治疗期间退出的比例分别为3.5%、12.6%、20%和14.3%，而中度患者在3、12、24和36个月时退出的比例分别为4.2%、13.7%、22.9%和14.0%。在不良事件数量和血压测量方面，安全性令人满意。未报告逆行射精。
在一般临床实践的自然条件下，退出原因与症状严重程度无关。
