Park Y C, Nishioka T, Arai Y, Tomoyoshi T, Kurita T, Hayashida H, Nagai N, Inoue H, Kataoka K, Kitagawa Y
Department of Urology, School of Medicine, Kinki University.
Hinyokika Kiyo. 1992 Jul;38(7):857-68.
In this study the multicenter, fixed-flexible dose regimen was taken to evaluate the effective dose range of Terazosin for the treatment of micturition disturbance in benign prostatic hypertrophy (BPH) and to clarify the characteristics of patients who are more responsive to Terazosin therapy. After a 1-week washout (placebo) the first two weeks 1 mg/day of Terazosin was administered, then depending on efficacy of subjective symptoms, Terazosin doses were increased up to 2 mg/day and 4 mg/day at intervals of two weeks. After six weeks the final efficacy and safety were assessed. The subjective symptom improvement rate was 18.5% by 1 mg/day, 55.6% by 2 mg/day and 65.4% by 4 mg/day cumulatively. The objective symptom improvement rate were 13.2% by 1 mg/day, 42.1% by 2 mg/day and 50.0% by 4 mg/day cumulatively. The global improvement rate was 14.5% by 1 mg/day, 50.0% by 2 mg/day and 61.8% by 4 mg/day cumulatively. The patients who had a higher subjective symptom score in the lead-in period were more improved rather than those who had a lower score. In objective symptoms, voided volume, maximum flow rate (MFR), MFR nomogram score and average flow rate improved and the ratio of residual urine volume decreased. There was no relationship between clinical improvement on either subjective or objective symptoms and prostatic weight. Adverse reactions, such as dizziness, vertigo, tinnitus, nausea and blurred vision; were seen in 10 cases. In conclusion Terazosin was effective and well tolerated for the treatment of patients who had micturition disturbance with BPH in the dose range of 2 to 4 mg/day.
本研究采用多中心、固定-灵活剂量方案，以评估特拉唑嗪治疗良性前列腺增生（BPH）所致排尿障碍的有效剂量范围，并阐明对特拉唑嗪治疗反应更佳的患者特征。经过1周的洗脱期（安慰剂）后，前两周给予特拉唑嗪1mg/天，然后根据主观症状的疗效，每隔两周将特拉唑嗪剂量增至2mg/天和4mg/天。六周后评估最终疗效和安全性。累积主观症状改善率在1mg/天时为18.5%，2mg/天时为55.6%，4mg/天时为65.4%。累积客观症状改善率在1mg/天时为13.2%，2mg/天时为42.1%，4mg/天时为50.0%。累积整体改善率在1mg/天时为14.5%，2mg/天时为50.0%，4mg/天时为61.8%。导入期主观症状评分较高的患者改善程度大于评分较低的患者。在客观症状方面，排尿量、最大尿流率（MFR）、MFR列线图评分和平均尿流率均有所改善，残余尿量比例降低。主观或客观症状的临床改善与前列腺重量之间无相关性。出现头晕、眩晕、耳鸣、恶心和视力模糊等不良反应的有10例。总之，特拉唑嗪在2至4mg/天的剂量范围内对治疗BPH所致排尿障碍的患者有效且耐受性良好。
