Fujita T, Ohshima S, Asano H, Ono Y, Kinukawa T, Kato N, Hirabayashi S
Department of Urology, Nagoya Memorial Hospital.
Hinyokika Kiyo. 1992 May;38(5):613-21.
Thirty-five patients with prostatic hyperplasia were entered into a randomized controlled study using bunazosin hydrochloride(alpha 1-adrenergic blocker). Eighteen patients were allocated to be treated with an initial dose of 1.5 mg/day (group 1) and 17 patients received an initial dose of 3.0 mg/day (group 2). Subjective symptoms and parameters of urodynamic studies were evaluated after 4 weeks and 12 weeks. There were 5 withdrawals or exclusions within 4 weeks and 6 within 12 weeks. Therefore, 15 patients in group 1 and 15 patients in group 2 were eligible for evaluation at 4 weeks, 12 patients in group 1 and 11 patients in group 2 were eligible for evaluation at 12 weeks. The rates of the improvement in subjective symptoms such as retarded urination, protracted urination, weakened urinary stream, abdominal straining on voiding, and sense of residual urine were 40%, 25% in group 1 and 46.7%, 36.4% in group 2, at 4 weeks and at 12 weeks, respectively. The rate of improvement in objective parameters of the urodynamic study such as voiding volume, residual volume, maximum flow rate and average flow rate were 26.7%, 16.7% in group 1 and 26.7%, 20.0% in group 2, at 4 weeks and at 12 weeks, respectively. Thus, these improvements were not correlated with the dosage of drug. Adverse effects such as diarrhea, mild headache, palpitation and gastric disturbance were observed in 2 patients in group 1, and 3 patients in group 2. In the 24 patients treated with the drug over 12 weeks, there were no specific adverse effects due to prolonged administration. These findings showed that bunazosin hydrochloride is beneficial for the treatment of prostatic hyperplasia, and could be safety administered for a prolonged period of time up to 12 weeks.
35例前列腺增生患者进入一项使用盐酸布那唑嗪（α1肾上腺素能阻滞剂）的随机对照研究。18例患者被分配接受初始剂量1.5毫克/天的治疗（第1组），17例患者接受初始剂量3.0毫克/天的治疗（第2组）。在4周和12周后评估主观症状和尿动力学研究参数。4周内有5例退出或被排除，12周内有6例。因此，第1组15例患者和第2组15例患者在4周时符合评估条件，第1组12例患者和第2组11例患者在12周时符合评估条件。在4周和12周时，第1组排尿迟缓、排尿时间延长、尿流变弱、排尿时腹部用力和残余尿感等主观症状的改善率分别为40%、25%，第2组分别为46.7%、36.4%。尿动力学研究客观参数如排尿量、残余尿量、最大流速和平均流速在4周和12周时，第1组的改善率分别为26.7%、16.7%，第2组分别为26.7%、20.0%。因此，这些改善与药物剂量无关。第1组2例患者和第2组3例患者观察到腹泻轻、头痛、心悸和胃部不适等不良反应。在接受该药物治疗超过12周的24例患者中，未因长期给药出现特定不良反应。这些结果表明，盐酸布那唑嗪对前列腺增生治疗有益，并且可以安全地长期给药长达12周。
