Kumamoto Y, Tsukamoto T, Yachiku S, Kaneko S, Koyanagi T, Togashi M, Maru A, Tsuchida S, Nishizawa O, Orikasa S
Department of Urology, Sapporo Medical College.
Hinyokika Kiyo. 1990 Oct;36(10):1213-32.
A multicenter clinical trial was carried out on 372 patients in double-blind conditions in order to determine the clinical effects of Ea-0643 (bunazosin hydrochloride) on voiding disorders in benign prostatic hypertrophy, compared with paraprost and placebo. Of the 372 patients, 129 were assigned to bunazosin hydrochloride, 118 to paraprost and 125 to placebo. The improvement rating for all five subjective symptoms improved with passage of time in all the bunazosin hydrochloride, paraprost and placebo groups. A higher improvement rating was obtained in the bunazosin hydrochloride group for retarded urination, urinary stream condition and abdominal pressure at voiding, while the improvement rating was higher for prolonged urination in the placebo group and for residual urine in the paraprost group, but there was no significant difference in improvement ratings between the groups. The daily frequency of voiding decreased to a significant extent in the bunazosin hydrochloride and placebo group at week 1, and there was a significant difference between the bunazosin hydrochloride and the paraprost groups and between the placebo and the paraprost groups. The improvement rating for conditions of voiding was higher with the bunazosin hydrochloride group, when "slightly or better improved" cases were taken into account, but there was no difference between the groups. As for objective symptoms, maximum and average flow rate, useful measures for clinical evaluation of drug effects on voiding disorders, were significantly increased, with a decrease to match in residual urine ratio in the bunazosin hydrochloride group. In terms of maximum and average flow rate bunazosin hydrochloride was significantly superior to paraprost at weeks 1 and 2 and superior to placebo at weeks 2 and 4 and at the final evaluation as well. In terms of residual urine ratio bunazosin hydrochloride was superior to both paraprost and placebo. The global improvement rating, as assessed by the U- and chi 2-tests, was significantly higher in the bunazosin hydrochloride group than in the paraprost group, and there was a significant difference in global improvement ratings, as assessed by the chi 2-test, between the placebo and the paraprost groups, when "moderately or better improved" cases were taken into account. The stratified analysis of the prostate glands, subjective symptoms, maximum flow rate and residual urine ratio revealed that in patients with more advanced conditions the bunazosin hydrochloride group showed significantly superior improvement rates than the paraprost and placebo groups.(ABSTRACT TRUNCATED AT 400 WORDS)
为了确定Ea - 0643（盐酸布那唑嗪）与帕罗西汀和安慰剂相比对良性前列腺增生排尿障碍的临床疗效，在双盲条件下对372例患者进行了一项多中心临床试验。372例患者中，129例被分配至盐酸布那唑嗪组，118例至帕罗西汀组，125例至安慰剂组。在所有盐酸布那唑嗪、帕罗西汀和安慰剂组中，随着时间推移，所有五项主观症状的改善评分均有所提高。盐酸布那唑嗪组在排尿迟缓、尿流情况和排尿时腹压方面获得了更高的改善评分，而安慰剂组在排尿时间延长方面改善评分更高，帕罗西汀组在残余尿量方面改善评分更高，但各组之间的改善评分无显著差异。在第1周时，盐酸布那唑嗪组和安慰剂组的每日排尿频率显著降低，盐酸布那唑嗪组与帕罗西汀组之间以及安慰剂组与帕罗西汀组之间存在显著差异。当考虑“略有改善或改善更好”的病例时，盐酸布那唑嗪组排尿情况的改善评分更高，但各组之间无差异。至于客观症状，作为评估药物对排尿障碍疗效的有用指标，最大尿流率和平均尿流率显著增加，盐酸布那唑嗪组残余尿率相应降低。在最大尿流率和平均尿流率方面，盐酸布那唑嗪在第1周和第2周时显著优于帕罗西汀，在第2周、第4周以及最终评估时优于安慰剂。在残余尿率方面，盐酸布那唑嗪优于帕罗西汀和安慰剂。通过U检验和卡方检验评估的总体改善评分，盐酸布那唑嗪组显著高于帕罗西汀组，当考虑“中度或改善更好”的病例时，通过卡方检验评估，安慰剂组和帕罗西汀组之间的总体改善评分存在显著差异。对前列腺、主观症状、最大尿流率和残余尿率进行分层分析显示，在病情更严重的患者中，盐酸布那唑嗪组的改善率显著高于帕罗西汀组和安慰剂组。（摘要截选至400字）
