Koyanagi T, Togashi M, Maru A, Orikasa S, Soma F, Shimazaki J, Yasuda K, Aso Y, Honma Y, Miyake K
Department of Urology, Hokkaido University School of Medicine.
Hinyokika Kiyo. 1990 Oct;36(10):1233-52.
The therapeutic utility of bunazosin hydrochloride was evaluated by a multi-center (67 hospitals) double-blind controlled study in patients who complained of voiding disturbances due to neurogenic bladder. For means of comparison, bethanechol chloride and placebo were used as reference drugs. Bunazosin hydrochloride was orally administered 1.5 mg per day for the first week and 3.0 mg per day for two weeks thereafter (Group E). Bethanechol chloride 15 mg (Group B) and placebo (Group P) were orally administered three times daily for three weeks. Three hundred and twenty-three cases were subjected to this study. The global improvement rating was analyzed for 244 cases (83 in Group E, 78 in Group B and 83 in Group P). The global utility rating (GUR) was analyzed for 252 cases (84 in Group E, 81 in Group B and 87 in Group P). Three hundred and twenty cases (107 in Group E, 104 in Group B and 109 in Group P) were analyzed with respect to overall safety rating (OSR). The global improvement ratings (excellent and good) were 32.5% in Group E, 28.2% in Group B and 21.2% in Group P. In the evaluation of GUR, Group E was superior to Group P. In addition, the incidence judged to be useless in Group E was significantly lower than that in Group B. There were no differences in OSR among these three groups. In the total evaluation of the subjective symptoms, the rates of improvement were not different among these three groups. In the total evaluation of the objective findings, the improvement rate in Group E was significantly higher than that in Group P. In addition, the deterioration rate in Group E was significantly lower than that in Group B. In objective findings before and after administration of bunazosin hydrochloride (Group E), the volume of residual urine, the rate of residual urine and the average flow rate improved significantly However, the bladder capacity, the maximum resting bladder pressure and the maximum urethral pressure did not change significantly. Bunazosin hydrochloride improved the objective findings regardless of the bladder capacity and the maximum resting bladder pressure. These significant improvements were marked in the neurogenic bladder patients who were able to urinate and in the patients whose urethral pressure was high. There were no differences in the incidence of side effects or in the appearance of abnormal values of laboratory findings in these three groups. Neither specific signs nor serious clinical side effects except those reported previously were observed.(ABSTRACT TRUNCATED AT 400 WORDS)
通过一项多中心（67家医院）双盲对照研究，对盐酸布那唑嗪在因神经源性膀胱而出现排尿障碍的患者中的治疗效用进行了评估。作为对照手段，使用氯贝胆碱和安慰剂作为参比药物。盐酸布那唑嗪在第一周每天口服1.5毫克，此后两周每天口服3.0毫克（E组）。氯贝胆碱15毫克（B组）和安慰剂（P组）每天口服三次，持续三周。共有323例患者参与了这项研究。对244例患者（E组83例、B组78例、P组83例）进行了整体改善评级分析。对252例患者（E组84例、B组81例、P组87例）进行了整体效用评级（GUR）分析。对320例患者（E组107例、B组104例、P组109例）进行了总体安全性评级（OSR）分析。整体改善评级（优和良）在E组为32.5%，B组为28.2%，P组为21.2%。在GUR评估中，E组优于P组。此外，E组中判定为无效的发生率显著低于B组。这三组在OSR方面没有差异。在主观症状的总体评估中，这三组的改善率没有差异。在客观检查结果的总体评估中，E组的改善率显著高于P组。此外，E组的恶化率显著低于B组。在盐酸布那唑嗪给药前后（E组）的客观检查结果中，残余尿量、残余尿率和平均尿流率有显著改善。然而，膀胱容量、最大静息膀胱压力和最大尿道压力没有显著变化。盐酸布那唑嗪改善了客观检查结果，无论膀胱容量和最大静息膀胱压力如何。这些显著改善在能够排尿的神经源性膀胱患者以及尿道压力高的患者中尤为明显。这三组在副作用发生率或实验室检查结果异常值的出现方面没有差异。除先前报告的那些之外，未观察到特定体征或严重临床副作用。（摘要截短至400字）
