Uchibayashi T, Nakajima K, Nihino A, Hisazumi H
Department of Urology, School of Medicine, Kanazawa University.
Hinyokika Kiyo. 1991 Sep;37(9):1077-85.
Oxybutynin hydrochloride (Pollakisu tablets) was administered at a daily dose of 6 or 9 mg to 75 elderly patients with urinary tract disorders, including neurogenic bladder and unstable bladder, with chief complaints of pollakisuria, urgency on urination and urinary incontinence. A post-marketing follow-up survey (phase IV study) was then performed to evaluate the efficacy safety and usefulness of Pollakisu tablets in these patients. The administration of Pollakisu tablets produced good results in the comprehensive assessment of overall improvement, being rated as "improved" or better in 57.5% of the patients and "slightly improved" or better in 89.0%. The assessment of general safety revealed that the drug caused almost no problems, with "no problem in safety" accounting for 97.3% of the responses. The assessment of the usefulness indicated that Pollakisu tablets are highly useful, being rated as "useful" or better in 58.9% and as "slightly useful" or better in 82.2%. Evaluation of the results according to daily dose indicated that a dose of 6 mg per day was appropriate for elderly patients from the viewpoint of drug efficacy and safety. With respect to adverse reactions, thirst was found in 5 and dysuria in 3 of the 73 patients. The overall incidence of adverse reactions was 11.0%. The above results indicate the efficacy, safety and usefulness of Pollakisu tablets in treating elderly patients with pollakisuria, urgency on urination and urinary incontinence.
对75例患有尿路疾病（包括神经源性膀胱和不稳定膀胱）、主要症状为尿频、尿急和尿失禁的老年患者，给予盐酸奥昔布宁（波拉克苏片），每日剂量为6毫克或9毫克。随后进行了上市后随访调查（IV期研究），以评估波拉克苏片在这些患者中的疗效、安全性和实用性。波拉克苏片给药后在总体改善的综合评估中取得了良好效果，57.5%的患者被评为“改善”或更好，89.0%的患者被评为“稍有改善”或更好。总体安全性评估显示，该药物几乎没有问题，“安全性无问题”的回答占97.3%。实用性评估表明，波拉克苏片非常有用，58.9%的患者被评为“有用”或更好，82.2%的患者被评为“稍有有用”或更好。根据每日剂量对结果进行评估表明，从药物疗效和安全性的角度来看，每日6毫克的剂量对老年患者是合适的。关于不良反应，73例患者中有5例出现口渴，3例出现排尿困难。不良反应的总发生率为11.0%。上述结果表明波拉克苏片在治疗老年尿频、尿急和尿失禁患者方面的疗效、安全性和实用性。
