Goto M, Kato K, Kondo A, Otani T, Takita T, Kobayashi M
Department of Urology, School of Medicine, Nagoya University.
Hinyokika Kiyo. 1988 Mar;34(3):541-50.
Clinical effects and therapeutic usefulness of oxybutynin hydrochloride were evaluated in a long-term clinical trial on patients with unstable bladders and neurogenic bladders. Of the 46 patients entered into the trial, 37 were those diagnosed with an unstable bladder and 9 with a neurogenic bladder with overactive detrusor. In 37 of the cases (80%), the period of drug administration reached up to 12 weeks and in 16 cases (34%) the drugs were administered for more than 24 weeks. The average administration period was 165.9 days. The average total given dose was 1776.9 mg and average dose per day was 10.7 mg. Excellent and good responses were obtained in 76.3, 88.9 and 69.6% at 12 and 24 weeks after start of administration and at the time of discontinuing the drug, respectively. The cystometric changes at pre- and post-administration were evaluated on 23 cases and revealed a significant increase in volume at first sensation and maximum desire to void. Maximum resting intravesical pressure was significantly declined and uninhibited detrusor contractions were significantly suppressed. Side effects were noted in 11 of the 46 cases (23.9%), most of which were well tolerated by the patients. In 4 cases the drug had to be discontinued because of the side effects. Dry mouth was the most common side effect, occupying almost half of the incidents. No significant abnormality was noted on blood laboratory data, blood pressure or heart rate, following the drug administration. In one case slight increase in serum glutamic-oxalacetic transaminase and glutamic-pyruvic transaminase was encountered, but its relationship with the drug was obscure. The clinical usefulness of this drug (excellent and good) was 78.9, 88.9 and 69.6% at 12 and 24 weeks after start of administration, and at the time of drug discontinuation, respectively. The present long-term trial proved that oxybutynin hydrochloride is an exceedingly effective and safe agent for clinical management of unstable bladder and overactive neurogenic bladder.
在一项针对不稳定膀胱和神经源性膀胱患者的长期临床试验中，对盐酸奥昔布宁的临床疗效和治疗效用进行了评估。进入该试验的46例患者中，37例被诊断为不稳定膀胱，9例为逼尿肌过度活跃的神经源性膀胱。在37例（80%）病例中，给药期长达12周，16例（34%）给药超过24周。平均给药期为165.9天。平均总给药剂量为1776.9毫克，平均每日剂量为10.7毫克。给药开始后12周、24周以及停药时，分别有76.3%、88.9%和69.6%的患者获得了优效和良好反应。对23例患者给药前后的膀胱测压变化进行了评估，结果显示首次有尿意时的容量和最大排尿欲望显著增加。最大静息膀胱内压显著下降，逼尿肌无抑制性收缩得到显著抑制。46例中有11例（23.9%）出现副作用，大多数患者对这些副作用耐受性良好。4例因副作用不得不停药。口干是最常见的副作用，几乎占所有副作用事件的一半。给药后，血液实验室数据、血压或心率均未发现明显异常。有1例患者血清谷草转氨酶和谷丙转氨酶略有升高，但其与药物的关系尚不明确。该药物（优效和良好）的临床效用在给药开始后12周、24周以及停药时分别为78.9%、88.9%和69.6%。本次长期试验证明，盐酸奥昔布宁是临床治疗不稳定膀胱和逼尿肌过度活跃的神经源性膀胱的极其有效且安全的药物。
