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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 阮雍順 | 利用經皮貼片或者口服Oxybutynin治療兒童神經性逼尿肌過動症的安全性以及有效性的評估 | 2009/10/12 下午 05:25:05 | 0 |
| 原 文 | 題 目 | Efficacy and Safety of Transdermal and Oral Oxybutynin in Children With Neurogenic Detrusor Overactivity |
| 作 者 | Patrick C. Cartwright, Douglas E. Coplen, Barry A. Kogan, Weining Volinn, Eileen Finan and Gary Hoel | |
| 出 處 | Journal of Urology | |
| 出版日期 | 2009, October, Vol. 182, p1548-1554 | |
| 評 論 | 目前而言，oxybutynin是唯一被核准使用於治療兒童過動性膀胱的藥物，但是因為抗膽鹼藥物的副作用，使用口服oxybutynin在兒童的服藥順應性並不高，所以又發展出經膀胱灌注或是經皮貼片的給藥方式。本文作者利用經皮貼片以及口服oxybutynin來治療兒童神經性逼尿肌過動症，並分別比較兩者給藥途徑的安全性以及有效性。本研究一共納入57位兒童，經皮貼片41位以及口服16位，給藥的劑量經皮貼片是口服藥物的三分之ㄧ，一週給予兩次貼片，而口服藥物是每天給予，共接受為期十二週的治療。在試驗結果發現，oxybutynin經皮貼片以及口服oxybutynin都可以明顯增加了利用導尿所測得的膀胱容量；而利用尿路動力學檢查，包括膀胱容量、不自主收縮時逼尿肌壓力以及發生不自主收縮時膀胱的容量，兩組也都有明顯改善，顯示雖然只用了口服劑量的三分之ㄧ，經皮貼片也是相當有效的方式。有研究認為口乾、臉潮紅的副作用可能和oxybutynin代謝產物N- desethyloxybutynin也有關係，而血中N-desethyloxybutynin的含量則是經皮貼片明顯少於口服oxybutynin，所以經皮貼片可能因此可以減少全身性的副作用。值得注意的是利用經皮貼片給藥有較多的皮膚紅腫以及搔癢的副作用，雖然只有一位因為皮膚的副作用而退出研究，但是相信要如何發展出不會引起皮膚紅腫搔癢的貼片，應該也是未來要努力的目標。 | |
| abstract |
Purpose: We evaluated the efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. Materials and Methods: Children with neurogenic detrusor overactivity 6 to 15 years old and previously receiving oxybutynin were assigned randomly at a 3:1 ratio to treatment with transdermal or oral oxybutynin. Initial dosages (transdermal 1.3, 2.9 or 3.9 mg daily; oral 5, 10 or 15 mg daily), based on pre-study dosages, were adjusted after 2 weeks and then maintained for 12 weeks. The primary efficacy end point was change from baseline to last observation in average urine volume collected by clean intermittent catheterization. Results: A total of 57 patients were randomized to receive transdermal (41) or oral (16) oxybutynin. Safety data were available for 55 patients and efficacy data were available for 52. Mean ± SD urine volume increased from 95 ± 64 ml to 125 ± 74 ml (p <0.001) with transdermal oxybutynin and from 114 ± 75 ml to 166 ± 92 ml (p = 0.002) with oral oxybutynin. Transdermal oxybutynin resulted in significant improvement in all measured urodynamic parameters. Similar trends and a significant increase in maximal cystometric bladder capacity were observed in the smaller oral oxybutynin group. There were 12 treatment related adverse events noted with transdermal oxybutynin (mild skin reaction) and 1 with oral oxybutynin (vasodilatation). The ratio of N-desethyloxybutynin-to-oxybutynin plasma concentrations was substantially lower with transdermal (1.4) than with oral (6.7) oxybutynin. Conclusions: Transdermal oxybutynin was a well tolerated and effective alternative to oral oxybutynin in treating neurogenic detrusor overactivity in children who previously tolerated oxybutynin. |
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