O'Leary Margie, Erickson Janet R, Smith Christopher P, McDermott Charlotte, Horton John, Chancellor Michael B
Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
J Spinal Cord Med. 2003 Summer;26(2):159-62. doi: 10.1080/10790268.2003.11753678.
This study evaluated the effects and tolerability of extended-release oxybutynin chloride on the frequency of voiding and catheterization and urodynamic capacity in spinal cord injury (SCI) patients with defined detrusor hyperreflexia.
This was a 12-week, prospective, dose-titration study of extended-release oxybutynin (oxybutynin XL). SCI patients with urodynamically defined detrusor hyperreflexia were recruited for this study. Following a 7-day washout period, patients were evaluated via video-urodynamic study and then treatment was initiated at a dosage of 10 mg per day. Dosage was increased in weekly intervals to a maximum of 30 mg per day. Micturation frequency diaries and urodynamics were completed at baseline and repeated at week 12. Tolerability information was collected at each follow-up visit.
Ten patients (mean age = 49 years) with complete or incomplete SCI were enrolled. Participants reported clinical improvement (decreased urinary frequency and fewer incontinence episodes) with oxybutynin therapy following titration to 30 mg per day. All patients chose a final effective dosage of greater than 10 mg, with 4 patients taking the maximum of 30 mg per day. Mean cystometric bladder capacity increased from 274 mL to 380 mL (P = 0.008). No patient experienced serious adverse events during the 12-week study.
Oxybutynin XL is safe and effective in patients with detrusor hyperreflexia secondary to SCI. The onset of clinical efficacy occurs within 1 week, and daily dosages up to 30 mg are well tolerated.
本研究评估了氯巴占缓释片对脊髓损伤（SCI）伴明确逼尿肌反射亢进患者的排尿频率、导尿频率及尿动力学容量的影响和耐受性。
这是一项为期12周的氯巴占缓释片前瞻性剂量滴定研究。招募了经尿动力学检查确诊为逼尿肌反射亢进的SCI患者。经过7天的洗脱期后，通过视频尿动力学研究对患者进行评估，然后以每日10毫克的剂量开始治疗。每周增加一次剂量，最大剂量为每日30毫克。在基线时完成排尿频率日记和尿动力学检查，并在第12周重复进行。在每次随访时收集耐受性信息。
纳入了10例完全性或不完全性SCI患者（平均年龄=49岁）。参与者报告称，在滴定至每日30毫克的氯巴占治疗后，临床症状有所改善（排尿频率降低，尿失禁发作减少）。所有患者选择的最终有效剂量均大于10毫克，4例患者每日服用最大剂量30毫克。平均膀胱测压容量从274毫升增加到380毫升（P=0.008）。在为期12周的研究中，没有患者发生严重不良事件。
氯巴占缓释片对SCI继发逼尿肌反射亢进患者安全有效。临床疗效在1周内出现，每日剂量高达30毫克时耐受性良好。
