Department of Urology, King Abdulaziz University Medical City, Jeddah, Saudi Arabia.
J Urol. 2010 Dec;184(6):2423-8. doi: 10.1016/j.juro.2010.08.028. Epub 2010 Oct 16.
The short-term outcomes of initial detrusor injections vs combined detrusor-trigone botulinum toxin-A injections were determined in patients with spinal cord injury-neurogenic detrusor overactivity.
Adults with refractory spinal cord injury-neurogenic detrusor overactivity who strictly discontinued anticholinergics were recruited for the study. At a 1:1 ratio patients randomly received 300 U botulinum toxin-A intradetrusor injections excluding the trigone (detrusor arm) or 200 U intradetrusor plus 100 U intratrigonal injections (combined arm). Study end points were determination of the impact on incontinence episodes, complete dryness, quality of life, reusing anticholinergics, maximum detrusor pressure, reflex volume, maximum cystometric capacity, vesicoureteral reflux and adverse events. Patients were evaluated at baseline, and 2, 8, 12 and 18 weeks after injection. Statistical significance was considered at p<0.05.
Analysis included 18 patients per arm with no significant baseline differences. On within group analysis all parameters improved significantly compared to baseline. On between group analysis in the detrusor vs the combined arm at week 8 incontinence decreased by 52.4% vs 80.9% (number needed to treat 1.91 vs 1.23 patients, p<0.001), complete dryness was achieved in 33.3% vs 66.7% of patients (number needed to treat 3 vs 1.5, p<0.001) and quality of life score was decreased by 46.76% vs 48.13% (number needed to treat 2.14 vs 2.08, p<0.44). The absolute difference was 60% vs 82.5% for reflex volume (p<0.001), 66.2% vs 68.4% for maximum cystometric capacity (p<0.22) and -42.3% vs -41.9% for maximum detrusor pressure (p<0.21). At week 18 anticholinergics were needed again in 9 (50%) and 4 patients (22.2%) patients, respectively. No patient showed new or upgraded vesicoureteral reflux or reported significant adverse events.
In the short term all parameters improved significantly in each arm. The superiority of including rather than excluding the trigone was significant.
比较初次膀胱内注射与联合膀胱三角区注射肉毒毒素 A 治疗脊髓损伤后神经源性逼尿肌过度活动患者的短期疗效。
本研究纳入严格停止使用抗胆碱能药物的难治性脊髓损伤后神经源性逼尿肌过度活动的成年患者。按照 1:1 的比例，患者随机接受 300 U 肉毒毒素 A 膀胱内注射（不包括三角区）或 200 U 膀胱内注射加 100 U 三角区注射（联合组）。研究终点为评估逼尿肌过度活动对尿失禁发作、完全干燥、生活质量、重新使用抗胆碱能药物、最大逼尿肌压力、反射容积、最大膀胱容量、膀胱输尿管反流和不良反应的影响。患者在基线时和注射后 2、8、12 和 18 周进行评估。p<0.05 认为差异有统计学意义。
每组各有 18 例患者，基线无显著差异。组内分析显示所有参数与基线相比均显著改善。组间分析显示，在膀胱内注射组和联合组中，第 8 周时，尿失禁分别减少 52.4%和 80.9%（需要治疗的人数分别为 1.91 和 1.23 例，p<0.001），完全干燥的患者比例分别为 33.3%和 66.7%（需要治疗的人数分别为 3 和 1.5 例，p<0.001），生活质量评分分别降低 46.76%和 48.13%（需要治疗的人数分别为 2.14 和 2.08 例，p<0.44）。反射容积的绝对差值为 60%比 82.5%（p<0.001），最大膀胱容量为 66.2%比 68.4%（p<0.22），最大逼尿肌压力为-42.3%比-41.9%（p<0.21）。第 18 周时，9 例（50%）和 4 例（22.2%）患者再次需要使用抗胆碱能药物。无患者出现新的或升级的膀胱输尿管反流，也无患者报告明显的不良反应。
在短期内，每个治疗组的所有参数均显著改善。包括而不是排除三角区的优势具有显著意义。
