Pediatric Surgery 2nd University of Naples, Via Pansini 5, Naples 80131, Italy.
Toxins (Basel). 2012 Dec 28;5(1):16-24. doi: 10.3390/toxins5010016.
This retrospective study was performed to verify the efficacy and safety of Onabotulinumtoxin A (BTX-A) in treating children with neurogenic bladder (NB) secondary to myelomeningocele (MMC) with detrusor overactivity/low compliance. From January 2002 to June 2011, 47 patients out of 68 with neuropathic bladder were selected (22 females, 25 males, age range 5-17 years; mean age 10.7 years at first injection). They presented overactive/poor compliant neurogenic bladders on clean intermittent catheterization, and were resistant or non compliant to pharmacological therapy. Ten patients presented second to fourth grade concomitant monolateral/bilateral vesicoureteral reflux (VUR). All patients were incontinent despite catheterization. In the majority of patients Botulinum-A toxin was administered under general/local anesthesia by the injection of 200 IU of toxin, without exceeding the dosage of 12 IU/kg body weight, diluted in 20 cc of saline solution in 20 sites, except in the periureteral areas. Follow-up included clinical and ultrasound examination, urodynamics performed at 6, 12 and 24 weeks, and annually thereafter. Seven patients remained stable, 21 patients required a second injection after 6-9 months and 19 a third injection. VUR was corrected, when necessary, in the same session after the BT-A injection, by 1-3 cc of subureteral Deflux®. Urodynamic parameters considered were leak point pressure (LPP), leak point volume (LPV) and specific volume at 20 cm H(2)O pressure. The results were analyzed using the Wilcoxon test. All patients experienced a significant 66.45% average increase of LPV (Wilcoxon paired rank test = 7169 × 10(-10)) and a significant 118.57% average increase of SC 20 (Wilcoxon paired rank test = 2.466 × 10(-12)). The difference between preoperative and postoperative LPP resulted not significant (Wilcoxon paired rank test = 0.8858) No patient presented severe systemic complications; 38/47 patients presented slight hematuria for 2-3 days. Two patients had postoperative urinary tract infection. All patients were hospitalized for 24 h with catheterization. Thirty-eight out of 47 patients achieved dryness between CIC; nine patients improved their incontinence but still need pads. Ten patients have resumed anticholinergic agents. Our results suggest that the use of BTX-A is safe and effective in patients with MMC with a positive effect on their dryness and quality of life.
本回顾性研究旨在验证肉毒毒素 A(BTX-A)治疗伴有逼尿肌过度活动/顺应性降低的神经源性膀胱(NB)的疗效和安全性。2002 年 1 月至 2011 年 6 月,在 68 例神经源性膀胱患者中选择了 47 例(女 22 例,男 25 例,年龄 5-17 岁;首次注射时平均年龄 10.7 岁)。他们在间歇性清洁导尿时表现出逼尿肌过度活动/顺应性不良的神经源性膀胱,且对药物治疗有抵抗或不依从。10 例患者伴有二至四级单侧/双侧膀胱输尿管反流(VUR)。尽管导尿,所有患者仍有尿失禁。大多数患者在全身/局部麻醉下接受 BTX-A 治疗,注射 200IU 毒素,不超过 12IU/kg 体重,在 20 个部位用 20cc 生理盐水稀释,除了在输尿管周围区域。随访包括临床和超声检查,在 6、12 和 24 周进行尿动力学检查,此后每年进行一次。7 例患者病情稳定,21 例患者在 6-9 个月后需要第二次注射,19 例患者需要第三次注射。在 BT-A 注射后,如有必要,在同一手术中通过 1-3cc 的下尿路 Deflux®矫正 VUR。考虑的尿动力学参数包括漏点压(LPP)、漏点体积(LPV)和 20cmH2O 压力下的特定体积。结果采用 Wilcoxon 检验进行分析。所有患者的 LPV 平均增加 66.45%(Wilcoxon 配对等级检验=7169×10(-10)),SC20 平均增加 118.57%(Wilcoxon 配对等级检验=2.466×10(-12))。术前和术后 LPP 差异无统计学意义(Wilcoxon 配对等级检验=0.8858)。无患者出现严重全身并发症;47 例患者中有 38 例出现 2-3 天轻微血尿。2 例患者术后发生尿路感染。所有患者均因导尿住院 24 小时。47 例患者中有 38 例在 CIC 之间实现了干燥;9 例患者改善了尿失禁,但仍需要使用尿垫。10 例患者恢复了抗胆碱能药物治疗。我们的结果表明,BTX-A 在伴有 MMC 的患者中使用是安全有效的,对其干燥和生活质量有积极影响。