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一项三角肌与非三角肌部位肉毒毒素 A 注射治疗脊髓损伤后伴发尿失禁和膀胱顺应性不良患者的单盲随机对照试验。

A single-blind randomized control trial of trigonal versus nontrigonal Botulinum toxin-A injections for patients with urinary incontinence and poor bladder compliance secondary to spinal cord injury.

机构信息

Department of Urology, Guangdong Provincial Work Injury Rehabilitation Hospital, Guangzhou, People's Republic of China.

Department of Urology, Qingyan City People's Hospital, Guangdong, People's Republic of China.

出版信息

J Spinal Cord Med. 2021 Sep;44(5):757-764. doi: 10.1080/10790268.2020.1712892. Epub 2020 Jan 31.

Abstract

To evaluate the effect of trigonal Botulinum toxin-A (BTX-A) injections on patients with urinary incontinence (UI) and poor bladder compliance (BC) secondary to spinal cord injury (SCI). A single-blind randomized control trial. Department of urology in three hospitals. SCI patients with UI and poor BC were randomly assigned to either the experimental group or the control group. The experimental group received an injection of 240 U BTX-A into the detrusor plus 60 U BTX-A into the trigone, while the control group received 300 U BTX-A into the detrusor sparing the trigone. Video urodynamic outcomes, including vesicoureteric reflux (VUR), detrusor leak point pressure (DLPP), and detrusor leak point volume (DLPV), were measured at baseline and week 12. UI episodes, voiding volume, and Incontinence Quality of Life (I-QoL) were assessed at baseline, week 2, 4, 8 and 12. No patient reported new-onset VUR. Compared with baseline data, a significant improvement was achieved in both groups, whereas compared with DLPP and DLPV, a significant difference was noted between the two groups 12 weeks after injection. In the experimental group, the improvement of mean weekly UI episodes, voiding volume, and I-QoL were significantly better than those in the control group at 4, 8, and 12 weeks, respectively (all P < 0.05). Systemic complications of BTX-A injection were not reported. Trigonal BTX-A injection is more effective and safer than nontrigonal BTX-A injection for SCI patients with UI secondary to neurogenic-poor BC and does not result in VUR.

摘要

评估三角区肉毒杆菌毒素 A(BTX-A)注射对脊髓损伤(SCI)继发尿失禁(UI)和膀胱顺应性差(BC)患者的疗效。一项单盲随机对照试验。三所医院的泌尿科。将具有 UI 和差 BC 的 SCI 患者随机分配至实验组或对照组。实验组向逼尿肌内注射 240 U BTX-A 加三角区 60 U BTX-A,对照组向逼尿肌内注射 300 U BTX-A 而避开三角区。基线和第 12 周时,通过视频尿动力学评估包括上尿路反流(VUR)、逼尿肌漏点压(DLPP)和逼尿肌漏点容积(DLPV)等结果。在基线、第 2、4、8 和 12 周时评估 UI 发作次数、排尿量和尿失禁生活质量(I-QoL)。没有患者报告新出现的 VUR。与基线数据相比,两组患者均取得了显著改善,而与 DLPP 和 DLPV 相比,注射后 12 周两组之间差异有统计学意义。在实验组中,与对照组相比,在第 4、8 和 12 周时,平均每周 UI 发作次数、排尿量和 I-QoL 的改善情况均显著更好(均 P<0.05)。未报告 BTX-A 注射的全身并发症。三角区 BTX-A 注射对于继发于神经源性差 BC 的 SCI 患者的 UI 比非三角区 BTX-A 注射更有效且更安全,且不会导致 VUR。

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