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多沙唑嗪与替扎尼定治疗儿童排尿功能障碍:一项前瞻性随机开放标签试验。

Doxazosin versus tizanidine for treatment of dysfunctional voiding in children: a prospective randomized open-labeled trial.

机构信息

Voiding Dysfunction and Urodynamic Section, Urology and Nephrology Center, Mansoura University, and Children's Hospital, Mansoura, Egypt.

出版信息

Urology. 2012 Feb;79(2):428-33. doi: 10.1016/j.urology.2011.10.043. Epub 2011 Dec 22.

DOI:10.1016/j.urology.2011.10.043
PMID:22196407
Abstract

OBJECTIVE

To examine the efficacy and tolerability of tizanidine for the treatment of dysfunctional voiding in children compared with those of doxazosin.

METHODS

A total of 40 children with dysfunctional voiding were enrolled in a prospective, randomized, 2-parallel group, flexible-dose study. The evaluations were performed in accordance with the International Children's Continence Society guidelines. The children were followed up after 1 week and then monthly for 6 months for the clinical, urine culture, and urodynamic parameters. The degree of improvement was assessed using a satisfaction scale that ranged from 0 (no improvement at all) to 10 (total improvement).

RESULTS

A total of 40 patients with a mean±SD age of 7±2.6 years were enrolled. The clinical and urodynamic parameters were comparable between both groups. At the last follow-up visit, both groups had had similar improvement in the severity of symptoms, satisfaction scale, and noninvasive flowmetry parameters. In the doxazosin group, urge episodes was the only symptom that showed a significant reduction compared with the baseline values (P=.028). However, the incidence of nocturnal enuresis, urgency attacks, and daytime incontinence were significantly reduced compared with baseline in the tizanidine group (P=.003, P=.008, and P=.017, respectively). Adverse effects were recorded in 6 patients (15%). Epigasteric pain was reported in 2 children (10%) who received doxazosin. In the tizanidine group, a loss of appetite was noted in 2 children (10%), epigastric pain in 1 (5%), and headache in 1 (5%).

CONCLUSION

Tizanidine could be a safe and effective treatment of children with dysfunctional voiding due to pelvic floor/skeletal sphincter dysfunction. More placebo-controlled trails with larger sample sizes are needed.

摘要

目的

研究替扎尼定治疗儿童功能性排尿障碍的疗效和耐受性,并与多沙唑嗪进行比较。

方法

共纳入 40 例功能性排尿障碍患儿,采用前瞻性、随机、2 平行组、灵活剂量研究。评估按照国际儿童尿控协会指南进行。患儿在第 1 周和之后的 6 个月每月进行随访,评估临床、尿液培养和尿动力学参数。使用 0 (无改善)到 10 (完全改善)的满意度量表评估改善程度。

结果

共纳入 40 例年龄均数±标准差为 7±2.6 岁的患儿。两组的临床和尿动力学参数相似。在最后一次随访时,两组在症状严重程度、满意度量表和无创流量测量参数方面均有相似的改善。在多沙唑嗪组,与基线值相比,仅尿急发作的症状显著减少(P=.028)。然而,与基线相比,替扎尼定组夜间遗尿、尿急发作和日间尿失禁的发生率显著降低(P=.003、P=.008 和 P=.017)。6 例(15%)患儿记录到不良反应。2 例(10%)接受多沙唑嗪治疗的患儿出现上腹痛。替扎尼定组 2 例(10%)患儿出现食欲不振,1 例(5%)患儿出现上腹痛,1 例(5%)患儿出现头痛。

结论

替扎尼定可能是治疗盆底/骨骼括约肌功能障碍引起的儿童功能性排尿障碍的安全有效方法。需要更多安慰剂对照、更大样本量的试验。

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