Pediatric Uro-Nephrologic Center, Queen Silvia Children's Hospital, University of Gothenburg, Göteborg, Sweden.
J Urol. 2010 Jul;184(1):274-9. doi: 10.1016/j.juro.2010.01.055. Epub 2010 May 15.
We compared the rates of febrile urinary tract infection, kidney damage and reflux resolution in children with vesicoureteral reflux treated in 3 ways, including antibiotic prophylaxis, endoscopic therapy and surveillance with antibiotics only for symptomatic urinary tract infection.
Children 1 to younger than 2 years with grade III-IV reflux were recruited into this prospective, open, randomized, controlled, multicenter study and followed for 2 years after randomization. The main study end points were recurrent febrile urinary tract infection, renal status on dimercapto-succinic acid scintigraphy and reflux status. Outcomes were analyzed by the intent to treat principle.
During a 6-year period 128 girls and 75 boys entered the study. In 96% of cases reflux was detected after urinary tract infection. The randomization procedure was successful and resulted in 3 groups matched for relevant factors. Recruitment was slower than anticipated but after patients were entered adherence to the protocol was good. Of the children 93% were followed for the intended 2 years without a treatment arm change. All except 2 patients completed 2-year followup scintigraphy.
Recruitment was difficult but a substantial number of children were entered and randomly assigned to 3 groups with similar basic characteristics. Good adherence to the protocol made it possible to address the central study questions.
我们比较了三种治疗方法（抗生素预防、内镜治疗和仅对有症状尿路感染使用抗生素的观察）在治疗儿童膀胱输尿管反流中的发热性尿路感染、肾损伤和反流缓解率。
本前瞻性、开放、随机、对照、多中心研究招募了 1 至 2 岁以下、有 III-IV 级反流的儿童，并在随机分组后随访 2 年。主要研究终点是复发性发热性尿路感染、二巯丁二酸闪烁显像的肾脏状况和反流状况。结果按意向治疗原则进行分析。
在 6 年期间，共有 128 名女孩和 75 名男孩入组该研究。96%的病例在尿路感染后发现反流。随机分组程序成功，结果 3 组具有相关因素的匹配。招募速度比预期慢，但入组后对方案的依从性良好。93%的儿童按照预期随访 2 年，无治疗组改变。除 2 例患者外，所有患者均完成了 2 年的随访闪烁显像。
虽然招募工作困难，但仍有相当数量的儿童被纳入并随机分配到具有相似基本特征的 3 组。良好的方案依从性使得能够解决核心研究问题。
