BACKGROUND & AIMS:
INTRODUCTION:High-grade vesicoureteral reflux (VUR) in infants is associated with congenital renal abnormalities, recurrent UTI, and bladder dysfunction. Endoscopic treatment (ET) is a well-established method in children with low to moderate reflux grades, but there is a lack of randomised controlled trials regarding the use of ET versus continuous antibiotic prophylaxis in infants with high-grade VUR.
OBJECTIVE:This study aimed to determine whether high-grade VUR in infants can be treated with endoscopic injection and whether ET is superior to antibiotic prophylaxis in the treatment of VUR.
MATERIALS AND METHODS:This prospective, randomised, controlled, multicentre, 1-year follow-up trial comprised 77 infants (55 boys, 22 girls) <8 months of age with VUR grade 4-5 (n = 30/n = 47). Of the infants, 52 (68%) had bilateral VUR. Thirty-nine were randomised to antibiotic prophylaxis and 38 to ET (with prophylaxis until resolution). Voiding cystourethrogram, ultrasound, renal scintigraphy, and free voiding observation were performed at study entry and after 1 year to evaluate VUR grade, and renal and bladder function.
RESULTS:VUR grade ≤2 was seen in 22 (59%) infants in the endoscopy group and eight (21%) in the prophylaxis group at follow-up (p = 0.0014). The success rate in the endoscopy group was 100% in unilateral grade 4, falling to 31% in bilateral grade 5 (p = 0.0094). Correspondingly, the results in the prophylaxis group were 40% in grade 4 down to 0% in bilateral grade 5 (p = 0.037) (Table). Logistic regression analyses identified ET, VUR grade 4, unilaterality, and low residual urine at baseline as positive predictors of VUR down-grading to ≤2 (area under ROC curve 0.88). In four patients with reflux resolution after one injection, dilating reflux recurred at the 1-year follow-up. One patient had a UTI possibly related to ET. In our material four patients required re-implantation, of whom one was obstructive after injection.
DISCUSSION:The opportunity to offer even small infants with high-grade VUR an alternative, minimally invasive treatment option is a great advance in paediatric urology. In this high-risk group, bilateral VUR grade 5 stands out with its poor bladder function and low chance of resolution. The recurrence rate of dilating VUR after successful ET is consistent with previous studies. The limitations are the relatively small number of patients and the short follow-up.
CONCLUSION:High-grade VUR in infants can be treated with injection therapy and the resolution rate is higher than that of prophylaxis treatment. The complication rate is low and VUR grade 4, unilaterality, and low residual urine are favourable for the resolution and down-grading of VUR.
背景与目标:
简介:婴儿高级别膀胱输尿管反流(VUR)与先天性肾脏异常,复发性尿路感染和膀胱功能障碍有关。对于低至中度反流级别的儿童,内镜治疗(ET)是一种行之有效的方法,但是对于高级别VUR的婴儿使用ET与持续预防抗生素的关系,尚缺乏随机对照试验。
目的:本研究旨在确定内镜下注射是否可以治疗婴儿中高级别的VUR,以及在VUR的治疗中,ET是否优于抗生素预防。
材料与方法:这项前瞻性,随机,对照,多中心,为期1年的随访研究纳入了77个婴儿(55个男孩,22个女孩)<8个月大且VUR为4-5级(n = 30 / n = 47)。 。在婴儿中,有52名(68%)患有双侧VUR。 39名被随机分配至抗生素预防性治疗,38名被随机分配至ET(预防性治疗直至消退)。在研究开始时和1年后进行了膀胱膀胱心电图,超声检查,肾闪烁显像和自由排尿观察,以评估VUR等级以及肾和膀胱功能。
结果:在随访中,内窥镜检查组的22名(59%)婴儿中观察到VUR≤2,而预防组中的8例(21%)观察到VUR≤2(p = 0.0014)。内窥镜检查组的成功率在单侧4级中为100%,在双侧5级中降至31%(p = 0.0094)。相应地,预防组的结果从4年级的40%降至双边5年级的0%(p = 0.037)(表)。 Logistic回归分析确定ET,VUR 4级,单侧性和基线尿液残留低是VUR降级至≤2的阳性预测指标(ROC曲线下面积为0.88)。一例注射后有4例反流消退的患者,在1年的随访中再次发生了扩张性反流。一名患者的尿路感染可能与ET有关。在我们的材料中,四名患者需要重新植入,其中一名在注射后阻塞。
讨论:有机会为小婴儿提供高级别的VUR,这是儿科泌尿外科的一大进步。在这一高危人群中,双侧VUR 5级膀胱功能差且解决机会低,因此脱颖而出。成功的ET后扩张VUR的复发率与以前的研究一致。局限性在于患者人数相对较少且随访时间短。
结论:婴幼儿高危型VUR可以通过注射疗法治疗,其分辨率高于预防性治疗。并发症发生率低,VUR 4级,单侧性和残留尿少有利于VUR的分解和降级。