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聚丙烯酸-聚醇共聚物(PPC)与葡聚糖-透明质酸共聚物(Dx/HA)作为内镜治疗原发性膀胱输尿管反流(VUR)的填充剂的随机临床试验的长期结果。

Long-term outcome of randomized clinical trial between polyacrylate-polyalcohol copolymer (PPC) and dextranomer-hyaluronic acid copolymer (Dx/HA) as bulking agents for endoscopic treatment of primary vesicoureteral reflux (VUR).

机构信息

Pediatric Urology Division, Pediatric Surgery Department, Hospital Sant Joan de Déu, University of Barcelona, Passeig Sant Joan de Déu 2, 08950, Barcelona, Spain.

出版信息

World J Urol. 2023 Oct;41(10):2855-2859. doi: 10.1007/s00345-023-04548-z. Epub 2023 Aug 16.

Abstract

OBJECTIVE

The aim of our study is to compare long-term outcome of endoscopic treatment of VUR using PPC or Dx/HA.

PATIENTS AND METHODS

From October 2014 to April 2017 patients with VUR grades from 3 to 5 that needed endoscopic treatment were eligible for this RCT. Patients were randomized in two groups: PPC and Dx/HA. A VCUG was performed at 6 months; if VUR > 3 was still present a second ET was performed. We included for this long-term follow-up study those patients that were successfully treated at short-term follow-up. At 36 months postoperative VCUG was performed to assess outcome. Success was considered if postoperative VUR grade was 0 at 36 months, and there was no ureteral obstruction.

RESULTS

In the previous study, 60/73 ureters were successfully treated in 36/44 patients, and then we have analyzed 60 ureters in 36 patients. Three patients were lost in long-term follow-up, and then we analyzed 57 ureters in 33 patients divided. PPC group 18 patients (28 ureters); and Dx/HA group 15 patients (29 ureters). After 3 years of follow-up the VCUG showed a success rate of 26/28 of RU in PPC and 26/29 of DX/HA. Two RU in PPC group had ureteral obstruction, and then the successful rate for PPC group dropped to 24/28. The overall successful rate at long-term was 72.7% of the RU in PPC group and 70.3% in Dx/HA group.

CONCLUSION

PPC and Dx/HA has similar long-term outcome in VUR resolution, but ureteral obstruction could be present at long-term follow-up in PPC group.

摘要

目的

本研究旨在比较 PPC 与 Dx/HA 内镜治疗 VUR 的长期疗效。

患者和方法

2014 年 10 月至 2017 年 4 月,患有 3 至 5 级 VUR 需要内镜治疗的患者符合本 RCT 标准。患者随机分为 PPC 组和 Dx/HA 组。术后 6 个月行 VCUG,如果仍存在 VUR>3 级,则行第二次 ET。本长期随访研究纳入短期随访成功治疗的患者。术后 36 个月行 VCUG 评估结果。如果术后 36 个月 VUR 分级为 0,且无输尿管梗阻,则视为成功。

结果

在之前的研究中,44 例患者中的 36 例成功治疗了 60/73 个输尿管,然后我们分析了 36 例患者的 60 个输尿管。3 例患者在长期随访中丢失,然后我们分析了 57 个输尿管,分为 33 例患者。PPC 组 18 例(28 个输尿管);Dx/HA 组 15 例(29 个输尿管)。3 年后的 VCUG 显示,PPC 组的 28 个 RU 中有 26 个成功,Dx/HA 组的 29 个 RU 中有 26 个成功。PPC 组的 2 个 RU 有输尿管梗阻,然后 PPC 组的成功率降至 24/28。长期来看,PPC 组的 RU 成功率为 72.7%,Dx/HA 组为 70.3%。

结论

PPC 和 Dx/HA 在 VUR 缓解方面具有相似的长期疗效,但在 PPC 组中,输尿管梗阻可能在长期随访中出现。

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