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西洛多辛用于小儿肾结石患者冲击波碎石术后药物排石治疗的安全性和有效性

Safety and efficacy of Silodosin as medical expulsive therapy after shock wave lithotripsy in paediatric patients ‍‍with renal stones.

作者信息

Amer Mohammed Lotfi, Elkholefy Mohamed Essam, Dawoud Heba, Gaber Mohamed, El-Gamal Osama Mostafa, Gameel Tarek

机构信息

Urology Department, Faculty of Medicine, Tanta University Hospital, Tanta, Egypt.

Paediatric Department, Faculty of Medicine, Tanta University Hospital, Tanta, Egypt.

出版信息

Urolithiasis. 2025 May 20;53(1):95. doi: 10.1007/s00240-025-01760-x.

Abstract

This study was designed to assess the safety and efficacy of Silodosin as a medical expulsive therapy following shockwave lithotripsy (SWL) in paediatric patients with renal stones. In this prospective randomized controlled study conducted at Tanta University Hospital from January 2022 to March 2024, thirty children with a single de novo radiopaque renal pelvic stone less than 2 cm scheduled for SWL were randomized into two equal groups. Group A (n = 15) received Silodosin 4 mg once daily after the first SWL session, and Group B (n = 15) received a matching placebo. The first dose was administered on the night of the initial SWL session and continued until stone-free status was confirmed, for a maximum of 4 weeks. The stone expulsion time was set as a primary outcome, while the secondary outcomes were one-session stone-free rate (SFR), postoperative pain scores, and Silodosin related adverse events. The results showed that the mean stone expulsion time in group A (11.4 ± 1.8 days) was significantly shorter compared to group B (16.4 ± 1.6 days; P < 0.0001). One-session SFR was 86.6% in Silodosin group compared to 73.3% in Placebo group (P = 0.6). Pain visual analogue scores were significantly lower in group A (2.31 ± 1.75) than in group B (5.08 ± 2.43; P = 0.003). No severe drug-related adverse effects were reported in either group. In conclusion, Silodosin appears to be a safe and effective adjunct to SWL in paediatric patients, significantly reducing stone expulsion time and postoperative pain. Larger studies are needed to confirm these findings.

摘要

本研究旨在评估西洛多辛作为冲击波碎石术(SWL)后用于小儿肾结石患者药物排石治疗的安全性和有效性。在2022年1月至2024年3月于坦塔大学医院进行的这项前瞻性随机对照研究中,30名单发初发不透X线肾盂结石且直径小于2 cm、计划接受SWL的儿童被随机分为两组,每组15人。A组在首次SWL治疗后每天服用一次4 mg西洛多辛,B组服用匹配的安慰剂。首剂在首次SWL治疗当晚服用,并持续至结石清除状态得到确认,最长服用4周。结石排出时间被设定为主要结局指标,次要结局指标为单次治疗结石清除率(SFR)、术后疼痛评分以及与西洛多辛相关的不良事件。结果显示,A组的平均结石排出时间(11.4±1.8天)显著短于B组(16.4±1.6天;P<0.0001)。西洛多辛组的单次治疗SFR为86.6%,而安慰剂组为73.3%(P=0.6)。A组的疼痛视觉模拟评分(2.31±1.75)显著低于B组(5.08±2.43;P=0.003)。两组均未报告严重的药物相关不良反应。总之,西洛多辛似乎是小儿患者SWL治疗的一种安全有效的辅助药物,可显著缩短结石排出时间和术后疼痛。需要更大规模的研究来证实这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50c1/12092508/55756a53f61a/240_2025_1760_Fig1_HTML.jpg

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