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普瑞巴林、索利那新及其联合治疗对输尿管双J支架相关症状的影响:一项随机对照临床试验。

The effects of pregabalin, solifenacin and their combination therapy on ureteral double-J stent-related symptoms: A randomized controlled clinical trial.

作者信息

Falahatkar Siavash, Beigzadeh Mohammadreza, Mokhtari Gholamreza, Esmaeili Samaneh, Kazemnezhad Ehsan, Amin Atiyeh, Herfeh Nadia Rastjou, Falahatkar Reza

机构信息

Urology Research Center, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.

出版信息

Int Braz J Urol. 2021 May-Jun;47(3):596-609. doi: 10.1590/S1677-5538.IBJU.2020.0848.

Abstract

BACKGROUND

Many medical therapies have been tested to deal with urinary stent-related symptoms (USRS). Several preventive and pharmaceutical methods have been already used for better compatibility of stents. However, the existing evidence for pharmacological treatment is still controversial. This study aims to evaluate the effects of pregabalin, solifenacin, and combination therapy on ureteral double-J stent-related symptoms following ureteroscopy and transureteral lithotripsy (TUL).

MATERIALS AND METHODS

In a randomized controlled clinical trial, from November 2017 to March 2019, 256 patients who underwent ureteroscopy were enrolled. Patients were randomly divided into four groups including: group A received pregabalin 75mg BID (twice daily), group B received solifenacin 5mg orally once daily, group C received combination of pregabalin and solifenacin and the group D (control) given no drugs.

RESULTS

One hundred and fifty-one (58.9%) males and 101 (41.1%) females were enrolled in this study with a mean age of 43.47±7 (p=0.32, p=0.67). USSQ domains score such as urinary symptoms, pain, general condition, work performance, sexual matters and additional problems were significantly differenced during second and fourth week of follow-up among study groups (p <0.0001). In Tukey's multiple comparison test, urinary symptoms (p=0.735), pain (p=0.954) and sexual matters (p=0.080) in second week and work performance in forth week in group B was not significantly better than group D. Only group C in all indexes of USSQ showed significantly beneficial effects over group D (p <0.0001).

CONCLUSION

Combination therapy of pregabalin and solifenacin has a significant effect on stent-related symptoms and is preferred over monotherapy of the respected medications.

摘要

背景

许多医学疗法已被用于治疗与输尿管支架相关的症状(USRS)。已经采用了几种预防和药物方法来提高支架的兼容性。然而,药物治疗的现有证据仍存在争议。本研究旨在评估普瑞巴林、索利那新及联合治疗对输尿管镜检查和经输尿管碎石术(TUL)后输尿管双J支架相关症状的影响。

材料与方法

在一项随机对照临床试验中,2017年11月至2019年3月,纳入了256例行输尿管镜检查的患者。患者被随机分为四组,包括:A组每日两次服用75mg普瑞巴林,B组每日口服一次5mg索利那新,C组接受普瑞巴林和索利那新联合治疗,D组(对照组)不给予药物。

结果

本研究共纳入151名(58.9%)男性和101名(41.1%)女性,平均年龄为43.47±7岁(p=0.32,p=0.67)。在随访的第二周和第四周,各研究组之间的输尿管支架症状问卷(USSQ)领域评分,如尿路症状、疼痛、总体状况、工作表现、性功能问题和其他问题,存在显著差异(p<0.0001)。在Tukey多重比较检验中,B组第二周的尿路症状(p=0.735)、疼痛(p=0.954)和性功能问题(p=0.080)以及第四周的工作表现并不显著优于D组。在USSQ的所有指标中,只有C组对D组显示出显著的有益效果(p<0.0001)。

结论

普瑞巴林和索利那新联合治疗对支架相关症状有显著效果,优于各自药物的单一治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7c20/7993956/ecdddbc8dd5f/1677-6119-ibju-47-03-0596-gf01.jpg

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