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评估膀胱内用药对体外冲击波碎石术后输尿管支架症状的安全性和有效性的双盲随机对照试验。

Double-blind randomized controlled trial assessing the safety and efficacy of intravesical agents for ureteral stent symptoms after extracorporeal shockwave lithotripsy.

作者信息

Beiko Darren T, Watterson James D, Knudsen Bodo E, Nott Linda, Pautler Stephen E, Brock Gerald B, Razvi Hassan, Denstedt John D

机构信息

Division of Urology, University of Western Ontario, London, Ontario, Canada.

出版信息

J Endourol. 2004 Oct;18(8):723-30. doi: 10.1089/end.2004.18.723.

Abstract

BACKGROUND AND PURPOSE

Ureteral stents are a significant source of pain and discomfort for many urologic patients. A novel approach to addressing this problem is the intravesical instillation of a selected pharmacologic agent after stent insertion. The purpose of this study was to assess the safety and efficacy of intravesical instillation of various agents in reducing ureteral stent-associated discomfort in patients requiring a stent after extracorporeal shockwave lithotripsy (SWL).

PATIENTS AND METHODS

In this double-blind prospective trial, 42 patients were randomized to receive intravesical instillation of one of three agents (oxybutynin, alkalinized lidocaine, or ketorolac) or a control solution (0.9% sodium chloride) immediately after stent insertion at time of SWL. The four groups of patients were demographically similar. Preoperative, intraoperative, and postoperative data were collected prospectively and analyzed statistically. The primary outcome measure was reduction in ureteral stent symptoms, and the secondary outcome measure was the safety of intravesical instillation of each agent through assessment of drug-related adverse events.

RESULTS

There were no intraoperative or postoperative complications, nor were there any serious side effects attributable to any of the intravesically instilled agents. There was a statistically significant decrease in stent-related discomfort at the 1-hour time point in the group of patients who received intravesical ketorolac compared with the control group.

CONCLUSIONS

Intravesical instillation represents a novel approach to the problem of ureteral stent-related discomfort. From our results, ketorolac appears to be the most effective intravesical agent in reducing stent-related patient discomfort, and we have established that intravesical instillation of ketorolac is safe in humans.

摘要

背景与目的

输尿管支架是许多泌尿外科患者疼痛和不适的重要来源。解决这一问题的一种新方法是在支架置入后膀胱内灌注一种选定的药物。本研究的目的是评估在体外冲击波碎石术(SWL)后需要置入支架的患者中,膀胱内灌注各种药物在减轻输尿管支架相关不适方面的安全性和有效性。

患者与方法

在这项双盲前瞻性试验中,42例患者在SWL时支架置入后立即被随机分为接受三种药物(奥昔布宁、碱化利多卡因或酮咯酸)之一或对照溶液(0.9%氯化钠)的膀胱内灌注。四组患者在人口统计学上相似。前瞻性收集术前、术中和术后数据并进行统计学分析。主要结局指标是输尿管支架症状的减轻,次要结局指标是通过评估药物相关不良事件来评估每种药物膀胱内灌注的安全性。

结果

术中或术后均无并发症,也没有任何因膀胱内灌注药物引起的严重副作用。与对照组相比,接受膀胱内酮咯酸灌注的患者组在1小时时间点时与支架相关的不适有统计学意义的降低。

结论

膀胱内灌注是解决输尿管支架相关不适问题的一种新方法。根据我们的结果,酮咯酸似乎是减轻与支架相关的患者不适最有效的膀胱内用药,并且我们已经证实酮咯酸膀胱内灌注在人体中是安全的。

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