A Novel Drug Eluting Ureteral Stent: A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac Loaded Ureteral Stent
A Novel Drug Eluting Ureteral Stent: A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of a Ketorolac Loaded Ureteral Stent
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DOI：
10.1016/j.juro.2009.11.035
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发表时间：
2010-03-01
影响因子：
6.6
通讯作者：
Lingeman, James E.
中科院分区：
文献类型：
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作者：
Krambeck, Amy E.;Walsh, Robert S.;Lingeman, James E.
目的：我们评价了酮咯酸负载输尿管支架与标准支架（对照）相比的短期安全性和有效性。材料与方法：在这项前瞻性、多中心、双盲研究中，患者在输尿管镜检查后以1：1的比例随机接受酮咯酸负载支架或对照支架。主要终点是对疼痛进行干预，定义为计划外的医生联系、疼痛药物的改变或早期支架移除。次要终点包括药物使用和疼痛视觉模拟评分。共20例患者进行了血清酮咯酸levels.Results的安全性测试：没有一个安全性队列检测血清酮咯酸水平。在276例患者中，初次（酮咯酸负荷组9.0% vs对照组7.0%，p = 0.66）或二次（酮咯酸负荷组22.6% vs对照组25.2%，p = 0.67）干预率无差异。第3天酮咯酸支架组的平均疼痛药丸计数低于对照组（p
Purpose: We evaluated the short-term safety and efficacy of a ketorolac loaded ureteral stent compared to a standard stent (control). Materials andMethods: In this prospective, multicenter, double-blind study patients were randomized 1:1 to ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for ketorolac levels.Results: None of the safety cohort had detectable serum ketorolac levels. Among the 276 patients there was no difference in primary (9.0% ketorolac loaded vs, 7.0% control, p = 0.66) or secondary (22.6% ketorolac loaded vs 25.2% control p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the ketorolac loaded stent group than in the control group (p