Berger David A, Ross Michael A, Hollander Jay B, Ziadeh James, Chen Charity, Jackson Raymond E, Swor Robert A
Department of Emergency Medicine, Oakland University William Beaumont School of Medicine, Royal Oak, MI.
Department of Emergency Medicine, Emory University School of Medicine, Atlanta, GA.
Am J Emerg Med. 2015 Dec;33(12):1721-4. doi: 10.1016/j.ajem.2015.08.006. Epub 2015 Aug 7.
The objective of the study is to determine if tamsulosin initiated in the emergency department (ED) decreases the time to ureteral stone passage at 1 week or time to pain resolution, compared to placebo.
We performed a prospective, randomized, double-blinded, placebo-controlled trial of tamsulosin vs placebo in ED patients with ureterolithiasis on computed tomography. Patients were identified and enrolled between April 2007 and February 2009 and were randomized to either 0.4 mg of tamsulosin or placebo for 1 week. We contacted participants using a telephone survey on post-ED visit days 1, 2, 3, and 7. The primary outcome was time to stone passage, with secondary outcomes being maximum pain score and amount of pain medication required.
Of the 127 patients enrolled during this study, 15 were lost to follow-up, and 12 required surgical interventions before the 7-day mark, leaving 100 patients for analysis. Of the 100 patients, 53 received tamsulosin and 47 received placebo. There was no difference between groups in percentage of male, mean age, initial serum creatinine, average stone size, stone location, and history of prior stone. The probability that the patient did not pass a stone at 7 days was not different between tamsulosin and placebo, 62.1% (95% confidence interval, 49.1%-75.1%) vs 54.4% (95% confidence interval, 40.3%-68.6%; P = .58). There was no significant difference in the high pain score (P = .12) or hydrocodone/acetaminophen intake (P = .76) between treatment groups at any of the time points.
This study reveals no difference in the proportion of stone passage or high pain score and pain medication utilization at 7 days between tamsulosin and placebo.
本研究的目的是确定与安慰剂相比,在急诊科(ED)开始使用坦索罗辛是否能缩短输尿管结石在1周内排出的时间或疼痛缓解的时间。
我们对接受计算机断层扫描的输尿管结石ED患者进行了一项前瞻性、随机、双盲、安慰剂对照试验,比较坦索罗辛与安慰剂的效果。在2007年4月至2009年2月期间识别并纳入患者,将其随机分为接受0.4毫克坦索罗辛或安慰剂治疗1周。我们在ED就诊后的第1、2、3和7天通过电话调查联系参与者。主要结局是结石排出时间,次要结局是最大疼痛评分和所需止痛药物的量。
在本研究期间纳入的127例患者中,15例失访,12例在第7天前需要手术干预,剩余100例患者进行分析。在这100例患者中,53例接受坦索罗辛治疗,47例接受安慰剂治疗。两组在男性比例、平均年龄、初始血清肌酐、平均结石大小、结石位置和既往结石病史方面无差异。坦索罗辛组和安慰剂组患者在7天时结石未排出的概率无差异,分别为62.1%(95%置信区间,49.1%-75.1%)和54.4%(95%置信区间,40.3%-68.6%;P = 0.58)。在任何时间点,治疗组之间的高疼痛评分(P = 0.12)或氢可酮/对乙酰氨基酚摄入量(P = 0.76)均无显著差异。
本研究表明,坦索罗辛和安慰剂在7天时结石排出比例、高疼痛评分及止痛药物使用方面无差异。