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坦索罗辛用于急诊科输尿管结石治疗:一项随机对照试验

Tamsulosin for ureteral stones in the emergency department: a randomized, controlled trial.

作者信息

Ferre Robinson M, Wasielewski Jessica N, Strout Tania D, Perron Andrew D

机构信息

Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, TX, USA.

出版信息

Ann Emerg Med. 2009 Sep;54(3):432-9, 439.e1-2. doi: 10.1016/j.annemergmed.2008.12.026. Epub 2009 Feb 5.

Abstract

STUDY OBJECTIVE

The alpha-adrenergic antagonist tamsulosin hydrochloride has become an increasingly common adjunct in the treatment of ureteral calculi; however, its efficacy in a general emergency department (ED) population has not been investigated.

METHODS

We conducted a randomized, controlled trial of adult ED patients with distal ureteral calculi diagnosed by computed tomography scan. Patients were randomized to receive either a 10-day course of ibuprofen and oxycodone plus tamsulosin or ibuprofen and oxycodone alone. The primary outcome measure was successful spontaneous ureteral stone expulsion at 14 days. Secondary outcomes included time to stone passage, self-reported pain scores, number of colicky pain episodes, unscheduled return ED/primary care visits, number of days of missed work/usual function, amount of analgesic used, and adverse events.

RESULTS

Eighty subjects were enrolled in the study, with 77 completing the trial. Mean stone size was 3.6 mm (95% confidence interval [CI] 3.4 to 3.9). Successful spontaneous stone expulsion at 14 days was similar between the groups, with 27 (77.1%) subjects in the tamsulosin group and 24 (64.9%) subjects in the standard therapy group reporting spontaneous stone passage, a difference of 12% (95% CI -8.4% to 32.8%). At 2-, 5-, and 14-day follow-up, there were no clinically important (or statistically significant) differences between the groups for any secondary outcome measure. No adverse events were reported in either group.

CONCLUSION

In this cohort of adult ED patients with distal ureteral calculi, treatment with tamsulosin did not substantially improve any of the studied outcome measures compared with treatment with ibuprofen and oxycodone alone.

摘要

研究目的

α-肾上腺素能拮抗剂盐酸坦索罗辛已成为输尿管结石治疗中越来越常用的辅助药物;然而,其在普通急诊科(ED)患者中的疗效尚未得到研究。

方法

我们对经计算机断层扫描诊断为远端输尿管结石的成年ED患者进行了一项随机对照试验。患者被随机分为接受为期10天的布洛芬和羟考酮加坦索罗辛疗程或仅接受布洛芬和羟考酮。主要结局指标是14天时输尿管结石自然排出成功。次要结局包括结石排出时间、自我报告的疼痛评分、绞痛发作次数、非计划返回ED/初级保健就诊次数、误工/日常功能丧失天数、使用的镇痛药量以及不良事件。

结果

80名受试者参与了该研究,77名完成了试验。平均结石大小为3.6毫米(95%置信区间[CI] 3.4至3.9)。两组在14天时输尿管结石自然排出成功情况相似,坦索罗辛组有27名(77.1%)受试者报告结石自然排出,标准治疗组有24名(64.9%)受试者报告结石自然排出,差异为12%(95% CI -8.4%至32.8%)。在2天、5天和14天随访时,两组在任何次要结局指标上均无临床重要(或统计学显著)差异。两组均未报告不良事件。

结论

在这组成年ED远端输尿管结石患者中,与仅用布洛芬和羟考酮治疗相比,坦索罗辛治疗并未显著改善任何研究的结局指标。

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