Background

Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.

Objective

To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo.

Design, setting, and participants

We conducted a double-blind, placebo-controlled study of 3296 patients with distal ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin.

Intervention

Participants were randomly assigned (1:1) into tamsulosin (0.4 mg) or placebo groups for 4 wk.

Outcome measurements and statistical analysis

The primary end point of analysis was the overall stone expulsion rate, defined as stone expulsion, confirmed by negative findings on computed tomography, over a 28-d surveillance period. Secondary end points included time to stone expulsion, use of analgesics, and incidence of adverse events.

Results and limitations

Among 3450 patients randomized between September 1, 2011, and August 31, 2013, 3296 (96%) were included in the primary analysis. Tamsulosin benefits from a higher stone expulsion rate than the placebo (86% vs 79%; p < 0.001) for distal ureteral stones. Subgroup analysis identified a specific benefit of tamsulosin for the treatment of large distal ureteral stones (>5 mm). Considering the secondary end points, tamsulosin-treated patients reported a shorter time to expulsion (p < 0.001), required lower use of analgesics compared with placebo (p < 0.001), and significantly relieved renal colic (p < 0.001). No differences in the incidence of adverse events were identified between the two groups.

Conclusions

Our data suggest that tamsulosin use benefits distal ureteral stones in facilitating stone passage and relieving renal colic. Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones >5 mm, but no effect for stones ≤5 mm.

Patient summary

In this report, we looked at the efficacy and safety of tamsulosin for the treatment of distal ureteral stones. We find that tamsulosin significantly facilitates the passage of distal ureteral stones and relieves renal colic.

中文翻译：

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坦索罗辛在带肾绞痛的输尿管结石药物排除治疗中的疗效和安全性：多中心，随机，双盲，安慰剂对照试验

背景

最近的大型高质量试验对使用坦索罗辛治疗输尿管结石的药物排除疗法的临床有效性提出了质疑。

客观的

与安慰剂相比，评价坦索罗辛治疗输尿管远端结石的疗效和安全性。

设计，设置和参与者

我们在30个中心对3296例输尿管远端结石患者进行了双盲，安慰剂对照研究，以评估坦洛新的疗效和安全性。

干涉

将参与者随机分配（1：1）坦洛新（0.4 mg）或安慰剂组，连续4周。

成果测量和统计分析

分析的主要终点是在28天的监视期内，通过计算机断层扫描的阴性结果确认的总体结石排出率，定义为结石排出。次要终点包括排石时间，使用止痛药和不良事件的发生率。

结果与局限性

在2011年9月1日至2013年8月31日之间随机分组的3450例患者中，有3296例（96％）包括在主要分析中。 对于输尿管远端结石，坦索罗辛的排石率高于安慰剂（86％比79％；p <0.001）。亚组分析确定坦索罗辛治疗大型远端输尿管结石（> 5 mm）的特殊益处。考虑到次要终点，坦索罗辛治疗的患者报告的驱逐时间更短（p  <0.001），与安慰剂相比使用镇痛药的次数更少（p  <0.001），肾绞痛明显缓解（p  <0.001）。两组之间没有发现不良事件发生率的差异。

结论

我们的数据表明坦洛新的使用有益于输尿管远端结石，以利于结石通过和减轻肾绞痛。亚组分析发现坦索罗辛对> 5 mm的结石有较高的排斥率，但对≤5mm的结石无作用。

病人总结

在本报告中，我们研究了坦索罗辛治疗输尿管远端结石的疗效和安全性。我们发现坦索罗辛显着促进远端输尿管结石的通过并减轻肾绞痛。