Efficacy and Safety of Tamsulosin in Medical Expulsive Therapy for Distal Ureteral Stones with Renal Colic: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
| Autor: | Shusheng Wang, Yonghai Zhang, Lin Qi, Jianggen Yang, Hua Xu, Guoqing Liu, Zhaolin Sun, Xiankui Liu, Zhiqiang Chen, Lingwu Chen, Kun Tang, Hong Li, Yongbin Liao, Huan Yang, Tiejun Pan, Weibing Li, Yongfu Long, Zhong Wu, Weilie Hu, Wei He, Xun Xu, Qiwu Mi, Yue Cheng, Zhangqun Ye, Siping Liu, Jinchun Xing, Xingfa Chen, Yaoliang Deng, Changbao Xu, Jiongming Li, Guohua Zeng, Xiaojian Gu, Wenxi Gao, Peiyu Liang, Xiaochun Zhang |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
business.industry Urology Incidence (epidemiology) 030232 urology & nephrology Placebo-controlled study Placebo Surgery Double blind 03 medical and health sciences 0302 clinical medicine Tamsulosin 030220 oncology & carcinogenesis medicine Clinical endpoint Renal colic medicine.symptom Adverse effect business medicine.drug |
| Zdroj: | European Urology. 73:385-391 |
| ISSN: | 0302-2838 |
| Popis: | Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo.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.Participants were randomly assigned (1:1) into tamsulosin (0.4mg) or placebo groups for 4 wk.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.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%; p0.001) for distal ureteral stones. Subgroup analysis identified a specific benefit of tamsulosin for the treatment of large distal ureteral stones (5mm). Considering the secondary end points, tamsulosin-treated patients reported a shorter time to expulsion (p0.001), required lower use of analgesics compared with placebo (p0.001), and significantly relieved renal colic (p0.001). No differences in the incidence of adverse events were identified between the two groups.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 stones5mm, but no effect for stones ≤5mm.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. |
| Databáze: | OpenAIRE |
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