Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

详细信息    查看全文

• 作者：Jeremy S. Furyk ; MBBS MPH&TM^a ; ^c ; ^d ; ^{Jeremy.Furyk@health.qld.gov.au" class="auth_mail" title="E-mail the corresponding author} ; ; Kevin Chu ; MBBS MS^d ; ^e ; Colin Banks ; MBBS^a ; Jaimi Greenslade ; PhD^e ; Gerben Keijzers ; MBBS PhD^f ; Ogilvie Thom ; MBBS^d ; ^g ; Tom Torpie ; MBBS^f ; Carl Dux ; MBBS^h ; Rajan Narula ; MBBS^b ; ^c
• 刊名：Annals of Emergency Medicine
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：67
• 期：1
• 页码：86-95.e2
• 全文大小：768 K

文摘

We assess the efficacy and safety of tamsulosin compared with placebo as medical expulsive therapy in patients with distal ureteric stones less than or equal to 10 mm in diameter.

Methods

This was a randomized, double-blind, placebo-controlled, multicenter trial of adult participants with calculus on computed tomography (CT). Patients were allocated to 0.4 mg of tamsulosin or placebo daily for 28 days. The primary outcomes were stone expulsion on CT at 28 days and time to stone expulsion.

Results

There were 403 patients randomized, 81.4% were men, and the median age was 46 years. The median stone size was 4.0 mm in the tamsulosin group and 3.7 mm in the placebo group. Of 316 patients who received CT at 28 days, stone passage occurred in 140 of 161 (87.0%) in the tamsulosin group and 127 of 155 (81.9%) with placebo, a difference of 5.0% (95% confidence interval –3.0% to 13.0%). In a prespecified subgroup analysis of large stones (5 to 10 mm), 30 of 36 (83.3%) tamsulosin participants had stone passage compared with 25 of 41 (61.0%) with placebo, a difference of 22.4% (95% confidence interval 3.1% to 41.6%) and number needed to treat of 4.5. There was no difference in urologic interventions, time to self-reported stone passage, pain, or analgesia requirements. Adverse events were generally mild and did not differ between groups.

Conclusion

We found no benefit overall of 0.4 mg of tamsulosin daily for patients with distal ureteric calculi less than or equal to 10 mm in terms of spontaneous passage, time to stone passage, pain, or analgesia requirements. In the subgroup with large stones (5 to 10 mm), tamsulosin did increase passage and should be considered.