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坦索罗辛治疗单纯性远端输尿管结石:一项双盲随机安慰剂对照试验。

Tamsulosin to treat uncomplicated distal ureteral calculi: a double blind randomized placebo-controlled trial.

作者信息

Abdel-Meguid Taha A, Tayib Abdulmalik, Al-Sayyad Ahmad

机构信息

Department of Urology, King Abdulaziz University Medical City, Jeddah, Saudi Arabia.

出版信息

Can J Urol. 2010 Jun;17(3):5178-83.

PMID:20566010
Abstract

PURPOSE

To evaluate efficacy and outcome of tamsulosin therapy for 4 mm-10 mm uncomplicated distal ureteral stones.

MATERIALS AND METHODS

A total of 150 patients (adults with newly diagnosed single unilateral distal ureteral 4 mm-10 mm stones) were double blindly randomized into GA or GB. All patients received traditional treatment of hydration and analgesia as needed. Additionally, patients received either placebo (GA) or 0.4 mg tamsulosin (GB) oral tablets once daily. Treatment and follow up were continued for up to 4 weeks. Endpoints were spontaneous stone passage rates (SPR) and passage time for different stone sizes within 4 weeks study period.

RESULTS

Analysis included 75 patients, in each group, with comparable characteristics. Overall SPR was 56% in GA and 81.3% in GB; achieving significant absolute risk reduction (ARR = 25.3%; p < 0.01) and number needed to treat (NNT) of 3.95. SPR for stones <or= 6 mm was 69.2% in GA versus 90.7% in GB (ARR = 21.5%, p < 0.01). For stones 7 mm-10 mm, SPR was 26.1% in GA and 57.1% in GB (ARR = 31.0%, p <0.01). NNT for <or= 6 mm and 7 mm-10 mm stones was 4.65 and 3.23, respectively (p < 0.05). Median time for passage of <or= 6 mm stones was 17 versus 9 days in GA and GB; while for 7 mm-10 mm stones it was 20 versus 15 days, respectively. During the first two weeks, 77.8% of <or= 6 mm stones in GB have passed versus 23.8% of 7 mm-10 mm stones. Analgesia consumption was significantly less in GB (p < 0.01). No significant adverse effects were observed.

CONCLUSIONS

Tamsulosin therapy for uncomplicated distal ureteral calculi augments SPR, shortens passage time and decrease need for analgesia. Particularly, tamsulosin shortens the passage time for smaller stones, and augments the passage rate for larger stones.

摘要

目的

评估坦索罗辛治疗4毫米至10毫米单纯性远端输尿管结石的疗效和结果。

材料与方法

总共150例患者(新诊断为单侧远端输尿管4毫米至10毫米结石的成年人)被双盲随机分为GA组或GB组。所有患者均根据需要接受水化和镇痛的传统治疗。此外,患者每天口服一次安慰剂(GA组)或0.4毫克坦索罗辛(GB组)片剂。治疗和随访持续长达4周。终点指标为4周研究期内不同结石大小的自然排石率(SPR)和排石时间。

结果

每组纳入75例具有可比特征的患者进行分析。GA组的总体SPR为56%,GB组为81.3%;实现了显著的绝对风险降低(ARR = 25.3%;p < 0.01),治疗所需人数(NNT)为3.95。6毫米及以下结石的GA组SPR为69.2%,GB组为90.7%(ARR = 21.5%,p < 0.01)。对于7毫米至10毫米的结石,GA组SPR为26.1%,GB组为57.1%(ARR = 31.0%,p < 0.01)。6毫米及以下和7毫米至10毫米结石的NNT分别为4.65和3.23(p < 0.05)。6毫米及以下结石在GA组和GB组的排石中位时间分别为17天和9天;而7毫米至10毫米结石的排石中位时间分别为20天和15天。在前两周内,GB组6毫米及以下结石的77.8%已排出,而7毫米至10毫米结石为23.8%。GB组的镇痛药物消耗量显著更少(p < 0.01)。未观察到显著的不良反应。

结论

坦索罗辛治疗单纯性远端输尿管结石可提高SPR,缩短排石时间并减少镇痛需求。特别是,坦索罗辛缩短了较小结石的排石时间,并提高了较大结石的排石率。

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