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体外冲击波碎石术后辅助坦索罗辛或硝苯地平治疗肾结石:一项双盲、随机、安慰剂对照试验。

Adjuvant tamsulosin or nifedipine after extracorporeal shock wave lithotripsy for renal stones: a double blind, randomized, placebo-controlled trial.

机构信息

Section of Endourology and Lithiasis, Department of Urology, University of São Paulo Medical School, São Paulo, São Paulo, Brazil.

出版信息

Urology. 2011 Nov;78(5):1016-21. doi: 10.1016/j.urology.2011.04.062. Epub 2011 Jul 29.

Abstract

OBJECTIVE

To evaluate the effects of the adjuvant use of tamsulosin or nifedipine after extracorporeal shock wave lithotripsy for nonlower pole kidney stones 5-20 mm in size.

METHODS

We conducted a randomized double-blind trial involving 136 patients with radiopaque kidney stones. The patients received daily treatment with 0.4 mg tamsulosin, 20 mg nifedipine retard, or placebo for ≤30 days after 1 session of extracorporeal shock wave lithotripsy. Success was defined as plain film radiography showing the patient was completely stone free or with asymptomatic stone fragments ≤4 mm in size at any time during the weekly follow-up.

RESULTS

The success rate was 60.5% (23 of 38) in the tamsulosin group, 48.6% (17 of 35) in the nifedipine group, and 36.8% (14 of 38) in the placebo group (P = .118). In the subgroup analysis, stones 10-20 mm had significantly greater success rates in the tamsulosin (13 of 21, 61.9%) and nifedipine (15 of 25, 60%) groups compared with the placebo group (6 of 23, 26.1%; P = .024), but not for stones 5-9 mm (P = .128). The number needed to treat was 2.9 for tamsulosin and 3 for nifedipine. Adverse events were more frequent in the nifedipine than in the placebo group (28.5% vs 2.6%, respectively, P = .009), but without a significant difference between the nifedipine and tamsulosin (28.5% vs 15.8%, P = .15) or the tamsulosin and placebo (P = .54) groups. No difference was found among the groups with regard to pain intensity, interval to clearance, or steinstrasse.

CONCLUSION

The stone-free rates after extracorporeal shock wave lithotripsy with adjuvant tamsulosin or nifedipine were significantly increased only for nonlower pole renal stones 10-20 mm in size compared with placebo. Nifedipine was associated with more adverse effects than placebo.

摘要

目的

评估在体外冲击波碎石术(extracorporeal shock wave lithotripsy,ESWL)后辅助使用坦索罗辛(tamsulosin)或硝苯地平(nifedipine)对大小为 5-20mm 的非下极肾结石的影响。

方法

我们进行了一项随机双盲试验,纳入了 136 名放射性肾结石患者。患者在单次 ESWL 后接受坦索罗辛 0.4mg、硝苯地平控释片 20mg 或安慰剂治疗,疗程 ≤30 天。成功定义为在每周随访期间的任何时间,平片显示患者完全无结石或无症状结石碎片 <4mm。

结果

坦索罗辛组的成功率为 60.5%(23/38),硝苯地平组为 48.6%(17/35),安慰剂组为 36.8%(14/38)(P=0.118)。在亚组分析中,10-20mm 大小的结石在坦索罗辛(21 例中的 13 例,61.9%)和硝苯地平(25 例中的 15 例,60%)组的成功率明显高于安慰剂组(23 例中的 6 例,26.1%;P=0.024),但 5-9mm 大小的结石无显著差异(P=0.128)。坦索罗辛的治疗需要数为 2.9,硝苯地平为 3。硝苯地平组的不良反应发生率高于安慰剂组(分别为 28.5%和 2.6%,P=0.009),但与坦索罗辛组(28.5%和 15.8%,P=0.15)或坦索罗辛组与安慰剂组(P=0.54)之间无显著差异。各组间的疼痛强度、清除间隔或 Steinstrasse 无差异。

结论

与安慰剂相比,在 ESWL 后辅助使用坦索罗辛或硝苯地平可显著提高大小为 10-20mm 的非下极肾结石的无结石率。硝苯地平的不良反应发生率高于安慰剂。

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