Section of Endourology and Lithiasis, Department of Urology, University of São Paulo Medical School, São Paulo, São Paulo, Brazil.
Urology. 2011 Nov;78(5):1016-21. doi: 10.1016/j.urology.2011.04.062. Epub 2011 Jul 29.
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.
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.
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.
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.
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。
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。
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。
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。
