Department of Urology, Hospital Regional de Alta Especialidad Del Bajío, Leon, Mexico.
Universidad de Guanajuato, Leon, Mexico.
Int J Clin Pract. 2022 Jan 31;2022:3757588. doi: 10.1155/2022/3757588. eCollection 2022.
Extracorporeal shock wave lithotripsy (ESWL) is an effective treatment for urolithiasis. Tamsulosin is capable of causing dilation and facilitating the migration of stones. The aim of this study is to evaluate the efficacy of adjuvant treatment with tamsulosin for improving the stone-free rate after a single session of ESWL in the treatment of kidney stones.
This is a randomized, nonplacebo-controlled study with a sample of 60 adults with a single radiopaque kidney stone of 5-20 mm in diameter. After the ESWL session, the patients were divided into two groups. The control group received standard treatment for analgesia consisting of oral diclofenac (75 mg/12 h) as needed. The tamsulosin group received standard treatment for analgesia plus oral tamsulosin (0.4 mg/day) for eight weeks. In both groups, stone-free status was determined using a CT scan eight weeks after ESWL. The protocol of this study was registered with ClinicalTrials.gov, identifier: NCT04819828.
Only 57 patients completed the study (28 tamsulosin and 29 control). Overall, the average stone diameter was 11.42 ± 4.52 mm. The stone-free rate was 50.88% (29 of 57) overall, 53.57% (15 of 28) for the tamsulosin group, and 48.27% (14 of 29) for the control group ( = 0.680). The estimated relative risk in favor of the tamsulosin group to achieve a stone-free status was 1.11 (95% CI 0.67-1.9). The estimated number needed to treat to achieve a single patient with renal stone-free status after eight weeks of ESWL adjuvant treatment with tamsulosin was 19.
Our findings suggest that tamsulosin as adjuvant treatment after a single ESWL session is well tolerated and safe, but it does not increase the stone-free rate in patients with a single radiopaque renal stone of 5-20 mm in diameter. Our results may support the use of tamsulosin with ESWL in the case of patients with a single radiopaque renal stone of 11-20 mm in diameter based on an apparent higher stone-free rate and a low rate of complications.
体外冲击波碎石术（ESWL）是治疗尿路结石的有效方法。坦索罗辛能够扩张并促进结石的迁移。本研究旨在评估坦索罗辛辅助治疗在单次 ESWL 治疗肾结石后提高结石清除率的效果。
这是一项随机、非安慰剂对照研究，纳入了 60 名成人患者，均为直径 5-20mm 的单个不透射线肾结石。在 ESWL 治疗后，患者分为两组。对照组接受标准止痛治疗，包括按需口服双氯芬酸（75mg/12h）。坦索罗辛组接受标准止痛治疗，外加口服坦索罗辛（0.4mg/天），疗程为 8 周。两组均在 ESWL 后 8 周进行 CT 扫描以确定结石清除状态。本研究方案已在 ClinicalTrials.gov 注册，编号：NCT04819828。
只有 57 名患者完成了研究（坦索罗辛组 28 名，对照组 29 名）。总体而言，平均结石直径为 11.42±4.52mm。结石清除率总体为 50.88%（57 名中的 29 名），坦索罗辛组为 53.57%（28 名中的 15 名），对照组为 48.27%（29 名中的 14 名）（=0.680）。坦索罗辛组更有利于达到结石清除状态的估计相对风险为 1.11（95%CI 0.67-1.9）。在接受坦索罗辛辅助治疗 8 周后，每治疗 19 例患者即可获得 1 例肾结石患者的结石清除状态。
我们的发现表明，在单次 ESWL 治疗后使用坦索罗辛作为辅助治疗是可以耐受且安全的，但不能提高直径为 5-20mm 的单个不透射线肾结石患者的结石清除率。我们的结果可能支持在直径为 11-20mm 的单个不透射线肾结石患者中使用坦索罗辛联合 ESWL，因为该方法似乎有更高的结石清除率和较低的并发症发生率。
