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西洛多辛与他达拉非在输尿管结石治疗中辅助大型输尿管镜操作的安全性和有效性:一项前瞻性随机试验

Safety and efficacy of silodosin and tadalafil in ease of negotiation of large ureteroscope in the management of ureteral stone: A prosective randomized trial.

作者信息

Bhattar Rohit, Jain Vipin, Tomar Vinay, Yadav Sher Singh

机构信息

Department of Urology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India.

出版信息

Turk J Urol. 2017 Dec;43(4):484-489. doi: 10.5152/tud.2017.83548. Epub 2017 Dec 1.

DOI:10.5152/tud.2017.83548
PMID:29201512
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5687212/
Abstract

OBJECTIVE

To evaluate the safety and efficacy of silodosin and tadalafil in ease of negotiation of large size ureteroscope (8/9.8 Fr) in the management of ureteral stone.

MATERIAL AND METHODS

Between June 2015 and May 2016, 86 patients presented with ureteral stone of size 6-15 mm were on consent randomly assigned to 1 of 3 outpatient treatment arms: silodosin (Group A), tadalafil (Group B), and placebo (Group C). After two weeks of therapy 67 patients underwent ureteroscopy, and ureteral orifice configuration, ureteroscopic negotiation, ureteral dilatation, operating time, procedural complication and drug related side effects were noted in each group.

RESULTS

Ureteral negotiation was significantly better in Groups A (73.9%) and B (69.6%) as compared to Group C (38.1%) (p<0.01). Statistically significant difference was noted in the requirement for dilatation in Group C (71.4%) as compared to Groups A (26.1%) and B (39.1%) (p<0.01). Ureteral orifice was found to be more dilated in Groups A (69.6%) and B (60.9%) as compared to Group C (28.6%). Mean operating time was statistically lower in Groups A (35.2 min) and B (34.91 min) as compared to Group C (41.14 min) (p<0.01).

CONCLUSION

Both silodosin and tadalafil not only relax ureteral smooth muscle but also help in forward propagation of large size ureteroscope (8/9.8 Fr) without any significant risk of adverse events.

摘要

目的

评估西洛多辛和他达拉非在大尺寸输尿管镜(8/9.8 Fr)处理输尿管结石时辅助操作的安全性和有效性。

材料与方法

2015年6月至2016年5月期间,86例输尿管结石大小为6 - 15 mm的患者经同意后被随机分配至3个门诊治疗组之一:西洛多辛组(A组)、他达拉非组(B组)和安慰剂组(C组)。治疗两周后,67例患者接受输尿管镜检查,并记录每组的输尿管口形态、输尿管镜操作的顺利程度、输尿管扩张情况、手术时间、手术并发症及药物相关副作用。

结果

与C组(38.1%)相比,A组(73.9%)和B组(69.6%)输尿管镜操作的顺利程度明显更高(p<0.01)。与A组(26.1%)和B组(39.1%)相比,C组(71.4%)的输尿管扩张需求有统计学显著差异(p<0.01)。与C组(28.6%)相比,A组(69.6%)和B组(60.9%)的输尿管口扩张更明显。与C组(41.14分钟)相比,A组(35.2分钟)和B组(34.91分钟)的平均手术时间在统计学上更低(p<0.01)。

结论

西洛多辛和他达拉非不仅能松弛输尿管平滑肌,还有助于大尺寸输尿管镜(8/9.8 Fr)的推进,且无明显不良事件风险。

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