Goyal Suresh Kumar, Singh Vikash, Pandey Himanshu, Chhabra Mahaveer Kumar, Aggarwal Satinder Pal, Bhat Amilal
Department of Urology, Dr. S. N. Medical College, Jodhpur, Rajasthan, India.
Department of Urology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Urol Ann. 2018 Jan-Mar;10(1):82-86. doi: 10.4103/UA.UA_36_17.
The objective of this study was to compare the relative efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteric stones.
This was a prospective study performed between December 2014 and February 2016. A total of 123 adult patients (>18 years of age) presenting with distal ureteric stones sized 6-10 mm were randomized to treatment with tamsulosin 0.4 mg once daily (Group A) or tadalafil10 mg once daily (Group B). Therapy was given for a maximum of 4 weeks. The stone expulsion rate was the primary endpoint. Time to stone expulsion, number of colic episodes, analgesic use, number of hospital visits for pain, endoscopic treatment, and adverse effects of the drugs were noted. Statistical analyses were done using Fisher's exact test and Chi-square test.
A total of 61 patients were included in tamsulosin group and 62 patients in tadalafil group. A statistically insignificant difference was found for stone clearance rate between both groups as a whole (Group A-73.77%, Group B-69.35%, = 0.690) as well as when we considered both subgroups (A1-78.05%, B1-75.0%, = 0.802; A2-65.0%, B2-55.6%, = 0.741). All the primary and secondary outcome measures were more in favour of stones ≤8 mm size than stones >8 mm size. No statistical difference was found for adverse drug effects except for retrograde ejaculation, which was significantly high in tamsulosin group ( < 0.001).
This study showed that although tamsulosin is more effective for stone clearance than tadalafil, but this difference was not significant ( = 0.690).
本研究旨在比较坦索罗辛和他达拉非作为远端输尿管结石药物排石疗法的相对疗效。
这是一项于2014年12月至2016年2月进行的前瞻性研究。共有123例成年患者（年龄>18岁），患有6 - 10毫米大小的远端输尿管结石，被随机分为两组，A组每天服用一次0.4毫克坦索罗辛，B组每天服用一次10毫克他达拉非。治疗最长持续4周。结石排出率是主要终点指标。记录结石排出时间、绞痛发作次数、止痛药物使用情况、因疼痛就医次数、内镜治疗情况以及药物不良反应。采用Fisher精确检验和卡方检验进行统计分析。
坦索罗辛组纳入61例患者，他达拉非组纳入62例患者。总体而言，两组之间的结石清除率无统计学显著差异（A组 - 73.77%，B组 - 69.35%，P = 0.690），在考虑两个亚组时也是如此（A1组 - 78.05%，B1组 - 75.0%，P = 0.802；A2组 - 65.0%，B2组 - 55.6%，P = 0.741）。所有主要和次要结局指标对≤8毫米大小的结石更有利，而不是>8毫米大小的结石。除逆行射精外，药物不良反应无统计学差异，逆行射精在坦索罗辛组显著更高（P<0.001）。
本研究表明，虽然坦索罗辛在结石清除方面比他达拉非更有效，但这种差异不显著（P = 0.690）。
