Department of Urology, Hamad General Hospital, Doha, Qatar.
Urology. 2010 Jan;75(1):4-7. doi: 10.1016/j.urology.2009.09.073.
To study the impact of tamsulosin on the rate of spontaneous passage of distal ureteral stones.
A total of 100 patients with stones sized 10 mm or smaller, located in the distal part of the ureter were included. Patients were randomly assigned to 2 equal groups. Group 1 received 0.4 mg tamsulosin once daily and group 2 received placebo. The investigators and the patients were masked to the type of treatment. Patients were followed-up until passage of the stone, or for a maximum of 4 weeks. The number of pain episodes, need for analgesia, stone expulsion rate and time, and possible side effects of medications were observed in both groups.
Apart from 4 patients in the placebo group who were lost to follow-up, all patients complied with the prescribed medications and continued the study. Stone expulsion occurred in 41 of 50 patients (82%) in group 1 and in 28 of 46 patients (61%) in group 2 (P = .02). The chance of stone expulsion was 3 times higher in the tamsulosin group (relative risk [RR] = 2.93; 95% CI, 1.152-7.45). In group 1, patients with stones sized < or = 5 mm showed a significantly higher expulsion rate compared to those with larger stones (> 5 mm). Age, gender, and stone laterality had no significant impact on the expulsion rate. The expulsion time was significantly shorter in the tamsulosin group (6.4 +/- 2.77 days vs 9.87 +/- 5.4 days for groups 1 and 2, respectively). Moreover, the frequency of pain episodes, the need for diclofenac, and its total dosage were significantly lower in the tamsulosin group. Side effects observed in both groups were comparable and mild, and no patient withdrew because of them.
Tamsulosin is a safe and effective drug that enhances spontaneous passage of distal ureteral stones sized 10 mm or smaller.
研究坦索罗辛对输尿管下段结石自行排出率的影响。
共纳入 100 例结石大小为 10mm 或以下、位于输尿管下段的患者。患者被随机分为两组，每组 50 例。第 1 组患者每日服用坦索罗辛 0.4mg，第 2 组患者服用安慰剂。研究者和患者均对治疗类型设盲。两组患者均随访至结石排出或最长 4 周。观察两组患者的疼痛发作次数、镇痛需求、结石排出率和时间，以及药物的可能不良反应。
除安慰剂组 4 例患者失访外，所有患者均按规定服药并继续研究。第 1 组 50 例患者中有 41 例（82%）结石排出，第 2 组 46 例患者中有 28 例（61%）结石排出（P=0.02）。坦索罗辛组结石排出的几率是安慰剂组的 3 倍（相对危险度 [RR]=2.93；95%可信区间，1.152-7.45）。第 1 组中结石大小≤5mm 的患者排出率明显高于结石大小＞5mm 的患者。年龄、性别和结石侧别对排出率无显著影响。坦索罗辛组的排出时间明显缩短（6.4±2.77 天比 1 组和 2 组分别为 9.87±5.4 天）。此外，坦索罗辛组疼痛发作次数、双氯芬酸需求及其总剂量均明显减少。两组的不良反应相似且均较轻，无患者因不良反应退出。
坦索罗辛是一种安全有效的药物，可促进 10mm 或以下输尿管下段结石的自然排出。
