不同剂量坦索罗辛治疗输尿管结石的效果观察

Observation on effect of different dosages of Tamsulosin in the treatment of patients with ureteral calculi

目的比较坦索罗辛0.4 mg和0.2 mg对输尿管结石的疗效和安全性。方法将符合纳入标准的64例输尿管结石患者随机分为试验组和对照组,每组34例,试验组口服坦索罗辛0.4 mg/d,对照组口服坦索罗辛0.2 mg/d,研究时间为8周。分别于基线第2、4、6、8周采集患者的结石排出率、结石排出时间和不良事件发生率的数据。比较不同剂量坦索罗辛对输尿管结石的疗效和安全性。结果 68例患者,最终试验组29例、对照组25例患者完成研究。两组患者结石排出率均随时间不断提高,从第4周起试验组结石排出率明显高于对照组(48%比36%,P<0.05)。对不同直径结石的分层分析显示,<5 mm直径的结石,试验组与对照组的结石排出率比较差异无统计学意义(75%比83%),5～10 mm直径的结石,试验组的结石排出率明显高于对照组(5～<8 mm:71%比45%;8～10 mm:57%比25%)(P<0.05)。整体上试验组的结石排出时间明显少于对照组[(10.34±6.23)d比(17.73±9.30)d](P<0.01),进一步分层分析显示,<5 mm结石试验组与对照组的结石排出时间比较差异无统计学意义[(7.72±4.55)d比(16.73±2.49)d],5～10 mm结石的排出时间试验组明显少于对照组[5～<8 mm:(14.39±6.31)d比(19.25±10.33)d;8～10 mm:(18.92±8.91)d比(27.67±13.52)d](P<0.01)。本研究中未见不良反应报告。结论治疗输尿管结石,坦索罗辛0.4 mg疗效优于0.2 mg,能明显增加5～10 mm直径输尿管结石的排出率,缩短其排出时间,且不会增加不良事件的发生率。

Objective To compare the efficacy and safety of Tamsulosin 0.4 mg and 0.2 mg in the treatment of patients with ureteral calculi. Methods 64 patients with ureteral stones were randomly divided into study group and control group, with 34 patients in each group. Patients took Tamsulosin 0.4 mg daily in the study group and 0.2 mg daily in the control group. This study lasted for 8 weeks and all the endpoints were collected in baseline, the 2nd, 4th and 8th week, including the expulsion rate, expulsion time and adverse events. The efficacy and safety of different dosages of Tamsulosin for the treatment of ureteral calculi were compared. Results Among 68 patients, 29 patients of study group and 25 patients of the control group completed the study. The expulsion rate increased as time went on in two groups and became significantly higher in study group from the 4th week （48% vs 36%, P 〈 0.05）. Stratified analysis by calculi diameters showed the expulsion rate was not significantly different between the two groups for the 〈5 mm calculi at the end of the study （75% vs 83%）, but significantly higher for the 5-10 mm calculi in study group （5-〈8 mm： 71% vs 45%; 8-10 mm： 57% vs 25%, P 〈 0.05）. The expulsion time decreased significantly in study group [（10.34±2.21） d vs （17.72± 2.63） d] （P 〈 0.01）. A further stratified analysis showed no significant difference in expulsion time for the 〈5 mm calculi [（7.72±1.63） d vs （6.73±1.43） d], but significantly shorter in expulsion time in the study group for the 5-10 mm calculi [5-〈8 mm： （14.39±2.13） d vs （19.25±2.71） d; 8-10 mm： （18.92±2.98） d vs （27.67±3.01） d] （P 〈 0.01）. There was no adverse events report in the study. Conclusion Tamsulosin 0.4 mg is a better alternative therapy than 0.2 mg for ureteral calculi, which can significantly increase the expulsion rate and decrease the expulsion time for the 5-10 mm calculi, without increasing the incidence of adverse events.