米拉贝隆联合坦索罗辛治疗输尿管镜碎石术后输尿管支架管相关症状的前瞻性随机对照研究

Mirabegron add-on therapy on Tamsulosin for the treatment of ureteral stent-related symptoms: A prospective randomized clinical study

目的前瞻性研究对比米拉贝隆+坦索罗辛与单用坦索罗辛在治疗输尿管镜碎石术后输尿管支架管相关症状的有效性。方法纳入北京和睦家医院2020年10月至2021年8月90例接受输尿管镜碎石手术并植入输尿管支架管患者。随机数表法进行前瞻性分组,坦索罗辛组45例患者术后服用盐酸坦索罗辛每日0.2 mg,联合治疗组45例患者服用盐酸坦索罗辛每日0.2 mg+米拉贝隆每日50 mg。记录分析患者术后止痛药服药量、输尿管支架管症状问卷评分(USSQ)、药物不良反应等指标,使用Mann-Whitney U检验进行非正态分布的计量资料组间比较。结果坦索罗辛组和联合治疗组中位年龄分别为41岁和44岁;中位术前疼痛评分均为8分;中位国际前列腺症状评分(IPSS)分别为5分和3分;中位生活质量评分(QOL)均为2分;中位结石直径均为7 mm;中位手术时间均为35 min;中位住院时间分别为17 h和19 h;中位带管时间分别为10、12 d。两组术后中位USSQ泌尿系症状评分分别为26分和28分;中位USSQ身体疼痛评分分别为15分和16分;中位USSQ整体健康评分分别为11分和12分;中位USSQ工作表现评分分别为12分和14分;中位USSQ性生活评分均为2分;中位USSQ附加问题评分分别为9分和10分。两组中位使用止痛药物数量分别为3片和2片。中国患者和外籍患者中位USSQ身体疼痛评分分别为15.5分和16.0分;中位使用止痛药量分别为1.5片和6.0片(P<0.05)。结论米拉贝隆对改善输尿管镜碎石术后输尿管支架管相关症状及疼痛控制无附加作用。外籍患者使用止痛药物量显著高于中国患者。

Objective To evaluate the efficacy of Mirabegron and Tamsulosin versus Tamsulosin in patients with ureteral stents after ureteroscopic lithotripsy.Methods A total of 90 patients from Beijing United Family Hospital underwent ureteroscopic lithotripsy and ureteral stenting from October 2020-August 2021 were included in this study,According to the random number table,45 patients were randomized to receive Tamsulosin 0.2 mg every day,another 45 patients received Tamsulosin 0.2 mg and Mirabegron 50 mg every day.The patients′characteristics,USSQ scores,and analgesic usage were recorded and analyzed.The Mann-Whitney U test was performed to compare variables of skewed distribution between the two groups.Results For the Tamsulosin group and combination group,the median age was 41 years and 44 years,the median pain score pre-operation was 8 in both groups,the median IPSS score was 5 and 3,the median QOL score was 2 in both groups,the median stone diameter was 7 mm in both groups,the median operation time was 35 min in both groups,the median length of hospital stay was 17 h and 19 h,the median stent placement time was 10 d and 12 d.The median USSQ urinary symptoms score was 26 and 28,the median USSQ body pain score was 15 and 16,the median USSQ general health score was 11 and 12,the median USSQ working performance score was 12 and 14,the median USSQ sexual matters score was 2 in both groups,the median USSQ additional problems score was 9 and 10.The median analgesic ibuprofen usage was 3 tablets and 2 tablets.For Chinese patients and foreign patients,the median USSQ body pain score was 15.5 and 16.0,the median analgesic usage was 1.5 tablets and 6.0 tablets(P<0.05).Conclusion Mirabegron does not add additional effects on the post ureterisocpic lithotripsy and ureteral stent placement related symptom and pain control.Foreign patients requested significantly more analgesics than Chinese patients.