米拉贝隆治疗2型糖尿病患者留置输尿管支架管期间下尿路症状研究

A Randomized Controlled Clinical Trial of Mirabegron in the Treatment of Lower Urinary Tract Symptoms in Patients with Type 2 Diabetes During Ureteral Stent Indwelling

目的评价米拉贝隆联合盐酸坦索罗辛治疗2型糖尿病患者留置输尿管支架管期间下尿路症状的安全性和有效性。方法选取95例行单侧输尿管镜碎石取石术和留置双J管的2型糖尿病患者,随机分为米拉贝隆和盐酸坦索罗辛组(A组,n=31)、索利那新和盐酸坦索罗辛组(B组,n=32)、盐酸坦索罗辛组(C组,n=32),分别给予米拉贝隆缓释片50 mg/次,1次/d;盐酸坦索罗辛缓释胶囊,0.2 mg/次,1次/d;琥珀酸索利那新片,5mg/次,1次/d;采用输尿管支架症状问卷评分表(USSQ)在术后4周评估患者留置输尿管支架管相关症状,在术前、术后2周、术后4周用世界卫生组织生存质量简表(WHO-QOL-BREF)评估总体生存质量评分,记录3组用药期间不良反应发生率。结果A、B组在USSQ评分表中下尿路症状(尿频、尿急、尿失禁)、躯体疼痛(尿道痛)及其他评分(一般健康指数、工作能力)低于C组,差异有统计学意义(P<0.05);术前总体生存质量评分各组间差异无统计学意义(P>0.05),术后2周总体生存质量评分A组(78.42±1.35)分和B组(72.11±1.46)分高于C组(64.3±1.32)分,A组总体生存质量评分最高,差异有统计学意义(P<0.05),在术后4周时各组评分差异无统计学意义(P>0.05);A组口干、便秘发生率最低。结论米拉贝隆联合盐酸坦索罗辛可用于2型糖尿病患者术后留置输尿管支架管的下尿路症状治疗,其疗效与索利那新联合盐酸坦索罗辛相当,术后2周生存质量评分和用药期间不良反应发生率优于索利那新联合盐酸坦索罗辛,可作为临床治疗药物的选择。

Objective To evaluate the safety and efficacy of mirabegron combined with tamsulosin hydrochloride in the treatment of lower urinary tract symptoms in patients with type Ⅱ diabetes mellitus during ureteral stent indwelling.Methods A total of 95 patients with type Ⅱ diabetes who underwent unilateral ureteroscopic lithotripsy and ureteral stent indwelling were randomly divided into three groups:mirabegron and tamsulosin hydrochloride group(group A,n=31),solifenacin and tamsulosin hydrochloride group(group B,n=32),and tamsulosin hydrochloride group(group C,n=32).Accordingly,patients were given mirabegron sustained release tablets 50 mg/time,1 time/d,tamsulosin hydrochloride sustained release capsules 0.2 mg/time,1 time/d,and solifenacin succinate tablets 5 mg/time,1 time/d.Symptoms related to ureteral stent indwelling were assessed by the ureteral stent symptom questionnaire(USSQ)4 weeks after surgery.Overall quality of life scores were evaluated by World Health Organization Quality of Life abbreviated version(WHO-QOL-BREF)before surgery,2 weeks after surgery,and 4 weeks after surgery.Incidence of adverse reactions during medication in the three groups was recorded.Results Lower urinary tract symptoms(frequency of urination,urgency of urination,incontinence),physical pain(urethral pain)and other scores(general health index,work ability)in the USSQ scale of group A and group B were lower than those of group C,and the difference was statistically significant(P<0.05).There was no statistically significant difference in preoperative overall quality of life scores among the groups(P>0.05).At 2 weeks after surgery,the overall quality of life score of group A(78.42±1.35)and group B(72.11±1.46)was higher than that of group C(64.3±1.32),with group A at the top,and the difference was statistically significant.At 4 weeks after surgery,there was no statistically significant difference in the quality of life scores of each group(P>0.05).Group A had the lowest incidence of dry mouth and constipation.Conclusion Mirabegron combined with tamsulosin hydrochloride can be used for the treatment of lower urinary tract symptoms in patients with type Ⅱ diabetes mellitus during postoperative ureteral stent indwelling.Compared with solifenacin combined with tamsulosin hydrochloride,it has similar curative effect,higher quality of life score at 2 weeks after surgery,and less incidence of adverse reactions during medication.It can be used as an alternative medication for clinical treatment.