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中华腔镜泌尿外科杂志(电子版) ›› 2021, Vol. 15 ›› Issue (04) : 338 -342. doi: 10.3877/cma.j.issn.1674-3253.2021.04.016

临床研究

米拉贝隆联合坦索罗辛治疗轻中度前列腺增生伴膀胱过度活动症的临床观察
刘泽林1, 黄欣1, 柯帅1, 王清华1, 翟官忠1, 郭佳1,()   
  1. 1. 430060 湖北,武汉大学人民医院泌尿外科
  • 收稿日期:2020-12-24 出版日期:2021-08-01
  • 通信作者: 郭佳
  • 基金资助:
    国家自然科学基金青年基金(81702539)

Efficacy and safety of mirabegron combined with tamsulosin for the treatment of benign prostatic hyperplasia with overactive bladder

Zelin Liu1, Xin Huang1, Shuai Ke1, Qinghua Wang1, Guanzhong Zhai1, Jia Guo1,()   

  1. 1. Department of Urology, Renmin Hospital of Wuhan University, Wuhan 430060, China
  • Received:2020-12-24 Published:2021-08-01
  • Corresponding author: Jia Guo
引用本文:

刘泽林, 黄欣, 柯帅, 王清华, 翟官忠, 郭佳. 米拉贝隆联合坦索罗辛治疗轻中度前列腺增生伴膀胱过度活动症的临床观察[J/OL]. 中华腔镜泌尿外科杂志(电子版), 2021, 15(04): 338-342.

Zelin Liu, Xin Huang, Shuai Ke, Qinghua Wang, Guanzhong Zhai, Jia Guo. Efficacy and safety of mirabegron combined with tamsulosin for the treatment of benign prostatic hyperplasia with overactive bladder[J/OL]. Chinese Journal of Endourology(Electronic Edition), 2021, 15(04): 338-342.

目的

探讨坦索罗辛联合米拉贝隆治疗轻中度前列腺增生(BPH)伴膀胱过度活动症(OAB)患者的安全性及疗效。

方法

2019年9月至2020年12月,采用前瞻性队列研究的方法,将武汉大学人民医院泌尿外科诊断为BPH合并OAB的患者通过纳入及排除标准后得到研究对象70例。采用随机数表法将研究对象分为坦索罗辛组和联合用药组,每组35例。坦索罗辛组单用坦索罗辛(0.2 mg/d);联合用药组同时服用坦索罗辛(0.2 mg/d)和米拉贝隆(50 mg/d)。在基线和治疗12周后,对患者进行复诊及随访,比较两组患者的症状改善情况[国际前列腺症状评分(IPSS)、储尿期症状评分(USPSS)、排尿期症状评分(VSS)、膀胱过度活动症评分(OABSS)]、尿流动力学参数改变情况[最大尿流率(Qmax)、残余尿量(RUV)]以及药物不良反应发生率。

结果

共获得65例(92.86%)BPH合并OAB患者的可靠随访数据,平均年龄62(50~80)岁。两组患者的IPSS、USPSS、VSS评分及Qmax在治疗结束(12周)时相比其对应基线水平均显著改善,差异均有统计学意义(P均<0.05);OABSS治疗前后比较,坦索罗辛组差异无统计学意义(P>0.05),联合用药组差异有统计学意义(P<0.05),且联合用药组OABSS降低程度(ΔOABSS)显著优于坦索罗辛组,差异有统计学意义(P<0.05);残余尿量治疗前后比较,两组的差异均无统计学意义(P均>0.05)。治疗结束后,联合用药组在IPSS、USPSS、OABSS评分方面相比坦索罗辛组均显著降低,差异有统计学意义(P均<0.05);在VSS、Qmax、RUV方面,联合用药组治疗后较坦索罗辛组差异无统计学意义(P均>0.05)。两组患者均未发生严重不良反应,共10例(15.38%)患者出现≥1次不良事件。

结论

坦索罗辛联合米拉贝隆治疗BPH轻中度梗阻症状合并OAB有明显疗效,其疗效优于单用坦索罗辛,且药物相关不良反应无明显增加。

Objective

To investigate the safety and efficacy of tamsulosin combined with mirabelone in the treatment of benign prostatic hyperplasia (BPH) with overactive bladder (OAB).

Methods

From September 2019 to December 2020, 70 patients diagnosed with BPH combined with OAB in the Urology Department of Wuhan University People's Hospital were selected and included in this study. The patients were divided into Group A and Group B, 35 cases in each group by random number table method in accordance with 1∶1 ratio. In group A, tamsolocine was used only (0.2 mg, once per day). In group B, tamsoroxine (0.2 mg, once per day) and mirabellon (50 mg, once per day) were administered simultaneously. At baseline and after 12 weeks symptoms improvement [international prostate symptom score (IPSS), urine storage period symptom scores (USPSS), voiding symptom scores (VSS), bladder excessive activity score (OABSS)], urine flow mechanics parameters change situation [maximum urinary flow rate (Qmax), residual urine volume (RUV)] and the incidence of drug related adverse reaction were compared between the two groups.

Results

A total of 65 patients (92.86%) with BPH and OAB were followed up reliably, with an average age of 62 (50-80) years. At the end of treatment (12 weeks), symptom scores of each stage and Qmax of the two groups were significantly improved compared with their corresponding baseline levels, and the differences were statistically significant (P<0.05). There was no significant difference in RUV between the two groups before and after treatment (all P was >0.05). After the end of treatment, IPSS, USPSS and OABSS in group B were significantly reduced compared with group A, and the differences were statistically significant (All P<0.05). In terms of VSS, Qmax and RUV, there were no statistically significant differences between group B and group A after treatment (all P>0.05). No serious adverse reactions occurred in both groups, with 10 patients (15.38%) suffering at least one adverse event.

Conclusion

The combination of tamsoroxin and mirabelone in the treatment of mild and moderate obstruction symptoms of BPH combined with OAB showed significant efficacy, which was superior to that of tamsoroxine alone, and no significant increase in drug-related adverse reactions was observed.

表1 两组轻中度BPH合并OAB患者基线资料比较
表2 两组轻中度BPH合并OAB患者治疗前后相关指标比较(±s
表3 两组BPH合并OAB患者治疗期间不良反应发生率[例(%)]
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