Department of Urology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
Department of Urology, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea.
Neurourol Urodyn. 2021 Jan;40(1):286-294. doi: 10.1002/nau.24552. Epub 2021 Jan 3.
This study aimed to investigate the efficacy and safety of mirabegron for Parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo-controlled, multicenter study.
Inclusion criteria are Parkinsonism with OAB symptoms for 4 weeks or more, OAB symptom score (OABSS) questionnaire scores greater than 2, and OABSS urgency question scores greater than 1. After a 2-week wash-out period, the patients were randomized into placebo and mirabegron groups at visit 2. Visit 3 was performed after 4 weeks of medication. Mirabegron was prescribed to the two groups for the rest of the study period at visit 4.
The mean age was 68.1 ± 8.1 years and 72 males and 64 females were included. A total of 136 patients were screened, 117 patients were randomized, and 25 patients dropped out. The OABSS scores were significantly different between the two groups at Weeks 4 and 8. The OABSS scores became the same in the two groups at Week 12 (visit 5). The postvoid residual urine volume showed a mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 4. Adverse events occurred in 27 patients (23.1%). The degree was mild in 26 cases (78.8%), moderate in five (15.2%), and severe in two (6.1%). Only 13 cases (39.4%) showed medication-related adverse events. Acute urinary retention occurred in a single case. The treatment satisfaction questionnaires showed no significant differences between the two groups.
Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events.
本研究旨在一项随机、安慰剂对照、多中心研究中，评估米拉贝隆治疗帕金森病伴膀胱过度活动症（OAB）患者的疗效和安全性。
纳入标准为帕金森病伴 OAB 症状 4 周以上，OAB 症状评分（OABSS）问卷评分＞2，OABSS 急迫问题评分＞1。经过 2 周洗脱期后，患者在第 2 次就诊时随机分为安慰剂组和米拉贝隆组。第 3 次就诊在用药 4 周后进行。第 4 次就诊时，米拉贝隆组和安慰剂组开始在整个研究期间接受剩余药物治疗。
平均年龄为 68.1±8.1 岁，纳入 72 名男性和 64 名女性。共筛选了 136 名患者，117 名患者随机分组，25 名患者脱落。两组患者在第 4 周和第 8 周时 OABSS 评分有显著差异。两组在第 12 周（第 5 次就诊）时 OABSS 评分相同。米拉贝隆组在第 4 次就诊时与安慰剂组相比，残余尿量轻度增加至 64ml。27 名患者发生不良事件（23.1%）。26 例（78.8%）程度为轻度，5 例（15.2%）为中度，2 例（6.1%）为重度。仅 13 例（39.4%）发生与药物相关的不良事件。发生 1 例急性尿潴留。治疗满意度问卷在两组之间无显著差异。
米拉贝隆治疗帕金森病伴 OAB 症状有效，不良事件可接受。
