Athanasiou Stavros, Pitsouni Eleni, Grigoriadis Themos, Zacharakis Dimitris, Salvatore Stefano, Serati Maurizio
Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, "Alexandra" Hospital, National and Kapodistrian University of Athens, Greece.
Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, "Alexandra" Hospital, National and Kapodistrian University of Athens, Greece.
Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:73-82. doi: 10.1016/j.ejogrb.2020.05.018. Epub 2020 May 15.
Reviews assessing mirabegron's safety and efficacy, synthesize data from both genders, without providing specific details for female patients with OAB. The aim of this study is to qualitatively and quantitatively synthesize data evaluating mirabegron's use on female patients with OAB. PubMed/Scopus/Cochrane library/Web of Knowledge were searched for full texted, published in English-language and in peer-reviewed journals, up to November 2019, using the keyword "mirabegron".Jadad score modified by adding allocation concealment, MINORS and RoB were used for the Methodological quality and risk of bias assessment. Twenty-one studies were included in this review;7 RCTs, 3 non-RCTs and 11 observational studies. Controlled trials were of unclear (75%), high (12.5%) or serious risk (12.5%) of bias. Twelve weeks of mirabegron use resulted in significant decrease of urgency, frequency, nocturia and UUI by 1.3-2.2,2.04-2.33,0.42-0.5 and 0.9-1.04 episodes/24 h, respectively. Quality of life and sexual health was improved significantly. Sexual dysfunction decreased from 98% (84/85) at baseline, to 60% (51/85) after 12-weeks of mirabegron (p-value < 0.001). Mirabegron had the same efficacy as anticholinergics in improving all OAB symptoms but with fewer adverse events. Hypertension and antimuscarinics' effects (i.e dry mouth, constipation) had an incidence of 2% (28/1221) and 1.9% (23/1221) when mirabegron was administered, respectively. Mirabegron is a safe and effective alternative therapy for females with OAB. However, there is a paucity of high-quality RCTs, with large sample sizes, long-term follow-up focusing on mirabegron's comparison to other therapies, quality of life and sexual health of female patients with OAB.
评估米拉贝隆安全性和有效性的综述汇总了来自两性的数据,未提供有关女性膀胱过度活动症(OAB)患者的具体细节。本研究的目的是定性和定量地汇总评估米拉贝隆在女性OAB患者中应用的数据。截至2019年11月,在PubMed/Scopus/Cochrane图书馆/科学网中检索以英文发表在同行评审期刊上的全文,使用关键词“米拉贝隆”。采用通过增加分配隐藏进行修改的Jadad评分、MINORS评分和偏倚风险(RoB)评估方法学质量和偏倚风险。本综述纳入了21项研究;7项随机对照试验(RCT)、3项非RCT和11项观察性研究。对照试验的偏倚风险不明确(75%)、高(12.5%)或严重(12.5%)。使用米拉贝隆12周后尿急、尿频、夜尿症和急迫性尿失禁分别显著减少1.3 - 2.2、2.04 - 2.33、0.42 - 0.5和0.9 - 1.04次/24小时。生活质量和性健康得到显著改善。性功能障碍从基线时的98%(84/85)降至米拉贝隆治疗12周后的60%(51/85)(p值<0.001)。米拉贝隆在改善所有OAB症状方面与抗胆碱能药物具有相同的疗效,但不良事件较少。使用米拉贝隆时,高血压和抗毒蕈碱药物的效应(即口干、便秘)发生率分别为2%(28/1221)和1.9%(23/1221)。米拉贝隆是女性OAB患者一种安全有效的替代疗法。然而,缺乏高质量、大样本量、长期随访且聚焦于米拉贝隆与其他疗法比较、女性OAB患者生活质量和性健康的RCT。