Balachandran Aswini, Curtiss Natasha, Basu Maya, Duckett Jonathan
Department of Obstetrics and Gynaecology, Medway Maritime Hospital, Windmill Road, Gillingham, Kent, ME7 5NY, UK,
Int Urogynecol J. 2015 Mar;26(3):367-72. doi: 10.1007/s00192-014-2462-2. Epub 2014 Jul 17.
Mirabegron is a new beta 3 agonist for the treatment of overactive bladder (OAB). Although there are extensive data from randomised controlled trials, there is little real world evidence about its effectiveness and side effects. We conducted a prospective cohort study to evaluate the effectiveness of mirabegron as third-line treatment in patients with refractory OAB who did not benefit from antimuscarinic therapy and bladder drill.
The study was a prospective consecutive cohort of 67 women treated with mirabegron 50 mg. All the patients had symptoms of urgency with or without urgency incontinence and had failed to improve with bladder drill and at least one antimuscarinic medication. The outcomes were assessed after 6 weeks using the International Consultation of Incontinence Modular Questionnaire Short Form (ICIQ-SF), Patient Global Impression of Improvement (PGI-I) scale and Kings Health Questionnaire (KHQ).
The mean number of previous antimuscarinics was 2.81 (range 1-6). Forty out of 67 patients (60 %) described an improvement in their OAB. Responders demonstrated a significant improvement in 5 out of 10 domains of the KHQ. Similarly, the ICI-Q score improved from a mean of 12.7 (±5.3) to 9.2 (±5.3; p ≤ 0.008). Seven women (10 %) stopped mirabegron because of side effects.
This post-marketing surveillance study confirms that mirabegron improves clinical and quality of life outcomes in patients with OAB. The rate of side effects was low. This study supports mirabegron use as a third-line treatment for overactive bladder.
米拉贝隆是一种用于治疗膀胱过度活动症(OAB)的新型β3肾上腺素能受体激动剂。尽管有来自随机对照试验的大量数据,但关于其有效性和副作用的真实世界证据却很少。我们进行了一项前瞻性队列研究,以评估米拉贝隆作为三线治疗药物,对未从抗胆碱能治疗和膀胱训练中获益的难治性OAB患者的有效性。
该研究是一项前瞻性连续队列研究,纳入了67名接受50毫克米拉贝隆治疗的女性患者。所有患者均有尿急症状,伴或不伴有急迫性尿失禁,且膀胱训练和至少一种抗胆碱能药物治疗均未能改善症状。6周后,使用国际尿失禁咨询委员会模块化问卷简表(ICIQ-SF)、患者整体改善印象(PGI-I)量表和国王健康问卷(KHQ)对结果进行评估。
之前使用抗胆碱能药物的平均数量为2.81种(范围为1 - 6种)。67名患者中有40名(60%)表示其OAB症状有所改善。有反应者在KHQ的10个领域中的5个领域有显著改善。同样,ICIQ-SF评分从平均12.7(±5.3)降至9.2(±5.3;p≤0.008)。7名女性(10%)因副作用停用了米拉贝隆。
这项上市后监测研究证实,米拉贝隆可改善OAB患者的临床症状和生活质量。副作用发生率较低。本研究支持将米拉贝隆用作膀胱过度活动症的三线治疗药物。