坦索罗辛和米拉贝琼联合用药与坦索罗辛单独用药治疗下尿路症状男性膀胱过度活动症的疗效和安全性比较 - TAME-Overactive Bladder:一项开放标签随机对照试验。

IF 0.8 Q3 MEDICINE, GENERAL & INTERNAL
Azhar Anwar, Vivek Gorka, Harmandeep Singh Chahal, Sandeep Sharma, Sunit Tandon, Naman Singhal, Pankaj Chandrakant Narwade, Nikhil Chauhan, Namita Bansal, Simran Kaur
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引用次数: 0

摘要

背景:目的:本研究旨在评估在坦索罗辛0.4毫克的基础上添加β-3肾上腺素受体激动剂(米瑞贝隆50毫克)治疗伴有良性前列腺增生(BPE)症状(OABS)的老年男性的安全性和有效性:这是一项开放标签随机对照试验。90名患有BPE且国际前列腺症状评分(IPSS)超过7分并以OABS为主的男性被纳入研究。每名患者都接受了详细的病史、尿流率测定和基线评分,包括 IPSS、OABS 评分(OABSS)和 QoL 评估。在获得书面知情同意后,患者被随机分为两组,每组 45 人。第一组接受坦索罗辛 0.4 毫克和安慰剂,第二组接受坦索罗辛 0.4 毫克加米拉贝琼 50 毫克的联合用药,每天一次,睡前服用。第 2、4 和 8 周对患者进行随访。通过重复症状病史、尿流率测定、IPSS、OABSS 和 QoL 评分来评估 8 周后的疗效:治疗 8 周后,两组收集的数据均与基线参数进行了比较。联合疗法与单用坦索罗辛相比,OABSS(P = 0.046)、IPSS(P = 0.006)和 QoL(P = 0.038)均有显著改善。不良反应轻微,且具有自限性:结论:坦索罗辛与米拉贝琼联合用药在改善以 OABS 为主的男性 BPE 患者的 OABSS、IPSS 和 QoL 方面既有效又安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Efficacy and Safety of a Combination of Tamsulosin and Mirabegron versus Tamsulosin Alone in the Management of Overactive Bladder in Males with Lower Urinary Tract Symptoms - TAME-Overactive Bladder: An Open-labeled Randomized Controlled Trial.

Background: Overactive bladder (OAB) is a common condition in elderly men with coexisting benign prostatic enlargement (BPE), and it significantly impairs their quality of life (QoL).

Aim: This study aimed to assess the safety and efficacy of adding beta-3 adrenergic receptor agonist (mirabegron 50 mg) to tamsulosin 0.4 mg for symptomatic men with BPE and OAB symptoms (OABS).

Materials and methods: It was an open-labeled randomized controlled trial. Ninety men with BPE and International Prostate Symptom Score (IPSS) of more than seven with predominant OABS were enrolled for the study. A detailed history, uroflowmetry, and baseline scores, including IPSS, OABS score (OABSS), and QoL assessment, were done for each patient. After written informed consent, patients were randomized into two groups of 45 each. Group-1 received tamsulosin 0.4 mg and placebo, and Group-2 received a combination of tamsulosin 0.4 mg plus mirabegron 50 mg once daily at bedtime. Follow-up of patients was done at 2nd, 4th, and 8th weeks. Efficacy at 8 weeks was assessed using repeat history for symptoms, uroflowmetry, IPSS, OABSS, and QoL score.

Results: After 8 weeks of therapy, collected data were compared to baseline parameters in both groups. Significant improvement with respect to OABSS (P = 0.046), IPSS (P = 0.006), and QoL (P = 0.038) was observed with combination therapy versus tamsulosin alone. There were mild adverse effects, which were self-limiting.

Conclusions: A combination of tamsulosin with mirabegron is effective and safe in improving the OABSS, IPSS, and QoL in men with BPE who have predominant OABS.

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