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膀胱内注射A型肉毒毒素后加用米拉贝隆可改善难治性膀胱过度活动症患者的治疗效果。

Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder.

作者信息

Wang Chung-Cheng, Lee Cheng-Ling, Hwang Yi-Ting, Kuo Hann-Chorng

机构信息

Department of Urology, En Chu Kong Hospital, College of Medicine, National Taiwan University, New Taipei City, Taiwan.

Department of Biomedical Engineering, Chung Yuan Christian University, Taoyuan, Taiwan.

出版信息

Low Urin Tract Symptoms. 2021 Oct;13(4):440-447. doi: 10.1111/luts.12384. Epub 2021 May 6.

Abstract

OBJECTIVES

To investigate whether adding an anticholinergic or beta-3 agonist can improve the therapeutic effect of intravesical onabotuliumtoxinA injection in patients with refractory overactive bladder (OAB).

METHODS

Ninety OAB patients who received an intravesical 100-U onabotulinumtoxinA injection 1 month previously were consecutively invited into a prospective, randomized, open-label study. They were randomly adding on solifenacin 5 mg daily (QD) (30 patients), mirabegron 50 mg QD (31 patients), or no medication (29 patients, control). All enrolled patients completed a 3-day voiding diary, Overactive Bladder Symptom Score (OABSS) and Urgency Severity Scale (USS) questionnaires, Global Response Assessment (GRA) scale, and uroflowmetry at baseline (1 month after intravesical onabotulinumtoxinA injection) and 3-, 6-, 9-, and 12-month follow-up. The primary end point was the effective therapeutic outcome defined as no OAB wet during the 12-month period. The secondary end point included changes of GRA, OABSS, and the parameters of the voiding diary at 3 months.

RESULTS

The baseline data were comparable among the three groups. The percentage of OAB wet in the mirabegron-added-on group was significantly less than that in the solifenacin-added-on and onabotulinumtoxinA-only groups at four different time points (P = .02). At 3 months, the changes of GRA, OABSS, USS, urge urinary incontinence, frequency, nocturia episodes, and functional bladder capacity in the mirabegron-added-on group were significantly greater than those in the other groups. No serious adverse events were reported.

CONCLUSIONS

Adding mirabegron could increase the therapeutic effects, mainly on OAB symptoms and GRA scale, after intravesical onabotulinumtoxinA injection in refractory OAB patients.

摘要

目的

探讨添加抗胆碱能药物或β-3激动剂是否能提高膀胱内注射A型肉毒毒素对难治性膀胱过度活动症(OAB)患者的治疗效果。

方法

连续邀请90例1个月前接受过膀胱内100单位A型肉毒毒素注射的OAB患者参加一项前瞻性、随机、开放标签研究。他们被随机分为每日加用索利那新5毫克(30例患者)、米拉贝隆50毫克(31例患者)或不加用药物(29例患者,对照组)。所有入组患者在基线(膀胱内注射A型肉毒毒素1个月后)以及3、6、9和12个月随访时完成3天排尿日记、膀胱过度活动症症状评分(OABSS)和尿急严重程度量表(USS)问卷、整体反应评估(GRA)量表以及尿流率测定。主要终点是定义为12个月期间无OAB漏尿的有效治疗结果。次要终点包括3个月时GRA、OABSS以及排尿日记参数的变化。

结果

三组间基线数据具有可比性。在四个不同时间点,加用米拉贝隆组的OAB漏尿百分比显著低于加用索利那新组和仅使用A型肉毒毒素组(P = 0.02)。在3个月时,加用米拉贝隆组的GRA、OABSS、USS、急迫性尿失禁、尿频、夜尿次数和功能性膀胱容量的变化显著大于其他组。未报告严重不良事件。

结论

对于难治性OAB患者,膀胱内注射A型肉毒毒素后加用米拉贝隆可提高治疗效果,主要体现在OAB症状和GRA量表方面。

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