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体外磁刺激联合米拉贝隆治疗女性膀胱过度活动症的疗效:一项单中心随机假对照研究

The Impact of Extracorporeal Magnetic Stimulation as Addition to Mirabegron in Overactive Bladder Treatment in Women: A Single-Centre Randomized Sham-Controlled Study.

作者信息

Bele Uros, Serdinšek Tamara, Homšak Evgenija, But Igor

机构信息

Medical Faculty, University of Maribor, 2000 Maribor, Slovenia.

Department for Urology, Medical University of Graz, 8036 Graz, Austria.

出版信息

J Clin Med. 2024 Feb 5;13(3):916. doi: 10.3390/jcm13030916.

Abstract

The purpose of our prospective, single-blinded, randomized, sham-controlled study was to investigate the effect of the additional extracorporeal magnetic stimulation (ExMI) to pharmacological treatment in overactive bladder syndrome (OAB) in women. We recruited 56 women with OAB, who were allocated into two study groups: the active group received mirabegron 50 mg daily and a total of 16 sessions of ExMI in 8 weeks, whereas the sham group received mirabegron 50 mg daily and sham stimulation following the same treatment protocol. Treatment success was evaluated after 4 and 8 weeks. Both groups experienced significant reduction in daytime urinary frequency, nocturia, and number of weekly incontinence episodes after 8 weeks. There were no statistically significant differences in end-point daytime urinary frequency and nocturia between groups. However, the overall average reduction rate in weekly number of incontinence episodes was 43.7% in treatment group and 24.2% in the control group. The number of urinary incontinence episodes in the treatment and control group was reduced for 3.8 ± 11.8 vs. 2.5 ± 4.3 episodes at week 4 and additional 3.3 ± 6 vs. 0.4 ± 3.2 episodes at week 8, respectively ( = 0.013). Moreover, IIQ-7 score showed a significantly greater score reduction and patients' evaluated improvement of symptoms was higher in the active group. The addition of ExMI to mirabegron in OAB treatment further improves the weekly incontinence episode reduction rate and also leads to grater improvement in symptoms.

摘要

我们这项前瞻性、单盲、随机、假刺激对照研究的目的是调查在女性膀胱过度活动症(OAB)的药物治疗中额外进行体外磁刺激(ExMI)的效果。我们招募了56名患有OAB的女性,她们被分为两个研究组:治疗组每天服用50毫克米拉贝隆,并在8周内总共接受16次ExMI治疗;而假刺激组每天服用50毫克米拉贝隆,并按照相同的治疗方案接受假刺激。在4周和8周后评估治疗效果。8周后,两组的日间尿频、夜尿和每周尿失禁发作次数均显著减少。两组之间终点时的日间尿频和夜尿在统计学上没有显著差异。然而,治疗组每周尿失禁发作次数的总体平均减少率为43.7%,对照组为24.2%。治疗组和对照组的尿失禁发作次数在第4周分别减少了3.8±11.8次和2.5±4.3次,在第8周分别又减少了3.3±6次和0.4±3.2次(P = 0.013)。此外,国际尿失禁咨询委员会尿失禁问卷简表(IIQ-7)评分显示,治疗组的评分显著降低更多,且患者对症状改善的评估更高。在OAB治疗中,在米拉贝隆基础上加用ExMI可进一步提高每周尿失禁发作次数的减少率,并且还能使症状得到更大改善。

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