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A型肉毒杆菌毒素改善难治性膀胱过度活动症患者的健康状况和泌尿症状:真实生活经验

Onabotulinumtoxin-A improves health status and urinary symptoms in subjects with refractory overactive bladder: Real-life experience.

作者信息

Tamburro Fabiola R, Castellan Pietro, Neri Fabio, Berardinelli Francesco, Bada Maida, Sountoulides Petros, Giuliani Nicola, Finazzi Agrò Enrico, Schips Luigi, Cindolo Luca

机构信息

1 Department of Urology, ASL02 Abruzzo, 'S.Pio da Pietrelcina' Hospital, Vasto, Italy.

2 Department of Urology, G. d'Annunzio University of Chieti-Pescara, Chieti, Italy.

出版信息

Urologia. 2018 Nov;85(4):163-168. doi: 10.1177/0391560318759258. Epub 2018 Mar 28.

Abstract

OBJECTIVE

: Onabotulinumtoxin-A has been approved for wet overactive bladder refractory to anticholinergics in randomised controlled trials; however, data from real-life practice are scarce. This study was designed to assess the efficacy of intravesical onabotulinumtoxin-A injections, focusing on health status, urinary symptoms and subjective satisfaction.

METHODS

: Data from consecutive patients with overactive bladder-refractory to anticholinergics treated with onabotulinumtoxin-A were prospectively collected and analysed. Standard doses (100-150 U) were used, followed by repeat sessions when clinical benefits diminished. Efficacy and safety of repeat onabotulinumtoxin-A administrations were assessed at 12-week post-injection. Clinical parameters evaluated were: change in the magnitude and frequency of incontinence, urgency and nocturia episodes, change in the number of pads used and procedural complications. Quality of life was evaluated using the 36-Item Short-Form Health Survey, Overactive Bladder Screener and Treatment Benefit Scale questionnaires.

RESULTS

: Consecutive overactive bladder-refractory to anticholinergics patients ( n = 22) (median duration of oral therapy: 10 months) were enrolled. No intraoperative complications occurred, but two urinary retention cases were recorded. Forty-five percent of patients (10/22) were re-treated (median duration of perceived benefits: 18 months, range: 8-55 months). The number of urinary incontinence, frequency and nocturia episodes, and pads used went from 3.6, 11.3, 2.7 and 2.4 preoperatively to 1.0, 5.8, 0.7 and 0.7 postoperatively ( p < 0.005). Quality of life (36-Item Short-Form Health Survey) was significantly improved and symptom scores (Overactive Bladder Screener) were reduced, from 34.5 to 17.1 at week 12 ( p < 0.05). Eighty-seven percent of patients indicated improvement/great improvement in their condition (Treatment Benefit Scale).

CONCLUSION

: Intradetrusor injections of onabotulinumtoxin-A in patients with overactive bladder-refractory to anticholinergics significantly improved health status and urinary symptoms, with high subjective satisfaction.

摘要

目的

在随机对照试验中,注射用A型肉毒毒素已被批准用于治疗抗胆碱能药物难治性的湿性膀胱过度活动症;然而,来自实际临床的相关数据却很少。本研究旨在评估膀胱内注射用A型肉毒毒素的疗效,重点关注健康状况、泌尿系统症状及主观满意度。

方法

前瞻性收集并分析连续使用注射用A型肉毒毒素治疗抗胆碱能药物难治性膀胱过度活动症患者的数据。采用标准剂量(100 - 150单位),当临床疗效减退时进行重复注射。在注射后12周评估重复注射用A型肉毒毒素的疗效和安全性。评估的临床参数包括:尿失禁的程度和频率、尿急及夜尿次数的变化、使用尿垫数量的变化以及手术并发症。使用36项简明健康调查量表、膀胱过度活动症筛查量表和治疗获益量表问卷评估生活质量。

结果

纳入连续22例抗胆碱能药物难治性膀胱过度活动症患者(口服治疗的中位时长:10个月)。术中无并发症发生,但记录到2例尿潴留病例。45%的患者(10/22)接受了再次治疗(感知获益的中位时长:18个月,范围:8 - 55个月)。尿失禁、排尿频率和夜尿次数以及使用尿垫数量,术前分别为3.6次、11.3次、2.7次和2.4片,术后分别降至1.0次、5.8次、0.7次和0.7片(p < 0.005)。生活质量(36项简明健康调查量表)显著改善,症状评分(膀胱过度活动症筛查量表)降低,在第12周时从34.5降至17.1(p < 0.05)。87%的患者表示病情有所改善/大幅改善(治疗获益量表)。

结论

对于抗胆碱能药物难治性膀胱过度活动症患者,膀胱逼尿肌内注射用A型肉毒毒素可显著改善健康状况和泌尿系统症状,且患者主观满意度较高。

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