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重复注射A型肉毒毒素治疗难治性膀胱过度活动症:中期结果、安全性概况和停药率。

Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates.

机构信息

Medical Research Council Centre for Transplantation, King's College London, King's Health Partners, Guy's Hospital, London, UK.

出版信息

Eur Urol. 2012 Apr;61(4):834-9. doi: 10.1016/j.eururo.2011.12.011. Epub 2011 Dec 13.

Abstract

BACKGROUND

Efficacy and safety of botulinum toxin type A (BoNTA) injection is supported by level 1 evidence, but data regarding repeated injections are limited in patients with refractory overactive bladder (OAB) and idiopathic detrusor overactivity (IDO).

OBJECTIVES

Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO.

DESIGN, SETTING, AND PARTICIPANTS: Prospective data from a single centre were collected from the first 100 patients.

INTERVENTION

Bladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting.

MEASUREMENTS

OAB symptoms, quality of life, discontinuation rates, interinjection interval, and adverse events were recorded. Data comparisons were performed using a generalised linear model or a chi-square test where appropriate.

RESULTS AND LIMITATIONS

Two hundred seven injections were performed in 100 patients. All patients had 1 injection, 53 had a total of 2, 20 had 3, 13 had 4, 10 had 5, 5 had 6, 3 had 7, 1 had 8, 1 had 9, and 1 had 10 injections. Statistics were applied up to five repeated injections. A statistically significant reduction in frequency, urgency, and urge urinary incontinence were seen following the first BoNTA injection compared to baseline. This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections. Thirty-seven patients stopped treatment after the first two injections; thereafter, dropouts were rare. The most common reasons for discontinuing treatment were poor efficacy (13%) and clean intermittent self-catheterisation (CISC)-related issues (11%). The incidence of CISC after the first injection was 35%. Bacteriuria was detected in 21% of patients. The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients.

CONCLUSIONS

BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO. The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues.

摘要

背景

A型肉毒毒素(BoNTA)注射的疗效和安全性得到了一级证据的支持,但对于难治性膀胱过度活动症(OAB)和特发性逼尿肌过度活动症(IDO)患者重复注射的数据有限。

目的

描述采用重复 BoNTA 作为 IDO 管理策略的患者的中期结果和停药率。

设计、地点和参与者:这项前瞻性研究的数据来自单一中心的前 100 名患者。

干预措施

在门诊环境下对膀胱进行 BoNTA(主要为 200 U 注射用肉毒毒素 A;Allergan Ltd.,Marlow,Buckinghamshire,UK)注射。

测量

记录 OAB 症状、生活质量、停药率、注射间隔和不良反应。使用广义线性模型或卡方检验进行适当的数据比较。

结果和局限性

100 名患者共进行了 207 次注射。所有患者均接受了 1 次注射,53 名患者总共接受了 2 次,20 名患者接受了 3 次,13 名患者接受了 4 次,10 名患者接受了 5 次,5 名患者接受了 6 次,3 名患者接受了 7 次,1 名患者接受了 8 次,1 名患者接受了 9 次,1 名患者接受了 10 次注射。统计应用于最多五次重复注射。与基线相比,第一次 BoNTA 注射后,频率、紧迫性和急迫性尿失禁明显减少。这种改善在重复注射后得以维持,并且在比较注射之间的差异时没有统计学差异。37 名患者在接受前两次注射后停止治疗;此后,辍学者很少。停止治疗的最常见原因是疗效不佳(13%)和与间歇性导尿相关的问题(11%)。第一次注射后发生间歇性导尿的比例为 35%。21%的患者检测到菌尿。平均注射间隔为 322 天。局限性包括一些患者同时使用抗毒蕈碱药物。

结论

BoNTA 可为难治性 IDO 患者提供安全有效的中期治疗选择。停止治疗最常见的原因是疗效不佳和与间歇性导尿相关的问题。

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