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比较两种A型肉毒杆菌毒素注射治疗重度神经源性逼尿肌过度活动症患者的疗效:一项病例对照研究。

Comparing two types of botulinum-A toxin detrusor injections in patients with severe neurogenic detrusor overactivity: a case-control study.

作者信息

Grosse Joachim, Kramer Guus, Jakse Gerhard

机构信息

University Clinic of Urology, Universitätsklinikum der RWTH Aachen, Aachen, Germany.

出版信息

BJU Int. 2009 Sep;104(5):651-6. doi: 10.1111/j.1464-410X.2009.08466.x. Epub 2009 Mar 5.

Abstract

OBJECTIVE

To compare the efficacy of two types of botulinum toxin type A (BTX-A; Dysport, Ipsen Ltd, Slough, UK) or Botox (Allergan Inc., Irvine, CA, USA) and examine the possible dose-effect relation for Dysport in those patients, as multifocal detrusor injections with BTX-A are effective for severe neurogenic detrusor overactivity in adults.

PATIENTS AND METHODS

This was an open-label, observational case-control study comparing Dysport and Botox, and the dose-effect relation for Dysport. The patients included were treated with either Dysport (cases; 500, 750, or 1000 IU), or with Botox (controls: 300 IU, and exceptionally 200 or 400 IU). The continence volume (primary), mean and maximum catheterized volume, and antimuscarinic use were assessed, and cystometric variables measured were overactivity volume (primary), detrusor compliance, and cystometric capacity. All variables were assessed at baseline, 3 and 9 months after treatment, and results analysed using analysis of variance (paired) t-tests, chi-square tests and regression analysis.

RESULTS

There were 28 cases and 28 matched controls; their demographic characteristics, bladder management, and baseline values were comparable between the groups. At 3 months there was a significant improvement in cystometric variables and continence volume in both groups, but in mean catheterized volume and reduced use of antimuscarinics in cases only. At 9 months there was no significant improvement over baseline except for the continence volume in the cases. There were no significant differences in results between the groups except for the continence volume at 3 months (459 mL after Dysport and 396 mL after Botox; P=0.015). There was no dose-related response for Dysport at 3.8 months of follow-up. The interval between injections (9.5, 14.5 and 16.1 months for Dysport 500, 750, and 1000 IU; 10.1 months for Botox) was not significant. There were nine non-responders in the Dysport group and seven in the Botox group; the patient characteristics and baseline data were comparable to those of the responders. There was transient hypoasthenia in one of the responders (750 IU Dysport).

CONCLUSIONS

A single treatment session with either Dysport or Botox in a setting combined with antimuscarinics might improve the patient's condition for up to a year. There was no clear dose-related effect for Dysport in adults.

摘要

目的

比较两种A型肉毒杆菌毒素(BTX-A;英国斯劳市益普生有限公司生产的Dysport和美国加利福尼亚州欧文市艾尔建公司生产的保妥适)的疗效,并研究Dysport在这些患者中的可能剂量效应关系,因为BTX-A多点注射治疗成人严重神经源性逼尿肌过度活动有效。

患者与方法

这是一项开放标签的观察性病例对照研究,比较Dysport和保妥适以及Dysport的剂量效应关系。纳入的患者接受Dysport(病例组;500、750或1000国际单位)或保妥适(对照组:300国际单位,特殊情况下为200或400国际单位)治疗。评估控尿尿量(主要指标)、平均和最大导尿量以及抗毒蕈碱药物的使用情况,并测量膀胱测压变量,包括过度活动尿量(主要指标)、逼尿肌顺应性和膀胱测压容量。所有变量在基线、治疗后3个月和9个月进行评估,并使用方差分析(配对)t检验、卡方检验和回归分析对结果进行分析。

结果

共有28例病例和28例匹配的对照;两组之间的人口统计学特征、膀胱管理和基线值具有可比性。3个月时,两组的膀胱测压变量和控尿尿量均有显著改善,但仅病例组的平均导尿量和抗毒蕈碱药物使用减少。9个月时,除病例组的控尿尿量外,与基线相比无显著改善。除3个月时的控尿尿量外(Dysport治疗后为459毫升,保妥适治疗后为396毫升;P = 0.015),两组结果无显著差异。随访3.8个月时,Dysport没有剂量相关反应。注射间隔(Dysport 500、750和1000国际单位分别为9.5、14.5和16.1个月;保妥适为10.1个月)无显著差异。Dysport组有9例无反应者;保妥适组有7例无反应者;无反应者的患者特征和基线数据与有反应者相当。1例有反应者(750国际单位Dysport)出现短暂肌无力。

结论

在联合使用抗毒蕈碱药物的情况下,单次注射Dysport或保妥适可能使患者病情改善长达一年。Dysport在成人中没有明确的剂量相关效应。

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