Schurch Brigitte
Neuro-Urology, Swiss Paraplegic Center, Balgrist University Hospital, Zurich, Switzerland.
Drugs. 2006;66(10):1301-18. doi: 10.2165/00003495-200666100-00001.
This review highlights a recent innovation in the medical treatment of detrusor overactivity (DO). Anticholinergics are usually the gold standard to treat bladder overactivity. Adverse effects and lack of efficacy are the two main causes for considering alternative treatments. Until recently, invasive surgery (mainly bladder augmentation) was the only available treatment option for patients with intractable DO. This article considers botulinum toxin type A (BTX-A) injection as an alternative treatment to surgery in patients with DO who do not respond to anticholinergic therapy. To identify papers for inclusion in this review, we searched PubMed with the keywords 'botulinum toxin', 'overactive bladder', 'urinary incontinence' and 'neurogenic bladder' for the years 2000-5. Review articles were not included. Abstracts were cited only if they contained important new information. Experimental animal studies and articles or book chapters related to the use of botulinum toxin for other indications (such as achalasia and cervical dystonia) were analysed with regard to the mechanisms of action of botulinum toxin. From this review, it appears that BTX-A injection into the detrusor muscle is a very effective method for treating urinary incontinence secondary to neurogenic detrusor overactivity (NDO), as well as urinary incontinence due to idiopathic overactive bladder (IDO). In both conditions, the duration of effect seems to be at least 6 months. Overall success rates seem to be similar in both patient populations. For NDO, only one evidence-based medicine level 1 study is available, whereas for IDO, only evidence-based medicine level 3 or 4 studies have been published. Particularly in this latter indication, injection technique and outcome parameters vary from study to study and need to be standardised. Without randomised controlled studies aimed at comparing different techniques and dosages, it remains difficult to decide what technique is optimal for treating patients with IDO who are not willing to perform clean intermittent self-catheterisation (CISC). Therefore, studies that compare different dosages and techniques with the risk of needing CISC in regard to the duration of the effect are mandatory. As more studies of repeated injections have been published, it appears that, at least at medium follow-up, the toxin remains as effective as after the first injection, and there is no evidence of change in bladder compliance or detrusor fibrosis. However, long-term observational studies are necessary to assess these last points. Finally, the commonly reported dose appears to be well tolerated, since few adverse effects have been reported.
本综述重点介绍了逼尿肌过度活动症(DO)医学治疗方面的一项最新创新。抗胆碱能药物通常是治疗膀胱过度活动症的金标准。不良反应和疗效不佳是考虑采用替代治疗的两个主要原因。直到最近,侵入性手术(主要是膀胱扩大术)仍是难治性DO患者唯一可用的治疗选择。本文将A型肉毒杆菌毒素(BTX-A)注射视为对抗胆碱能治疗无反应的DO患者手术的替代治疗方法。为确定纳入本综述的论文,我们在2000年至2005年期间使用关键词“肉毒杆菌毒素”、“膀胱过度活动症”、“尿失禁”和“神经源性膀胱”在PubMed上进行了搜索。不包括综述文章。仅在摘要包含重要新信息时才会引用。对实验动物研究以及与肉毒杆菌毒素用于其他适应症(如贲门失弛缓症和颈部肌张力障碍)相关的文章或书籍章节,就肉毒杆菌毒素的作用机制进行了分析。从本综述来看,向逼尿肌肌肉注射BTX-A似乎是治疗神经源性逼尿肌过度活动症(NDO)继发的尿失禁以及特发性膀胱过度活动症(IDO)所致尿失禁的一种非常有效的方法。在这两种情况下,疗效持续时间似乎至少为6个月。总体成功率在这两类患者群体中似乎相似。对于NDO,仅有一项循证医学1级研究,而对于IDO,仅发表了循证医学3级或4级研究。特别是在后一种适应症中,不同研究的注射技术和结局参数各不相同,需要进行标准化。由于缺乏旨在比较不同技术和剂量的随机对照研究,对于不愿进行清洁间歇性自我导尿(CISC)的IDO患者,仍难以确定哪种技术是最佳治疗方法。因此,必须开展研究比较不同剂量和技术在疗效持续时间方面与需要CISC的风险。随着更多关于重复注射的研究发表,似乎至少在中期随访时,毒素的效果与首次注射后一样有效,并且没有证据表明膀胱顺应性或逼尿肌纤维化发生改变。然而,需要长期观察性研究来评估这些最后一点。最后,由于报告的不良反应很少,常用剂量似乎耐受性良好。