Costa J, Borges A, Espírito-Santo C, Ferreira J, Coelho M, Moore P, Sampaio C
Instituto de Farmacologia e Terapêutica Geral, Faculdade de Medicina Lisboa, Av. Prof. Egas Moniz, Lisboa, Portugal, 1649-028.
Cochrane Database Syst Rev. 2005 Jan 25(1):CD004314. doi: 10.1002/14651858.CD004314.pub2.
Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases are idiopathic, and generally it is a life-long disorder. In recent years, botulinum toxin type A (BtA) has become first line therapy for cervical dystonia. However, not all patients respond well to BtA, and 5 to 10% become resistant to it. Botulinum toxin B (BtB) is an alternative to BtA and offers the potential to help patients who do not respond to BtA. At present there is no compelling theoretical reason why it should not be as effective as, or even more effective than, BtA.
To compare the clinical efficacy and safety of BtA versus BtB in cervical dystonia.
Studies for inclusion in the review were identified using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, by handsearching the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, by communication with other researchers in the field, by searching reference lists of papers found using the above search strategies, and by contact with authors and drug manufacturer.
Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA versus BtB for the treatment of cervical dystonia. Trials must have been randomised and placebo-controlled.
A paper pro-forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Differences were settled by discussion. The outcome measures used included improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, changes in pain scores, changes in quality of life assessments, and frequency and severity of adverse events.
We cannot give any results since we have only identified two ongoing trials and there are no preliminary results or interim analyses available for them. The full results of these trials are expected in late 2004 or 2005.
AUTHORS' CONCLUSIONS: It is currently not possible to make definitive comparisons between BtA and BtB for the treatment of cervical dystonia; uncontrolled comparisons should be regarded with suspicion.
颈部肌张力障碍是局限性肌张力障碍最常见的形式。其特征为头部的不自主姿势,且常伴有颈部疼痛。功能障碍和社交退缩很常见。大多数病例为特发性,通常是一种终身性疾病。近年来,A型肉毒毒素(BtA)已成为颈部肌张力障碍的一线治疗方法。然而,并非所有患者对BtA反应良好,5%至10%的患者会对其产生耐药性。B型肉毒毒素(BtB)是BtA的替代药物,有可能帮助那些对BtA无反应的患者。目前,没有令人信服的理论依据表明它不如BtA有效,甚至不比BtA更有效。
比较BtA与BtB治疗颈部肌张力障碍的临床疗效和安全性。
通过使用Cochrane运动障碍组试验注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE、EMBASE,手工检索《运动障碍杂志》以及运动障碍和肉毒毒素国际大会的摘要,与该领域的其他研究人员交流,检索使用上述检索策略找到的论文的参考文献列表,并与作者和药品制造商联系,来确定纳入综述的研究。
如果研究评估了BtA与BtB治疗颈部肌张力障碍的疗效,则被认为符合纳入综述的条件。试验必须是随机且安慰剂对照的。
使用纸质预印本,由两名独立评审员进行双份提取,从纳入的研究中收集数据。两名评审员分别对每个试验的内部有效性进行评估。差异通过讨论解决。使用的结局指标包括症状评定量表的改善情况、患者和临床医生的主观评估、疼痛评分的变化、生活质量评估的变化以及不良事件的频率和严重程度。
由于我们仅确定了两项正在进行的试验,且没有它们的初步结果或中期分析,因此无法给出任何结果。这些试验的完整结果预计在2004年末或2005年得出。
目前无法对BtA和BtB治疗颈部肌张力障碍进行明确比较;非对照比较应谨慎对待。