Ojo Oluwadamilola O, Fernandez Hubert H
Center for Neurologic Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA; Neurology Unit, Department of Medicine, College of Medicine, University of Lagos, Lagos, Nigeria.
Center for Neurologic Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA; Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA.
Toxicon. 2015 Dec 1;107(Pt A):72-6. doi: 10.1016/j.toxicon.2015.09.037. Epub 2015 Oct 9.
Based largely on old retrospective reports, the recommendation of injecting BoNT as infrequently as possible, with the lowest possible dose, was formed. While BoNT is inherently immunogenic, with improved production, most patients no longer develop immune resistance and poor response to BoNT is often due to other factors. In a randomized controlled trial (RCT) using abobotulinumtoxinA for cervical dystonia (CD) by the German Dystonia Study Group, half of the patients treated with 250 and 500 U, and 39% in the 1000 U group required retreatment after 8 weeks. In a RCT comparing onabotulinumtoxinA and incobotulinumtoxinA for CD by Benecke et al., waning of effect was noted in 70 days for both toxins. Finally, two long-term prospective trials employing flexible intervals, with reinjections based on patient's request, have been performed using incobotulinumtoxinA. In the CD study, 22.5% were re-injected in <10 weeks and 24.6% between 10 and 12 weeks. In the blepharospasm study, the median injection interval was 6-10 weeks for 23.7% and 10-12 weeks for 32.3%) While long-term studies utilizing flexible/shortened intervals, with vigilance over immunogenicity are needed, the majority of current evidence no longer support the very stringent adherence to strict 90-day BoNT injection intervals.
很大程度上基于以往的回顾性报告,形成了尽可能少注射肉毒毒素(BoNT)且使用尽可能低剂量的建议。虽然BoNT本身具有免疫原性,但随着生产工艺的改进,大多数患者不再产生免疫抵抗,对BoNT反应不佳往往是由其他因素导致的。在德国肌张力障碍研究组使用A型肉毒杆菌毒素治疗颈部肌张力障碍(CD)的一项随机对照试验(RCT)中,接受250单位和500单位治疗的患者中有一半,以及1000单位组中的39%在8周后需要再次治疗。在Benecke等人比较A型肉毒毒素和C型肉毒毒素治疗CD的一项RCT中,两种毒素在70天时均出现效果减弱。最后,已经进行了两项长期前瞻性试验,采用灵活的间隔时间,并根据患者的要求进行再次注射,使用的是C型肉毒毒素。在CD研究中,22.5%的患者在不到10周时再次注射,24.6%的患者在10至12周之间再次注射。在眼睑痉挛研究中,23.7%的患者注射间隔中位数为6至10周,32.3%的患者为10至12周。虽然需要进行长期研究,采用灵活/缩短的间隔时间,并警惕免疫原性,但目前的大多数证据不再支持严格遵守90天的BoNT注射间隔。