Santamato Andrea, Panza Francesco, Intiso Domenico, Baricich Alessio, Picelli Alessandro, Smania Nicola, Fortunato Francesca, Seripa Davide, Fiore Pietro, Ranieri Maurizio
Physical Medicine and Rehabilitation Section - "OORR Hospital", University of Foggia, Italy.
Geriatric Unit & Gerontology-Geriatrics Research Laboratory, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy.
J Neurol Sci. 2017 Jul 15;378:182-186. doi: 10.1016/j.jns.2017.04.052. Epub 2017 May 1.
Current guidelines suggested a dosage up to 600units (U) of botulinum toxin type A (BoNT-A) (onabotulinumtoxinA or incobotulinumtoxinA) in reducing spastic hypertonia with low prevalence of complications, although a growing body of evidence showed efficacy with the use of high doses (>800U). The available evidence mainly referred to a single set of injections evaluating the efficacy and safety of the neurotoxin 30days after the treatment. In a prospective, non-randomized, open-label study, we studied the safety of repeated higher doses of incobotulinumtoxinA in post-stroke upper and lower limb spasticity. Two years after the first set of injections, we evaluated in 20 stroke survivors with upper and lower limb spasticity the long-term safety of repeated high doses of incobotulinumtoxinA (up to 840U) for a total of eight sets of injections. Patients reported an improvement of their clinical picture concerning a reduction of spasticity measured with the Asworth Scale (AS) for elbow, wrist, fingers and ankle flexor muscles and disability measured with the Disability Assessment Scale (DAS) 30days after the last set of injections (eighth set) compared to the baseline (p<0.0001). No difference in AS and DAS scores has been found between t (30days after the first injection set) and t (30days after the eighth set of injections), with also similar safety. In a two-year follow-up, repeated high doses of incobotulinumtoxinA, administered for eight sets of injections, appeared to be safe in patients with upper and lower limb spasticity after stroke without general adverse effects.
目前的指南建议，使用高达600单位（U）的A型肉毒杆菌毒素（BoNT-A）（onabotulinumtoxinA或incobotulinumtoxinA）来减轻痉挛性肌张力亢进，并发症发生率较低，尽管越来越多的证据表明高剂量（>800U）使用也有效。现有证据主要涉及单次注射一组神经毒素后30天评估其疗效和安全性的研究。在一项前瞻性、非随机、开放标签研究中，我们研究了重复使用更高剂量的incobotulinumtoxinA治疗中风后上肢和下肢痉挛的安全性。在首次注射一组药物两年后，我们评估了20例有上肢和下肢痉挛的中风幸存者重复高剂量（高达840U）注射incobotulinumtoxinA共八组的长期安全性。患者报告，与基线相比，在最后一组注射（第八组）30天后，根据阿什沃思量表（AS）测量的肘部、腕部、手指和踝部屈肌痉挛减轻，以及根据残疾评估量表（DAS）测量的残疾情况改善，临床症状有所改善（p<0.0001）。在第一次注射一组后30天（t）和第八组注射后30天（t）之间，未发现AS和DAS评分有差异，安全性也相似。在两年的随访中，重复高剂量注射incobotulinumtoxinA共八组，对于中风后有上肢和下肢痉挛的患者似乎是安全的，没有出现全身性不良反应。
