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长期肉毒毒素治疗获得性颈肌张力障碍的疗效和安全性:25 年随访。

Efficacy and safety of long-term botulinum toxin treatment for acquired cervical dystonia: a 25-year follow-up.

机构信息

Movement Disorders Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168, Rome, Italy.

Medicine of the Ageing, Fondazione Policlinico Universitario "Agostino Gemelli"-IRCCS, Largo A Gemelli, 8, 00168, Rome, Italy.

出版信息

J Neurol. 2023 Jan;270(1):340-347. doi: 10.1007/s00415-022-11343-0. Epub 2022 Sep 6.

DOI:10.1007/s00415-022-11343-0
PMID:36068376
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9813057/
Abstract

Botulinum toxin A (BoNT/A) is the first-line treatment for idiopathic cervical dystonia (ICD) and is widely used in the clinical setting. To date, scanty data are available on the effectiveness of BoNT in treating acquired cervical dystonia (ACD). Here we present a long-term follow-up of ACD patients treated with BoNT/A that focused on safety and efficacy. The study included subjects who had received at least six treatments of three commercially available BoNT/A drugs [abobotulinumtoxinA (A/Abo), incobotulinumtoxinA (A/Inco) and onabotulinumtoxinA (A/Ona)]. Safety and efficacy were assessed based on patients' self-reports regarding adverse effects (AE), duration of improvement of dystonia and/or pain relief. Global clinical improvement was measured on a six-point scale. 23 patients with ACD were administered 739 treatments (A/Abo in 235, A/Inco in 72, A/Ona in 432) with a mean number of treatments of 31 ± 20 (range 6-76) and duration of 10 ± 6 weeks (range 2-25). The mean dose was 737 ± 292 U for A/Abo, 138 ± 108 U for A/Inco and 158 ± 80 U for A/Ona. The average benefit duration was 89 ± 26 (A/Abo), 88 ± 30 days (A/Inco), and 99 ± 55 days (A/Ona) (p = 0.011); global clinical improvement for all sessions was 4 ± 1. ANOVA one-way analysis indicated that A/Ona had the best profile in terms of duration (p < 0.05), whereas A/Abo had the best pain relief effect (p = 0.002). Side effects were reported in 9% of treatments (67/739), with ten treatments (1%) complicated by two side effects. Most side effects were rated mild to moderate; severe side effects occurred following three treatments with the three different BoNT; two required medical intervention. No allergic reactions were reported. Even after 25 years of repeated treatments, all serotypes of BoNT demonstrate positive effects in treating ACD with long-lasting efficacy and safety.

摘要

肉毒毒素 A(BoNT/A)是特发性颈肌张力障碍(ICD)的一线治疗药物,在临床中广泛应用。目前,有关 BoNT 治疗获得性颈肌张力障碍(ACD)的疗效数据很少。本文报道了我们对接受 BoNT/A 治疗的 ACD 患者进行的长期随访结果,重点关注安全性和疗效。该研究纳入了至少接受 6 次三种市售 BoNT/A 药物[阿替菌素(A/Abo)、依替菌素(A/Inco)和奥那菌素(A/Ona)]治疗的患者。安全性和疗效评估基于患者对不良反应(AE)、肌张力障碍改善和/或疼痛缓解持续时间的自我报告。采用 6 分制评估整体临床改善情况。23 例 ACD 患者接受了 739 次治疗(A/Abo 235 次,A/Inco 72 次,A/Ona 432 次),平均治疗次数为 31±20(范围 6-76),治疗持续时间为 10±6 周(范围 2-25)。A/Abo 的平均剂量为 737±292 U,A/Inco 为 138±108 U,A/Ona 为 158±80 U。平均获益持续时间为 A/Abo 89±26 天、A/Inco 88±30 天和 A/Ona 99±55 天(p=0.011);所有疗程的整体临床改善均为 4±1。方差分析单向分析表明,A/Ona 在持续时间方面具有最佳的疗效(p<0.05),而 A/Abo 具有最佳的止痛效果(p=0.002)。9%(67/739)的治疗中报告了不良反应,1%(10/739)的治疗中出现了两种不良反应。大多数不良反应为轻度至中度;三种不同 BoNT 中有三种治疗后出现严重不良反应,两种需要医学干预。未报告过敏反应。即使经过 25 年的重复治疗,所有 BoNT 血清型均显示出治疗 ACD 的积极效果,且疗效持久、安全性好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c807/9813057/6e338347baba/415_2022_11343_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c807/9813057/6e338347baba/415_2022_11343_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c807/9813057/6e338347baba/415_2022_11343_Fig1_HTML.jpg

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