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肉毒毒素治疗痉挛的未批准注射方案的获益与风险。

Benefits and Risks of Non-Approved Injection Regimens for Botulinum Toxins in Spasticity.

机构信息

Physical Medicine and Rehabilitation Section, "OORR Hospital", University of Foggia, Viale Pinto, 71100, Foggia, Italy.

"Fondazione Turati" Rehabilitation Centre, Vieste, Foggia, Italy.

出版信息

Drugs. 2017 Sep;77(13):1413-1422. doi: 10.1007/s40265-017-0786-1.

DOI:10.1007/s40265-017-0786-1
PMID:28726023
Abstract

Spasticity with muscle paresis and loss of dexterity is a common feature of upper motor neuron syndrome due to injuries or the pyramidal tract in several neurological conditions. Botulinum toxin type A has been considered the gold standard treatment for spasticity and movement disorders, with efficacy, reversibility, and low prevalence of complications. During the last 30 years, thousands of studies of its use have been performed, but few guidelines are available. Therefore, there is great variability in both the doses and intervals of administration and the approaches taken by clinicians with considerable experience in spasticity and movement disorder treatment. In the present review article, we provide a short overview of the benefits and risks of non-approved injection regimens and doses for botulinum toxins, focusing on the treatment of post-stroke spasticity, where there is great interest in the potential for increasing the number of treatment/years and the dose of botulinum toxin treatment for subjects with upper and lower limb spasticity. However, many doubts exist regarding antibody development and possible adverse effects.

摘要

痉挛伴肌肉无力和灵活性丧失是多种神经状况中因损伤或锥体束所致上运动神经元综合征的常见特征。肉毒毒素 A 已被认为是治疗痉挛和运动障碍的金标准,具有疗效、可逆转性和低并发症发生率。在过去 30 年中,已经进行了数千项关于其使用的研究,但很少有指南。因此,在剂量和给药间隔以及在痉挛和运动障碍治疗方面经验丰富的临床医生所采取的方法方面存在很大差异。在本文综述中,我们简要概述了未经批准的肉毒毒素注射方案和剂量的益处和风险,重点关注卒中后痉挛的治疗,对于上肢和下肢痉挛患者,增加治疗次数/年数和肉毒毒素治疗剂量的潜力引起了极大的关注。然而,对于抗体产生和可能的不良反应存在许多疑问。

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Benefits and Risks of Non-Approved Injection Regimens for Botulinum Toxins in Spasticity.肉毒毒素治疗痉挛的未批准注射方案的获益与风险。
Drugs. 2017 Sep;77(13):1413-1422. doi: 10.1007/s40265-017-0786-1.
2
High doses of incobotulinumtoxinA for the treatment of post-stroke spasticity: are they safe and effective?高剂量的因可保妥适用于治疗中风后痉挛:它们安全且有效吗?
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Employment of higher doses of botulinum toxin type A to reduce spasticity after stroke.使用高剂量A型肉毒杆菌毒素减轻中风后的痉挛状态。
J Neurol Sci. 2015 Mar 15;350(1-2):1-6. doi: 10.1016/j.jns.2015.01.033. Epub 2015 Feb 7.
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Safety and self-reported efficacy of botulinum toxin for adult spasticity in current clinical practice: a prospective observational study.在当前临床实践中,肉毒毒素治疗成人痉挛的安全性和自我报告疗效:一项前瞻性观察研究。
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引用本文的文献

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Toxins (Basel). 2024 Sep 29;16(10):420. doi: 10.3390/toxins16100420.
2
Stroke rehabilitation: from diagnosis to therapy.中风康复:从诊断到治疗。
Front Neurol. 2024 Aug 13;15:1402729. doi: 10.3389/fneur.2024.1402729. eCollection 2024.
3
Electrical Stimulation of Injected Muscles to Boost Botulinum Toxin Effect on Spasticity: Rationale, Systematic Review and State of the Art.

本文引用的文献

1
Long-term safety of repeated high doses of incobotulinumtoxinA injections for the treatment of upper and lower limb spasticity after stroke.重复高剂量注射英妥昔单抗A治疗中风后上肢和下肢痉挛的长期安全性。
J Neurol Sci. 2017 Jul 15;378:182-186. doi: 10.1016/j.jns.2017.04.052. Epub 2017 May 1.
2
Do flexible inter-injection intervals improve the effects of botulinum toxin A treatment in reducing impairment and disability in patients with spasticity?灵活的注射间隔时间能否改善A型肉毒毒素治疗对减轻痉挛患者的功能障碍和残疾的效果?
Med Hypotheses. 2017 May;102:28-32. doi: 10.1016/j.mehy.2017.03.011. Epub 2017 Mar 7.
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电刺激注射肌肉以增强肉毒杆菌毒素对痉挛的作用:理论依据、系统评价与现状
Toxins (Basel). 2021 Apr 23;13(5):303. doi: 10.3390/toxins13050303.
4
Software Suite Training Tool for MSK Exploration and Botulinum Toxin Infiltration Based on Ultrasound Imaging for the Spasticity Treatment.基于超声成像的肌肉骨骼超声探索和肉毒毒素渗透的软件套件培训工具,用于治疗痉挛。
J Med Syst. 2019 Jun 19;43(8):238. doi: 10.1007/s10916-019-1331-4.
5
Botulinum Toxin Type A for the Treatment of Lower Limb Spasticity after Stroke.A型肉毒毒素治疗脑卒中后下肢痉挛。
Drugs. 2019 Feb;79(2):143-160. doi: 10.1007/s40265-018-1042-z.
6
Safety Profile of High-Dose Botulinum Toxin Type A in Post-Stroke Spasticity Treatment.高剂量A型肉毒毒素治疗脑卒中后痉挛的安全性。
Clin Drug Investig. 2018 Nov;38(11):991-1000. doi: 10.1007/s40261-018-0701-x.
Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study.
用于肢体痉挛的高达800单位的因卡波糖毒素A剂量的安全性和有效性:TOWER研究。
Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.
4
Safety of botulinum toxin short interval therapy using incobotulinumtoxin A.使用因卡波糖毒素A进行肉毒杆菌毒素短间隔治疗的安全性。
J Neural Transm (Vienna). 2017 Apr;124(4):437-440. doi: 10.1007/s00702-016-1628-0. Epub 2016 Oct 17.
5
Neutralizing Antibody and Botulinum Toxin Therapy: A Systematic Review and Meta-analysis.中和抗体与肉毒杆菌毒素疗法:系统评价与荟萃分析
Neurotox Res. 2016 Jan;29(1):105-17. doi: 10.1007/s12640-015-9565-5.
6
Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial.阿替利珠单抗治疗成人脑卒中和创伤性脑损伤后上肢痉挛性偏瘫的安全性和有效性:一项双盲随机对照试验。
Lancet Neurol. 2015 Oct;14(10):992-1001. doi: 10.1016/S1474-4422(15)00216-1. Epub 2015 Aug 26.
7
A clinically relevant BTX-A injection protocol leads to persistent weakness, contractile material loss, and an altered mRNA expression phenotype in rabbit quadriceps muscles.一种具有临床相关性的肉毒杆菌毒素A注射方案会导致兔股四头肌出现持续性无力、收缩物质损失以及mRNA表达表型改变。
J Biomech. 2015 Jul 16;48(10):1700-6. doi: 10.1016/j.jbiomech.2015.05.018. Epub 2015 Jun 5.
8
High doses of onabotulinumtoxinA in post-stroke spasticity: a retrospective analysis.大剂量A型肉毒杆菌毒素治疗中风后痉挛:一项回顾性分析。
J Neural Transm (Vienna). 2015 Sep;122(9):1283-7. doi: 10.1007/s00702-015-1384-6. Epub 2015 Feb 28.
9
Employment of higher doses of botulinum toxin type A to reduce spasticity after stroke.使用高剂量A型肉毒杆菌毒素减轻中风后的痉挛状态。
J Neurol Sci. 2015 Mar 15;350(1-2):1-6. doi: 10.1016/j.jns.2015.01.033. Epub 2015 Feb 7.
10
Can botulinum toxin type A injection technique influence the clinical outcome of patients with post-stroke upper limb spasticity? A randomized controlled trial comparing manual needle placement and ultrasound-guided injection techniques.A型肉毒毒素注射技术会影响中风后上肢痉挛患者的临床疗效吗?一项比较手工进针法与超声引导注射技术的随机对照试验。
J Neurol Sci. 2014 Dec 15;347(1-2):39-43. doi: 10.1016/j.jns.2014.09.016. Epub 2014 Sep 19.