Neuromuscular agents

神经肌肉剂
  • 文章类型: Journal Article
    目的:研究慢性偏头痛(CM)患者在治疗后头痛天数/月减少至<15天/月时,持续的单曲霉素A治疗反应的长期(56周)益处。
    背景:在经历CM的患者中,关于每月头痛天数减少至与发作性偏头痛一致的水平的数据有限。了解CM中持续预防性治疗反应的影响可以提供有关成功治疗影响的重要信息。
    方法:两个3期研究评估偏头痛预防治疗成人中的onabotulinumtoxinA治疗试验包括24周,随机化,双盲,安慰剂对照阶段和32周开放标签阶段。合并数据以确定在双盲期(第21-24周;任何连续12周;第13-24周)和整个研究(第53-56周;任何连续12周;任何4周期间)的几个时间段期间在治疗期间具有<15天/月头痛的个体的比例。我们评估了六项头痛影响测试(HIT-6)和偏头痛特定生活质量问卷2.1版(MSQv2.1)对平均每月头痛天数和基线变化的长期影响。
    结果:我们分析了1384名患有慢性偏头痛的参与者n=688;安慰剂,n=696;开放标签:n=688[单糖霉素A])。在完成完整的56周治疗期之前,对onabotulinumtoxinA和安慰剂的停药率为25.4%(n=175)和29.3%(n=204),分别。在双盲阶段的第13-24周,与安慰剂治疗(342/696[49.1%])相比,接受单苯磺胺毒素A治疗(386/688[56.1%])的患者头痛天数<15天/月(p=0.010),与安慰剂反应者相比,onabotulinumtoxinA每月头痛天数更少。在第25-56周,使用onabotulinumtoxinA达到<15个月头痛日的参与者比例为60.9%(419/688),在第53-56周,为81.1%(558/688),在任何连续12周内为79.4%(546/688)周。HIT-6和MSQv2.1问卷相对于基线的平均变化在所有时期都超过了组内最小重要差异阈值。在第24周,在第21-24周期间达到<15个月头痛日的接受过奥溴霉素A治疗的参与者的平均HIT-6评分降低幅度更大(-6.5vs.-1.4)和更大的平均MSQv2.1角色-功能限制性得分改善(21.3vs.6.4)比同期未达到<15个月头痛日的人。
    结论:与保持在或高于15个月头痛天数阈值的参与者相比,使用onabotulinumtoxinA治疗达到<15个月头痛天数的参与者在头痛相关残疾和偏头痛特异性生活质量方面取得了有意义的益处。在56周内观察到的持续益处支持长期使用抗菌药毒素A预防CM。
    OBJECTIVE: To characterize the long-term (56-week) benefits of continuous onabotulinumtoxinA treatment response in individuals with chronic migraine (CM) who achieved reduction to <15 headache days/month with treatment.
    BACKGROUND: There are limited data exploring reductions in monthly headache days to levels consistent with episodic migraine among those experiencing CM. Understanding the impact of sustained preventive treatment response in CM can provide important information about the impact of successful therapy.
    METHODS: The two Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy trials of onabotulinumtoxinA in adults included a 24-week, randomized, double-blind, placebo-controlled phase and a 32-week open-label phase. Data were pooled to determine proportions of individuals with <15 headache days/month while on treatment during several time periods in the double-blind phase (Weeks 21-24; any 12 consecutive weeks; Weeks 13-24) and the entire study (Weeks 53-56; any 12 consecutive weeks; any 4-week period). We assessed the long-term impact on mean monthly headache days and changes from baseline on the six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life questionnaire version 2.1 (MSQv2.1).
    RESULTS: We analyzed 1384 participants with chronic migraine (double-blind: onabotulinumtoxinA, n = 688; placebo, n = 696; open-label: n = 688 [onabotulinumtoxinA]). The discontinuation rates prior to the completion of the full 56-week treatment period for onabotulinumtoxinA and placebo were 25.4% (n = 175) and 29.3% (n = 204), respectively. During Weeks 13-24 of the double-blind phase, significantly more onabotulinumtoxinA-treated (386/688 [56.1%]) than placebo-treated (342/696 [49.1%]) individuals had <15 headache days/month (p = 0.010), with fewer monthly headache days for onabotulinumtoxinA versus placebo responders. The proportions of participants achieving <15 monthly headache days with onabotulinumtoxinA were 60.9% (419/688) at Weeks 25-56, 81.1% (558/688) at Weeks 53-56, and 79.4% (546/688) during any consecutive 12-week period. Mean changes from baseline on the HIT-6 and MSQv2.1 questionnaire surpassed within-group minimal important difference thresholds in all periods. At Week 24, onabotulinumtoxinA-treated participants who achieved <15 monthly headache days during Weeks 21-24 had a greater mean HIT-6 score reduction (-6.5 vs. -1.4) and greater mean MSQv2.1 Role-Function Restrictive score improvements (21.3 vs. 6.4) than those who did not achieve <15 monthly headache days during the same period.
    CONCLUSIONS: Participants who achieved <15 monthly headache days with onabotulinumtoxinA treatment achieved meaningful benefits in headache-related disability and migraine-specific quality of life compared with those who remained at or above the 15-monthly headache days threshold. Sustained benefits observed over 56 weeks support long-term onabotulinumtoxinA use for the prevention of CM.
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  • 文章类型: English Abstract
    A recent publication in the Nederlands Tijdschrift Voor Tandheelkunde (Dutch Journal of Dentistry) suggests botulinum toxin as a primary treatment for bruxism, especially for severe complaints of teeth grinding or jaw clenching. However, in the opinion of Lobbezoo et al., some outdated views on bruxism are used, and botulinum toxin is incorrectly classified as safe, according to them. In this Vision article, the authors describe the current insights into bruxism; they indicate how the presence of bruxism can be assessed in the clinic; when and how bruxism is treated; and finally, what the role of botulinum toxin is: an ultimum refugium. Therefore, regarding the use of botulinum toxin within the discipline of orofacial pain and dysfunction Lobbezoo et al. recommend: think twice!
    In een recente publicatie in het Nederlands Tijdschrift Voor Tandheelkunde wordt botulinetoxine gesuggereerd als een primaire behandeling voor bruxisme, vooral bij ernstige klachten van tandenknarsen of kaakklemmen. Daarbij worden volgens Lobbezoo et al. echter enige achterhaalde opvattingen over bruxisme gehanteerd en wordt botulinetoxine volgens hen ten onrechte als veilig gekwalificeerd. In dit Visie-artikel gaan de auteurs in op de huidige inzichten over bruxisme, geven ze aan hoe de aanwezigheid van bruxisme in de kliniek vastgesteld kan worden, wanneer en hoe bruxisme wordt behandeld en tot slot wat de plek van botulinetoxine daarbij is: een ultimum refugium. Lobbezoo et al. adviseren omtrent het toepassen van botulinetoxine binnen de discipline orofaciale pijn en disfunctie derhalve: bezint eer ge begint!
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  • 文章类型: Journal Article
    这项研究的目的是评估A型肉毒杆菌毒素治疗青少年难治性膀胱过度活动症的临床有效性和安全性。回顾性分析2018年1月至2023年8月杭州市第三人民医院泌尿外科收治的37例青少年难治性膀胱过度活动症患者。这些患者接受10U/mL浓度的A型肉毒毒素膀胱内注射,平均有20个注射点。我们记录了治疗前和治疗后1个月的排尿日记和尿动力学参数的变化。治疗1个月后,在几个参数中观察到了显著的改善,当与预处理值比较时。这些包括白天排尿频率(11.13±6.45),平均单个空隙体积(173.24±36.48)mL,夜间排尿频率(2.43±0.31),紧急发作(3.12±0.27),初始膀胱容量(149.82±41.34)mL,最大膀胱容量(340.25±57.12)mL(均P<.001)。第一次治疗后,5例患者有轻度血尿,4例患者有尿路感染,1例患者有尿潴留,插管后缓解了。其他患者均未出现严重并发症或不良反应。随访时间6~18个月,疗效持续时间从2到8个月不等。最初治疗失败的八名患者在重新注射后症状缓解。在对常规药物治疗反应不佳的难治性膀胱过度活动症青少年中,A型肉毒毒素可以安全有效地给药。它显着改善了下尿路症状,并提高了这些患者的生活质量。
    The objective of this study was to assess the clinical effectiveness and safety of type A botulinum toxin in the treatment of refractory overactive bladder in adolescents. We conducted a retrospective analysis of 37 adolescent patients with refractory overactive bladder who were treated at the Urology Department of Hangzhou Third People\'s Hospital between January 2018 and August 2023. These patients received intravesical injections of type A botulinum toxin at a concentration of 10 U/mL, with an average of 20 injection points. We recorded changes in urination diaries and urodynamic parameters both before and 1 month after treatment. After 1 month of treatment, significant improvements were observed in several parameters, when compared to the pretreatment values. These included daytime frequency of urination (11.13 ± 6.45), average single void volume (173.24 ± 36.48) mL, nighttime frequency of urination (2.43 ± 0.31), urgency episodes (3.12 ± 0.27), initial bladder capacity (149.82 ± 41.34) mL, and maximum bladder capacity (340.25 ± 57.12) mL (all P < .001). After the first treatment, 5 patients had mild hematuria, 4 patients had urinary tract infection, and 1 patient had urinary retention, which was relieved after catheterization. No serious complications or adverse reactions were observed in other patients. The follow-up period ranged from 6 to 18 months, and the duration of efficacy varied from 2 to 8 months. Eight patients who initially had treatment failure achieved symptom relief after reinjection. In adolescents with refractory overactive bladder who do not respond well to conventional drug therapy, type A botulinum toxin can be administered safely and effectively. It significantly improves lower urinary tract symptoms and enhances the quality of life for these patients.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:卒中后痉挛(PSS)影响高达40%的卒中患者。A型肉毒杆菌神经毒素(BoNT-A)已被证明可以改善痉挛状态,但其应用的最佳时机仍不清楚。虽然已知上肢PSS的几种预测因子,它们在临床实践中与BoNT-A治疗有关的效用尚未完全阐明。COLOSSEO-BoNT研究旨在研究PSS的预测因素以及BoNT-A时机在现实世界中对痉挛相关指标的影响。
    方法:招募将涉及大约960名最近经历过缺血性中风的患者(在10天内,V0),并将随访24个月。参数将以特定的时间间隔收集:(V1)4、(V2)8、(V3)12、(V4)18个月和(V5)登记后24个月。将在整个康复和门诊就诊过程中对患者进行监测,并根据其BoNT-A治疗状态进行比较-区分在不同时间接受治疗的患者和未经治疗而接受康复的患者。潜在的预测因素将包括Fugl-Meyer评估,美国国立卫生研究院卒中量表(NIHSS),中风放射学特征,性能状态,治疗和获得患者护理途径。结果将使用改良的Ashworth量表和被动运动范围评估肌肉僵硬度,以及生活质量的衡量标准,疼痛,和功能。
    背景:本研究经过了生物医学博士基金会伦理委员会的审查和批准,罗马,意大利。不管结果如何,研究结果将通过在同行评审期刊上发表和在国家和国际会议上的演讲来传播。
    背景:NCT05379413。
    BACKGROUND: Poststroke spasticity (PSS) affects up to 40% of patients who had a stroke. Botulinum neurotoxin type A (BoNT-A) has been shown to improve spasticity, but the optimal timing of its application remains unclear. While several predictors of upper limb PSS are known, their utility in clinical practice in relation to BoNT-A treatment has yet to be fully elucidated. The COLOSSEO-BoNT study aims to investigate predictors of PSS and the effects of BoNT-A timing on spasticity-related metrics in a real-world setting.
    METHODS: The recruitment will involve approximately 960 patients who have recently experienced an ischaemic stroke (within 10 days, V0) and will follow them up for 24 months. Parameters will be gathered at specific intervals: (V1) 4, (V2) 8, (V3) 12, (V4) 18 months and (V5) 24 months following enrolment. Patients will be monitored throughout their rehabilitation and outpatient clinic journeys and will be compared based on their BoNT-A treatment status-distinguishing between patients receiving treatment at different timings and those who undergo rehabilitation without treatment. Potential predictors will encompass the Fugl-Meyer assessment, the National Institute of Health Stroke Scale (NIHSS), stroke radiological characteristics, performance status, therapies and access to patient care pathways. Outcomes will evaluate muscle stiffness using the modified Ashworth scale and passive range of motion, along with measures of quality of life, pain, and functionality.
    BACKGROUND: This study underwent review and approval by the Ethics Committee of the Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy. Regardless of the outcome, the findings will be disseminated through publication in peer-reviewed journals and presentations at national and international conferences.
    BACKGROUND: NCT05379413.
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  • 文章类型: Journal Article
    音乐家的针对特定任务的肌张力障碍是精细运动控制的复杂障碍,对其病因了解不完全。肉毒杆菌毒素在上肢任务特异性肌张力障碍中的试验相对较少,先前的研究已经产生了可变的结果,导致人们对这种方法在精英表演者中的实用性持怀疑态度。
    我们进行了双盲,安慰剂对照,随机化,在21名专业音乐家中进行的诺克肉毒杆菌毒素-A的交叉研究,这些音乐家患有局部上肢任务特异性肌张力障碍,影响他们的乐器表现,使用一种新的范例,即初始注射,然后每隔两周和四周进行一次加强注射。主要结果指标是与注册相比,在第8周,两名专家评估者使用临床总体印象数字量表对活动臂的盲性肌张力障碍评分的变化。
    在六年的时间里,有19名男性和2名女性患有音乐家肌张力障碍。19名患者完成了研究。与基线相比,对主要结果指标的分析显示,肌张力障碍严重程度的变化为P=0.04,整体音乐表现的改善为P=0.027。没有观察到临床上明显的弱点,并没有发现毒素的中和抗体。
    尽管样本量很小,我们的研究表明,注射前肉毒杆菌毒素A作为音乐家任务特异性肌张力障碍的治疗有统计学意义.通过加强注射来定制毒素的使用,可以改善给药策略和结果。对患者有意义的益处在视频评估中清晰可见。除了它对音乐家肌张力障碍的应用外,这种方法可能与优化肉毒杆菌毒素在其他形式的局灶性肌张力障碍如眼睑痉挛中的应用有关,宫颈肌张力障碍,作家抽筋,和痉挛性发声障碍.
    UNASSIGNED: Musician\'s focal task-specific dystonia is a complex disorder of fine motor control, with incomplete understanding of its etiology. There have been relatively few trials of botulinum toxin in upper limb task-specific dystonia, and prior studies have yielded variable results, leading to skepticism regarding the utility of this approach in elite performers.
    UNASSIGNED: We conducted a double-blind, placebo-controlled, randomized, cross-over study of incobotulinum toxin-A in 21 professional musicians with focal upper extremity task-specific dystonia affecting performance on their instrument, using a novel paradigm of initial injections followed by booster injections at two- and four-week intervals. The primary outcome measure was the change in blinded dystonia rating of the active arm by two expert raters using a Clinical Global Impression numeric scale at week 8 compared to enrollment.
    UNASSIGNED: 19 men and 2 women with musicians\' dystonia were enrolled over a six-year period. Nineteen patients completed the study. Analysis of the primary outcome measure in comparison to baseline revealed a change in dystonia severity of P = 0.04 and an improvement in overall musical performance of P = 0.027. No clinically significant weakness was observed, and neutralizing antibodies to toxin were not found.
    UNASSIGNED: Despite its small sample size, our study demonstrated a statistically significant benefit of incobotulinum toxin-A injections as a treatment for musicians\' task-specific dystonia. Tailoring the use of toxin with booster injections allowed refinement of dosing strategy and outcomes, with benefits that were meaningful to patients clearly visible on videotaped evaluations. In addition to its application to musicians\' dystonia, this approach may have relevance to optimize application of botulinum toxin in other forms of focal dystonia such as blepharospasm, cervical dystonia, writer\'s cramp, and spasmodic dysphonia.
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  • 文章类型: Journal Article
    背景:超声检查(US)已成为指导肉毒杆菌神经毒素(BoNT)在面部肌肉中注射的重要工具,提高精度和安全性。这篇叙述性评论探讨了美国在BoNT管理中的作用,特别是在复杂的解剖区域,强调其对治疗定制的影响,实时可视化,减少并发症。
    方法:使用PubMed进行了全面的文献检索,MEDLINE,Embase,和Cochrane图书馆,获取2018年1月至2023年12月发表的文章。搜索词包括“肉毒杆菌神经毒素,\“\”面部解剖学,\"\"超声引导注射,“和”面部肌肉超声解剖学。“研究重点是在面部肌肉中进行美国指导的BoNT注射。数据提取和合成由两名审阅者独立进行,专注于研究设计,超声检查技术,结果,和结论。
    结果:评论发现,美国指南通过提供面部肌肉和血管的实时可视化,显着提高了BoNT注射的精度,从而降低不良事件的风险。美国启用量身定制的注射策略,确保对称的面部表情和尽量减少过度治疗。该技术还提供即时反馈,允许现场调整,以提高治疗疗效和安全性。然而,审查确定了局限性,包括不同研究中美国技术的潜在选择偏差和变异性。
    结论:美国对面部肌肉注射BoNT的指导在精确度方面提供了巨大的好处,安全,和治疗定制。尽管有明显的局限性,将US纳入临床实践有望提高患者在美学和治疗过程中的预后.需要进一步的研究来标准化美国技术并扩大研究的包容性,以全面验证这些发现。
    BACKGROUND: Ultrasonography (US) has become an essential tool for guiding botulinum neurotoxin (BoNT) injections in facial muscles, enhancing precision and safety. This narrative review explores the role of US in BoNT administration, particularly in complex anatomical regions, highlighting its impact on treatment customization, real-time visualization, and complication reduction.
    METHODS: A comprehensive literature search was conducted using PubMed, MEDLINE, Embase, and Cochrane Library for articles published from January 2018 to December 2023. Search terms included \"Botulinum neurotoxin,\" \"facial anatomy,\" \"ultrasonography guided injection,\" and \"facial muscle sonoanatomy.\" Studies focusing on US-guided BoNT injections in facial muscles were included. Data extraction and synthesis were performed independently by two reviewers, focusing on study design, ultrasonography techniques, outcomes, and conclusions.
    RESULTS: The review found that US guidance significantly enhances the precision of BoNT injections by providing real-time visualization of facial muscles and blood vessels, thereby reducing the risk of adverse events. US enables tailored injection strategies, ensuring symmetrical facial expressions and minimizing over-treatment. The technique also offers immediate feedback, allowing for on-the-spot adjustments to improve treatment efficacy and safety. However, the review identified limitations, including potential selection bias and variability in US techniques across different studies.
    CONCLUSIONS: US guidance for BoNT injections into facial muscles offers substantial benefits in terms of precision, safety, and treatment customization. Despite the identified limitations, the integration of US into clinical practice is poised to enhance patient outcomes in aesthetic and therapeutic procedures. Further research is needed to standardize US techniques and broaden the inclusivity of studies to validate these findings comprehensively.
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  • 文章类型: Journal Article
    背景:偏瘫肩痛(HSP)是中风后常见的并发症。严重影响上肢运动功能的恢复。偏瘫患者早期肩痛主要是由中枢神经损伤或神经可塑性引起的神经性疼痛。在肩关节中常用的皮质类固醇注射可以减轻肩痛;然而,副作用还包括软组织退化或肌腱脆性增加,长期影响仍然存在争议。肉毒杆菌毒素注射相对较新,被认为可以阻断肩关节腔中疼痛受体的传递,并抑制神经致病物质的产生,以减少神经源性炎症。有研究认为,中风后偏瘫的肩痛是由与肩关节疼痛有关的中枢系统改变引起的,持续性疼痛可能导致皮质感觉中枢或运动中枢的重组。然而,目前尚无确凿的证据表明肉毒杆菌毒素对疼痛的改善是否会影响脑功能。在以前的研究中,肉毒杆菌毒素与糖皮质激素(曲安奈德注射液)治疗肩痛,缺乏观察大脑功能变化的差异。由于以前评估疼痛改善的内容主要是主观的,缺乏客观量化的考核指标。功能性近红外成像(fNIRS)可以解决这个问题。
    方法:本研究方案是为双盲,无肱二头肌长腱鞘炎或肩峰滑囊炎的卒中后HSP患者的随机对照临床试验。78名患者将被随机分配到A型肉毒杆菌毒素组或糖皮质激素组。在基线,每组患者将接受肩部腔注射肉毒杆菌毒素或糖皮质激素,随访1周和4周.主要结果是视觉模拟量表(VAS)上的肩痛变化。次要结果是通过fNIRS成像评估相应脑区的氧合血红蛋白水平变化,肩部屈曲,外部旋转运动范围,上肢Fugl-Meyer,并修改了Ashworth分数。
    结论:超声引导下A型肉毒杆菌毒素肩关节腔注射可能为HSP患者疼痛改善提供证据。这项试验的结果也有助于分析肩痛的变化与脑血流动力学和肩关节运动功能变化之间的相关性。
    背景:中国临床试验注册,ChiCTR2300070132。2023年4月3日注册,https://www。chictr.org.cn/showproj.html?proj=193722。
    BACKGROUND: Hemiplegic shoulder pain (HSP) is a common complication after stroke. It severely affects the recovery of upper limb motor function. Early shoulder pain in hemiplegic patients is mainly neuropathic caused by central nerve injury or neuroplasticity. Commonly used corticosteroid injections in the shoulder joint can reduce shoulder pain; however, the side effects also include soft tissue degeneration or increased tendon fragility, and the long-term effects remain controversial. Botulinum toxin injections are relatively new and are thought to block the transmission of pain receptors in the shoulder joint cavity and inhibit the production of neuropathogenic substances to reduce neurogenic inflammation. Some studies suggest that the shoulder pain of hemiplegia after stroke is caused by changes in the central system related to shoulder joint pain, and persistent pain may induce the reorganization of the cortical sensory center or motor center. However, there is no conclusive evidence as to whether or not the amelioration of pain by botulinum toxin affects brain function. In previous studies of botulinum toxin versus glucocorticoids (triamcinolone acetonide injection) in the treatment of shoulder pain, there is a lack of observation of differences in changes in brain function. As the content of previous assessments of pain improvement was predominantly subjective, objective quantitative assessment indicators were lacking. Functional near-infrared imaging (fNIRS) can remedy this problem.
    METHODS: This study protocol is designed for a double-blind, randomized controlled clinical trial of patients with post-stroke HSP without biceps longus tenosynovitis or acromion bursitis. Seventy-eight patients will be randomly assigned to either the botulinum toxin type A or glucocorticoid group. At baseline, patients in each group will receive shoulder cavity injections of either botulinum toxin or glucocorticoids and will be followed for 1 and 4 weeks. The primary outcome is change in shoulder pain on the visual analog scale (VAS). The secondary outcome is the assessment of changes in oxyhemoglobin levels in the corresponding brain regions by fNIRS imaging, shoulder flexion, external rotation range of motion, upper extremity Fugl-Meyer, and modified Ashworth score.
    CONCLUSIONS: Ultrasound-guided botulinum toxin type A shoulder joint cavity injections may provide evidence of pain improvement in patients with HSP. The results of this trial are also help to analyze the correlation between changes in shoulder pain and changes in cerebral hemodynamics and shoulder joint motor function.
    BACKGROUND: Chinese clinical Trial Registry, ChiCTR2300070132. Registered 03 April 2023, https://www.chictr.org.cn/showproj.html?proj=193722 .
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