Gaid Moheb, Brown Caroline, Ippolito Mario, Degtiar Vadim, Maisonobe Pascal, Orridge Samantha
Colman Centre for Specialist Rehabilitation Services, Norwich, UK.
York and Scarborough Teaching Hospitals NHS Foundation Trust, York, UK.
NeuroRehabilitation. 2025 Jun;56(4):525-534. doi: 10.1177/10538135251325755. Epub 2025 Mar 20.
BackgroundAbobotulinumtoxinA (aboBoNT-A) is approved worldwide in indications related to excessive muscle activity, including focal upper and lower limb spasticity.ObjectiveWe evaluated real-world outcomes associated with on-label use of aboBoNT-A for adult focal spasticity in UK routine clinical practice.MethodsThis was a multicenter, retrospective, 52-week study analyzing data from patients who had received ≥1 injection of aboBoNT-A in line with the Summary of Product Characteristics. Primary endpoints were the average aboBoNT-A dose received per treatment cycle and average interval between cycles.ResultsFor the 108 patients included, the median (Q1, Q3) age was 52.5 (41.0, 69.0) years and the most common underlying neurological condition was stroke (61.1%). The mean (SD) total dose of aboBoNT-A received was 540.8 (268.5) U (cycle 1), 586.1 (279.4) U (cycle 2), 558.0 (258.5) U (cycle 3), and 464.3 (209.6) U (cycle 4). The mean (SD) interval between cycles was 153.8 (56.9) days. Of 82 goals assessed, 71 (86.6%) were achieved. Seven patients (5.8%) in the safety population (= 121) experienced adverse events, none of which were considered related to aboBoNT-A treatment.ConclusionsThese data further document aboBoNT-A as an effective and well-tolerated treatment for adult focal spasticity, supporting use in clinical practice.
背景
阿柏西普肉毒杆菌毒素A(aboBoNT - A)在全球范围内被批准用于与肌肉活动过度相关的适应症,包括局灶性上肢和下肢痉挛。
目的
我们评估了在英国常规临床实践中,按照药品说明书使用aboBoNT - A治疗成人局灶性痉挛的实际疗效。
方法
这是一项多中心、回顾性、为期52周的研究,分析了符合产品特性摘要接受≥1次aboBoNT - A注射的患者数据。主要终点是每个治疗周期接受的aboBoNT - A平均剂量以及周期之间的平均间隔时间。
结果
纳入的108例患者中,年龄中位数(四分位间距)为52.5(41.0,69.0)岁,最常见的潜在神经疾病是中风(61.1%)。接受的aboBoNT - A总平均(标准差)剂量在第1周期为540.8(268.5)单位,第2周期为586.1(279.4)单位,第3周期为558.0(258.5)单位,第4周期为464.3(209.6)单位。周期之间的平均(标准差)间隔时间为153.8(56.9)天。在评估的82个目标中,71个(86.6%)得以实现。安全人群(n = 121)中有7例患者(5.8%)发生不良事件,其中无一例被认为与aboBoNT - A治疗相关。
结论
这些数据进一步证明aboBoNT - A是治疗成人局灶性痉挛的一种有效且耐受性良好的疗法,支持其在临床实践中的应用。