Khatkova S E, Pogoreltseva O A, Orlova O R, Konovalova Z N, Yakovleva P N, Zakharov D V, Korenko A N, Krasavina D A, Kostenko E V, Abramov V G, Dudin V A, Novikov S A
A.I. Burnasyan Federal Medical Biophysical Center, Moscow, Russia.
National Medical Research, Treatment and Rehabilitation Center, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(12):79-85. doi: 10.17116/jnevro202412412179.
Evaluation of the safety and effectiveness of Relatox, botulinum toxin type A in patients with focal spasticity (FS) of the upper limb as a result of a cerebrovascular accident (CVA) or traumatic brain injury (TBI).
A multicenter, prospective, single-blinded, randomized, comparative clinical study included 210 patients of both sexes aged 18-75 years after moderate to severe TBI and CVA in seven sites in the Russian Federation. The patients were randomized into two groups. Group 1 patients (=105) with focal spasticity of the upper limb received Relatox injections into the muscles of the target pathological patterns (flexion of the elbow, hand, or fingers); Group 2 patients (=105) received Dysport injections (reference agent). The drugs were injected with electromyographic (EMG) or ultrasound (US) control at a dose of no more than 400 Units of Relatox or 1000 Units of Dysport. Botulinum therapy was administered to patients for the first time or repeatedly, but not earlier than 3 months after CVA or TBI and 3 months (12 weeks) after the previous injection. At 4 and 12 weeks, spasticity was assessed using the Modified Ashworth Scale (MAS) for the muscles of the target spasticity pattern of the upper limb, the severity of disability was used to assess the Disability Assessment Scale (DAS), the severity of pain was evaluated using to the Numerical Pain Rating Scale (NPRS), and the satisfaction with treatment was measured by the Patient Global Impression of Improvement (PGI-I). The rate of adverse events (AEs) was reported.
A decrease in spasticity (decrease in MAS values) was shown in both groups without statistically significant intergroup differences at 4 weeks after injection for the muscles of the leading spasticity pattern of the upper limb (efficacy was assessed jointly for all target patterns) compared to the total score at the screening visit. The effect persisted for 12 weeks (more pronounced in the Relatox group). A significant decrease in pain severity according to the NPRS scale without significant intergroup differences was reported in both groups (slightly greater in Relatox group patients). The decrease in the mean DAS score with a statistically significant intergroup difference in hygiene, dressing, and overall well-being according to the PGI-I overall improvement scale was also greater in patients who received Relatox. Few local and systemic AEs were reported in both groups, with no intergroup differences. There were no significant deviations in laboratory parameters.
The results indicate the safety, good tolerability, and efficacy of Relatox in patients with focal spasticity of the upper limb after focal brain damage due to CVA or TBI, comparable and even slightly longer in duration than those of Dysport, which supports its widespread use in the rehabilitation.
评估Relatox（A型肉毒毒素）对因脑血管意外（CVA）或创伤性脑损伤（TBI）导致上肢局灶性痉挛（FS）患者的安全性和有效性。
一项多中心、前瞻性、单盲、随机、对照临床研究纳入了俄罗斯联邦七个地点的210例年龄在18 - 75岁之间、患有中度至重度TBI和CVA的男女患者。患者被随机分为两组。第1组患者（n = 105）上肢局灶性痉挛，接受Relatox注射到目标病理模式的肌肉（肘部、手部或手指屈曲）；第2组患者（n = 105）接受Dysport注射（对照剂）。药物在肌电图（EMG）或超声（US）控制下注射，Relatox剂量不超过400单位，Dysport剂量不超过1000单位。肉毒毒素治疗首次或重复给予患者，但不早于CVA或TBI后3个月以及上次注射后3个月（12周）。在4周和12周时，使用改良Ashworth量表（MAS）评估上肢目标痉挛模式肌肉的痉挛程度，使用残疾评估量表（DAS）评估残疾严重程度，使用数字疼痛评分量表（NPRS）评估疼痛严重程度，通过患者总体改善印象（PGI - I）测量治疗满意度。报告不良事件（AE）发生率。
与筛查访视时的总分相比，两组在上肢主要痉挛模式肌肉注射后4周时痉挛均有减轻（MAS值降低），组间差异无统计学意义（对所有目标模式联合评估疗效）。效果持续12周（Relatox组更明显）。两组根据NPRS量表疼痛严重程度均显著降低，组间差异无统计学意义（Relatox组患者略大）。接受Relatox治疗的患者，根据PGI - I总体改善量表，在卫生、穿衣和总体幸福感方面，平均DAS评分降低且组间差异有统计学意义。两组均报告了少量局部和全身AE，组间无差异。实验室参数无显著偏差。
结果表明Relatox对因CVA或TBI导致局灶性脑损伤后上肢局灶性痉挛患者具有安全性、良好的耐受性和有效性，与Dysport相当，甚至持续时间略长，支持其在康复中广泛应用。
