Department of Clinical Neuroscience, Graduate School of Medicine, Tokushima University, Tokushima 770-8503, Japan.
National Hospital Organization Utano Hospital, Kyoto 616-8255, Japan.
Toxins (Basel). 2022 Oct 28;14(11):739. doi: 10.3390/toxins14110739.
All the currently used type A botulinum neurotoxins for clinical uses are of subtype A1. We compared the efficacy and safety for the first time head-to-head between a novel botulinum toxin A2NTX prepared from subtype A2 and onabotulinumtoxinA (BOTOX) derived from A1 for post-stroke spasticity. We assessed the modified Ashworth scale (MAS) of the ankle joint, the mobility scores of Functional Independence Measure (FIM), and the grip power of the unaffected hand before and after injecting 300 units of BOTOX or A2NTX into calf muscles. The procedure was done in a blinded manner for the patient, the injecting physician, and the examiner. Stroke patients with chronic spastic hemiparesis (15 for A2NTX and 16 for BOTOX) were enrolled, and 11 for A2NTX and 13 for BOTOX (MAS of ankle; > or = 2) were entered for the MAS study. Area-under-curves of changes in MAS (primary outcome) were greater for A2NTX by day 30 ( = 0.044), and were similar by day 60. FIM was significantly improved in the A2NTX group ( = 0.005), but not in the BOTOX group by day 60. The hand grip of the unaffected limb was significantly decreased in the BOTOX-injected group ( = 0.002), but was unaffected in the A2NTX-injected group by day 60, suggesting there was less spread of A2NTX to the upper limb than there was with BOTOX. Being a small-sized pilot investigation with an imbalance in the gender of the subjects, the present study suggested superior efficacy and safety of A2NTX, and warrants a larger scale clinical trial of A2NTX to confirm these preliminary results.
所有目前用于临床的 A 型肉毒毒素都是 A1 亚型。我们首次对头对头比较了新型 A2 型肉毒毒素 A2NTX（由 A2 型制备）和 A1 型制备的肉毒毒素（BOTOX）治疗脑卒中后痉挛的疗效和安全性。我们评估了小腿肌肉注射 300 单位 BOTOX 或 A2NTX 前后踝关节改良 Ashworth 量表（MAS）、功能性独立测量（FIM）移动评分和未受累手握力。患者、注射医师和检查者对该过程均采用盲法。入组了 15 例 A2NTX 和 16 例 BOTOX 的慢性偏瘫痉挛患者，其中 11 例 A2NTX 和 13 例 BOTOX（踝关节 MAS；>或=2）纳入 MAS 研究。30 天时 A2NTX 变化曲线下面积（AUC）（主要结局）更大（=0.044），60 天时相似。A2NTX 组 FIM 显著改善（=0.005），但 BOTOX 组 60 天时无改善。60 天时 BOTOX 组未受累手的握力显著下降（=0.002），而 A2NTX 组无影响，提示 A2NTX 向上肢扩散较 BOTOX 少。由于该研究为性别不平衡的小型先导研究，本研究提示 A2NTX 具有更好的疗效和安全性，需要进行更大规模的 A2NTX 临床试验来确认这些初步结果。
