Department of Clinical Neuroscience, Institute of Health Biosciences, Tokushima University Graduate School, Tokushima City, Tokushima, Japan.
Curr Med Res Opin. 2010 Aug;26(8):1983-92. doi: 10.1185/03007995.2010.497103.
To evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke upper limb spasticity.
In a multicentre, randomised, double-blind, parallel-group, placebo-controlled study, 109 patients with upper limb spasticity were randomised to receive a single treatment with lower-dose (120-150 U) or higher-dose (200-240 U) BoNTA or placebo into upper limb muscles.
NCT00460564.
The tone of the wrist flexor was assessed at baseline and at weeks 0, 1, 4, 6, 8 and 12 using the Modified Ashworth Scale (MAS) for wrist, finger, thumb and disability in activities of daily living (ADL) was rated using the 4-point Disability Assessment Scale (DAS). The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS wrist score in the higher-dose groups.
Subjects were randomised with 51 in the higher BoNTA group, 26 in the higher-dose placebo group, 21 in the lower BoNTA group and 11 in the lower-dose placebo group. Significant improvement in spasticity with higher-dose BoNTA was demonstrated by a mean difference in the AUC of the change from baseline in the MAS wrist score between the higher-dose BoNTA group and the higher-dose placebo group of -6.830 (p < 0.001, t-test), no significant different was demonstrated between the lower-dose BoNTA group and the lower-dose placebo group (p = 0.215, t-test). Significant improvements with higher-dose BoNTA were also observed in the DAS scores for limb position (p = 0.001-0.022) at all time points and dressing (p = 0.018-0.038, Wilcoxon test) at weeks 6, 8 and 12. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BoNTA-treated and placebo-treated patients. The long-term efficacy and safety, and the effects on rehabilitation of BoNTA on upper limb will be evaluated using the data obtained in the open-label phase.
Higher-dose BoNTA reduced spasticity in upper limb muscles and improved ADL performance in terms of limb position and dressing. BoNTA is safe and effective in the treatment of post-stroke upper limb spasticity.
评估一次性注射肉毒毒素 A（BoNTA）治疗日本脑卒中后上肢痉挛患者的疗效和安全性。
在一项多中心、随机、双盲、平行分组、安慰剂对照研究中，109 例上肢痉挛患者被随机分为接受低剂量（120-150U）或高剂量（200-240U）BoNTA 或安慰剂治疗上肢肌肉。
NCT00460564。
采用改良 Ashworth 量表（MAS）评估腕屈肌的张力，分别在基线和 0、1、4、6、8 和 12 周进行评估。采用 4 分残疾评估量表（DAS）评估日常生活活动（ADL）的残疾程度。主要终点是高剂量组 MAS 腕部评分的变化曲线下面积（AUC）。
51 例患者被随机分配至高剂量 BoNTA 组，26 例患者被随机分配至高剂量安慰剂组，21 例患者被随机分配至低剂量 BoNTA 组，11 例患者被随机分配至低剂量安慰剂组。高剂量 BoNTA 组与高剂量安慰剂组之间，MAS 腕部评分的 AUC 变化的平均差异为-6.830（p < 0.001，t 检验），提示痉挛显著改善，而低剂量 BoNTA 组与低剂量安慰剂组之间无显著差异（p = 0.215，t 检验）。高剂量 BoNTA 还显著改善了 DAS 评分中的肢体位置（p = 0.001-0.022）和穿衣（p = 0.018-0.038，Wilcoxon 检验）在所有时间点，且在第 6、8 和 12 周时。BoNTA 治疗组和安慰剂治疗组之间治疗相关不良事件的频率无临床相关差异。将使用开放标签阶段获得的数据评估 BoNTA 对上肢的长期疗效和安全性以及对康复的影响。
高剂量 BoNTA 降低了上肢肌肉的痉挛程度，并改善了肢体位置和穿衣方面的 ADL 表现。BoNTA 治疗脑卒中后上肢痉挛安全有效。
