Jahangir A W, Tan H J, Norlinah M I, Nafisah W Y, Ramesh S, Hamidon B B, Raymond A A
Department of Medicine, Faculty of Medicine, Hospital Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, 56000 Cheras, Kuala Lumpur.
Med J Malaysia. 2007 Oct;62(4):319-22.
Botulinum toxin is effective in reducing spasticity post stroke. As there are limited data on post stroke spasticity in Asia, we undertake this study to determine the effectiveness and safety of intramuscular injection of botulinum toxin type-A (BTX-A), in the treatment of chronic focal post-stroke hand spasticity, and the impact of BTX-A on the activities of daily living and quality of life, in comparison to placebo, in Malaysian stroke patients. This was a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of BTX-A in 27 subjects with wrist and finger spasticity after a stroke. The outcome measures were assessed with the Modified Ashworth Scale (MAS) to assess spasticity of the flexor muscles, Barthel Index (BI) for activities of daily living and EQ-5D and EQ VAS for quality of life. Assessments were performed at baseline and 1 and 3 months after injection. Compared to placebo, the BTX-A group had greater improvement in the flexor tone of the wrist and fingers (p = 0.001 and p < 0.001, respectively), at first month follow-up visit and sustained the improvement through to three months. Although there was an improvement in the measures of global function and quality of life in the BTX-A group, there was no significant improvement in between the two groups. No serious BTX-A related adverse effects were reported. The results of this study demonstrate that intramuscular injection of botulinum toxin A is safe and effective in the treatment of chronic focal post-stroke spasticity of the hand.
肉毒杆菌毒素在减轻中风后痉挛方面有效。由于亚洲关于中风后痉挛的数据有限,我们开展这项研究,以确定肌肉注射A型肉毒杆菌毒素(BTX-A)治疗马来西亚中风患者慢性局灶性中风后手部痉挛的有效性和安全性,以及BTX-A对日常生活活动和生活质量的影响,并与安慰剂进行比较。这是一项随机、双盲、安慰剂对照研究,旨在评估BTX-A对27名中风后手腕和手指痉挛患者的疗效和安全性。通过改良Ashworth量表(MAS)评估屈肌痉挛程度,用Barthel指数(BI)评估日常生活活动能力,用EQ-5D和EQ VAS评估生活质量。在基线、注射后1个月和3个月进行评估。与安慰剂组相比,BTX-A组在首次随访的第1个月时手腕和手指的屈肌肌张力有更大改善(分别为p = 0.001和p < 0.001),并持续改善至3个月。虽然BTX-A组的整体功能和生活质量指标有所改善,但两组之间无显著差异。未报告与BTX-A相关的严重不良反应。本研究结果表明,肌肉注射肉毒杆菌毒素A治疗慢性局灶性中风后手部痉挛是安全有效的。