Bakheit A M, Pittock S, Moore A P, Wurker M, Otto S, Erbguth F, Coxon L
Stroke Unit, Mount Gould Hospital, Plymouth, UK.
Eur J Neurol. 2001 Nov;8(6):559-65. doi: 10.1046/j.1468-1331.2001.00277.x.
To study the efficacy and safety of botulinum toxin type A (BtxA) in the treatment of upper limb muscle spasticity, caused by stroke.
This was a randomized, controlled trial. Patients received either placebo injections or a total of 1000 IU of BtxA (Dysport) into five muscles of the affected arm. Muscle tone was assessed using the Modified Ashworth Scale (MAS). Other outcome measures were the change in the joint range of motion (ROM), the Barthel index, pain score, goal attainment and the subjective evaluation of benefit by patients and investigators. The patients were assessed blind to randomization at baseline and 4, 8, 12 and 16 weeks after treatment.
Fifty nine patients were recruited and received treatment. One patient was lost to follow-up before the last scheduled visit of the study. The group of patients who received BtxA had a significant reduction in the summed MAS score at week 4 compared with the placebo group (P=0.004). The magnitude of benefit over the 16 week follow-up period was significantly reduced for the BtxA group in the wrist (P=0.004) and the finger joints (P=0.001) when compared with the placebo. There was no statistically significant difference between the groups in the joint ROM, muscle pain, goal-attainment or the Barthel index scores at week 4 of the study. At week 16, the BtxA group showed significantly greater improvement in the passive ROM at the elbow (P=0.036). The patients' global assessment of benefit at the end of the study showed that 16 (50%) patients in the placebo group had 'much improved' or had 'some improvement' compared with 24 (92.3%) patients in the BtxA group (P=0.007). The investigators' rating for the same item was 16 (50%) and 23 (88.4%) patients, respectively (P=0.002). Sixteen and twenty patients in the BtxA and placebo groups, respectively, had an adverse event. The most frequently reported adverse events were accidental injury, respiratory and urinary tract infections and muscle pain.
The findings of the present study suggest that treatment with BtxA in a dose of 1000 units reduces muscle tone in patients with post-stroke upper limb spasticity. This effect is sustained for at least 16 weeks. BtxA is safe in the dose used in this study. IMPORTANT NOTE: The authors wish to emphasize that the botulinum toxin preparation used in this study was Dysport (Ipsen Ltd) which has a different therapeutic equivalence from other commercially available product, Botox (Allergan Inc.).
研究A型肉毒毒素（BtxA）治疗中风所致上肢肌肉痉挛的疗效和安全性。
这是一项随机对照试验。患者接受安慰剂注射或向患侧手臂的五块肌肉共注射1000 IU的BtxA（Dysport）。使用改良Ashworth量表（MAS）评估肌张力。其他结局指标包括关节活动范围（ROM）的变化、Barthel指数、疼痛评分、目标达成情况以及患者和研究者对获益的主观评价。在基线以及治疗后4、8、12和16周对患者进行评估，评估时患者对随机分组情况不知情。
招募了59例患者并接受治疗。1例患者在研究的最后一次预定访视前失访。与安慰剂组相比，接受BtxA治疗的患者在第4周时MAS总分显著降低（P = 0.004）。与安慰剂组相比，BtxA组在16周随访期内手腕（P = 0.004）和手指关节（P = 0.001）的获益程度显著降低。在研究的第4周，两组在关节ROM、肌肉疼痛、目标达成情况或Barthel指数评分方面无统计学显著差异。在第16周时，BtxA组在肘关节被动ROM方面显示出显著更大的改善（P = 0.036）。研究结束时患者对总体获益的评估显示，安慰剂组有16例（50%）患者“明显改善”或“有所改善”，而BtxA组有24例（92. – 3%）患者（P = 0.007）。研究者对同一项目的评分分别为16例（50%）和23例（88.4%）患者（P = 0.002）。BtxA组和安慰剂组分别有16例和20例患者发生不良事件。最常报告的不良事件是意外伤害、呼吸道和泌尿道感染以及肌肉疼痛。
本研究结果表明，1000单位剂量的BtxA治疗可降低中风后上肢痉挛患者的肌张力。这种效果至少持续16周。本研究中使用的BtxA剂量是安全的。重要提示：作者希望强调，本研究中使用的肉毒毒素制剂是Dysport（益普生有限公司），其治疗等效性与其他市售产品保妥适（艾尔建公司）不同。
