Bakheit A M, Thilmann A F, Ward A B, Poewe W, Wissel J, Muller J, Benecke R, Collin C, Muller F, Ward C D, Neumann C
Stroke Unit, Mount Gould Hospital, Plymouth, UK.
Stroke. 2000 Oct;31(10):2402-6. doi: 10.1161/01.str.31.10.2402.
We sought to define an effective and safe dose of botulinum toxin type A (Dysport) for the treatment of upper limb muscle spasticity due to stroke.
This was a prospective, randomized, double-blind, placebo-controlled, dose-ranging study. Patients received either a placebo or 1 of 3 doses of Dysport (500, 1000, 1500 U) into 5 muscles of the affected arm. Efficacy was assessed periodically by the Modified Ashworth Scale and a battery of functional outcome measures.
Eighty-three patients were recruited, and 82 completed the study. The 4 study groups were comparable at baseline with respect to their demographic characteristics and severity of spasticity. All doses of Dysport studied showed a significant reduction from baseline of muscle tone compared with placebo. However, the effect on functional disability was not statistically significant and was best at a dose of 1000 U. There were no statistically significant differences between the groups in the incidence of adverse events.
The present study suggests that treatment with Dysport reduces muscle tone in patients with poststroke upper limb spasticity. Treatment was effective at doses of Dysport of 500, 1000, and 1500 U. The optimal dose for treatment of patients with residual voluntary movements in the upper limb appears to be 1000 U. Dysport is safe in the doses used in this study.
我们试图确定一种有效且安全的A型肉毒毒素（丽舒妥）剂量，用于治疗中风所致的上肢肌肉痉挛。
这是一项前瞻性、随机、双盲、安慰剂对照、剂量范围研究。患者接受安慰剂或3种剂量（500、1000、1500单位）的丽舒妥之一，注射到患侧手臂的5块肌肉中。通过改良Ashworth量表和一系列功能结局指标定期评估疗效。
招募了83名患者，82名完成了研究。4个研究组在基线时的人口统计学特征和痉挛严重程度方面具有可比性。与安慰剂相比，所有研究剂量的丽舒妥均显示肌张力较基线有显著降低。然而，对功能障碍的影响无统计学意义，且在1000单位剂量时效果最佳。各组不良事件发生率无统计学差异。
本研究表明，丽舒妥治疗可降低中风后上肢痉挛患者的肌张力。500、1000和1500单位剂量的丽舒妥治疗均有效。对于上肢仍有自主运动的患者，最佳治疗剂量似乎为1000单位。本研究中使用的丽舒妥剂量是安全的。
