Rollnik J D, Matzke M, Wohlfarth K, Dengler R, Bigalke H
Department of Neurology and Clinical Neurophysiology, Medical School of Hannover, Germany.
Eur Neurol. 2000;43(1):9-12. doi: 10.1159/000008121.
Several studies support the hypothesis that low-dose botulinum toxin treatment may be as beneficial as high-dose regimen. Therefore, we studied 115 patients (aged 27-84; mean 58.0, SD = 12.9 years; 68% females, 32% males) suffering from cervical dystonia (n = 66), blepharospasm (n = 28), and facial hemispasm (n = 21) over a period of 2 years in an open label, non-controlled pilot study. Patients received low-dose treatment with botulinum toxin type A (Dysport((R))). The toxin was diluted in 20 ml of 0.1% albumin solution to arrive at a concentration of 25 MU/ml and injected under EMG control. Patients responded to the treatment about 1 week after injection (mean 7.3 days, SD = 4.6). The mean duration of beneficial effects was 11.7 weeks (SD = 5.6). Patients evaluated the clinical global improvement on a scale ranging from 0 to 4. For the whole population, the mean was 2.7 points (SD = 1.1). In none of the subjects could antibodies to botulinum toxin type A be detected, and only a few side effects were observed. In conclusion, low-dose therapy with botulinum toxin A merits further controlled studies.
多项研究支持低剂量肉毒杆菌毒素治疗可能与高剂量方案同样有效的假说。因此，我们在一项开放标签、非对照的试点研究中，对115例患者（年龄27 - 84岁；平均58.0岁，标准差 = 12.9岁；女性68%，男性32%）进行了为期2年的研究，这些患者患有颈部肌张力障碍（n = 66）、眼睑痉挛（n = 28）和面部痉挛（n = 21）。患者接受了A型肉毒杆菌毒素（Dysport((R))）的低剂量治疗。毒素用20毫升0.1%白蛋白溶液稀释，使其浓度达到25 MU/ml，并在肌电图控制下注射。患者在注射后约1周（平均7.3天，标准差 = 4.6）对治疗产生反应。有益效果的平均持续时间为11.7周（标准差 = 5.6）。患者用0至4的量表评估临床总体改善情况。对于全体患者，平均值为2.7分（标准差 = 1.1）。在所有受试者中均未检测到抗A型肉毒杆菌毒素抗体，且仅观察到少数副作用。总之，A型肉毒杆菌毒素低剂量疗法值得进一步进行对照研究。
