Jost W H, Kohl A, Brinkmann S, Comes G
Department of Neurology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany.
J Neural Transm (Vienna). 2005 Jul;112(7):905-13. doi: 10.1007/s00702-004-0234-8. Epub 2004 Nov 3.
This randomized controlled trial was performed to compare the novel botulinum toxin type A free of complexing proteins (NT 201) with the marketed preparation BOTOX degrees regarding efficacy and tolerability.
Fourteen healthy volunteers received a single intramuscular injection into the extensor digitorum brevis (EDB) muscle of either 4 units NT 201, or 4 units of BOTOX degrees randomised by foot. Compound muscle action potential (CMAP) measurements were recorded for up to 90 days after injection.
Both drugs produced a maximum decline between Day 7 and Day 14. At Day 90, administration of both drugs resulted in approximately a 40% CMAP decline as compared to baseline. Duration of paralytic effect was comparable in both groups, at all response thresholds tested. Both drugs were well tolerated.
The effects of small amounts of NT 201 and BOTOX degrees injected into the EDB muscle are comparable in terms of efficacy, time to onset of action, duration of action, and tolerability.
开展这项随机对照试验，以比较不含复合蛋白的新型A型肉毒毒素（NT 201）与市售制剂保妥适在疗效和耐受性方面的差异。
14名健康志愿者被随机分为两组，分别向其趾短伸肌（EDB）肌肉内注射4单位NT 201或4单位保妥适。在注射后长达90天的时间内记录复合肌肉动作电位（CMAP）测量值。
两种药物均在第7天至第14天之间出现最大降幅。在第90天时，与基线相比，两种药物的使用均导致CMAP下降约40%。在所有测试的反应阈值下，两组的麻痹效应持续时间相当。两种药物的耐受性均良好。
向EDB肌肉注射少量NT 201和保妥适，在疗效、起效时间、作用持续时间和耐受性方面效果相当。
