Brashear Allison, McAfee Anita L, Kuhn Elizabeth R, Ambrosius Walter T
Department of Neurology, Indiana University School of Medicine, Indianapolis, IN 46202-5250, USA.
Arch Phys Med Rehabil. 2003 Jan;84(1):103-7. doi: 10.1053/apmr.2003.50070.
To determine if botulinum toxin type B (MyoBloc) decreases spasticity.
Investigator-initiated trial, open-label, single-treatment session.
Single site.
Ten patients with stable upper-limb spasticity and an Ashworth Scale score of 2 or higher at the elbow, wrist, and fingers.
Total dose of 10,000U of botulinum toxin type B injected into 5 major muscles.
The Ashworth Scale, goniometry, and functional assessments were performed at injection and weeks 4, 8, and 12. The principal investigator (PI) global assessment of change (GAC) and the patient GAC were done at weeks 4, 8, and 12 postinjection. The safety of the procedure was measured by adverse events and vital signs.
Improvements in Ashworth Scale scores were observed at weeks 4, 8, and 12 postinjection. At week 4, the mean changes (in Ashworth score) were elbow, -1.0 (P=.016); wrist, -1.7 (P=.004); finger, -1.35 (P=.02); at week 8: elbow, -.83 (P=.016); wrist, -1.00 (P=.016); finger, -.94 (P=.08); and at week 12: elbow, -.61 (P=.07); wrist, -1.00 (P=.016); and finger, -.89 (P=.10). The PI GAC improved at all visits. Nine of the 10 subjects reported dry mouth at week 4, with resolution by week 12. No changes were seen on the functional measures.
Botulinum toxin type B may be useful in treatment of spasticity.
确定B型肉毒毒素(MyoBloc)是否能减轻痉挛。
研究者发起的试验,开放标签,单次治疗。
单一研究点。
10例上肢痉挛稳定且肘部、腕部和手指的Ashworth量表评分达到2级或更高的患者。
将10000U的B型肉毒毒素注射到5块主要肌肉中。
在注射时以及第4、8和12周进行Ashworth量表评估、角度测量和功能评估。在注射后第4、8和12周进行主要研究者(PI)的整体变化评估(GAC)和患者GAC。通过不良事件和生命体征来衡量该治疗程序的安全性。
注射后第4、8和12周观察到Ashworth量表评分有所改善。在第4周,(Ashworth评分的)平均变化为:肘部,-1.0(P = 0.016);腕部,-1.7(P = 0.004);手指,-1.35(P = 0.02);在第8周:肘部,-0.83(P = 0.016);腕部,-1.00(P = 0.016);手指,-0.94(P = 0.08);在第12周:肘部,-0.61(P = 0.);腕部,-1.00(P = 0.016);手指,-0.89(P = 0.10)。PI GAC在所有访视时均有改善。10名受试者中有9名在第4周报告口干,至第12周症状缓解。功能测量方面未见变化。
B型肉毒毒素可能对痉挛治疗有效。