Botulinum toxin versus trihexyphenidyl in cervical dystonia

Botulinum toxin versus trihexyphenidyl in cervical dystonia
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肉毒杆菌毒素与苯海索治疗颈肌张力障碍

DOI:
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发表时间:
1996
期刊:
影响因子:
9.9
通讯作者:
J. D. Speelman
J. D. Speelman
中科院分区:
医学1区
文献类型:
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作者:
J. Brans;R. Lindeboom;PhD Snoek J.W. MD;M. Zwarts;T. V. van Weerden;E. Brunt;J. V. van Hilten;W. van der Kamp;M. Prins;J. D. Speelman

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背景资料:A型肉毒毒素(BTA)正在取代苯海索作为治疗特发性颈肌张力障碍(ICD)的首选药物,但从未进行过直接的比较研究。方法:本试验采用前瞻性、随机、双盲设计,比较BTA与苯海索的疗效。66例ICD患者随机接受苯海索片加安慰剂注射或安慰剂片加BTA注射治疗。按照固定的时间表每天给药。在进入研究时和8周后再次在EMG指导下注射Dysport或生理盐水。在基线和12周后通过不同的临床评定量表评估患者的疗效。结果:64例患者完成了研究,每组32例。BTA的平均剂量为292个小鼠单位(第一阶段)和262个小鼠单位(第二阶段)。苯海索的平均剂量为16.25 mg。多伦多西部痉挛性斜颈评定量表(TWSTRS-残疾)的残疾部分(主要结局)、Tsui量表和一般健康感知子量表的变化显著有利于BTA。更多接受BTA治疗的患者在TWSTRS残疾(14对6)和Tsui量表(23对12)上至少改善3分。BTA组的不良反应发生率明显较低。结论:BTA治疗ICD疗效显著,不良反应少。神经病学1996;46:1066-1072
Background: Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. Methods: This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind design. Sixty-six consecutive patients with ICD were randomized to treatment with trihexyphenidyl tablets plus placebo injection or placebo tablets plus BTA injections. Table tswere administered daily according to a fixed schedule. Dysport or saline was injected under EMG guidance at study entry and again after 8 weeks. Patients were assessed for efficacy at baseline and after 12 weeks by different clinical rating scales. Results: Sixty-four patients completed the study, 32 in each group. Mean dose of BTA was 292 mouse units (first session) and 262 mouse units (second session). Mean dose of trihexyphenidyl was 16.25 mg. The changes on the Disability section of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-Disability) (primary outcome), Tsui Scale, and the General Health Perception Subscale were significantly in favor of BTA. More patients treated with BTA had an improvement of at least three points on the TWSTRS-Disability (14 versus 6) and on the Tsui Scale (23 versus 12). Adverse effects were significantly less frequent in the BTA group. Conclusion: BTA is significantly more effective in the treatment of ICD, with less adverse effects. NEUROLOGY 1996;46: 1066-1072
DOI: 10.1056/nejm199101033240101
发表时间: 1991-01-03
影响因子: 158.5
作者:
WEIDNER, N;SEMPLE, JP;FOLKMAN, J
通讯作者: FOLKMAN, J