Miller Diana, Richardson Diana, Eisa Mahmood, Bajwa Rizma Jalees, Jabbari Bahman
Department of Neurology, Yale University School of Medicine, New Haven, Connecticut 06510, USA.
Pain Med. 2009 Sep;10(6):1012-7. doi: 10.1111/j.1526-4637.2009.00658.x. Epub 2009 Jul 6.
To investigate the efficacy and tolerability of Botulinum neurotoxin-A (BoNT-A) in the patients with refractory neck pain.
An analgesic effect is suggested for BoNT-A by a number of animal studies. Two blinded studies suggested efficacy of BoNT-A in a chronic neck pain.
Forty-seven subjects were enrolled in a prospective, double-blind, placebo-controlled study. A total of 150 to 300 units of BoNT-A were injected into the neck and shoulder muscles based on pain localization. Subjects completed the visual analog scale (VAS), Pain Frequency Questionnaire and the Modified Oswestry Pain Questionnaire (MOPQ) at baseline, 3 and 8 weeks after the treatment. The primary outcomes consisted of: 1) > or =50% improvement on the VAS; and 2) > or =30% reduction in pain day frequency. The secondary outcome was an improvement of ADL in MOPQ. Excellent responders (ERs) were those who met all three outcomes.
At 2 months, a significant reduction in the mean VAS (pain intensity) was noted in the BoNT-A group compared with the placebo (P = 0.0018, CI 95% from 2.51 to 7.89). At 2 months, there were six ERs in the BoNT-A group and one ER in the placebo group (P = 0.0152).
Administration of BoNT-A into the neck and shoulder muscles for treatment of chronic refractory neck pain met one of the two primary outcomes: reduction in pain intensity. More ERs were noted in the Botox group.
探讨A型肉毒杆菌毒素（BoNT-A）治疗难治性颈部疼痛患者的疗效和耐受性。
多项动物研究表明BoNT-A具有镇痛作用。两项双盲研究提示BoNT-A对慢性颈部疼痛有效。
47名受试者纳入一项前瞻性、双盲、安慰剂对照研究。根据疼痛部位，将总共150至300单位的BoNT-A注射到颈部和肩部肌肉。受试者在基线、治疗后3周和8周完成视觉模拟量表（VAS）、疼痛频率问卷和改良奥斯威斯疼痛问卷（MOPQ）。主要结局包括：1）VAS改善≥50%；2）疼痛天数频率降低≥30%。次要结局是MOPQ中日常生活活动能力的改善。优秀应答者（ERs）是指符合所有三项结局的患者。
2个月时，与安慰剂组相比，BoNT-A组的平均VAS（疼痛强度）显著降低（P = 0.0018，95%CI为2.51至7.89）。2个月时，BoNT-A组有6名优秀应答者，安慰剂组有1名优秀应答者（P = 0.0152）。
将BoNT-A注射到颈部和肩部肌肉治疗慢性难治性颈部疼痛达到了两个主要结局之一：疼痛强度降低。肉毒杆菌素组的优秀应答者更多。
