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肉毒杆菌毒素在挥鞭样损伤相关疾病中作用的前瞻性随机对照研究。

A prospective randomized controlled study of the role of botulinum toxin in whiplash-associated disorder.

作者信息

Carroll Aine, Barnes Mike, Comiskey Catherine

机构信息

National Rehabilitation Hospital, Dublin, Ireland.

出版信息

Clin Rehabil. 2008 Jun;22(6):513-9. doi: 10.1177/0269215507086778.

DOI:10.1177/0269215507086778
PMID:18511531
Abstract

OBJECTIVES

To investigate the effectiveness of botulinum toxin in preventing the development of chronic whiplash-associated disorder.

DESIGN

Prospective, randomized, placebo-controlled double-blind study.

SETTING

Regional Neurological Rehabilitation Centre with participants being at home.

SUBJECTS

Thirty-seven patients with whiplash-associated disorder who remained symptomatic two months after injury.

INTERVENTIONS

Patients were randomized to receive either 250 units botulinum toxin type A (Dysport) or placebo (normal saline). Four trigger points were injected with 0.625 mL of injectant.

OUTCOME MEASURES

Tenderness to palpation scores, visual analogue pain scale, Vernon-Mior Neck Pain and Disability Index and cervical range of motion. Follow-up assessments were carried out at four weeks and three months after treatment.

RESULTS

Twenty participants received botulinum toxin and 17 received placebo. Both groups showed a tendency towards improvement in pain scores, Vernon-Mior Index and range of motion at four weeks and three months, with the changes being more pronounced in the toxin group. The change in Vernon-Mior Index in the toxin group was both statistically and clinically significant (i.e. a change of score of > or = 5 from baseline to follow-up). Group comparisons did not meet statistical significance.

CONCLUSION

The improvements in outcome measures suggest that botulinum toxin type A may have a role to play in the management of whiplash-associated disorder but larger studies are required to clarify the situation.

摘要

目的

研究肉毒杆菌毒素在预防慢性挥鞭样损伤相关疾病发展中的有效性。

设计

前瞻性、随机、安慰剂对照双盲研究。

地点

地区神经康复中心,参与者在家中。

研究对象

37例挥鞭样损伤相关疾病患者,受伤两个月后仍有症状。

干预措施

患者被随机分为两组,分别接受250单位A型肉毒杆菌毒素(Dysport)或安慰剂(生理盐水)。四个触发点各注射0.625 mL注射剂。

观察指标

触痛评分、视觉模拟疼痛量表、Vernon-Mior颈部疼痛和功能障碍指数以及颈椎活动范围。治疗后四周和三个月进行随访评估。

结果

20名参与者接受肉毒杆菌毒素治疗,17名接受安慰剂治疗。两组在四周和三个月时疼痛评分、Vernon-Mior指数和活动范围均有改善趋势,毒素组变化更明显。毒素组Vernon-Mior指数的变化在统计学和临床上均有显著意义(即从基线到随访评分变化≥5分)。组间比较无统计学意义。

结论

观察指标的改善表明,A型肉毒杆菌毒素可能在挥鞭样损伤相关疾病的治疗中发挥作用,但需要更大规模的研究来明确情况。

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