Headache Research Unit, Department of Neurology and GIGA-Neurosciences, Liège University.
Acta Neurol Belg. 2010 Sep;110(3):221-9.
Available preventive treatments for primary headaches such as migraines and tension-type headaches have limited efficacy and often disabling side effects (Schoenen 2004, Schoenen 2000). There is thus room for new more effective and better tolerated therapeutic approaches as long as they can be proven superior to placebo. Based on pilot studies and open trials, botulinum toxin (BT) appeared in the headache armamentarium more than a decade ago and it remains widely used in North America since. The initial enthusiasm for BT was not confirmed by subsequent randomized controlled trials reviewed in this article, neither in tension-type headache, nor in episodic migraine and hence BT was considered a "dead end road" by certain headache experts. A promising "path" for BT may, however, exist. In two recent trials (PREEMPT 1 and 2), OnabotulinumtoxinA (Botox) was found effective in chronic migraine. The therapeutic gain over placebo is modest (+/- 11%), but chronic migraine is most disabling, often drug resistant and a serious public health problem, as it affects 1-2% of people in the general population. Because the PREEMPT trials leave unsolved a number of clinically relevant questions, OnabotulinumtoxinA cannot become yet the pre-emptor of CM treatment. Although the path is promising, it seems wise, at this stage, to restrict its use to specialized headache centres where BT can be included in a multidisciplinary approach for chronic headache patients.
对于原发性头痛（如偏头痛和紧张型头痛），现有的预防治疗方法疗效有限，且常常伴有严重的副作用（Schoenen 2004，Schoenen 2000）。因此，只要能够证明比安慰剂更有效和更好耐受，就需要新的、更有效的治疗方法。基于初步研究和开放试验，肉毒杆菌毒素（BT）在十多年前就进入了头痛治疗领域，并且在北美得到了广泛应用。本文回顾的随后的随机对照试验并未证实 BT 在紧张型头痛、阵发性偏头痛中的初始疗效，因此某些头痛专家认为 BT 是一条“死胡同”。然而，BT 可能存在一条有前途的“路径”。在最近的两项试验（PREEMPT 1 和 2）中，肉毒杆菌毒素 A（Botox）被证明对慢性偏头痛有效。与安慰剂相比，治疗效果略有改善（+/- 11%），但慢性偏头痛最具致残性，通常对药物有抵抗力，是一个严重的公共卫生问题，因为它影响一般人群中 1-2%的人。由于 PREEMPT 试验留下了一些临床相关问题未解决，肉毒杆菌毒素 A 还不能成为 CM 治疗的首选药物。虽然这条道路很有希望，但在现阶段，明智的做法是将其使用限制在专门的头痛中心，在那里 BT 可以作为慢性头痛患者多学科治疗方法的一部分。
