Blumenfeld Andrew
San Diego, CA 92130, USA.
Headache. 2003 Sep;43(8):853-60. doi: 10.1046/j.1526-4610.2003.03163.x.
To measure the effect of botulinum toxin type A (Botox, Allergan, Inc, Irvine, CA) treatment in 271 patients diagnosed with headache in accordance with International Headache Society (IHS) criteria.
Botulinum toxin type A has shown promise for the treatment of headache in several clinical trials, but uncertainty remains as to how botulinum toxin type A optimally should be used for treating headache and which patients are best suited for this treatment.
This was a retrospective chart review of all patients who received botulinum toxin type A for the treatment of headache from January 1999 to February 2002. Patients were injected with an average dose of 63.2 U (SD, 14.5) of botulinum toxin type A on 2 or more visits, with treatments involving a "fixed-site" or a "follow-the-pain" (or a combination of both) approach. In the fixed-site approach, botulinum toxin type A was injected into the procerus, corrugator, frontalis, and temporalis muscles. In the follow-the-pain approach, botulinum toxin type A was injected into a combination of the procerus, corrugator, frontalis, temporalis, occipitalis, trapezius, and/or semispinalis capitis muscles. The primary outcomes for the trial were the reduction in headache days per month or headache intensity (0 to 3 scale) (or both) from baseline. Patients were diagnosed according to IHS criteria and subsequently classified into the following categories: chronic daily headache (more than 15 headache days per month), episodic tension-type headache, episodic migraine, and "mixed" HA (less than 15 headache days per month, combination of migraine and tension-type headache).
Treatment period was an average of 8.6 months (SD, 6.4); patients received an average of 3.4 doses (SD, 1.6) 3 months apart. Of the 271 patients, 29 (10.7%) had episodic migraine, 17 (6.3%) had episodic tension-type headache, 71 (26.2%) had mixed headache, and 154 (56.8%) had chronic daily headache. Two-hundred fifty-six patients had data for the number of headache days per month, 117 had data for headache intensity, and all 271 had data for headache days or headache intensity. Botulinum toxin type A treatment significantly reduced the number of headache days per month from 18.9 (SD, 10.3) to 8.3 (SD, 8.9) (n=256, P<.001)--a 56% reduction. Headache intensity decreased from 2.4 points (SD, 0.6) to 1.8 points (SD, 0.8) (n=117, P<.001)--a 25% reduction. Of 263 patients surveyed, 225 (85.6%) reported improvement in headache frequency and intensity. There was no correlation of effect/lack of effect with reason for treatment, duration/number of treatments, injection technique, mean/total dose, age, gender, or comorbidity. Approximately 95% of patients did not experience medication side effects.
These results suggest that botulinum toxin type A may be an effective and safe prophylactic treatment for a variety of moderate to severe chronic headache types.
根据国际头痛协会（IHS）标准，评估A型肉毒毒素（保妥适，艾尔建公司，尔湾，加利福尼亚州）治疗271例诊断为头痛患者的疗效。
在多项临床试验中，A型肉毒毒素已显示出治疗头痛的前景，但关于A型肉毒毒素如何最佳地用于治疗头痛以及哪些患者最适合这种治疗仍存在不确定性。
这是一项对1999年1月至2002年2月期间接受A型肉毒毒素治疗头痛的所有患者的回顾性病历审查。患者平均接受63.2 U（标准差，14.5）的A型肉毒毒素注射，注射次数为2次或更多次，治疗采用“固定部位”或“痛点跟踪”（或两者结合）方法。在固定部位方法中，A型肉毒毒素注射到降眉间肌、皱眉肌、额肌和颞肌。在痛点跟踪方法中，A型肉毒毒素注射到降眉间肌、皱眉肌、额肌、颞肌、枕肌、斜方肌和/或头半棘肌的组合中。该试验的主要结局是每月头痛天数或头痛强度（0至3级）（或两者）较基线的降低。患者根据IHS标准进行诊断，随后分为以下类别：慢性每日头痛（每月头痛超过15天）、发作性紧张型头痛、发作性偏头痛和“混合型”头痛（每月头痛少于15天，偏头痛和紧张型头痛的组合）。
治疗期平均为8.6个月（标准差，6.4）；患者平均接受3.4剂（标准差，1.6），间隔3个月。在271例患者中，29例（10.7%）患有发作性偏头痛，17例（6.3%）患有发作性紧张型头痛，71例（26.2%）患有混合型头痛，154例（56.8%）患有慢性每日头痛。256例患者有每月头痛天数的数据，117例患者有头痛强度的数据，所有271例患者有头痛天数或头痛强度的数据。A型肉毒毒素治疗使每月头痛天数从18.9天（标准差，10.3）显著减少至8.3天（标准差，8.9）（n = 256，P <.001）——减少了56%。头痛强度从2.4分（标准差，0.6）降至1.8分（标准差，0.8）（n = 117，P <.001）——减少了25%。在接受调查的263例患者中，225例（85.6%）报告头痛频率和强度有所改善。疗效/无效与治疗原因、治疗持续时间/次数、注射技术、平均/总剂量、年龄、性别或合并症无关。约95%的患者未出现药物副作用。
这些结果表明，A型肉毒毒素可能是治疗多种中度至重度慢性头痛类型的有效且安全的预防性治疗方法。
