Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, 50935 Cologne, Germany.
J Headache Pain. 2010 Feb;11(1):33-44. doi: 10.1007/s10194-009-0163-x. Epub 2009 Nov 6.
The majority of patients with migraine headaches are treated in non-specialized institutions though data on treatment outcomes are largely derived from tertiary care centers. The current non-interventional study explores efficacy and tolerability outcomes of patients with episodic migraines receiving topiramate as preventive agent in a general practice setting. A total of 366 patients (87% female, mean age 41.8 +/- 11.6 years) were eligible for migraine prevention and treated with flexible dose topiramate for 6 months (core phase), and optionally for a total of 12 months (follow-up phase). Overall, 261 patients (77.7% of safety analysis set, SAF) completed the core phase. Reasons for discontinuation included adverse events (2.1%), lost to follow-up (1.8%), other reasons (1.5%), and end of therapy (0.3%) though in the majority of patients who discontinued no reasons were listed. The median daily dose at endpoint was 50 mg/day (range, 25-187.5 mg/day). The median days with migraine headaches decreased from 6.0 to 1.2 days (p < 0.001), median pain intensity score decreased from 17.0 to 3.2 points (p < 0.001). In women with reported menstruation-associated migraine, the median number of migraine attacks decreased from 4.0 to 0.9 (p < 0.001). Absenteeism as well as triptan use decreased significantly, and significant improvements in activities of daily living and quality of life were reported. The most frequently reported AEs were paraesthesia (4.2%) and nausea (3%). Results suggest that migraine prevention with topiramate in a general practice is generally well tolerated and associated with a significant improvement in migraine headaches and related functional impairment.
大多数偏头痛患者在非专科医院接受治疗，尽管治疗结果数据主要来自于三级保健中心。目前这项非干预性研究探索了在一般实践环境中接受托吡酯作为预防药物的发作性偏头痛患者的疗效和耐受性结果。共有 366 名患者（87%为女性，平均年龄 41.8 +/- 11.6 岁）有资格接受偏头痛预防，并接受了为期 6 个月（核心期）的托吡酯灵活剂量治疗，可选地还接受了总共 12 个月（随访期）的治疗。总体而言，261 名患者（安全性分析集 SAF 的 77.7%）完成了核心期。停药的原因包括不良事件（2.1%）、失访（1.8%）、其他原因（1.5%）和治疗结束（0.3%），尽管大多数停药的患者未列出原因。终点时的中位日剂量为 50mg/天（范围 25-187.5mg/天）。偏头痛天数从 6.0 天减少到 1.2 天（p < 0.001），疼痛强度评分从 17.0 分减少到 3.2 分（p < 0.001）。在报告与月经相关的偏头痛的女性中，偏头痛发作次数从 4.0 次减少到 0.9 次（p < 0.001）。旷工和曲坦类药物的使用显著减少，日常生活活动和生活质量显著改善。报告最频繁的 AEs 是感觉异常（4.2%）和恶心（3%）。结果表明，托吡酯在一般实践中的偏头痛预防通常具有良好的耐受性，并与偏头痛和相关功能障碍的显著改善相关。
