Silberstein S D
Department of Neurology, Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA.
Neurol Sci. 2004 Oct;25 Suppl 3:S244-5. doi: 10.1007/s10072-004-0297-1.
The importance of evidence-based medicine is often underestimated when migraine preventive treatments are chosen. Evidence from large, well-conducted, placebo-controlled trials of sufficient duration should be given particular consideration when evaluating the efficacy, tolerability and safety of a medication for a broad range of patients. Pizotifen, propranolol, flunarizine, amitriptyline, divalproex sodium and topiramate have all been evaluated for efficacy in migraine prevention in double-blind, placebo-controlled trials. The largest clinical programme in migraine prevention, studying these or any other agents, was comprised of 2 pivotal trials, as well as other studies, evaluating topiramate for preventive therapy in migraine. Results from these trials indicated that topiramate (100 mg/day) has proven safety and efficacy in migraine prevention. Response rates were high, and onset of action usually occurred within the first month of treatment. Therefore, topiramate has demonstrated safety and represents an effective option in the prevention of migraine, as supported by extensive clinical research.
在选择偏头痛预防性治疗方法时,循证医学的重要性常常被低估。在评估一种药物对广大患者的疗效、耐受性和安全性时,应特别考虑来自大规模、实施良好、持续时间足够长的安慰剂对照试验的证据。在双盲、安慰剂对照试验中,均已对苯噻啶、普萘洛尔、氟桂利嗪、阿米替林、丙戊酸钠和托吡酯预防偏头痛的疗效进行了评估。在偏头痛预防方面规模最大的临床项目,研究这些药物或任何其他药物,包括2项关键试验以及其他研究,评估托吡酯用于偏头痛的预防性治疗。这些试验的结果表明,托吡酯(100毫克/天)在预防偏头痛方面已证明具有安全性和疗效。缓解率很高,且起效通常发生在治疗的第一个月内。因此,正如广泛的临床研究所支持的那样,托吡酯已证明具有安全性,是预防偏头痛的一种有效选择。