Pascual Julio, Diener Hans-Christoph, Massiou Hélène
Service of Neurology, University Hospital, Salamanca 39008, Spain.
J Headache Pain. 2006 Feb;7(1):27-33. doi: 10.1007/s10194-006-0266-6. Epub 2006 Jan 31.
Randomised controlled trials cannot collect all the data relevant for use in everyday clinical practice because drug exposure is limited, endpoints are restricted and some patient populations are excluded. Postmarketing surveillance (PS) studies can add important information for real-world clinical practice. Acute migraine therapy with almotriptan 12.5 mg was evaluated in 4 PS studies, 2 conducted in Spain, 1 in Germany and 1 in France. Almotriptan was associated with a high rate of treatment response and was well tolerated in all 4 studies. In the Spanish and German studies, 2-hour pain-relief, 2-hour pain-free, and sustained painfree rates were enhanced when patients treated mild pain. Patient satisfaction with almotriptan, assessed in the German and French studies, was high and the majority of patients preferred almotriptan to their previous acute migraine therapy. In conclusion, PS studies augment our knowledge of antimigraine therapy, giving a more complete picture of how such agents work in the general population.
随机对照试验无法收集日常临床实践中使用所需的所有相关数据，因为药物暴露有限、终点受限且一些患者群体被排除在外。上市后监测（PS）研究可为实际临床实践增添重要信息。在4项PS研究中评估了12.5毫克阿莫曲坦的急性偏头痛治疗效果，其中2项在西班牙进行，1项在德国进行，1项在法国进行。在所有4项研究中，阿莫曲坦的治疗反应率很高且耐受性良好。在西班牙和德国的研究中，当患者治疗轻度疼痛时，2小时疼痛缓解率、2小时无痛率和持续无痛率均有所提高。在德国和法国的研究中评估的患者对阿莫曲坦的满意度很高，大多数患者更喜欢使用阿莫曲坦而非他们之前的急性偏头痛治疗药物。总之，PS研究增强了我们对抗偏头痛治疗的认识，更全面地展现了此类药物在普通人群中的作用方式。
