Pilgrim A J
Glaxo Group Research Ltd, Greenford, Middlesex, UK.
Eur Neurol. 1991;31(5):295-9. doi: 10.1159/000116757.
The clinical development of sumatriptan has involved large international multicentre trials. To allow comparison of results obtained in a variety of clinical settings, great emphasis was placed on the use of consistent methodology across the programme. This applied to selection of patients, trial design, symptom evaluation and statistical analysis. Patients were selected for the major trials if they fulfilled the International Headache Society's diagnostic criteria for migraine or cluster headache. Relief of the headache was used as the main efficacy measure and this was assessed using standardized self-rating scales. All major controlled trials in migraine employed a parallel group design to avoid carryover effects and to ensure blinding was not compromised; however, because of the rarity of cluster headache, a crossover trial was performed in this indication. Appropriate statistical analyses were then performed on the data. The rationale for the methodology adopted is discussed. Strict adherence to these principles has allowed us to compare the results of sumatriptan treatment across a wide range of countries and treatment settings, and a selection of different administration routes.
舒马曲坦的临床开发涉及大型国际多中心试验。为了便于比较在各种临床环境中获得的结果，该项目非常强调在整个研究过程中使用一致的方法。这适用于患者选择、试验设计、症状评估和统计分析。如果患者符合国际头痛协会的偏头痛或丛集性头痛诊断标准，就会被选入主要试验。头痛缓解被用作主要疗效指标，并使用标准化的自评量表进行评估。偏头痛的所有主要对照试验都采用平行组设计，以避免残留效应并确保盲法不受影响；然而，由于丛集性头痛罕见，该适应症采用了交叉试验。然后对数据进行适当的统计分析。文中讨论了所采用方法的基本原理。严格遵守这些原则使我们能够比较舒马曲坦在广泛的国家和治疗环境以及不同给药途径中的治疗结果。
