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预测对舒马曲坦的反应:舒马曲坦与那拉曲坦综合患者数据库

Predicting the response to sumatriptan: the Sumatriptan Naratriptan Aggregate Patient Database.

作者信息

Christoph-Diener Hans, Ferrari Michel, Mansbach Hank

机构信息

Dept. of Neurology, University of Essen, Hufelandstr. 55, 45147 Essen, Germany.

出版信息

Neurology. 2004 Aug 10;63(3):520-4. doi: 10.1212/01.wnl.0000133207.70312.30.

Abstract

OBJECTIVE

The efficacy and tolerability profiles of sumatriptan and other 5HT(1B/1D) agonists (triptans) have been well established. However, the determinants for optimal response to sumatriptan are unknown. The Sumatriptan Naratriptan Aggregate Patient (SNAP) database contains data from 128 clinical trials including 28,407 migraine sufferers treating over 130,000 attacks. The authors analyzed these data to identify factors predicting response (headache relief and pain-free response) to sumatriptan.

METHODS

The authors assessed 24 possible univariate predictors of headache response in 3,706 patients (18 years and older) receiving sumatriptan tablets 100 mg or placebo in a double-blind study using recursive partitioning and logistic regression techniques.

RESULTS

The authors found seven predictors of headache relief 2 hours postdose. Moderate pain at baseline was the strongest predictor (adjusted p = 3.32 x 10(-35)), followed by absence of a disability requiring bedrest (adjusted p = 3.11 x 10(-18)). Other predictors included absence at baseline of vomiting, pulsating pain, nausea, or photophobia/phonophobia, and onset of headache during daytime hours. Logistic regression confirmed that treatment with sumatriptan was the strongest predictor of headache relief, with significant baseline covariates being pain severity, level of disability, and presence or absence of vomiting. A similar pattern of results was reported for predictors of pain-free response 2 hours after taking sumatriptan.

CONCLUSIONS

Pretreatment pain severity is the most important predicting factor for response to sumatriptan in migraine attacks: the lower baseline severity, the better.

摘要

目的

舒马曲坦及其他5-羟色胺(1B/1D)激动剂(曲坦类药物)的疗效和耐受性已得到充分证实。然而,对舒马曲坦产生最佳反应的决定因素尚不清楚。舒马曲坦与那拉曲坦汇总患者(SNAP)数据库包含来自128项临床试验的数据,涉及28407名偏头痛患者,治疗超过130000次发作。作者分析这些数据以确定预测对舒马曲坦反应(头痛缓解和无痛反应)的因素。

方法

在一项双盲研究中,作者使用递归分割和逻辑回归技术,评估了3706名(18岁及以上)接受100毫克舒马曲坦片或安慰剂治疗的患者中24个可能的头痛反应单变量预测因素。

结果

作者发现了给药后2小时头痛缓解的7个预测因素。基线时中度疼痛是最强的预测因素(校正p = 3.32×10⁻³⁵),其次是无需卧床休息的残疾情况(校正p = 3.11×10⁻¹⁸)。其他预测因素包括基线时无呕吐、搏动性疼痛、恶心或畏光/畏声,以及白天出现头痛。逻辑回归证实,舒马曲坦治疗是头痛缓解的最强预测因素,显著的基线协变量为疼痛严重程度、残疾程度以及是否存在呕吐。服用舒马曲坦后2小时无痛反应的预测因素也报告了类似结果模式。

结论

治疗前疼痛严重程度是偏头痛发作对舒马曲坦反应的最重要预测因素:基线严重程度越低越好。

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