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首页> 外文期刊>The Canadian Journal of Neurological Sciences: le Journal Canadien des Sciences Neurologiques >Pregabalin for the Management of Cervicogenic Headache: A Double Blind Study
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Pregabalin for the Management of Cervicogenic Headache: A Double Blind Study

机译：普瑞巴林用于治疗颈源性头痛：双盲研究

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摘要

Objectives: The primary objective was to evaluate the effects of pregabalin relative to placebo in patients with chronic unilateral cervicogenic headache. Primary and secondary end points: To assess the change from baseline in the frequency of cervicogenic headache days per 28-day period between placebo and treatment group. To assess the change from baseline in the intensity of headache, and health outcome measures. Study design: This was a double-blind, randomized, placebo-controlled, parallel-group study, evaluating the efficacy and safety of pregabalin in patients with cervicogenic headache. Procedures: The study consisted of two phases. A baseline of -28 days and a double-blind placebo-controlled phase: with an escalation and maintenance phase, during which patients remained at their highest dose until the end of the study, at Day 86. Results: Forty one patients were randomized, predominantly females, with a mean age of 52 years old. At screening, both groups had, on average, 26 headache-days per month. By the final phase of the study, the number of headache days dropped to 16 per month for the pregabalin group while remaining stable for the placebo group (p = 0.037). No serious adverse events were reported during the study. Conclusion: In this study, primary objectives were achieved with a statistically significant change of ten days in frequency of headache days; with minor side effects that were well tolerated.
机译：目的：主要目的是评估普瑞巴林相对于安慰剂在慢性单侧宫颈源性头痛患者中的作用。主要和次要终点：评估安慰剂和治疗组之间每28天的宫颈源性头痛天数相对于基线的变化。评估头痛强度与基线水平相比的变化，并评估健康状况。研究设计：这是一项双盲，随机，安慰剂对照，平行组研究，评估普瑞巴林对宫颈源性头痛患者的疗效和安全性。程序：研究包括两个阶段。基线为-28天，为双盲安慰剂对照阶段：逐步升级和维持阶段，在此期间患者在研究的第86天一直保持最高剂量，直到研究结束。结果：41位患者被随机分配，多数为女性，平均年龄为52岁。筛查时，两组平均每月头痛26天。在研究的最后阶段，普瑞巴林组的头痛天数降至每月16天，而安慰剂组则保持稳定（p = 0.037）。研究期间未报告严重不良事件。结论：在这项研究中，头痛的发生频率在十天内的统计学上显着变化实现了主要目标。具有很好的耐受性。

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