克拉霉素短期给药后在CLARICOR试验中出现的额外心源性猝死：为何如此，以及他汀类药物为何具有保护作用？
Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial: why is this so, and why are statins protective?
作者信息
Winkel Per, Hilden Jørgen, Fischer Hansen Jørgen, Hildebrandt Per, Kastrup Jens, Kolmos Hans Jørn, Kjøller Erik, Jespersen Christian M, Gluud Christian, Jensen Gorm Boje
机构信息
Rigshospitalet, Copenhagen University Hospital and Institute of Preventive Medicine, The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen, Denmark.
出版信息
Cardiology. 2011;118(1):63-7. doi: 10.1159/000324533. Epub 2011 Mar 26.
OBJECTIVES
To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease.
METHODS
Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital (nonsudden) death.
RESULT
In 100 of 189 (53%) cardiovascular (CV) deaths in which it was possible to examine the question, there was a strong association between place of death and the classification of CV death as sudden or not-sudden. The excess mortality in the clarithromycin group was confined to sudden CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69-4.05, p < 0.0005). Other categories of deaths showed no marked drug-placebo difference.
CONCLUSIONS
Short-term clarithromycin administration was significantly associated with increased risk of sudden CV death in stable coronary heart disease patients not using statins.
目的
阐明在CLARICOR试验中，对稳定型冠状动脉疾病患者进行2.6年随访期间观察到的克拉霉素所致额外死亡率的潜在机制。
方法
采用Cox分析，将院外死亡作为猝死的替代指标，与院内（非猝死）死亡进行比较。
结果
在189例心血管（CV）死亡中的100例（53%）中，可以对该问题进行研究，死亡地点与CV死亡分类为猝死或非猝死之间存在强烈关联。克拉霉素组的额外死亡率仅限于试验入组时未服用他汀类药物的患者的猝死性CV死亡（风险比：2.61，95%置信区间：1.69 - 4.05，p < 0.0005）。其他死亡类别未显示出明显的药物 - 安慰剂差异。
结论
在未使用他汀类药物的稳定型冠心病患者中，短期服用克拉霉素与猝死性CV死亡风险增加显著相关。
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