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枸橼酸西地那非治疗男性患者时心肌梗死急性风险的评估。

Evaluation of acute risk for myocardial infarction in men treated with sildenafil citrate.

作者信息

Mittleman Murray A, Maclure Malcolm, Glasser Dale B

机构信息

Cardiovascular Epidemiology Research Unit, Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Am J Cardiol. 2005 Aug 1;96(3):443-6. doi: 10.1016/j.amjcard.2005.03.097.

DOI:10.1016/j.amjcard.2005.03.097
PMID:16054479
Abstract

Sexual intercourse is a rare trigger of acute myocardial infarction (MI). In the 2 hours after intercourse, the risk for MI is increased twofold to fourfold. However, there is limited information on the risk for MI after intercourse in men receiving treatment for erectile dysfunction. This study aimed to evaluate whether the use of sildenafil citrate in men with erectile dysfunction is associated with the triggering of acute MI. A self-matched case-crossover approach was used to evaluate the incidence of MI in men enrolled in 80 clinical trials of sildenafil at sites worldwide from 1993 to 2000. The risk for MI was assessed during 2 hazard periods: within 24 and within 6 hours after the ingestion of sildenafil. Relative risk was estimated using the Mantel-Haenszel estimator for sparse person-time data. A total of 69 MIs were observed during >11,000 person-years of exposure to sildenafil. The mean time between the last dose of sildenafil and the onset of MI was 14 +/- 2.9 days. The relative risk for MI was 0.80 (95% confidence interval [CI] 0.52 to 1.26) within 24 hours after taking sildenafil and 0.79 (95% CI 0.33 to 1.87) within 6 hours after taking sildenafil. In conclusion, these data indicate that sildenafil was not associated with short-term risk for MI and are consistent with the growing body of evidence that sildenafil use is not associated with an increased risk for cardiovascular events.

摘要

性交是急性心肌梗死(MI)的罕见诱因。在性交后的2小时内,发生心肌梗死的风险会增加两倍至四倍。然而,对于接受勃起功能障碍治疗的男性,性交后发生心肌梗死的风险相关信息有限。本研究旨在评估勃起功能障碍男性使用枸橼酸西地那非是否与急性心肌梗死的触发有关。采用自我匹配的病例交叉方法,对1993年至2000年在全球各地进行的80项西地那非临床试验中登记的男性心肌梗死发病率进行评估。在两个危险期评估心肌梗死风险:服用西地那非后24小时内和6小时内。使用Mantel-Haenszel估计器对稀疏人时数据估计相对风险。在超过11000人年的西地那非暴露期间,共观察到69例心肌梗死。最后一剂西地那非与心肌梗死发作之间的平均时间为14±2.9天。服用西地那非后24小时内心肌梗死的相对风险为0.80(95%置信区间[CI]0.52至1.26),服用西地那非后6小时内为0.79(95%CI0.33至1.87)。总之,这些数据表明西地那非与心肌梗死的短期风险无关,并且与越来越多的证据一致,即使用西地那非与心血管事件风险增加无关。

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