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Atorvastatin safety and pharmacokinetics in acute kawasaki disease patients with coronary artery abnormalities
阿托伐他汀在急性川崎病冠状动脉异常患者中的安全性和药代动力学
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| 其它 | Introduction: Despite therapy with intravenous immunoglobulin, 25% of children with Kawasaki disease (KD) develop coronary artery abnormalities (CAA) and endothelial cell (EC) dysfunction. Based on the pleiotropic effects of statins on restoring EC homeostasis, we performed a Phase I clinical trial of atorvastatin for acute KD patients with early CAA. Hypothesis: A sixweek (wk) course of atorvastatin in acute KD patients (pts) with CAA will be safe, welltolerated and restore EC homeostasis. Methods: This twocenter, Phase I, open label, dose escalation trial enrolled acute KD subjects aged 217 years with an initial CA Z score ≥ 2.5 in a 6wk study of atorvastatin (0.125, 0.25, 0.5 and 0.75 mg/kg/day). Demographic, clinical and laboratory data, and echo core lab readings were collected at baseline, |
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