他汀药物应用中肝功能受损的处理策略-严晓伟PPT.ppt

NAFLD的疗效评估 症状积分：原发疾病和肝病相关症状积分 人体学指标：BMI、腰围、血压、肝脾大小 临床事件：肝病和代谢紊乱相关事件，特别是血管事件 实验室指标：肝功能、血脂、血糖/IR，必要时查氧应激/脂质过氧化、炎症、纤维化血清学标记物 影像学：体脂和肝脏脂肪多少及分布，有无肝硬化、肝占位、胆道病变征象，有无动脉硬化 肝活检：肝组织学损伤的真实变化 不良反应：药物副反应、药源性疾病 他汀治疗过程中的监测-国外 肝脏安全性检查： 基线检查：开始治疗前 复查：开始治疗后12周或剂量增加后12周 没有科学依据支持长期监测的必要性，因为肝酶监测并不能提供临床益处，反而有可能造成不适当的停药并增加费用 Am J Cardiol 2006;97[suppl]:77C–81C Am J Cardiol 2006;97[suppl]:89C–94C 1.开始药物治疗时 血脂、安全性检查(肌酶、肝酶等) 达标、安全 未达标 6-12月复查 调整剂量———— 达标、安全 2. 4~8周复查 ———— 6-12月复查 中国成人血脂异常防治指南（2006修订版草案） 他汀治疗过程中的监测-中国 总 结 目前市场上的他汀，总体是安全的，且耐受性良好。综合现有证据，支持他汀是对肝脏安全的药物 ALT升高：起始或中等剂量的发生率1%，高剂量时发生率3%，转氨酶异常与临床肝病发生率增高不具有相关性 他汀相关的孤立转氨酶升高，不代表明显肝损害或肝功能不全 从预防心脑血管事件的角度来看，在临床中需充分使用他汀，不应该因过分关注肝毒性而影响患者从他汀类药物的治疗中获益。 This presentation summarizes the efforts of the National Lipid Association and NLA Statin Safety Task Force to thoroughly evaluate statin safety. The full report is available as a supplement in the April 17, 2006 American Journal of Cardiology. This data comes from the meta-analysis completed by Professor Law. Keep in mind that this data is from randomized clinical trials, so it doesnt exactly fit into the prescribing information which may be closer to what is seen in clinical practice. There were 21 major statin trials encompassing 180,000 people, included in this analysis. The results showed that a single measure of ALT greater than three times ULN was found in 300 patients out of 100,000 or 0.3 percent. Interestingly, there were similar elevations found in 200 of the patients on placebo, so not only is the number of patients with single elevations small, but there is significant background noise from placebo. On repeat measurement, the number of patients with elevations 3 times the ULN drops down to 110 patients per 100,000 or just over 0.1 percent. These are very small numbers. And as Dr. Law said, In conclusion, thus, one would have to monitor ALT in a hundred thousand patients each year for three years to detect basically a hundred patients who have consecutive elevations i