2018 年第 3 期 第 13 卷

应用15_mg剂量瑞舒伐他汀对心血管疾病极高风险患者血脂水平及颈动脉斑块的影响和安全性观察

Effect of 15 mg rosuvastatin on blood lipid and carotid plaque in patients with very high cardiovascular risk

作者：吴文法余慧文邓婉青

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单位：510220广州市红十字会医院全科医学科

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• 摘要：

• 目的    探讨应用15 mg剂量瑞舒伐他汀对心血管疾病极高风险患者血脂水平及颈动脉斑块的影响和安全性。方法    选取2014年1月至2016年1月在广州市红十字会医院首次确诊颈动脉斑块且被评估为心血管疾病极高风险患者320例；采用随机数字表法分为10 mg、15 mg、20 mg瑞舒伐他汀组和40 mg阿托伐他汀组，每组80例，各组患者服用相应剂量的药物治疗12个月。测定治疗前和治疗后1、12个月后的低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、总胆固醇、丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）和肌酸激酶水平；测定和评估治疗前和治疗12个月后的颈动脉内膜中层厚度（IMT）和斑块积分。结果    治疗1个月后，15 mg瑞舒伐他汀组LDL-C和总胆固醇水平明显低于10 mg瑞舒伐他汀组和40 mg阿托伐他汀组［（2.1±0.4）mmol/L比（2.4±0.6）、（2.3±0.5）mmol/L，（3.3±0.7）mmol/L比（4.0±0.4）、（3.6±0.5）mmol/L］，而明显高于20 mg瑞舒伐他汀组［（1.9±0.5）mmol/L、（3.1±0.6）mmol/L］，差异均有统计学意义（均P＜0.05）。治疗12个月后，15 mg瑞舒伐他汀组LDL-C和总胆固醇水平明显低于、HDL-C水平明显高于10 mg瑞舒伐他汀组和40 mg阿托伐他汀组［（1.8±0.6）mmol/L比（2.0±0.7）、（1.9±0.7）mmol/L，（2.8±0.6）mmol/L比（3.1±0.6）、（3.0±0.6）mmol/L，（1.01±0.27）mmol/L比（0.82±0.32）、（0.96±0.29）mmol/L］，15 mg瑞舒伐他汀组颈动脉IMT和斑块积分明显低于10 mg瑞舒伐他汀组和40 mg阿托伐他汀组［（1.50±0.36）mm比（1.69±0.31）、（1.61±0.31）mm，（2.01±0.30）分比（2.48±0.33）、（2.25±0.32）分］，差异均有统计学意义（P＜0.01或P＜0.05）；而与20 mg瑞舒伐他汀组比较差异均无统计学意义（均P＞0.05）。20 mg瑞舒伐他汀组的ALT/AST升高＜3倍正常值上限和肌酸激酶升高＜5倍正常值上限发生率明显高于10 mg、15 mg瑞舒伐他汀组和40 mg阿托伐他汀组（P＜0.01或P＜0.05）。结论    15 mg剂量瑞舒伐他汀具有强化降脂及延缓、阻止颈动脉斑块进展甚至可能逆转、消退颈动脉斑块的作用，优于40 mg剂量阿托伐他汀而不亚于20 mg剂量瑞舒伐他汀；其安全性与10 mg剂量瑞舒伐他汀或40 mg剂量阿托伐他汀相当，而优于20 mg剂量瑞舒伐他汀。

• Objective    To investigate the effect and safety of 15 mg rosuvastatin on blood lipid level and carotid plaque in patients with very high cardiovascular risk. Methods    Totally 320 newly diagnosed carotid plaque patients with very high risk of cardiovascular diseases were enrolled from January 2014 to January 2016 in Guangzhou Red Cross Hospital to randomly have 10 mg dose rosuvastatin, 15 mg rosuvastatin, 20 mg rosuvastatin and 40 mg atorvastatin for 12 months(n=80). Low-density lipoprotein cholesterol（LDL-C）, high-density lipoprotein cholesterol（HDL-C）, total cholesterol, alanine aminotransferase（ALT）, aspartate aminotransferase（AST） and creatine kinase（CK） were tested before and 1, 12 months after treatment. Carotid intima-media thickness（IMT） and the score of plaques were measured before and 12 months after treatment. Results    One month after treatment, levels of LDL-C and total cholesterol in 15 mg rosuvastatin group were significantly lower than those in 10 mg rosuvastatin group and 40 mg atorvastatin group［（2.1±0.4）mmol/L vs（2.4±0.6）,（2.3±0.5）mmol/L; （3.3±0.7）mmol/L vs（4.0±0.4）,（3.6±0.5）mmol/L］; levels of LDL-C and total cholesterol in 15 mg rosuvastatin group were significantly higher than those in 20 mg rosuvastatin group［（1.9±0.5）mmol/L,（3.1±0.6）mmol/L］（P＜0.05）. Twelve months after treatment, levels of LDL-C and total cholesterol were significantly lower and HDL-C was significantly higher in 15 mg rosuvastatin group than those in 10 mg rosuvastatin group and 40 mg atorvastatin group［（1.8±0.6）mmol/L vs （2.0±0.7）,（1.9±0.7）mmol/L; （2.8±0.6）mmol/L vs（3.1±0.6）,（3.0±0.6）mmol/L; （1.01±0.27）mmol/L vs （0.82±0.32）,（0.96±0.29）mmol/L］; carotid IMT and the score of plaques in 15 mg rosuvastatin group were significantly lower than those in 10 mg rosuvastatin group and 40 mg atorvastatin group［（1.50±0.36）mm vs （1.69±0.31）,（1.61±0.31）mm; （2.01±0.30）points vs （2.48±0.33）,（2.25±0.32）points］（P＜0.01 or P＜0.05）; there were no significant differences between 15 mg rosuvastatin group and 20 mg rosuvastatin group（P＞0.05）. Rates of ALT/AST increasing＜3 times upper limit of normal value and CK increasing＜5 times upper limit of normal value in 10 mg, 15 mg rosuvastatin groups and 40 mg atorvastatin group were significantly higher than those in 40 mg atorvastatin group（P＜0.01 or P＜0.05）. Conclusions    Rosuvastatin 15 mg has intensive lipid-lowering effect that can delay even reverse the progression of carotid plaque. The efficacy of 15 mg rosuvastatin is superior to 40 mg atorvastatin and non-inferior to 20 mg rosuvastatin; the safety is equal to 10 mg rosuvastatin and 40 mg atorvastatin.