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目的评价瑞舒伐他汀治疗中国高胆固醇血症患者的疗效和安全性。方法采用随机、双盲、多中心研究。患者经6周筛选后符合 LDL-C≥4.14 mmol/L(160 mg/dl),<6.50 mmol/L(250 mg/dl)、TG<4.52 mmol/L(400 mg/dl)者以2:1随机接受瑞舒伐他汀10 mg/d 或阿托伐他汀10mg/d 治疗。12周后瑞舒伐他汀组 LDL-C 未达到 ATPⅢ治疗目标者,予瑞舒伐他汀20 mg 延续治疗8周。结果 304例进入随机治疗阶段,瑞舒伐他汀10 mg/d 组201例,阿托伐他汀10 mg/d 组103例。意向治疗人群290例,符合方案人群263例。瑞舒伐他汀组治疗12周后血 LDL-C 显著下降,下降幅度为45.6%,显著大于阿托伐他汀组的39.0%(P<0.001)。瑞舒伐他汀组患者 LDL-C 达标率也较阿托伐他汀组(78.0%比72.7%)有增高趋势,且在高危人群中优势更为明显(56.5%比35.0%),但差异未达到统计学意义。瑞舒伐他汀降低 TG(-22.8%)以及升高 HDL-C(+6.6%)和ApoA-1(+12.5%)的幅度与阿托伐他汀组差别无统计学意义(分别为-16.6%,+4.3%和+9.8%)。29例患者接受20 mg/d 瑞舒伐他汀延续治疗,22例完成治疗患者中10例(45.5%)LDL-C达标。研究中未发现药物相关的严重不良反应事件。结论本组研究显示瑞舒伐他汀10 mg 降低LDL-C 的疗效优于同等剂量的阿托伐他汀,治疗3个月安全性与之类似。
Objective To evaluate the efficacy and safety of rosuvastatin in Chinese patients with hypercholesterolemia. Methods Randomized, double-blind, multicenter studies were performed. Patients who were eligible for LDL-C ≥4.14 mmol / L (160 mg / dl), <6.50 mmol / L (250 mg / dl) and TG <4.52 mmol / L (400 mg / dl) 1 Randomized to receive rosuvastatin 10 mg / d or atorvastatin 10 mg / d. After 12 weeks, LDL-C in rosuvastatin group did not reach the goal of ATP Ⅲ treatment, and 20 mg of rosuvastatin was continued for 8 weeks. Results 304 patients entered the randomized treatment phase, rosuvastatin 10 mg / d group 201 cases, atorvastatin 10 mg / d group 103 cases. Intention to treat 290 patients, in line with the program population of 263 cases. After 12 weeks of treatment, the LDL-C level in the rosuvastatin group was significantly decreased by 45.6%, which was significantly higher than that in the atorvastatin group (39.0%, P <0.001). The compliance rate of LDL-C in rosuvastatin group was also higher than that in atorvastatin group (78.0% vs 72.7%), and the advantage was more obvious in high-risk population (56.5% vs. 35.0%), but the difference did not reach Statistical significance. There was no significant difference in the magnitude of rosuvastatin lowering of TG (-22.8%) and increasing HDL-C (+ 6.6%) and ApoA-1 (+ 12.5%) compared with atorvastatin group (-16.6% , + 4.3% and + 9.8%). Twenty-nine patients received continuation of 20 mg / d rosuvastatin, and 10 (45.5%) of 22 completed patients achieved LDL-C compliance. No drug-related serious adverse events were found in the study. Conclusions This study shows that rosuvastatin 10 mg is superior to equivalent dose of atorvastatin in lowering LDL-C, with safety similar for 3 months.