【摘要】 目的 对比瑞舒伐他汀依折麦布固定剂量复方制剂与单药自由联合用于他汀类药物单药治疗不达标患者的调脂疗效和安全性。方法 选择自2024年3月至6月于中山大学附属第一医院高血压心血管病科、佛山市南海区第四人民医院心内科、佛山市第一人民医院心内科、广东省人民医院心内科经他汀类药物单药治疗低密度脂蛋白胆固醇(low-density lipoprotein cholesterol, LDL-C)未达标后换用瑞舒伐他汀依折麦布固定剂量复方制剂的45例高胆固醇血症患者为研究组，通过厦门区域性健康医疗大数据平台倾向性匹配120例使用瑞舒伐他汀和依折麦布单药自由联合的高胆固醇血症患者为对照组，对比研究组与对照组治疗4～6周LDL-C水平、LDL-C下降幅度，总胆固醇(total cholesterol, TC)、高密度脂蛋白胆固醇(high-density lipoprotein cholesterol, HDL-C)、三酰甘油(triglycerides, TG)变化以及安全性指标水平。结果 研究组治疗4～6周LDL-C水平明显低于对照组[(1.70±0.44)mmol/L vs(2.12±0.87)mmol/L,P<0.01],LDL-C下降幅度明显高于对照组[(43.17±16.11)%vs(29.14±29.13)%,P<0.01]。研究组LDL-C水平达标率明显高于对照组(71.11%vs 45.00%,P=0.003)。研究组与对照组治疗4～6周HDL-C、TG水平及HDL-C和TG下降幅度比较，差异无统计学意义(P>0.05)。研究组治疗4～6周TC水平明显低于对照组，下降幅度明显高于对照组，差异有统计学意义(P<0.05,P<0.01)。研究组与对照组治疗4～6周安全性指标天冬氨酸转氨酶、丙氨酸转氨酶、肌酸激酶、血清肌酐、估算肾小球滤过率水平比较，差异无统计学意义(P>0.05)。结论 瑞舒伐他汀依折麦布固定剂量复方制剂相较单药自由联合能够进一步降低他汀类药物单药治疗不达标的高胆固醇血症患者的LDL-C水平，提高达标率，且安全性良好。更多还原

【Abstract】 Objective To compare the lipid-lowering efficacy and safety of fixed-dose combination and free combination of rosuvastatin and ezetimibe in hypercholesterolemia patients who fail to achieve low-density lipoprotein cholesterol(LDL-C) goal with statin monotherapy.Methods A total of 45 hypercholesterolemia patients who switched from statin monotherapy to fixed-dose combination of rosuvastatin and ezetimibe after failing to achieve target LDL-C goal admitted at cardiological departments of First Affiliated Hospital of Sun Yat-sen University, Nanhai Fourth People’s Hospital, Foshan First People’s Hospital, and Guangdong Provincial People’s Hospital between March and June 2024 were enrolled and served as the study group.Another 120 hypercholesterolemia patients who treated with free combination of rosuvastatin and ezetimibe were selected from Xiamen Regional Health Medical Big Data Platform with propensity score matching and served as control group.The LDL-C level, LDL-C reduction, and changes in TC,HDL-C and TG levels in 4-6 weeks after the medication switch, as well as the safety indicators(AST,ALT,CK,Cre and eGFR) were compared between the two groups.Results In 4-6 weeks after the medication switch, the patients in the study group exhibited a significant decrease in LDL-C level(1.70±0.44 mmol/L vs 2.12±0.87 mmol/L,P<0.01),obvious LDL-C reduction [(43.17±16.11)% vs(29.14±29.13)%,P<0.01] when compared to those of the control group.The LDL-C goal attainment rate was significantly higher in the study group than the control group(71.11% vs 45.00%,P=0.003).In addition, there were no statistical differences in the levels of HDL-C and TG and the reductions of HDL-C and TG between the two groups in 4-6 weeks after treatment(P>0.05).The study group obtained notably lower TC level and TC reduction than the control group in the time(P<0.05,P<0.01).After treatment, no statistical differences were observed between the two groups in terms of AST,ALT,CK,Cre and eGFR(P>0.05).Conclusion Compared to free combination of rosuvastatin and ezetimibe, fixed-dose combination can further reduce LDL-C level in hypercholesterolemia patients who have not achieved LDL-C goal with statin monotherapy, with higher LDL-C goal attainment rate and good safety.更多还原