他汀类药物联合依折麦布用于冠心病患者治疗的有效性和安全性评价

Effectiveness and safety of the combination therapy of ezetimibe/statins for patients with coronary heart disease

目的:研究中强度他汀联用依折麦布在冠状动脉粥样硬化性心脏病患者中与中、高强度他汀单用的有效性与安全性差异。方法:检索北京安贞医院HIS系统中2018年1月至2019年4月门诊及住院数据库,筛选出住院就诊记录后3~5周有门诊复查记录的病例。根据病例所使用的他汀类药物分为中强度他汀组、中强度他汀联用依折麦布组及高强度他汀组。比较门诊记录与住院记录血脂指标变化及变化率,并以门诊记录的低密度脂蛋白胆固醇(LDL-C)值,评估病例降脂目标达成率,对比各组降脂疗效的差距。以门诊记录病例中谷草转氨酶(AST)、谷丙转氨酶(ALT)以及肌酸激酶(CK)值超过正常上限2倍及3倍的人数,评估各组安全性差异。结果:共有371例患者纳入研究。联用组降脂目标达成率显著高于中、高强度他汀组;联用组LDL-C绝对变化、相对变化均显著优于中、高强度他汀组(P>0.05);安全性无显著差异(P<0.05)。结论:对于冠状动脉粥样硬化性心脏病患者的降脂治疗,中强度他汀联用依折麦布治疗方案降脂效果优于中、高强度他汀单用,且安全性无显著差异。

OBJECTIVE To evaluate the efficacy and safety of the combination therapy of ezetimibe/moderate-intensity statin, and compare with those of moderate-or high-intensity statin monotherapy.METHODS The outpatient and inpatient database from January 2018 to April 2019 in the HIS system of Beijing Anzhen Hospital was retrieved, and the cases with outpatient review records 3 to 5 weeks after the inpatient visit were screened out. According to the type of statin the cases used, three groups including moderate-intensity statin therapy group, ezetimibe/moderate-intensity statin therapy group and high-intensity statin therapy group were determined. The changes of LDL-C, TC, TG, HDL-C and the rate of LDL-C goal attainment among the groups were compared, and AST/ALT and CK were compared to evaluate the safety.RESULTS In the total of 371 cases were selected. Both the percentage decrease and the absolute reduction in LDL-c and TC of ezetimibe/moderate-intensity statin therapy group were significantly higher than those in the other groups(P<0.05). And a significantly greater percentage of patients achieved LDL-C goals was shown in ezetimibe/moderate-intensity statin therapy group when compared with the other groups(P<0.05).CONCLUSION For the lipid-lowering treatment of patients with coronary heart disease, the combination therapy of ezetimibe/moderate-intensity statin may be more effective with the same safety than statin monotherapy.