中国临床药学杂志

目的 比较英克司兰与依洛尤单抗联合他汀类药物对超高危动脉粥样硬化性心血管病（ASCVD）患者的降脂疗效。方法纳入2023年7月至2024年2月收治的超高危ASCVD病例76例，根据用药方案分为他汀类药物组（A组）33例、英克司兰联合他汀类药物组（B组）23例和依洛尤单抗联合他汀类药物组（C组）20例。比较治疗前、治疗3个月和6个月后3组总胆固醇、三酰甘油、低密度脂蛋白C(LDL-C)、高密度脂蛋白C、载脂蛋白A、脂蛋白a水平和生活质量。比较治疗6个月内的药物不良反应发生情况。结果 治疗3个月后，A组、B组和C组的LDL-C降幅分别为44.4%、51.9%和52.2%,LDL-C达标率分别为18.2%、47.8%和50.0%；治疗6个月后，A组、B组和C组的LDL-C降幅分别为48.1%、59.3%和60.9%,LDL-C达标率分别为28.3%、60.4%和59.8%。降脂疗效方面，与A组比较，B、C组各项血脂指标明显降低（P<0.05），但B组与C组间比较差异无统计学意义（P > 0.05）。治疗3个月和6个月后，C组躯体疼痛得分低于B组和A组。3组各时间点的ALT、AST、Scr水平和eGFR比较差异均无统计学意义（P > 0.05）;3组不良反应总发生率比较差异无统计学意义（P > 0.05），治疗过程中均无严重的不良反应发生。结论英克司兰与依洛尤单抗联合他汀类药物对超高危ASCVD的降脂疗效相当，均优于单用他汀类药物。英克司兰联合他汀类药物治疗超高危ASCVD安全性良好，可显著提高患者的用药舒适性，进而提高用药依从性。

AIM To compare the lipid-lowering effects of inclisiran and evolocumab combined with statins in ultra-highrisk atherosclerotic cardiovascular disease(ASCVD) patients. METHODS From July 2023 to February 2024, 76 ultra-high-risk ASCVD patients were recruited in the study and divided into 3 groups based on the medication regimen: statin monotherapy group(Group A, n=33), inclisiran combined with statins group(Group B, n=23), and evolocumab combined with statins group(Group C,n=20). Levels of total cholesterol, triglycerides, low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C), apolipoprotein A, and lipoprotein(a), as well as quality of life, were compared among 3 groups before treatment, after3 months of medication, and after 6 months of medication. The incidence of adverse drug reactions within 6 months of treatment was compared. RESULTS After 3 months of treatment, the reductions in LDL-C were 44.4% for Group A, 51.9% for Group B, and 52.2% for Group C and the LDL-C target achievement rates were 18.2% for Group A, 47.8% for Group B, and 50.0%for Group C. After 6 months of treatment, the reductions were 48.1% for Group A, 59.3% for Group B, and 60.9% for Group C. The LDL-C target achievement rates were 28.3% for Group A, 60.4% for Group B, and 59.8% for Group C, with LDL-C <1.4 mmol·L^-1 as the criterion. Compared with Group A, the lipid levels in Group B and Group C were significantly lower(P <0.05). After 3 months and 6 months of treatment, the bodily pain scores in Group C were lower than those in Group B and Group A. There were no statistically significant differences in the levels of alanine aminotransferase(ALT), aspartate aminotransferase(AST), serum creatinine(Scr) and estimated glomerular filtration rate(eGFR) among the 3 groups at all time points(P > 0.05).There was no statistically significant difference in the total incidence of adverse reactions among the 3 groups(P > 0.05), and no serious adverse reactions occurred during treatment in any group. CONCLUSION The lipid-lowering effects of inclisiran and evolocumab combined with statins are comparable in ultra-high-risk ASCVD, and both are superior to statins alone. Inclisiran combined with statins in the treatment of ultra-high-risk ASCVD can significantly improve patients' medication comfort and has also shown a good safety profile, thereby improving medication compliance.