英克司兰联合瑞舒伐他汀治疗极高危动脉粥样硬化性心血管疾病患者的临床研究OA

Objective To explore the clinical therapeutic effect of inclisiran injection combined with rosuvastatin tablets in the treatment of patients with extremely high-risk atherosclerotic cardiovascular disease(ASCVD).Methods The patients with extremely high-risk ASCVD were divided into the treatment group and the control group according to the actual clinical medication regimens they received.The control group was given rosuvastatin calcium tablets 10 mg,po,qd,while the treatment group was given inclisiran sodium injection 284 mg,ih,for the first time,and 284 mg,ih,again after 3 months on the basis of control group.The treatment duration for both groups was 6 months.The clinical efficacy,lipid profile,low-density lipoprotein cholesterol(LDL-C)target attainment rate,proprotein convertase subtilisin/kexin type 9(PCSK9)levels,cardiac function,plaque stability,safety evaluation,and cardiovascular benefits were compared between the two groups.Results A total of 98 patients were enrolled,with 51 in the control group and 47 in the treatment group.After treatment,the overall response rates in the control group and the treatment group and were 68.63％(35 cases/51 cases)and 87.23％(41 cases/47 cases),respectively;the LDL-C levels were(1.42±0.27)and(1.26±0.22)mmol·L-1,respectively;the LDL-C goal attainment rates at 3 months were 41.18％(21 cases/51 cases)and 61.70％(29 cases/47 cases),respectively;LDL-C goal attainment rates at 6 months were 52.94％(27 cases/51 cases)and 74.47％(35 cases/47 cases),respectively;PCSK9 levels at 3 months were(313.66±41.35)and(295.63±39.43)ng·mL-1,respectively;PCSK9 levels at 6 months were(203.71±33.39)and(184.29±31.54)ng·mL-1,respectively;carotid intima-media thickness were(1.01±0.27)and(0.91±0.11)mm,respectively;plaque areas were(18.52±3.76)and(16.31±3.63)mm2,respectively;proportions of unstable plaques were 39.22％(20 cases/51 cases)and 19.15％(9 cases/47 cases),respectively;high-density lipoprotein cholesterol(HDL-C)levels were(1.46±0.55)and(1.47±0.33)mmol·L-1,respectively;apolipoprotein A(ApoA)levels were(1.11±0.25)and(1.10±0.29)g·L-1,respectively.Except HDL-C level and ApoA level,comparisons of other indexes between the two groups showed statistically significant differences(P＜0.05,P＜0.01).No significant difference in the incidence of adverse events was observed between the control group(5.88％,3 cases/51 cases)and treatment group(8.51％,4 cases/47 cases)(P＞0.05).Conclusion The combination of inclisiran injection and rosuvastatin tablet is effective in the treatment of extremely high-risk ASCVD,significantly improving the total effective rate and the early and sustained LDL-C target attainment rate,and more effectively reducing LDL-C levels and stabilizing plaques.The mechanism may be related to significantly inhibiting PCSK9 levels and further enhancing lipid-lowering and plaque-stabilizing effects.