中国临床药理学杂志2026，Vol.42Issue(3)：301-305,5.DOI:10.13699/j.cnki.1001-6821.2026.03.001
依折麦布与阿利西尤单抗联合瑞舒伐他汀治疗冠心病的临床研究
Clinical trial of ezetimibe and alirocumab in combination with rosuvastatin in the treatment of coronary artery disease
摘要
Abstract
Objective To observe the clinical efficacy and safety of ezetimibe tablets or alirocumab injection in conjunction with rosuvastatin calcium tablets for the treatment of coronary heart disease(CHD).Methods Patients with CHD were randomly divided into two groups.Both groups took rosuvastatin calcium tablets,10 mg once daily.The control group additionally received ezetimibe tablets,10 mg once daily,while the treatment group received alirocumab injection(subcutaneous injection,75 mg per dose,once every two weeks).After 6 months of treatment,the two groups were compared in terms of clinical efficacy,lipid metabolism,cardiac function and myocardial injury markers.Adverse drug reactions during treatment were recorded.Results This study enrolled a total of 118 patients,with 59 assigned to treatment group and 59 to the control group.During the 6-month treatment period,4 patients in the control group dropped out due to changes in their condition.In treatment group,6 patients dropped out,comprising 3 due to changes in the treatment plan and 3 who voluntarily withdrew from the study midway.Ultimately,55 patients in the control group and 53 in the treatment group were included in the final analysis.After treatment,the total clinical effective rates were 90.57％(48 cases/53 cases)in treatment group and 72.73％(40 cases/55 cases)in control group,with statistically significant difference(P＜0.05).After treatment,the cholesterol levels in the treatment and control groups were(2.58±0.40)and(3.60±0.52)mmol·L-1,respectively;low-density lipoprotein cholesterol levels were(2.16±0.36)and(2.51±0.44)mmol·L-1,respectively;N-terminal pro-brain natriuretic peptide(NT-proBNP)levels were(301.12±20.11)and(326.54±25.84)pg·mL-1,respectively;cardiac troponin Ⅰ(cTn Ⅰ)levels were(0.53±0.19)and(0.90±0.26)μg·L-1,respectively;matrix metalloproteinase-9(MMP-9)levels were(31.04±4.05)and(37.25±4.72)ng·mL-1,respectively;left ventricular ejection fraction(LVEF)were(49.79±5.33)％and(45.09±5.21)％,respectively;left ventricular end-diastolic diameter(LVEDD)were(50.36±3.23)and(55.11±3.48)mm,respectively;and left ventricular end-systolic diameter(LVESD)were(35.04±3.72)and(40.64±3.97)mm,respectively.The aforementioned indicators in treatment group showed statistically significant differences compared to control group(all P＜0.05).Adverse drug reactions in control group included 2 cases of nausea and vomiting,2 cases of diarrhea,3 cases of fatigue and 2 cases of arthralgia.Treatment group reported 2 cases of nausea and vomiting,3 cases of diarrhea,2 cases of fatigue,1 case of arthralgia and 2 cases of injection site redness and swelling.The overall incidence rates of adverse drug reactions in treatment and control groups were 18.87％(10 cases/53 cases)and 16.36％(9 cases/55 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Both ezetimibe tablets and alirocumab injection demonstrate good therapeutic efficacy in the treatment of coronary heart disease.However,the combination of alirocumab injection with rosuvastatin calcium tablets can further improve lipid metabolism and cardiac function.关键词
阿利西尤单抗注射液/依折麦布片/瑞舒伐他汀钙片/冠心病Key words
alirocumab injection/ezetimibe tablet/rosuvastatin calcium tablet/coronary artery disease分类
医药卫生引用本文复制引用
伊新芝,刘洁茹,依力努尔·赛买提..依折麦布与阿利西尤单抗联合瑞舒伐他汀治疗冠心病的临床研究[J].中国临床药理学杂志,2026,42(3):301-305,5.基金项目
新疆维吾尔自治区自然科学基金资助项目(2022D01C269) （2022D01C269）
