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依洛尤单抗联合瑞舒伐他汀治疗老年冠心病多支病变不完全血运重建合并高胆固醇血症患者的临床研究 被引量:4

Clinical trial of evolocumab combined with rosuvastatin in the treatment of elderly patients with coronary heart disease with multi-branch lesions and incomplete revascularization combined with hypercholesterolemia
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摘要 目的观察依洛尤单抗注射液联合瑞舒伐他汀片治疗老年冠心病多支病变不完全血运重建合并高胆固醇血症患者的临床疗效及安全性。方法将老年冠心病多支病变不完全血运重建合并高胆固醇血症患者按治疗方法分为对照组和试验组。对照组给予瑞舒伐他汀片每次10 mg,qd,口服;试验组在对照组治疗的基础上,联合依洛尤单抗每次140 mg,每2周1次,皮下注射。2组患者均连续治疗4周。比较2组患者的临床疗效、冠状动脉病变指标变化、心绞痛的改善情况,以及药物不良反应的发生情况。结果试验组筛选134例,剔除42例,最终92例纳入分析;对照组筛选120例,剔除34例,最终86例纳入分析。治疗后,试验组和对照组的总有效率分别为92.39%(85例/92例)和81.40%(70例/86例),差异有统计学意义(P<0.05)。试验组和对照组治疗2周后的西雅图心绞痛问卷(SAQ)评分分别为(75.18±12.63)和(68.54±10.86)分,治疗4周后的SAQ评分分别为(89.53±18.72)和(78.43±16.05)分,差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的动脉粥样硬化斑块体积百分比分别为(51.01±4.02)%和(56.98±4.32)%,标准化的动脉粥样硬化斑块总体积分别为(204.44±20.17)和(258.36±24.75)mm^(3),最小管腔面积分别为(6.85±1.05)和(4.49±0.57)mm^(2),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有皮疹、局部红斑及瘀青和注射部位疼痛,对照组发生的药物不良反应有恶心呕吐和皮疹。试验组和对照组的总药物不良反应发生率分别为9.78%和6.98%,差异无统计学意义(P<0.05)。结论依洛尤单抗注射液联合瑞舒伐他汀片治疗老年冠心病多支病变不完全血运重建合并高胆固醇血症患者的临床疗效确切,其能显著地降低患者的血脂水平,改善心绞痛,促使斑块逆转,降低炎症反应,且不增加药物不良反应的发生率。 Objective To observe the clinical efficacy and safety of evolocumab injection combined with rosuvastatin in the treatment of elderly patients with coronary heart disease with incomplete revasculopathy and hypercholesterolemia.Methods Elderly patients with coronary artery disease with incomplete revascularization combined with hypercholesterolemia were divided into control and treatment groups acc or ding to treatment methods.Control group was given rosuvastatin tablets 10 mg per time,qd,orally;on the basis of control group,treatment group received evolocumab 140 mg per time,once two weeks,subcutaneous injection.Two groups were treated for 4 weeks.The clinical efficacy,changes of coronary artery disease indexes,improvement of angina pectoris and adverse drug reactions were compared between two groups.Results In the treatment group,134 cases were enrolled,42 cases were dropped out,and 92 cases were included in the analysis;in the control group,120 cases were enrolled,34 cases were dropped out,and 86 cases were included in the analysis.After treatment,the total effective rates of treatment and control groups were 92.39%(85 cases/92 cases)and 81.40%(70 cases/86 cases)with significant difference(P<0.05).After treatment of 2 weeks,the Seattle angina questionnaire(SAQ)scores of treatment and control groups were(75.18±12.63)and(68.54±10.86)points,and which were(89.53±18.72)and(78.43±16.05)points after 4 weeks of treatment,and the differences were statistically significant(all P<0.05).After treatment,the percentages of atherosclerotic plaque volume in treatment and control groups were(51.01±4.02)%and(56.98±4.32)%;the standardized total atherosclerotic plaque volume were(204.44±20.17)and(258.36±24.75)mm^(3);the minimum lumen area were(6.85±1.05)and(4.49±0.57)mm^(2),respectively;and the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were rash,local erythema and bruising and pain at the injection site,while those in the control group were nausea,vomiting and ras
作者 李海 康雅贤 李嘉晖 刘志军 LI Hai;KANG Ya-xian;LI Jia-hui;LIU Zhi-jun(Department of Cardiology,General Hospital of Ningxia Medical University,Yinchuan 750004,Ningxia Hui Autonomous Region,China;Department of Respiratory Medicine,Cardio-Cerebrovascular Hospital,General Hospital of Ningxia Medical University,Yinchuan 750004,Ningxia Hui Autonomous Region,China)
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2023年第21期3043-3047,共5页 The Chinese Journal of Clinical Pharmacology
基金 宁夏自然科学基金资助项目(2021AAC03346)。
关键词 依洛尤单抗注射液 瑞舒伐他汀片 冠心病多支病变不完全血运重建 高胆固醇血症 老年患者 临床疗效 安全性评价 evolocumab injection rosuvastatin tablet incomplete revascularization in coronary artery disease hypercholesterolemia elderly patient clinical efficacy safety evaluation
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