起始联合降脂策略对心内科门诊“极高危ASCVD”患者疗效及安全性观察——真实世界的前瞻性队列研究  

Observation on the efficacy and safety of initial combined lipid-lowering strategy in patients with"very high-risk ASCVD"in cardiology outpatient department:real-world prospective cohort study

作　　者：赵震宇[1] 李媛[2] 郭宇轩 毛萧萧 MD Sayed Ali Sheikh 夏珂[2] ZHAO Zhenyu;LI Yuan;GUO Yuxuan;MAO Xiaoxiao;MD Sayed Ali Sheikh;XIA Ke(Institute of Clinical Pharmacology,Xiangya Hospital,Central South University;Department of Cardiology,Xiangya Hospital,Central South University,Changsha 410008,Hunan,China;Internal Medicine Department,Cardiology,College of Medicine,Jouf University,Sakaka 72388,Saudi Arabia)

机构地区：[1]中南大学湘雅医院临床药理研究所 [2]中南大学湘雅医院心血管内科,湖南长沙410008 [3]Internal Medicine Department,Cardiology,College of Medicine,Jouf University,Sakaka 72388,Saudi Arabia

出　　处：《中国临床药理学与治疗学》2024年第8期907-916,共10页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：湖南省科技重大专项基金(2021SK1020);湖南省自然科学基金(2023JJ30948);湖南省卫生健康委基金(202203014687);中国心血管健康联盟-2020进·阶基金(2020-CCA-ACCESS-117)。

摘　　要：目的:在真实世界的前瞻性队列研究中观察心内科门诊“极高危ASCVD”患者在治疗起始阶段采用联合降脂策略的疗效与安全性。方法:连续入组2021年1月至6月在湘雅医院心内科高脂血症专病门诊就诊的“极高危ASCVD”患者,根据其实际降脂策略分为三组:阿托伐他汀单药组;阿托伐他汀联合依折麦布组;阿托伐他汀联合依洛尤单抗组。主要观察终点为治疗一个月后低密度脂蛋白胆固醇(LDL-C)、脂蛋白a[Lp(a)]、非-HDL-C变化,次要终点为总胆固醇(TC)、甘油三酯(TG)、LDL-C、超敏C反应蛋白(hs-CRP)变化及安全性指标。结果:无论哪种联合方式,在“极高危ASCVD”患者降脂起始阶段联合降脂治疗的疗效均显著优于阿托伐他汀单药组:LDL-C、Log[Lp(a)]、非-HDL-C、TC的降幅更大,差异均有统计学意义(均P<0.05)。在两种联合降脂方案中,阿托伐他汀联合依洛尤单抗与联合依折麦布相比,LDL-C、Log[Lp(a)]的降幅更大,差异均有统计学意义(P<0.05),TC、TG有一定的降幅,差异无统计学意义(P>0.05)。以“LDL-C<1.4 mmol/L或<1.8 mmol/L”作为降脂达标的标准时,两组联合降脂治疗的LDL-C达标率均高于阿托伐他汀单药组,差异均有统计学意义(均P<0.05);阿托伐他汀联合依洛尤单抗组的LDL-C达标率高于阿托伐他汀联合依折麦布组,差异均有统计学意义(均P<0.05)。单独或联合“LDL下降超过50%”的降幅为达标标准,三组均无人能达标。治疗后三组间的肝脏转氨酶水平变化差异均无统计学意义(均P<0.05);三组间心肌酶同工酶(CK-MB)均下降,但差异无统计学意义(P<0.05)。与阿托伐他汀单药组相比,两联合降脂组治疗组的血糖均下降,差异具有统计学意义(P<0.05);阿托伐他汀联合依折麦布组的血糖比阿托伐他汀联合依洛尤单抗组的降幅更大,差异有统计学意义(P<0.05)。结论:起始联合降脂治疗1个月对心内科门诊“极高危ASCVD”患者的降�AIM:To observe the efficacy and safety of combined lipid-lowering strategies in the initial stage of treatment in"very high-risk ASCVD"patients in cardiology outpatient clinics in a realworld prospective cohort study.METHODS:Patients with"very high-risk ASCVD"from January to June 2021 were consecutively enrolled and divided into three groups according to the actual lipid-lowering treatment strategies:Atorvastatin group;Atorvastatin combine with ezetimibe group;Atorvastatin combine with evolocumab group.The primary observation endpoints were the changes in LDL-C,Lp(a),and non-HDL-C after one month of treatment,and the secondary endpoints were the changes in TC,TG,HDL-C,Hs-CRP,and safety indicators.RESULTS:The efficacy of the combined lipidlowering strategy in the initial stage of treatment was significantly better than that of the Atorvastatin group:LDL-C,Log[Lp(a)],non-HDL-C,TC significantly decreased(all P<0.05).Compared with the Atorvastatin combine with Ezetimibe group,LDL-C and Log[Lp(a)]decreased significantly in the Atorvastatin combine with Evolocumab group(P<0.05),and TC and TG had decreased insignificantly(P>0.05).When"LDL-C<1.4mmol/L or<1.8 mmol/L"is used as the standard for lipid-lowering compliance,the LDL-C compliance rates of the two groups of combined lipid-lowering treatments are higher than those of the atorvastatin single-drug group.The differences were all statistically significant(all P<0.05);the LDL-C compliance rate of the atorvastatin combined with evolocumab group was higher than that of the atorvastatin combined with ezetimibe group,and the differences were statistically significant(All P<0.05).When the reduction rate of"LDL dropped by more than 50%"alone or in combination were used as the standard,no one in the three groups could reach the standard.The liver aminotransferase levels had no significant changes among the 3 groups after treatment(all P>0.05).Myocardial enzyme isoenzyme(CKMB)decreased among the 3 groups insignificantly(P>0.05).Compared with the Atorvastatin group,the blood su

关 键 词：起始联合降脂 极高危ASCVD 真实世界 前瞻性队列研究 早期达标 

分 类 号：R859.2[医药卫生—航空、航天与航海医学]