论文部分内容阅读
目的:探讨前蛋白转化酶枯草杆菌蛋白酶/kexin9型（PCSK9）抑制剂对极高危动脉粥样硬化性心血管疾病（ASCVD）患者的降脂效果及其安全性。方法:选择2019年4月至10月重庆医科大学附属第二医院门诊及住院的极高危ASCVD患者。应用随机数字表法将入选患者分为两组。阿托伐他汀组仅每晚单独给予阿托伐他汀20 mg口服，疗程为4周；联合用药组在口服阿托伐他汀的基础上皮下注射PCSK9抑制剂依洛尤单抗注射液140 mg，2周1次，疗程为4周。分别于治疗前及治疗4周后检测患者血脂谱水平，包括三酰甘油（TG）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）和脂蛋白-a（Lp-a）；并记录患者不良反应发生情况。结果:研究期间共纳入40例患者，阿托伐他汀组和联合用药组各20例。两组治疗前血脂谱水平差异无统计学意义；经过4周治疗后，两组TC和LDL-C水平以及联合用药组Lp-a水平均较治疗前明显降低，而两组TG和HDL-C水平与治疗前差异无统计学意义。进一步分析显示，联合用药组TC、LDL-C和Lp-a治疗前后的差值均较阿托伐他汀组明显增加〔TC差值（mmol/L）：2.78±1.98比0.54±0.83，LDL-C差值（mmol/L）：1.91±1.38比0.39±0.72，Lp-a差值（mg/L）：115.87±138.93比-84.19±251.85，均n P<0.05〕。联合用药组仅有1例患者发生过敏反应，主要表现为皮疹，经抗过敏治疗后好转；两组均无肝功能异常、肌酶增高等其他不良反应发生。n 结论:PCSK9抑制剂可快速有效降低极高危ASCVD患者TC、LDL-C及Lp-a水平，但对TG、HDL-C水平影响不大，并具有一定安全性。“,”Objective:To investigate the lowering effect on lipid and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in patients with extremely high risk atherosclerotic cardiovascular disease (ASCVD).Methods:The outpatients and in-patients with extremely high risk ASCVD admitted to the Second Affiliated Hospital of Chongqing Medical University from April to October in 2019 were enrolled. The enrolled patients were divided into two groups by random number table method. The patients in the atorvastatin group were given only 20 mg atorvastatin orally every night for 4 weeks. In the combined group, oral atorvastatin was administered with subcutaneous injection of 140 mg evolocumab, a PCSK9 inhibitor, once every 2 weeks, and the course of treatment was 4 weeks. Serum lipid profile was measured before and 4 weeks after treatment, including triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and lipoprotein-a (Lp-a). Adverse events were recorded.Results:During the study period, a total of 40 patients were enrolled, with 20 patients in the atorvastatin group and 20 in the combined group. There was no significant difference in blood lipid profile before treatment between the two groups. After 4 weeks of treatment, the levels of TC and LDL-C in the two groups and Lp-a level in the combined group were significantly lower than those before treatment, while the levels of TG and HDL-C in the two groups were not statistically significant. Further analysis showed that the differences in TC, LDL-C and Lp-a between before and after treatment in the combined group were significantly higher than those in the atorvastatin group [TC difference (mmol/L): 2.78±1.98 vs. 0.54±0.83, LDL-C difference (mmol/L): 1.91±1.38 vs. 0.39±0.72, Lp-a difference (mg/L): 115.87±138.93 vs. -84.19±251.85, all n P < 0.05]. Only 1 patient in the combined group developed allergic reaction, mainly manifested as skin rash, who alleviated after anti-allergic treatment. No other adverse reactions such as abnormal liver function and increased myozyme occurred in the two groups.n Conclusion:PCSK9 inhibitor could rapidly and effectively reduced the levels of TC, LDL-C and Lp-a in extremely high risk ASCVD patients, while had little effect on the levels of TG and HDL-C. It is safe to some extent.