依洛尤单抗在经皮冠状动脉介入治疗患者中的疗效与安全性分析

Efficacy and safety analysis of evolocumab in patients after percutaneous coronary intervention

目的描述南京鼓楼医院经皮冠状动脉介入治疗(Percutaneous coronary intervention,PCI)后连续使用依洛尤单抗至少6个月的超高危患者的特征和降脂治疗模式,观察应用依洛尤单抗真实世界的不同降脂方案的临床疗效和安全性,为临床合理应用提供参考。方法收集2022年1月1日-6月1日南京鼓楼医院心血管内科的动脉硬化性心血管疾病(Arteriosclerotic cardiovascular disease,ASCVD)超高危患者178例,依据降脂方案的用药种类不同,将其分为对照组和观察组。对照组82例,给予中等强度他汀类药物(阿托伐他汀20 mg/d或瑞舒伐他汀10 mg/d);观察组96例,在中等强度他汀类药物治疗的基础上,加用依洛尤单抗注射液(每次140 mg,2周1次,皮下注射)。记录两组患者基线和治疗后第1、3、6个月的血脂指标、肝酶指标、尿酸、肾功能水平、空腹血糖和不良反应。结果两组患者的年龄、体重指数(BMI)、合并疾病数量、学历等差异无统计学意义,但相较于对照组,观察组患者城市居民占比更高(P<0.05)。治疗后观察组患者低密度脂蛋白胆固醇(LDL-C)水平达标率更高,治疗6个月后,对照组和观察组的LDL-C分别为(1.5±0.2)mmol/L和(0.8±0.2)mmol/L,较治疗前均明显下降,差异有统计学意义(P<0.05),而两组患者的天冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、尿酸、空腹血糖、估算肾小球滤过率(eGFR)指标和不良反应发生率比较,差异没有统计学意义(P>0.05)。观察组的心绞痛复发、心源性死亡、再发心肌梗死和靶血管重建等的发生率低于对照组(6.3%vs.17.1%,P<0.05)。结论对PCI术后患者,给予依洛尤单抗联合他汀类药物,可以改善预后,而不会增加不良反应。

Objective To describe the characteristics and lipid-lowering treatment modes of ultra-high-risk patients who have been continuously using evolocumab for at least 6 months after percutaneous coronary intervention(PCI)in Nanjing Drum Tower Hospital,and to observe the clinical efficacy and safety of evolocumab in different lipid-lowering regimens in the real world,so as to provide reference for rational clinical application.Methods A total of 178 ultra-high-risk patients with arteriosclerotic cardiovascular disease(ASCVD)were collected from the Department of Cardiovascular Medicine of Nanjing Drum Tower Hospital from January 1,2022 to June 1,2022,and were divided into the control group and the observation group according to the different types of medication used in lipid-lowering regimens.In the control group,82 patients were given moderate-intensity statins(atorvastatin 20 mg/d or resuvastatin 10 mg/d),and in the observation group,96 patients were treated with evolocumab injection(140 mg per time,once every 2 weeks,subcutaneously)in addition to moderate-intensity statins.Lipid indices,liver enzyme indices,uric acid,renal function levels,fasting blood glucose and adverse events at baseline and at month 1,3 and 6 after treatment were observed in both groups.Results The differences in age,BMI,the number of comorbid diseases,and education between the two groups were not statistically significant,but compared with the control group,a higher percentage of patients in the observation group were urban residents(P<0.05).After treatment,the LDL-C level of patients in the observation group had a higher rate of reaching the standard,and after 6 months of treatment,the LDL-C of control group and observation group was(1.5±0.2)mmol/L and(0.8±0.2)mmol/L,respectively,which were significantly decreased compared with the pre-treatment period,and the difference was statistically significant(P<0.05),while there was no significant difference in AST,ALT,uric acid,fasting blood glucose,eGFR indexes and the incidence of adverse events between the two groups of patients(P>0.05).The incidence of angina recurrence,cardiogenic death,recurrent myocardial infarction and target vessel revascularization in observation group was lower than that in control group(6.3%vs.17.1%,P<0.05).Conclusion The application of a therapeutic regimen of evolocumab in combination with statins in post-PCI patients improves prognosis without increasing adverse effects.