依洛尤单抗联合他汀类药物治疗急性冠脉综合征患者高血脂的疗效与安全性评价

Evaluation of efficacy and safety of evolocumab combined with statins in treatment of hyperlipidemia in patients with acute coronary syndrome

  • 摘要:
      背景  血脂的管理和控制,尤其是血清低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)水平的降低对冠心病患者很重要。新型调脂药物依洛尤单抗注射液,以其优秀的降脂作用和良好的安全性越来越受关注。
      目的  评价依洛尤单抗注射液在急性冠脉综合征(acute coronary syndrome,ACS)患者高血脂治疗中的疗效与安全性。
      方法  选取2020年7月- 2021年6月在海军军医大学第一附属医院心内科住院的ACS患者,LDL-C均不达标(>1.4 mmol/L),将其随机分为常规治疗组(阿托伐他汀片20 mg或瑞舒伐他汀片10 mg,每晚1次)和联合治疗组(阿托伐他汀片20 mg或瑞舒伐他汀片10 mg,每晚1次+依洛尤单抗140 mg,每两周1次),每组各42例,治疗3个月。比较两组患者治疗前后外周血脂水平变化以及不良事件发生率。
      结果  治疗前两组基线指标、心血管危险因素、血脂水平差异均无统计学意义(P>0.05)。治疗后3个月,两组总胆固醇(total cholesterol,TC)、LDL-C、载脂蛋白B(apolipoprotein B,ApoB)均显著下降(P<0.05);联合治疗组的总三酰甘油(triglyceride,TG)显著下降(P<0.05);常规治疗组、联合治疗组脂蛋白alipoprotein(a),Lp(a)分别呈升高和下降的趋势,但差异均无统计学意义(P>0.05)。与常规治疗组比较,联合治疗组的TC、LDL-C、ApoB和Lp(a)降低幅度更大(P<0.05),LDL-C达标率更高(P<0.01)。两组均未发生严重不良事件;联合治疗组累计不良反应发生率明显高于常规治疗组(P<0.05),主要与皮下注射反应相关。
      结论  ACS患者的血脂管理,在他汀治疗基础上联合依洛尤单抗可进一步降低TC、LDL-C、ApoB水平,对TG、Lp(a)也有一定降幅,且安全性良好,依洛尤单抗是一种非常有前景的药物。

     

    Abstract:
      Background  The management and control of the lipid, especially the reduction of serum low density lipoprotein cholesterol (LDL-C) level plays an important role in patients with coronary heart disease. Evolocumab injection, a new lipid-lowering drug, has attracted more and more attention for its good effect and safety.
      Objective  To evaluate the efficacy and safety of evolocumab in the treatment of hyperlipidemia in patients with acute coronary syndrome.
      Methods  Patients with acute coronary syndrome who were hospitalized in the department of cardiology, the First Affiliated Hospital of Naval Military Medical University from July 2020 to June 2021 and whose low density lipoprotein cholesterol (LDL-C) did not reach the target (>1.4 mmol/L) were included. They were randomly divided into the conventional treatment group (atorvastatin 20 mg or rosuvastatin 10 mg once a night) and the combined treatment group (atorvastatin 20 mg or rosuvastatin 10 mg once a night & evolocumab 140 mg once two weeks), with 42 patients in each group, and the treatment lasted for 3 months. The changes of circulating blood lipid levels and the incidence of adverse events were compared between the two groups before and after treatment.
      Results  There were no significant differences in cardiovascular risk factors or lipid levels at baseline between the two groups (P>0.05). After 3 months of treatment, the levels of total cholesterol (TC), LDL-C, and apolipoprotein B (ApoB) in the two groups decreased significantly (P<0.05). And the level of TG in the combined treatment group also decreased significantly (P<0.05). The level of lipoprotein a (Lp(a)) increased in the conventional group while decreased in the combined treatment group, without statistically significant difference (P>0.05). Compared with the conventional treatment group, the combined treatment group had significantly greater decrease of TC, LDL-C, ApoB and Lp(a) (P<0.05), while a significantly higher control rate of LDL-C (P<0.05). No serious adverse event was observed in the two groups. The cumulative adverse reactions in the combined treatment group were significantly higher than those in the conventional treatment group (P<0.05), which was mainly related to subcutaneous injection reaction.
      Conclusion  For lipid management in patients with acute coronary syndrome, evolocumab combined with statin therapy can further reduce the levels of TC, LDL-C and ApoB, and reduce the levels of TG and Lp(a) to a certain extent, with good safety, which suggests that evolocumab is a very promising medicine.

     

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