PCSK9抑制剂依洛尤单抗注射液治疗他汀类药物不耐受的高脂血症患者临床观察

Clinical observation on the treatment of statin-intolerant hyperlipidemic patients with PCSK9 inhibitor Evolocumab injection

目的:探讨PCSK9抑制剂依洛尤单抗治疗他汀类药物不耐受的高脂血症患者降脂效果和安全性。方法:选取2019年8月-2020年8月本院收治的他汀类药物不耐受的高脂血症患者64例,随机分为对照组和实验组各32例。对照组口服血脂康胶囊,600 mg/次,2次/d,连服14 d;实验组在对照组的基础上联合PCSK9抑制剂依洛尤单抗注射液,治疗首日单次给予140 mg皮下注射。两组疗程均为14 d。比较两组患者治疗前后低密度脂蛋白胆固醇(LDL-C)、甘油三酯(TG)和血清总胆固醇(TC)的改善情况。结果:对照组治疗前后比较,LDL-C、TG和TC水平均降低,具有统计学意义(P<0.05或P<0.01);实验组治疗前后比较,LDL-C、TG和TC水平均降低,结果具有统计学意义(P<0.05或P<0.01);治疗后实验组LDL-C和TC水平的改善优于对照组,两组比较有统计学意义(P<0.01)。两组均未见明显不良反应发生。结论:血脂康联用依洛尤单抗能够显著降低血浆中的LDL-C和TC水平,且安全性好。

Objective:To investigate the lipid-lowering effect and safety of PCSK9 inhibitor Evolocumab in treating statin-intolerant hyperlipidemic patients.Methods:64 patients with statin-intolerant hyperlipidemia admitted to our hospital from August 2019 to August 2020 were selected and randomly divided into the control group and the experimental group,with 32 cases in each group.In the control group,Xuezhikang capsules were administered orally twice daily at 600 mg for 14 days.In the experimental group,the PCSK9 inhibitor Evolocumab 140 mg was administered once by subcutaneous injection in addition to the control group.The treatment duration in both groups was 14 days.The improvement of low-density lipoprotein cholesterol(LDL-C),triglyceride(TG),and total serum cholesterol(TC)before and after treatment was compared between the two groups.Results:In the control group,LDL-C,TG,and TC levels were reduced after administration,which was statistically significant(P<0.05 or P<0.01);in the experimental group,LDL-C,TG,and TC levels were reduced after administration,which was statistically significant(P<0.05 or P<0.01);The improvement in LDL-C and TC levels in the experimental group was better than that in the control group after treatment.The comparison between the two groups was statistically significant(P<0.01).No significant adverse effects were observed in either group during the study period.Conclusion:The combination of Xuezhikang with Evolocumab significantly reduced plasma LDL-C and TC levels and was safe.