依洛尤单抗在冠心病合并轻度肾功能不全患者中的应用

Application of evolocumab in patients with coronary heart disease complicated with mild renal insufficiency

  • 摘要: 目的 评价前蛋白转化酶枯草溶菌素9(PCSK9)抑制剂依洛尤单抗在冠状动脉粥样硬化性心脏病(冠心病)合并轻度肾功能不全患者中降低LDL-C水平的有效性和安全性。方法 回顾性收集心内科确诊为冠心病合并轻度肾功能不全估算的肾小球滤过率(eGFR)为60~90 mL/(min·1.73 m2)的患者,根据调脂治疗策略分为2组:使用PCSK9抑制剂依洛尤单抗联合他汀类药物(瑞舒伐他汀)治疗的为实验组(50例),单纯使用他汀类药物(瑞舒伐他汀)治疗的为对照组(42例),观察2组患者治疗1个月和3个月后的LDL-C水平、肾功能指标及2组患者不良反应和心血管事件的发生率。结果 与对照组相比,实验组治疗1个月后LDL-C水平降低(1.27±0.90)mmol/L vs. (1.75±0.82)mmol/L,P < 0.05;3个月后LDL-C水平明显降低(0.94±0.44)mmol/L vs. (1.53±0.53)mmol/L,P < 0.05。而实验组治疗1个月和3个月后肾功能指标变化差异无统计学意义(P > 0.05)。在3个月的治疗期内,2组患者均未观察到新发糖尿病、神经认知功能障碍的发生,且2组患者出现心血管事件(再次不稳定性心绞痛住院、AMI、再次PCI)和其他不良反应(皮疹、肌痛)等事件的发生率比较差异均无统计学意义(P均> 0.05)。结论 冠心病合并轻度肾功能不全患者中,与瑞舒伐他汀单药治疗相比,依洛尤单抗联合瑞舒伐他汀在1个月和3个月治疗期内能够明显降低LDL-C的水平,且安全性良好。

     

    Abstract: Objective To evaluate the efficacy and safety of evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in lowering LDL-C levels in patients with coronary heart disease complicated with mild renal insufficiency. Methods Clinical data of patients diagnosed with coronary heart disease complicated with mild renal insufficiency in Department of Cardiology (estimated glomerular filtration rate (eGFR) 60-90 mL/(min·1.73 m2)) were retrospectively collected. All patients were divided into two groups according to the LDL-C lowering strategy. In the experimental group (n=50), patients were treated with evolocumab, a PCSK9 inhibitor, combined with statins (rosuvastatin calcium tablets), and their counterparts in the control group (n=42) were treated with statins (rosuvastatin calcium tablets) alone. LDL-C level, renal function indicators, side effects and adverse cardiovascular events at 1 and 3 months were observed between two groups. Results Compared with the control group, the LDL-C level at 1 month was significantly lower in the experimental group ((1.27±0.90) mmol/L vs. (1.75±0.82) mmol/L, P < 0.05), and the LDL-C level 3 months was even lower ((0.94±0.44) mmol/L vs. (1.53±0.53) mmol/L, P < 0.05). However, no significant differences were noted in the changes of renal function indicators at l and 3 months between two groups (all P > 0.05). During 3-month treatment period, no adverse reactions, such as new-onset diabetes mellitus and neurocognitive dysfunction, were observed in both groups. The incidence of cardiovascular events (readmission for unstable angina, acute myocardial infarction and repeated percutaneous coronary intervention) and other adverse reactions (rash and myalgia) did not significantly differ between two groups (all P > 0.05). Conclusions In coronary heart disease patients complicated with mild renal insufficiency, evolocumab combined with rosuvastatin can significantly reduce LDL-C levels at 1 and 3 months and maintain high safety compared with compared to rosuvastatin alone.

     

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