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前蛋白转化酶枯草溶菌素9(PCSK9)抑制剂在慢性肾脏病患者中的疗效与安全性

Efficacy and safety of PCSK9 inhibitors in patients with chronic kidney disease.

作者信息

Tang Haixia, Li Xiaomin, Wang Fengmei, Liu Hong, Zhang Xiaoliang, Liu Bicheng, Wang Bin

机构信息

Department of Nephrology, Zhongda Hospital, Southeast University School of Medicine, Nanjing, China.

Department of Pharmacy, Zhongda Hospital, Southeast University School of Medicine, Nanjing, China.

出版信息

BMC Nephrol. 2025 Aug 19;26(1):472. doi: 10.1186/s12882-025-04347-1.

Abstract

BACKGROUND

This study aimed to assess the efficacy and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in lowering lipid levels among chronic kidney disease (CKD) patients, including those with stages 4-5 CKD.

METHODS

CKD patients with atherosclerotic cardiovascular disease treated between January 2022 and December 2022 at Zhong Da Hospital affiliated with Southeast University were enrolled in this study. Patients received either evolocumab or alirocumab for three months, either in combination with statin therapy with or without ezetimibe. Efficacy and safety measures were compared among the different groups before and after treatment.

RESULTS

A total of 496 CKD patients were included in the study, comprising 263 with stages 1-2 CKD, 170 with stage 3 CKD, and 63 with stages 4-5 CKD. Among them, 301 patients were classified into the atherosclerotic cardiovascular disease (ASCVD) group, whereas 195 were classified into the very-high-risk ASCVD group. LDL-C, total cholesterol (TC), and lipoprotein (a) (Lp(a)) levels decreased significantly in all groups, including stages 4-5 CKD patients, after treatment (P < 0.05). The serum creatinine (Scr) level and estimated glomerular filtration rate (eGFR) remained stable during treatment (P > 0.05). The incidence of adverse drug events did not differ significantly among the different kidney function groups (P ≥ 0.05).

CONCLUSIONS

PCSK9 inhibitors can be effectively and safely utilized for lipid-lowering therapy in CKD patients, even those with stages 4-5 CKD.

CLINICAL TRIAL NUMBER

Not applicable.

摘要

背景

本研究旨在评估前蛋白转化酶枯草溶菌素/克新9型(PCSK9)抑制剂在降低慢性肾脏病(CKD)患者血脂水平方面的疗效和安全性,包括4 - 5期CKD患者。

方法

纳入2022年1月至2022年12月在东南大学附属中大医院接受治疗的患有动脉粥样硬化性心血管疾病的CKD患者。患者接受依洛尤单抗或阿利西尤单抗治疗三个月,联合或不联合依折麦布进行他汀类治疗。比较不同组治疗前后的疗效和安全性指标。

结果

本研究共纳入496例CKD患者,其中1 - 2期CKD患者263例,3期CKD患者170例,4 - 5期CKD患者63例。其中,301例患者被分类为动脉粥样硬化性心血管疾病(ASCVD)组,195例被分类为极高风险ASCVD组。治疗后,所有组包括4 - 5期CKD患者的低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)和脂蛋白(a)[Lp(a)]水平均显著下降(P < 0.05)。治疗期间血清肌酐(Scr)水平和估算肾小球滤过率(eGFR)保持稳定(P > 0.05)。不同肾功能组的药物不良事件发生率无显著差异(P≥0.05)。

结论

PCSK9抑制剂可有效且安全地用于CKD患者的降脂治疗,即使是4 - 5期CKD患者。

临床试验编号

不适用。

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