背景:贫血是晚期慢性肾脏病患者中常见的发现,尤其是那些透析的人.最近引入的缺氧诱导因子脯氨酸酰羟化酶抑制剂(HIF-PHIs)引起了人们对此类药物的心血管和血栓并发症的一些担忧。
目的:本荟萃分析旨在评估终末期肾病(ESKD)患者使用HIF-PHIs与使用红细胞生成刺激剂(ESA)的标准治疗的安全性。
方法:于2022年4月检索数据库。评估了在血液透析或腹膜透析中使用HIF-PHIs或ESA对ESKD患者报告的全因死亡率发生率;主要心血管不良事件(MACEs);心肌梗死(MI);中风和血栓事件。数据是从发表的报告中提取的,并按照Cochrane建议进行质量评估.
结果:本研究纳入了来自10项随机对照试验的12,821例患者。大多数患者(83%)进行血液透析。6,461(50.3%)使用HIF-PHIs,6,360(49.6%)在ESA组中。HIF-PHIs组的全因死亡率汇总估计发生率为769(相对风险比(RR):1.04;置信区间(CI):0.95-1.14;p=0.52;I2=0%)。在报告MACE结局的三项研究的分析中,各组的MACE结局没有差异(RR:0.95;CI:0.87-1.04;p=0.69;I2=0%)。此外,MI的结局之间没有统计学差异,中风,或血栓事件。
结论:在接受透析的ESKD患者中,与标准治疗相比,使用HIF-PHIs的安全性结局并不逊色.
Anemia is a common finding among patients with advanced chronic kidney disease, especially those on dialysis. The recent introduction of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) has raised some concerns about the cardiovascular and thrombotic complications of this class of drugs.
This meta-analysis aimed to assess the safety of HIF-PHIs in patients with end-stage kidney disease (ESKD) versus standard therapy with erythropoiesis-stimulating agents (ESAs).
Databases were searched on April 2022. Studies that reported incidence of all-cause mortality; major cardiovascular adverse events (MACEs); myocardial infarction (MI); stroke and thrombotic events in the use of HIF-PHIs or ESA on ESKD patients in hemodialysis or peritoneal dialysis were evaluated. Data were extracted from published reports, and quality assessment was performed per Cochrane recommendations.
12,821 patients from ten randomized controlled trials were included in this study. Most patients (83%) were on hemodialysis. 6,461 (50.3%) were using HIF-PHIs, and 6,360 (49.6%) were in the ESA group. The pooled estimated incidence of all-cause mortality was 769 in the HIF-PHIs group (relative-risk ratios (RR): 1.04; confidence interval (CI): 0.95-1.14; p = 0.52; I2 = 0%). There was no difference in the groups regarding the outcomes of MACE in the analysis of the three studies that reported this outcome (RR: 0.95; CI: 0.87-1.04; p = 0.69; I2 = 0%). In addition, there was no statistical difference among the outcomes of MI, stroke, or thrombotic events.
Among patients with ESKD on dialysis, the use of HIF-PHIs was non-inferior regarding the safety outcomes when compared to standard of care therapy.