Locatelli Francesco, Zoccali Carmine
Department of Nephrology, Alessandro Manzoni Hospital, Lecco, Italy.
Renal Research Institute, New York, USA, Institute of Biology and Molecular Biology (BIOGEM), Ariano Irpino, Italy and IPNET, Reggio Calabria, Italy.
Clin Kidney J. 2023 Sep 11;17(1):sfad229. doi: 10.1093/ckj/sfad229. eCollection 2024 Jan.
Meta-analyses offer an estimate of the overall effect size and help address the inconsistency in findings across studies. The risk is the overemphasis on statistical significance while underrepresenting or misinterpreting clinical significance. There's also a lack of standardized methods for quantifying and reporting clinical significance and these measures are often missing or inconsistently reported in many meta-analyses, making it difficult for readers to determine the clinical relevance of the findings. A major merit of Minutolo's meta-analysis is to formally evaluate efficacy and safety of Hypoxia Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHI) as class and as single agents in comparison with ESA, by selecting from only phase-3 randomised clinical trials (RCTs) that compared HIF-PHIs with erythropoiesis-stimulating agents (ESAs) in dialysis and non-dialysis patients. From a clinical perspective, the primary evaluation in this meta-analysis should have been the percentage of patients able to reach and maintain the target haemoglobin (Hb) levels throughout the trials but only a few RCTs selected this primary end point. Any claimed superiority of one drug over another should consider the selected doses. The amount of iron administered to patients, their iron stores and level of inflammation are important confounding factors that affect the reliability of any comparison.
荟萃分析提供了总体效应大小的估计值,并有助于解决不同研究结果之间的不一致性。风险在于过度强调统计学显著性,而对临床显著性的呈现不足或解读有误。此外,缺乏量化和报告临床显著性的标准化方法,而且这些指标在许多荟萃分析中常常缺失或报告不一致,这使得读者难以确定研究结果的临床相关性。米努托洛荟萃分析的一个主要优点是,通过仅从3期随机临床试验(RCT)中进行选择,这些试验在透析和非透析患者中比较了缺氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI)作为一类药物和单一药物与促红细胞生成素(ESA)的疗效和安全性。从临床角度来看,该荟萃分析的主要评估应该是在整个试验过程中能够达到并维持目标血红蛋白(Hb)水平的患者百分比,但只有少数RCT选择了这个主要终点。任何声称一种药物优于另一种药物的说法都应该考虑所选的剂量。给予患者的铁量、他们的铁储备和炎症水平是影响任何比较可靠性的重要混杂因素。