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一项关于肾功能损害患者心力衰竭治疗的更新系统评价:形势尚未改变。

An updated systematic review on heart failure treatments for patients with renal impairment: the tide is not turning.

机构信息

Cardiology Department, Royal Papworth Hospital, Cambridge, UK.

Cardiology Department, Hospital da Arrabida, V. N. Gaia, Portugal.

出版信息

Heart Fail Rev. 2022 Sep;27(5):1761-1777. doi: 10.1007/s10741-022-10216-y. Epub 2022 Feb 7.

Abstract

Advanced chronic kidney disease (CKD) frequently aggravates heart failure (HF). However, these patients have inherently been excluded from most HF trials. We aim to provide updated estimates of the representation of patients with advanced CKD and the provision of baseline renal function indices in HF trials with a focused interest on the landmark trials. Updated systematic review was performed from the inception of MEDLINE to 31 December 2019 to identify all chronic HF randomized trials published in the three major cardiology and medical journals, respectively, which included mortality endpoint. The included studies were analysed based on the representativeness of the advanced CKD population and the reporting of baseline renal function. A total of 187 eligible randomized trials with 322,374 participants were included in our analysis. One hundred and six trials (56.7%) had exclusion criteria related to renal function, which remained a continuing trend-55.1% (27/49) from inception-2000, 53.4% (39/73) from 2001-2010 and 61.5% (40/65) from 2011 (P = 0.64). The exclusion criteria, however, have become less restrictive. There was a temporal improvement in the likelihood of HF trials in providing baseline renal function indices (28.6% from inception-2000 versus 53.4% from 2001-2010 and 83.1% from 2011, P < 0.001). Concordant findings were observed in the landmark trials. Patients with advanced CKD remain underrepresented in HF trials in the contemporary era, even though the exclusion criteria have become less restrictive, and the quality of renal function monitoring has improved. The continued underrepresentation of patients with advanced CKD in HF trials merits measured broadening of eligibility in further trial studies.

摘要

晚期慢性肾脏病(CKD)常加重心力衰竭(HF)。然而,这些患者在大多数 HF 试验中被固有地排除在外。我们旨在提供更新的估计,即对具有晚期 CKD 的患者的代表性和 HF 试验中基线肾功能指标的提供,重点关注标志性试验。从 MEDLINE 的开始到 2019 年 12 月 31 日,进行了更新的系统评价,以确定分别在三个主要心脏病学和医学杂志上发表的所有慢性 HF 随机试验,这些试验均包含死亡率终点。根据晚期 CKD 人群的代表性和基线肾功能的报告对纳入的研究进行分析。我们的分析共纳入了 187 项符合条件的随机试验,共有 322,374 名参与者。106 项试验(56.7%)有与肾功能相关的排除标准,这一趋势仍在继续-从开始时的 55.1%(27/49)-2000 年为 53.4%(39/73)-2010 年和 2011 年的 61.5%(40/65)(P=0.64)。然而,排除标准变得不那么严格了。HF 试验提供基线肾功能指标的可能性随着时间的推移而提高(从开始时的 28.6%到 2000 年为 53.4%,到 2010 年为 83.1%,P<0.001)。标志性试验也观察到了一致的结果。即使排除标准变得不那么严格,肾功能监测的质量也有所提高,但在当代,晚期 CKD 患者在 HF 试验中的代表性仍然不足。HF 试验中晚期 CKD 患者的代表性不足值得在进一步的试验研究中谨慎扩大纳入标准。

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