Mrochen Anne, Song Yu, Harders Verena, Sembill Jochen A, Sprügel Maximilian I, Hock Stefan, Lang Stefan, Engelhorn Tobias, Kallmünzer Bernd, Volbers Bastian, Kuramatsu Joji B
Department of Neurology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany.
Department of Neurosurgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Front Neurol. 2024 Aug 5;15:1357815. doi: 10.3389/fneur.2024.1357815. eCollection 2024.
General guideline recommendations in patients with intracerebral hemorrhage (ICH) include blood pressure-, temperature- and glucose management. The therapeutic effect of such a "care bundle" (blood pressure lowering, glycemic control, and treatment of pyrexia) on clinical outcomes becomes increasingly established. For the present study, we aimed to investigate associations of strict bundled care treatment (BCT) with clinical outcomes and characterize associations with key outcome effectors such as hematoma enlargement (HE) and peak perihemorrhagic edema (PHE).
We screened consecutive ICH patients ( = 1,322) from the prospective UKER-ICH cohort study. BCT was defined as achieving and maintaining therapeutic ranges for systolic blood pressure (110-160 mmHg), glucose (80-180 mg/dL), and body temperature (35.5-37.5°C) over the first 72 h. The primary outcome was the functional outcome at 12 months (modified Rankin Scale (mRS) 0-3). Secondary outcomes included mortality at 12 months, the occurrence of hematoma enlargement, and the development of peak perihemorrhagic edema. Confounding was addressed by a doubly robust methodology to calculate the absolute treatment effect (ATE) and by calculating e-values.
A total of 681 patients remained for analysis, and 182 patients fulfilled all three BCT criteria and were compared to 499 controls. The ATE of BCT to achieve the primary outcome was 9.3%, 95% CI (1.7 to 16.9), < 0.001; e-value: 3.1, CI (1.8). Mortality at 12 months was significantly reduced by BCT [ATE: -12.8%, 95% CI (-19.8 to -5.7), < 0.001; e-value: 3.8, CI (2.2)], and no association was observed for HE or peak PHE. Significant drivers of BCT effect on the primary outcome were systolic blood pressure control (ATE: 15.9%) and maintenance of normothermia (ATE: 10.9%).
Strict adherence to this "care bundle" over the first 72 h during acute hospital care in patients with ICH was independently associated with improved functional long-term outcome, driven by systolic blood pressure control and maintenance of normothermia. Our findings strongly warrant prospective validation to determine the generalizability especially in Western countries.ClinicalTrials.gov, identifier [ID: NCT03183167].
脑出血（ICH）患者的一般指南建议包括血压、体温和血糖管理。这种“护理套餐”（降压、血糖控制和发热治疗）对临床结局的治疗效果越来越得到证实。在本研究中，我们旨在调查严格的捆绑式护理治疗（BCT）与临床结局之间的关联，并描述其与关键结局效应指标如血肿扩大（HE）和出血周围水肿峰值（PHE）之间的关联。
我们从前瞻性UKER-ICH队列研究中筛选了连续的ICH患者（n = 1322）。BCT定义为在最初72小时内达到并维持收缩压（110 - 160 mmHg）、血糖（80 - 180 mg/dL）和体温（35.5 - 37.5°C）的治疗范围。主要结局是12个月时的功能结局（改良Rankin量表（mRS）0 - 3）。次要结局包括12个月时的死亡率、血肿扩大的发生情况以及出血周围水肿峰值的发展情况。通过双重稳健方法计算绝对治疗效果（ATE）并计算e值来处理混杂因素。
共有681例患者纳入分析，182例患者符合所有三项BCT标准，并与499例对照进行比较。BCT实现主要结局的ATE为9.3%，95%CI（1.7至16.9），P < 0.001；e值：3.1，CI（1.8）。BCT显著降低了12个月时的死亡率[ATE：-12.
