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AHEAD 研究:抗凝治疗患者头部损伤管理的观察性研究。

AHEAD Study: an observational study of the management of anticoagulated patients who suffer head injury.

机构信息

School of Health and Related Research, University of Sheffield, Sheffield, UK.

Emergency Department, Northern General Hospital, Sheffield, UK.

出版信息

BMJ Open. 2017 Jan 13;7(1):e014324. doi: 10.1136/bmjopen-2016-014324.

Abstract

OBJECTIVES

Management of anticoagulated patients after head injury is unclear due to lack of robust evidence. This study aimed to determine the adverse outcome rate in these patients and identify risk factors associated with poor outcome.

DESIGN

Multicentre, observational study using routine patient records.

SETTING

33 emergency departments in England and Scotland.

PARTICIPANTS

3566 adults (aged ≥16 years) who had suffered blunt head injury and were currently taking warfarin.

MAIN OUTCOME MEASURES

Primary outcome measure was rate of adverse outcome defined as death or neurosurgery following initial injury, clinically significant CT scan finding or reattendance with related complication within 10 weeks of initial hospital attendance. Secondary objectives included identifying risk factors for adverse outcome using univariable and multivariable analyses.

RESULTS

Clinical data available for 3534/3566 patients (99.1%), median age 79 years; mean initial international normalised ratio (INR) 2.67 (SD 1.34); 81.2% Glasgow Coma Scale (GCS) 15: 59.8% received a CT scan with significant head injury-related finding in 5.4% (n=208); 0.5% underwent neurosurgery; 1.2% patients suffered a head injury-related death. Overall adverse outcome rate was 5.9% (95% CI 5.2% to 6.7%). Patients with GCS=15 and no associated symptoms had lowest risk of adverse outcome (risk 2.7%; 95% CI 2.1 to 3.6). Patients with GCS=15 multivariable analysis (using imputation) found risk of adverse outcome to increase when reporting at least one associated symptom: vomiting (relative risk (RR) 1.8; 95% CI 1.0 to 3.4), amnesia (RR 3.5; 95% CI 2.1 to 5.7), headache (RR 1.3; 95% CI 0.8 to 2.2), loss of consciousness (RR 1.75; 95% CI 1.0 to 3.0). INR measurement did not predict adverse outcome in patients with GCS=15 (RR 1.1; 95% CI 1.0 to 1.2).

CONCLUSIONS

In alert warfarinised patients following head injury, the presence of symptoms is associated with greater risk of adverse outcome. Those with GCS=15 and no symptoms are a substantial group and have a low risk of adverse outcome.

TRIAL REGISTRATION NUMBER

NCT02461498.

摘要

目的

由于缺乏有力的证据,颅脑损伤后抗凝患者的管理仍不明确。本研究旨在确定这些患者的不良预后发生率,并确定与不良预后相关的风险因素。

设计

多中心、观察性研究,使用常规患者记录。

地点

英格兰和苏格兰的 33 个急诊部。

参与者

3566 名年龄≥16 岁、有颅脑钝伤且目前正在服用华法林的成年人。

主要结局测量

主要结局指标为初始损伤后 10 周内死亡或神经外科手术、临床显著 CT 扫描发现或因相关并发症再次就诊的不良预后发生率。次要目标包括使用单变量和多变量分析确定不良预后的风险因素。

结果

3534/3566 例患者(99.1%)可获得临床数据,中位年龄 79 岁;初始国际标准化比值(INR)平均为 2.67(标准差 1.34);格拉斯哥昏迷量表(GCS)评分为 15 的患者占 81.2%:5.4%(n=208)接受了 CT 扫描,其中 5.4%发现与头部损伤相关的显著发现;0.5%行神经外科手术;1.2%的患者发生颅脑损伤相关死亡。总体不良预后发生率为 5.9%(95%置信区间 5.2%至 6.7%)。GCS=15 且无相关症状的患者发生不良预后的风险最低(风险 2.7%;95%置信区间 2.1%至 3.6%)。GCS=15 的多变量分析(采用插补法)发现,报告至少一种相关症状时,不良预后的风险增加:呕吐(相对风险(RR)1.8;95%置信区间 1.0 至 3.4)、遗忘症(RR 3.5;95%置信区间 2.1 至 5.7)、头痛(RR 1.3;95%置信区间 0.8 至 2.2)、意识丧失(RR 1.75;95%置信区间 1.0 至 3.0)。INR 测量不能预测 GCS=15 的患者的不良预后(RR 1.1;95%置信区间 1.0 至 1.2)。

结论

在颅脑损伤后意识清醒的华法林化患者中,出现症状与不良预后风险增加相关。GCS=15 且无症状的患者是一个较大的群体,发生不良预后的风险较低。

试验注册

NCT02461498。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9af9/5253554/060b88e09370/bmjopen2016014324f01.jpg

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