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轻度颅脑损伤患者立即进行计算机断层扫描或入院观察后的医疗结局:随机对照试验。

Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial.

作者信息

af Geijerstam Jean-Luc, Oredsson Sven, Britton Mona

机构信息

Department of Medicine, Clinical Epidemiology Unit, Karolinska University Hospital, 171 76 Stockholm, Sweden.

出版信息

BMJ. 2006 Sep 2;333(7566):465. doi: 10.1136/bmj.38918.669317.4F. Epub 2006 Aug 8.

Abstract

OBJECTIVE

To compare immediate computed tomography during triage for admission with observation in hospital in patients with mild head injury.

DESIGN

Multicentre, pragmatic, non-inferiority randomised trial.

SETTING

39 acute hospitals in Sweden.

PARTICIPANTS

2602 patients (aged > or = 6) with mild head injury.

INTERVENTIONS

Immediate computed tomography or admission for observation.

MAIN OUTCOME MEASURE

Dichotomised extended Glasgow outcome scale (1-7 v 8). The non-inferiority margin was 5 percentage points.

RESULTS

At three months, 275 patients (21.4%) in the computed tomography group had not recovered completely compared with 300 (24.2%) admitted for observation. The difference was - 2.8 percentage points, non-significantly in favour of computed tomography (95% confidence interval - 6.1% to 0.6%). The worst outcomes (mortality and more severe loss of function) were similar between the groups. In the patients admitted for observation, there was a considerable delay in time to treatment in those who required surgery. None of the patients with normal findings on immediate computed tomography had complications later. Patients' satisfaction with the two strategies was similar.

CONCLUSIONS

The use of computed tomography in the management of patients with mild head injury is feasible and leads to similar clinical outcomes compared with observation in hospital.

TRIAL REGISTRATION

ISRCTN81464462.

摘要

目的

比较轻度颅脑损伤患者分诊时行即时计算机断层扫描与住院观察的效果。

设计

多中心、实用性、非劣效性随机试验。

地点

瑞典39家急症医院。

参与者

2602例轻度颅脑损伤患者(年龄≥6岁)。

干预措施

即时计算机断层扫描或住院观察。

主要结局指标

二分法扩展格拉斯哥预后量表(1 - 7分对8分)。非劣效界值为5个百分点。

结果

3个月时,计算机断层扫描组275例患者(21.4%)未完全康复,而住院观察组为300例(24.2%)。差异为 - 2.8个百分点,对计算机断层扫描组无显著优势(95%置信区间为 - 6.1%至0.6%)。两组中最差的结局(死亡率和更严重的功能丧失)相似。在住院观察的患者中,需要手术的患者治疗时间有相当大的延迟。即时计算机断层扫描结果正常的患者后来均无并发症。患者对两种策略的满意度相似。

结论

在轻度颅脑损伤患者的管理中使用计算机断层扫描是可行的,与住院观察相比,临床结局相似。

试验注册

ISRCTN81464462

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