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加速手术与髋部骨折标准护理的比较(HIP ATTACK):一项国际、随机、对照试验。

Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial.

出版信息

Lancet. 2020 Feb 29;395(10225):698-708. doi: 10.1016/S0140-6736(20)30058-1. Epub 2020 Feb 9.

Abstract

BACKGROUND

Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications.

METHODS

HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896).

FINDINGS

Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4-9) in the accelerated-surgery group and 24 h (10-42) in the standard-care group (p<0·0001). 140 (9%) patients assigned to accelerated surgery and 154 (10%) assigned to standard care died, with a hazard ratio (HR) of 0·91 (95% CI 0·72 to 1·14) and absolute risk reduction (ARR) of 1% (-1 to 3; p=0·40). Major complications occurred in 321 (22%) patients assigned to accelerated surgery and 331 (22%) assigned to standard care, with an HR of 0·97 (0·83 to 1·13) and an ARR of 1% (-2 to 4; p=0·71).

INTERPRETATION

Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care.

FUNDING

Canadian Institutes of Health Research.

摘要

背景

观察性研究表明,加速手术可改善髋部骨折患者的预后。HIP ATTACK 试验评估了加速手术是否可以降低死亡率和主要并发症。

方法

HIP ATTACK 是一项在 17 个国家的 69 家医院进行的国际、随机、对照试验。需要手术治疗且年龄在 45 岁及以上的髋部骨折患者符合条件。研究人员通过中央计算机随机分配系统,以随机变化的块大小(1:1)将患者随机分配至加速手术组(目标为诊断后 6 小时内进行手术)或标准护理组。主要结局为随机分组后 90 天的死亡率和主要并发症的复合结局(即死亡率和非致死性心肌梗死、卒、静脉血栓栓塞、脓毒症、肺炎、威胁生命的出血和大出血)。患者、医疗保健提供者和研究人员了解治疗分配情况,但结局裁决者对治疗分配情况不知情。根据意向治疗原则对患者进行分析。该研究在 ClinicalTrials.gov 注册(NCT02027896)。

结果

2014 年 3 月 14 日至 2019 年 5 月 24 日,共筛选了 27701 名患者,其中 7780 名符合条件。其中 2970 名患者入组并随机分配接受加速手术(n=1487)或标准护理(n=1483)。加速手术组从髋部骨折诊断到手术的中位时间为 6 小时(四分位距 4-9),标准护理组为 24 小时(10-42)(p<0·0001)。接受加速手术的 140 名(9%)患者和接受标准护理的 154 名(10%)患者死亡,风险比(HR)为 0.91(95%CI 0.72 至 1.14),绝对风险降低(ARR)为 1%(-1 至 3;p=0·40)。接受加速手术的 321 名(22%)患者和接受标准护理的 331 名(22%)患者发生主要并发症,HR 为 0.97(0.83 至 1.13),ARR 为 1%(-2 至 4;p=0·71)。

解释

在髋部骨折患者中,与标准护理相比,加速手术并未显著降低死亡率或主要并发症的复合结局风险。

资金来源

加拿大卫生研究院。

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