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高剂量地塞米松治疗心脏手术的长期结局和成本效益:一项随机试验。

Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery: a randomised trial.

机构信息

Department of Anesthesiology and Intensive Care, University Medical Center, Utrecht, the Netherlands.

Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands.

出版信息

Anaesthesia. 2017 Jun;72(6):704-713. doi: 10.1111/anae.13853. Epub 2017 Mar 20.

DOI:10.1111/anae.13853
PMID:28317094
Abstract

Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre, randomised, double-blind, placebo-controlled DExamethasone for Cardiac Surgery (DECS) trial were followed up for 12 months after their cardiac surgical procedure. In the DECS trial, patients received a single intra-operative dose of dexamethasone 1 mg.kg (n = 2239) or placebo (n = 2255). The effects on the incidence of major postoperative events were evaluated. Also, overall costs for the 12-month postoperative period, and cost effectiveness, were compared between groups. Of 4494 randomised patients, 4457 patients (99%) were followed up until 12 months after surgery. There was no difference in the incidence of major postoperative events, the relative risk (95%CI) being 0.86 (0.72-1.03); p = 0.1. Treatment with dexamethasone reduced costs per patient by £921 [€1084] (95%CI £-1672 to -137; p = 0.02), mainly through reduction of postoperative respiratory failure and duration of postoperative hospital stay. The probability of dexamethasone being cost effective compared with placebo was 97% at a threshold value of £17,000 [€20,000] per quality-adjusted life year. We conclude that intra-operative high-dose dexamethasone did not have an effect on major adverse events at 12 months after cardiac surgery, but was associated with a reduction in costs. Routine dexamethasone administration is expected to be cost effective at commonly accepted threshold levels for cost effectiveness.

摘要

术中预防性给予地塞米松可能改善心脏外科患者的短期临床结局。本研究旨在评估地塞米松与安慰剂相比的长期临床结局和成本效益。多中心、随机、双盲、安慰剂对照的心脏手术中地塞米松(DECS)试验中的患者在心脏手术后 12 个月进行随访。在 DECS 试验中,患者接受术中单次给予地塞米松 1mg/kg(n=2239)或安慰剂(n=2255)。评估主要术后事件发生率的影响。还比较了两组患者 12 个月术后期间的总费用和成本效益。在 4494 名随机患者中,4457 名(99%)患者随访至手术后 12 个月。主要术后事件发生率无差异,相对风险(95%CI)为 0.86(0.72-1.03);p=0.1。地塞米松治疗可降低每位患者 921 英镑[€1084]的费用(95%CI £-1672 至 -137;p=0.02),主要通过降低术后呼吸衰竭和术后住院时间来实现。在地塞米松与安慰剂相比的成本效益阈值为 17000 英镑[€20000]时,地塞米松的成本效益概率为 97%。我们得出结论,术中给予高剂量地塞米松对心脏手术后 12 个月的主要不良事件没有影响,但与降低成本有关。在通常接受的成本效益阈值下,常规给予地塞米松有望具有成本效益。

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