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羟乙基淀粉与生理盐水在重症监护患者复苏中的比较:来自 CHEST 的队列的长期结局和成本效益分析。

Hydroxyethyl starch versus saline for resuscitation of patients in intensive care: long-term outcomes and cost-effectiveness analysis of a cohort from CHEST.

机构信息

The George Institute for Global Health, Sydney, NSW, Australia; The University of Sydney, Sydney Medical School, Sydney, NSW, Australia.

The George Institute for Global Health, Sydney, NSW, Australia.

出版信息

Lancet Respir Med. 2016 Oct;4(10):818-825. doi: 10.1016/S2213-2600(16)30120-5. Epub 2016 Jun 17.

Abstract

BACKGROUND

Hydroxyethyl starch for fluid resuscitation in critically ill patients is not associated with improved short-term patient-centred outcomes compared with crystalloid fluid solutions. However, its effect on longer term health economic outcomes has not been reported.

METHODS

We did a prespecified cost-effectiveness analysis of a cohort of patients from New South Wales enrolled in the Crystalloid versus Hydroxyethyl Starch Trial (CHEST), who were randomised to treatment with either 6% hydroxyethyl starch with a molecular weight of 130 kD and a molar substitution ratio of 0·4 or 0·9% sodium chloride (saline) for fluid resuscitation. Clinical outcomes were mortality and life-years gained at 6 months and 24 months, health-related quality of life at 6 months, and quality-adjusted life-years gained at 6 months. Health economic outcomes were hospital and intensive-care unit (ICU) resource use and costs at 24 months and cost-effectiveness, which we defined as the probability of reaching a willingness-to-pay threshold of less than A$50 000 per quality-adjusted life-year gained at 6 months and $100 000 per life-year gained at 24 months. CHEST is registered with ClinicalTrials.gov, number NCT00935168.

FINDINGS

3537 (51%) of 7000 patients were enrolled into CHEST from New South Wales, of whom 3450 (98%) were included in our cost-effectiveness analysis. Mortality at both 6 months and 24 months did not differ between the hydroxyethyl starch and saline groups (6 months: 397/1684 [24%] vs 382/1706 [22%]; relative risk [RR] 1·05, 95% CI 0·93-1·19; p=0·41; 24 months: 586/1687 [35%] vs 594/1708 [35%]; RR 1·00, 95% CI 0·91-1·10; p=0·89). The mean number of life-years gained at 6 months and 24 months was similar between the hydroxyethyl starch and saline groups (6 months: 0·41 days [SD 0·18] vs 0·41 days [0·17]; p=0·25; 24 months: 1·46 years [SD 0·80] vs 1·47 years [0·79]; p=0·72). At 6 months, the mean health-related quality of life score was 0·67 (SD 0·34) with hydroxyethyl starch versus 0·69 (0·35) with saline (p=0·33). The mean number of quality-adjusted life-years gained did not differ between the hydroxyethyl starch and saline groups at 6 months (0·26 days [SD 0·18] vs 0·26 days [0·18]; p=0·33). Total hospital costs (including ICU costs) at 24 months were similar between the hydroxyethyl starch and saline groups (A$62 196 [55 935] vs $62 617 [56 452]; p=0·83). The probability that hydroxyethyl starch was cost effective was 11% at 6 months and 29% at 24 months.

INTERPRETATION

Although longer term clinical outcomes did not differ between patients resuscitated with hydroxyethyl starch or saline in the ICU, from a health-care payer's perspective, the probability that hydroxyethyl starch is cost effective in these patients is low.

FUNDING

Division of Critical Care and Trauma, George Institute for Global Health.

摘要

背景

与晶体液相比,羟乙基淀粉用于危重症患者的液体复苏与短期以患者为中心的结局改善无关。然而,其对长期健康经济结局的影响尚未报道。

方法

我们对新南威尔士州参加晶体液与羟乙基淀粉试验(CHEST)的患者队列进行了成本效益分析,这些患者被随机分配接受 6%羟乙基淀粉(分子量 130kD,摩尔取代比 0.4)或 0.9%氯化钠(盐水)治疗。临床结局为 6 个月和 24 个月时的死亡率和获得的生命年数、6 个月时的健康相关生活质量以及 6 个月时的质量调整生命年数。健康经济学结局为 24 个月时的医院和重症监护病房(ICU)资源使用和成本以及成本效益,我们将其定义为达到 6 个月时每获得 1 个质量调整生命年成本低于 50000 澳元且 24 个月时每获得 1 个生命年成本低于 100000 澳元的意愿支付阈值的概率。CHEST 在 ClinicalTrials.gov 上注册,编号为 NCT00935168。

结果

在来自新南威尔士州的 7000 名患者中,有 3537 名(51%)被纳入 CHEST,其中 3450 名(98%)被纳入我们的成本效益分析。6 个月和 24 个月时羟乙基淀粉组和盐水组的死亡率无差异(6 个月:397/1684 [24%] vs 382/1706 [22%];相对风险 [RR] 1.05,95%CI 0.93-1.19;p=0.41;24 个月:586/1687 [35%] vs 594/1708 [35%];RR 1.00,95%CI 0.91-1.10;p=0.89)。6 个月和 24 个月时羟乙基淀粉组和盐水组获得的平均生命年数相似(6 个月:0.41 天[SD 0.18] vs 0.41 天[0.17];p=0.25;24 个月:1.46 年[SD 0.80] vs 1.47 年[0.79];p=0.72)。6 个月时,羟乙基淀粉组的健康相关生活质量评分均值为 0.67(SD 0.34),盐水组为 0.69(0.35)(p=0.33)。6 个月时羟乙基淀粉组和盐水组获得的平均质量调整生命年数无差异(0.26 天[SD 0.18] vs 0.26 天[0.18];p=0.33)。24 个月时羟乙基淀粉组和盐水组的总医院成本(包括 ICU 成本)相似(A$62196 [55935] vs $62617 [56452];p=0.83)。6 个月时羟乙基淀粉具有成本效益的概率为 11%,24 个月时为 29%。

解释

尽管在 ICU 中用羟乙基淀粉或盐水复苏的患者长期临床结局无差异,但从医疗保健支付者的角度来看,这些患者使用羟乙基淀粉具有成本效益的概率较低。

资金来源

乔治全球健康研究院重症监护和创伤科。

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