糖皮质激素治疗和强化胰岛素治疗成人感染性休克：一项随机对照试验。

Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial.

出版信息

JAMA. 2010 Jan 27;303(4):341-8. doi: 10.1001/jama.2010.2.

DOI:10.1001/jama.2010.2

PMID:20103758

Abstract

CONTEXT

Corticosteroid therapy induces potentially detrimental hyperglycemia in septic shock. In addition, the benefit of adding fludrocortisone in this setting is unclear.

OBJECTIVES

To test the efficacy of intensive insulin therapy in patients whose septic shock was treated with hydrocortisone and to assess, as a secondary objective, the benefit of fludrocortisone.

DESIGN, SETTING, AND PATIENTS: A multicenter, 2 x 2 factorial, randomized trial, involving 509 adults with septic shock who presented with multiple organ dysfunction, as defined by a Sequential Organ Failure Assessment score of 8 or more, and who had received hydrocortisone treatment was conducted from January 2006 to January 2009 in 11 intensive care units in France.

INTERVENTIONS

Patients were randomly assigned to 1 of 4 groups: continuous intravenous insulin infusion with hydrocortisone alone, continuous intravenous insulin infusion with hydrocortisone plus fludrocortisone, conventional insulin therapy with hydrocortisone alone, or conventional insulin therapy with intravenous hydrocortisone plus fludrocortisone. Hydrocortisone was administered in a 50-mg bolus every 6 hours, and fludrocortisone was administered orally in 50-microg tablets once a day, each for 7 days.

MAIN OUTCOME MEASURE

In-hospital mortality.

RESULTS

Of the 255 patients treated with intensive insulin, 117 (45.9%), and 109 of 254 (42.9%) treated with conventional insulin therapy died (relative risk [RR], 1.07; 95% confidence interval [CI], 0.88-1.30; P = .50). Patients treated with intensive insulin experienced significantly more episodes of severe hypoglycemia (<40 mg/dL) than those in the conventional-treatment group, with a difference in mean number of episodes per patient of 0.15 (95% CI, 0.02-0.28; P = .003). At hospital discharge, 105 of 245 patients treated with fludrocortisone (42.9%) died and 121 of 264 (45.8%) in the control group died (RR, 0.94; 95% CI, 0.77-1.14; P = .50).

CONCLUSIONS

Compared with conventional insulin therapy, intensive insulin therapy did not improve in-hospital mortality among patients who were treated with hydrocortisone for septic shock. The addition of oral fludrocortisone did not result in a statistically significant improvement in in-hospital mortality.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00320099.

摘要

背景

皮质类固醇治疗会在感染性休克患者中引起潜在有害的高血糖。此外，在此情况下添加氟氢可的松的益处尚不清楚。

目的

测试强化胰岛素治疗在接受氢化可的松治疗的感染性休克患者中的疗效，并评估氟氢可的松的益处（次要目标）。

设计、地点和患者：这是一项多中心、2×2 析因、随机试验，涉及 509 名患有感染性休克的成年人，他们表现为多个器官功能障碍，定义为序贯器官衰竭评估（SOFA）评分≥8 分，并且已接受氢化可的松治疗。该试验于 2006 年 1 月至 2009 年 1 月在法国的 11 个重症监护病房进行。

干预措施

患者被随机分配到以下 4 组之一：单独接受氢化可的松的持续静脉内胰岛素输注、单独接受氢化可的松和氟氢可的松的持续静脉内胰岛素输注、单独接受氢化可的松的常规胰岛素治疗或接受静脉内氢化可的松和氟氢可的松的常规胰岛素治疗。氢化可的松以 50mg 剂量每 6 小时静脉推注，氟氢可的松以 50μg 片剂口服，每天一次，持续 7 天。

主要观察指标

院内死亡率。

结果

在接受强化胰岛素治疗的 255 名患者中，有 117 名（45.9%）和接受常规胰岛素治疗的 254 名患者中的 109 名（42.9%）死亡（相对风险[RR]，1.07；95%置信区间[CI]，0.88-1.30；P=0.50）。与常规治疗组相比，接受强化胰岛素治疗的患者经历了更多次严重低血糖发作（<40mg/dL），每位患者的平均发作次数差异为 0.15（95%CI，0.02-0.28；P=0.003）。出院时，接受氟氢可的松治疗的 245 名患者中有 105 名（42.9%）死亡，对照组的 264 名患者中有 121 名（45.8%）死亡（RR，0.94；95%CI，0.77-1.14；P=0.50）。