强化胰岛素治疗与常规胰岛素治疗：一项针对内科及外科危重症患者的随机对照试验。

Intensive versus conventional insulin therapy: a randomized controlled trial in medical and surgical critically ill patients.

作者信息

Arabi Yaseen M, Dabbagh Ousama C, Tamim Hani M, Al-Shimemeri Abdullah A, Memish Ziad A, Haddad Samir H, Syed Sofia J, Giridhar Hema R, Rishu Asgar H, Al-Daker Mouhamad O, Kahoul Salim H, Britts Riette J, Sakkijha Maram H

机构信息

Intensive Care Department, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.

出版信息

Crit Care Med. 2008 Dec;36(12):3190-7. doi: 10.1097/CCM.0b013e31818f21aa.

DOI:10.1097/CCM.0b013e31818f21aa

PMID:18936702

Abstract

OBJECTIVE

The role of intensive insulin therapy in medical surgical intensive care patients remains unclear. The objective of this study was to examine the effect of intensive insulin therapy on mortality in medical surgical intensive care unit patients.

DESIGN

Randomized controlled trial.

SETTINGS

Tertiary care intensive care unit.

PATIENTS

Medical surgical intensive care unit patients with admission blood glucose of > 6.1 mmol/L or 110 mg/dL.

INTERVENTION

A total of 523 patients were randomly assigned to receive intensive insulin therapy (target blood glucose 4.4-6.1 mmol/L or 80-110 mg/dL) or conventional insulin therapy (target blood glucose 10-11.1 mmol/L or 180-200 mg/dL).

MEASUREMENTS AND MAIN OUTCOMES

The primary end point was intensive care unit mortality. Secondary end points included hospital mortality, intensive care unit and hospital length of stay, mechanical ventilation duration, the need for renal replacement therapy and packed red blood cells transfusion, and the rates of intensive care unit acquired infections as well as the rate of hypoglycemia (defined as blood glucose < or = 2.2 mmol/L or 40 mg/dL). There was no significant difference in intensive care unit mortality between the intensive insulin therapy and conventional insulin therapy groups (13.5% vs. 17.1%, p = 0.30). After adjustment for baseline characteristics, intensive insulin therapy was not associated with mortality difference (adjusted hazard ratio 1.09, 95% confidence interval 0.70-1.72). Hypoglycemia occurred more frequently with intensive insulin therapy (28.6% vs. 3.1% of patients; p < 0.0001 or 6.8/100 treatment days vs. 0.4/100 treatment days; p < 0.0001). There was no difference between the intensive insulin therapy and conventional insulin therapy in any of the other secondary end points.

CONCLUSIONS

Intensive insulin therapy was not associated with improved survival among medical surgical intensive care unit patients and was associated with increased occurrence of hypoglycemia. Based on these results, we do not advocate universal application of intensive insulin therapy in intensive care unit patients.

TRIAL REGISTRATION

Current Controlled Trials registry (ISRCTN07413772) http://www.controlled-trials.com/ISRCTN07413772/07413772; 2005.

摘要

目的

强化胰岛素治疗在内外科重症监护患者中的作用仍不明确。本研究的目的是探讨强化胰岛素治疗对内外科重症监护病房患者死亡率的影响。

设计

随机对照试验。

地点

三级医疗重症监护病房。

患者

内外科重症监护病房中入院血糖>6.1 mmol/L或110 mg/dL的患者。

干预措施

共523例患者被随机分配接受强化胰岛素治疗（目标血糖4.4 - 6.1 mmol/L或80 - 110 mg/dL）或常规胰岛素治疗（目标血糖10 - 11.1 mmol/L或180 - 200 mg/dL）。

测量指标及主要结局

主要终点是重症监护病房死亡率。次要终点包括医院死亡率、重症监护病房和医院住院时间、机械通气时间、肾脏替代治疗及浓缩红细胞输血需求、重症监护病房获得性感染发生率以及低血糖发生率（定义为血糖≤2.2 mmol/L或40 mg/dL）。强化胰岛素治疗组和常规胰岛素治疗组在重症监护病房死亡率方面无显著差异（13.5%对17.1%，p = 0.30）。在对基线特征进行调整后，强化胰岛素治疗与死亡率差异无关（调整后的风险比为1.09，95%置信区间为0.70 - 1.72）。强化胰岛素治疗导致低血糖更频繁发生（患者比例为28.6%对3.1%；p < 0.0001或每100个治疗日发生率为6.8次对0.4次；p < 0.0001）。强化胰岛素治疗和常规胰岛素治疗在任何其他次要终点方面均无差异。