【NEJM】重症患者强化降糖未能获益——NICE SUGAR研究
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Background
The optimal target range for blood glucose in critically ill patients remains unclear.
背景：对于重症病人的最佳血糖控制目标仍未确定。
Methods
Within 24 hours after admission to an intensive care unit (ICU), adults who were expected to require treatment in the ICU on 3 or more consecutive days were randomly assigned to undergo either intensive glucose control, with a target blood glucose range of 81 to 108 mg per deciliter (4.5 to 6.0 mmol per liter), or conventional glucose control, with a target of 180 mg or less per deciliter (10.0 mmol or less per liter). We defined the primary end point as death from any cause within 90 days after randomization.
方法：入院24h即转入ICU治疗，且在ICU治疗3天以上的患者被随机分为两组，一组接受强化降糖治疗，血糖目标为81 -108 mg /dL (4.5 to 6.0 mmol /L), 另一组接受常规降糖治疗，血糖目标为180 mg /dL或更低 (≦10.0mmol /L), 主要终点为随机分组后90天内的死亡。
Results
Of the 6104 patients who underwent randomization, 3054 were assigned to undergo intensive control and 3050 to undergo conventional control; data with regard to the primary utcome at day 90 were available for 3010 and 3012 patients, respectively.The two groups had similar characteristics at baseline. A total of 829 patients (27.5%) in the intensive-control group and 751 (24.9%) in the conventional-control group died (odds ratio for intensive control, 1.14; 95% confidence interval, 1.02 to 1.28; P = 0.02). The treatment effect did not differ significantly between operative (surgical) patients and nonoperative (medical) patients (odds ratio for death in the intensive-control group, 1.31 and 1.07, respectively; P = 0.10). Severe hypoglycemia (blood glucose level, ≤40 mg per deciliter [2.2 mmol per liter]) was reported in 206 of 3016 patients (6.8%) in the intensive-control group and 15 of 3014 (0.5%) in the
conventional-control group (P<0.001). There was no significant difference between the two treatment groups in the median number of days in the ICU (P = 0.84) or hospital (P = 0.86) or the median number of days of mechanical ventilation (P = 0.56) or renal-replacement therapy (P = 0.39).
结果：共纳入6104例，3054例接受强化降糖治疗，3050例接受常规治疗。获得有效数据的强化降糖组为3010例，常规治疗组为3012例。在基线水平上两组情况类似。强化治疗组829人（27.5%）死亡，常规治疗组751人（24.9%）死亡（强化降糖组比值比为1.14；95%可信区间1.02-1.28，P=0.02）。在手术病人和非手术病人中，治疗结果没有显著差异(强化治疗组危险比 1.31 and 1.07, P = 0.10).严重低血糖（ 血糖 ≤40 mg /dL (2.2 mmol /L]) 在强化降糖组发生率为6.8%（206/3016），在常规治疗组为0.5%（15/3014），且P<0.001。两组在ICU的时间和住院天数，机械通气的时间以及是否接受器官移植没有显著差异。
Conclusions
In this large, international, randomized trial, we found that intensive glucose control
increased mortality among adults in the ICU: a blood glucose target of 180 mg
or less per deciliter resulted in lower mortality than did a target of 81 to 108 mg per
deciliter. (ClinicalTrials.gov number, NCT00220987.)
结论：强化降糖治疗增加了ICU患者的死亡率。血糖控制在180mg/dL以下比控制在81-108mg/dL有着更低的死亡率。
The optimal target range for blood glucose in critically ill patients remains unclear.
背景：对于重症病人的最佳血糖控制目标仍未确定。
Methods
Within 24 hours after admission to an intensive care unit (ICU), adults who were expected to require treatment in the ICU on 3 or more consecutive days were randomly assigned to undergo either intensive glucose control, with a target blood glucose range of 81 to 108 mg per deciliter (4.5 to 6.0 mmol per liter), or conventional glucose control, with a target of 180 mg or less per deciliter (10.0 mmol or less per liter). We defined the primary end point as death from any cause within 90 days after randomization.
方法：入院24h即转入ICU治疗，且在ICU治疗3天以上的患者被随机分为两组，一组接受强化降糖治疗，血糖目标为81 -108 mg /dL (4.5 to 6.0 mmol /L), 另一组接受常规降糖治疗，血糖目标为180 mg /dL或更低 (≦10.0mmol /L), 主要终点为随机分组后90天内的死亡。
Results
Of the 6104 patients who underwent randomization, 3054 were assigned to undergo intensive control and 3050 to undergo conventional control; data with regard to the primary utcome at day 90 were available for 3010 and 3012 patients, respectively.The two groups had similar characteristics at baseline. A total of 829 patients (27.5%) in the intensive-control group and 751 (24.9%) in the conventional-control group died (odds ratio for intensive control, 1.14; 95% confidence interval, 1.02 to 1.28; P = 0.02). The treatment effect did not differ significantly between operative (surgical) patients and nonoperative (medical) patients (odds ratio for death in the intensive-control group, 1.31 and 1.07, respectively; P = 0.10). Severe hypoglycemia (blood glucose level, ≤40 mg per deciliter [2.2 mmol per liter]) was reported in 206 of 3016 patients (6.8%) in the intensive-control group and 15 of 3014 (0.5%) in the
conventional-control group (P<0.001). There was no significant difference between the two treatment groups in the median number of days in the ICU (P = 0.84) or hospital (P = 0.86) or the median number of days of mechanical ventilation (P = 0.56) or renal-replacement therapy (P = 0.39).
结果：共纳入6104例，3054例接受强化降糖治疗，3050例接受常规治疗。获得有效数据的强化降糖组为3010例，常规治疗组为3012例。在基线水平上两组情况类似。强化治疗组829人（27.5%）死亡，常规治疗组751人（24.9%）死亡（强化降糖组比值比为1.14；95%可信区间1.02-1.28，P=0.02）。在手术病人和非手术病人中，治疗结果没有显著差异(强化治疗组危险比 1.31 and 1.07, P = 0.10).严重低血糖（ 血糖 ≤40 mg /dL (2.2 mmol /L]) 在强化降糖组发生率为6.8%（206/3016），在常规治疗组为0.5%（15/3014），且P<0.001。两组在ICU的时间和住院天数，机械通气的时间以及是否接受器官移植没有显著差异。
Conclusions
In this large, international, randomized trial, we found that intensive glucose control
increased mortality among adults in the ICU: a blood glucose target of 180 mg
or less per deciliter resulted in lower mortality than did a target of 81 to 108 mg per
deciliter. (ClinicalTrials.gov number, NCT00220987.)
结论：强化降糖治疗增加了ICU患者的死亡率。血糖控制在180mg/dL以下比控制在81-108mg/dL有着更低的死亡率。
