ABSTRACT
Background
The role of intensive insulin therapy in patients with severe sepsis is uncertain. Fluid resuscitation improves survival among patients with septic shock, but evidence is lacking to support the choice of either crystalloids or colloids.
摘要
背景 对严重败血症患者进行强化胰岛素治疗作用尚未明确。液体复苏能提高败血症休克患者的生存率，但是选择晶体还是胶体尚缺乏证据。

Methods
In a multicenter, two-by-two factorial trial, we randomly assigned patients with severe sepsis to receive either intensive insulin therapy to maintain euglycemia or conventional insulin therapy and either 10% pentastarch, a low-molecular-weight hydroxyethyl starch (HES 200/0.5), or modified Ringer's lactate for fluid resuscitation. The rate of death at 28 days and the mean score for organ failure were coprimary end points.
方法
我们进行了一个多中心，2X2析因试验，将严重败血症患者随机分组接受强化胰岛素治疗保持血糖正常或常规胰岛素治疗，同时接受一种低分子的羟乙基淀粉(HES 200/0.5)10%pentastarch或改良林格氏液进行液体复苏。复合观察终点为28天的死亡率和器官衰竭评分均值。

Results
The trial was stopped early for safety reasons. Among 537 patients who could be evaluated, the mean morning blood glucose level was lower in the intensive-therapy group (112 mg per deciliter [6.2 mmol per liter]) than in the conventional-therapy group (151 mg per deciliter [8.4 mmol per liter], P<0.001). However, at 28 days, there was no significant difference between the two groups in the rate of death or the mean score for organ failure. The rate of severe hypoglycemia (glucose level, 40 mg per deciliter [2.2 mmol per liter]) was higher in the intensive-therapy group than in the conventional-therapy group (17.0% vs. 4.1%, P<0.001), as was the rate of serious adverse events (10.9% vs. 5.2%, P=0.01). HES therapy was associated with higher rates of acute renal failure and renal-replacement therapy than was Ringer's lactate.
结论
试验因为安全原因提前结束。在可评估的537名患者中，早晨血糖强化治疗组(112毫克/分升[6.2毫摩尔/升]) 低于常规治疗组(151毫克/分升[8.4毫摩尔/升], P<0.001) 。但是28天的死亡率和器官衰竭评分均值两组间无显著差异。严重低血糖(血糖低于40毫克/分升[2.2毫摩尔/升]) 发生率强化治疗组高于常规治疗组(17.0%比4.1%, P<0.001),严重不良事件发生率也高(10.9%比5.2%, P=0.01)。HES治疗组较林格氏液组急性肾功能衰竭和需要肾脏替代治疗发生率高。

Conclusions
The use of intensive insulin therapy placed critically ill patients with sepsis at increased risk for serious adverse events related to hypoglycemia. As used in this study, HES was harmful, and its toxicity increased with accumulating doses.
结论
对败血症患者强化胰岛素治疗会增加低血糖相关的严重不良事件发生率。研究证实在败血症患者中使用HES是有害的，其毒性随着剂量蓄积而增加。

胰岛素强化治疗和胶体补充在败血症中的作用

摘要
背景----对严重败血症患者进行强化胰岛素治疗作用尚未明确。液体复苏能提高败血症休克患者的生存率，但是选择晶体还是胶体尚缺乏证据。
方法----我们进行了一个多中心，2X2析因试验，将严重败血症患者随机分组接受强化胰岛素治疗保持血糖正常或常规胰岛素治疗，同时接受一种低分子的羟乙基淀粉(HES 200/0.5)10%pentastarch或改良林格氏液进行液体复苏。复合观察终点为28天的死亡率和器官衰竭评分均值。
结论----试验因为安全原因提前结束。在可评估的537名患者中，早晨血糖强化治疗组(112毫克/分升[6.2毫摩尔/升]) 低于常规治疗组(151毫克/分升[8.4毫摩尔/升], P<0.001) 。但是28天的死亡率和器官衰竭评分均值两组间无显著差异。严重低血糖(血糖低于40毫克/分升[2.2毫摩尔/升]) 发生率强化治疗组高于常规治疗组(17.0%比4.1%, P<0.001),严重不良事件发生率也高(10.9%比5.2%, P=0.01)。HES治疗组较林格氏液组急性肾功能衰竭和需要肾脏替代治疗发生率高。
结论----对败血症患者强化胰岛素治疗会增加低血糖相关的严重不良事件发生率。研究证实在败血症患者中使用HES是有害的，其毒性随着剂量蓄积而增加。