About the author(作者简介):

Professor of Medicine
Director, Pulmonary and Critical Care Medicine
Thomas Jefferson University
Dr. Marik received his medical degree from the University of the Witwatersrand, Johannesburg, South Africa. He did his internship at Hillbrow Hospital and then completed his medical residency at Johannesburg Hospital, Johannesburg, South Africa. He was an attending at Baragwanath Hospital, in Soweto, South Africa. During this time he obtained a Master of Medicine Degree, Bachelor of Science Degree in Pharmacology, Diploma in Anesthesia as well as a Diploma in Tropical Medicine and Hygiene. Dr. Marik did a Critical Care Fellowship in London, Ontario, Canada, during which time he was admitted as a Fellow to the Royal College of Physicians and Surgeon of Canada. Dr. Marik is currently Professor of Medicine and Chief of Pulmonary and Critical Care Medicine, Thomas Jefferson University in Philadelphia. Dr. Marik has written over 200 peer reviewed journal articles, 30 book chapters and authored two critical care hand-books. He has presented over 160 lectures at National and International Meetings and Invited Grand Rounds.
In this article(文献贡献):
He was responsible for performing the metaanalysis, interpreting the data, and writing the manuscript.
文章简介(中英文)
Background(背景)
1. Prior to 2001,stress hyperglycemia was defined as a plasma glucose above 180~200mg/dL
2001年之前,应激性高血糖的界值为>180~200mg/dL
2. Following publication of the Leuven Intensive Insulin Therapy(IIT) Trial in 2001,tight glycemic control became the standard of care in ICUs around the world; and other authorities suggested that stress hyperglycemia be considered in any critically ill patients with a blood glucose in excess of 110mg/dL
随着2001年Leuven强化胰岛素研究的结果发表,严格血糖控制(TGC)成为世界范围内ICU的血糖控制标准;应激性高血糖的界值>110mg/dL
3. Recent studies suggest that this approach may be flawed;stress hyperglycemia was considered an adaptive response,providing a ready source of fuel during a time of increased demand.
然而今年的研究显示,TGC是有缺陷的;应激性高血糖可能是适应性反应,以满足能量需求的增加
Aim(研究目标)
1. To determine the benefits and risks of TGC in ICU patients
明确TGC的益处与风险
2. To explain the difference in outcomes among reported trials
解释各研究中结果差异的原因
Method(方法)
Identification of the Trials(研究的选择)
1. This study only included randomized controlled trials(RCTs) that specifically attempted to confirm the the benefits of IIT (blood glucose of 80~110mg/dL) as compared with less strict glycemic control in ICU patients
研究只选取对比IIT(80~110mg/dL)与常规的非严格血糖控制两者差异的RCT研究
2. database(数据库)2001~2009
2001~2009 MEDLINE,EMBASS,Cochrane Database of Systematic Review
2001~2009年以上数据库收集的相关文献
3. medical subject heading and keywords(主题词和关键词)
intensive care unit, critical care, critical illness, blood glucose, and RCT(publication type)
4. assess the methodologic quality of the includes trials(纳入研究的质量评估)
The allocation concealment was ranked as adequate, uncertain, or clearly inadequate, and the likelihood of bias was scored on the Jadad five-point scale,which contained two questions each on randomization and masking and one question on the reporting of dropouts and withdrawls.
隐藏分组的实施按三个标准评价:恰当、不清楚和不恰当;偏倚采用Jada评分量表评价:包括三个问题:1)研究是否随机(2分),2)研究是否双盲(2分),3)对退出和失访有无处理(1分)
Data Extraction and Quality Assessment(数据提取与质量评估)
1. data on study design, study size, study setting, patient characteristics, mean Acute Physiology And Chronic Health Evaluation(APACHE) II score, mean/median daily glucose level, mean daily insulin dose administered, mean daily caloric intake, and percentage of calories given intravenously during the ICU stay, as well as the percentage of patients who were diabetic or septic (on admission)
选取数据包括:研究设计,样本量,患者信息,APACHE II评分平均值,每日血糖平均值与中位数,胰岛素日剂量平均值,日能量均值,ICU停留时间内静脉营养比例,入ICU前即患糖尿病和脓毒症比例
2. The SD of the mean glucose level during the ICU stay was used as an index of glucose variability
血糖水平均值的标准差作为血糖变化的指标
Results (结果)
1. Trails Included
下表显示了研究纳入的过程,最后有7个RCT研究纳入
2. RCT质量评价结果 表1
3. 研究中TGC意义和风险的总体评价 表2
4.
1) The mean blood glucose level was 112mg/dL in the IIT patients as compared with 151mg/dL in the control group, the mean difference in glucose being 39mg/dL
IIT组的血糖控制水平为 112mg/dL(SD为39mg/dL),对照组为151mg/dL
2) IIT 不降低 :
i) 28天死亡率(OR 0.95; 95% CI:0.87-1.05)
ii)血行感染发生率 (OR 1.04; 95% CI:0.93-1.17)
iii)肾脏替代治疗率(OR 1.01; 95% CI:0.89-1.13)
3) 严格血糖控制组低血糖发生机率明显增多(OR 7.7; 95% CI:6.0-9.9 P<0.001)
4)
i)图2中显示,28天死亡率在Leuven的两项研究中并不一致; 而其不一致和静脉营养的比例相关(P=0.005,图3)
ii)图3显示:静脉(胃肠外)营养比例高的患者,应用严格的血糖控制明显受益,而比例低的患者未见益处;
iii)剔除采用静脉营养的患者,对照组的死亡率低于严格控制血糖组(OR 0.90; 95% CI:0.81-0.99 P=0.04;I2=0%)
iiii)这些结果提示严格的血糖控制对于肠内营养患者,可能是有害的
备注:
[1]:隐藏分组(分配隐藏)的概念: allocation concealment 国内译法不一,多主张译为:隐藏分组。最早称为盲法分组(blinded allocation),指分组人员不知道受试对象的任何情况,避免因各种人为因素影响随机分组造成的选择性偏倚的措施。为避免与实施过程中的盲法混淆,而将blinded allocation改称allocation concealment或concealed allocation。