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医博网推荐：大连医科大学附属第一医院黄伟教授对NICE-SUGAR研究的点评之二
Tagged Under : CSCCM, N Engl J Med, NICE-SUGAR研究, NICE-SUGAR试验, YeeBlog.com, 《新英格兰医学杂志》, 中国病理生理协会危重病医学专业委员会, 医博网, 大连医科大学附属第一医院, 大连医科大学附属第一医院黄伟, 强化血糖控制, 血糖, 降血糖, 黄伟
自从NICE-SUGAR研究的试验结果在N Engl J Med《新英格兰医学杂志》上（3月27日）发表以来，关于ICU患者强化血糖控制的争论似乎有了一个结论性的证据，在全世界范围内引发了很大的讨论。
我国一些学者也对NICE-SUGAR研究进行了认真的分析和精彩的解读，医博网（yeeblog.com）推荐并转载几位国内专家的解读，供大家参考。
大连医科大学附属第一医院黄伟教授对NICE-SUGAR研究进行了详细的点评，全文转载如下[该文章发表在黄伟教授的搜狐博客上]。
二话NICE SUGAR： 改弦更张
3月26日写过第一篇有关NICE SUGAR的报道，看来该研究的深远影响不会就此罢休– 截止刚才google搜索NICE SUGAR已经有近70000个结果了！
当然最重要的还是各相关协会以及相关指南的更改才是重头戏，为此我将尽力收集相关证据为大家全面理解该研究提供素材。– 一个不幸的消息是本文其实是重写的，第一便写完粘贴后，sohu博客闹鬼一般突然提示我必须重新登录，因此前功尽弃，现在已经没有回忆和重新打字的兴趣，只能copy+粘贴了.
第一个发表声明的就是之前将强化血糖控制的目标规定在110mg/dl的美国内分泌协会，概括而言，声明认为在未阐明各项强化血糖控制研究结论为何出现如此显著差异之前（就是Van den berge的鲁纹研究 和NICE SUGAR研究之间的差异），危重病血糖控制的目标还是订在144-180 mg/dl是合适的，当然个体化也很重要。声明全文如下(pdf格式点这里)：
Endocrine Society Statement to Providers on NICE-SUGAR
The NICE-SUGAR study, published in today’s New England Journal of Medicine1, reports on mortality in 6000 critically ill hyperglycemic patients randomly assigned to either tight control of blood sugar (target blood sugar of 80-108 mg/dl with an achieved mean-weighted glucose of 115 mg/dl) or looser control of blood sugar (target blood sugar of 144-180 mg/dl with an achieved mean-weighted glucose of 144 mg/dl) while they were in the intensive care unit. This multi-center, international study’s key conclusion was that relative mortality at 90 days was actually 10% higher in the tight control group (829/3010) than in the looser control group (751/3012), with this difference primarily reflecting more cardiovascular deaths in the tight control group.
The Endocrine Society commends the NICE-SUGAR investigators for producing an important and provocative addition to the medical literature and draws the following conclusions and recommendations from their data. First, near-normalization of blood sugar does not clearly improve outcomes in all critically ill hyperglycemic ICU patients, and there is even a suggestion that such an approach may worsen outcomes. Second, looser control of hyperglycemia, i.e., target blood glucose of 144-180 mg/dl, is a reasonable, and perhaps preferable, option in this particular group of very sick patients. Third, it is essential to assess clinically meaningful outcomes, such as mortality, as well as surrogate or intermediate endpoints, such as blood sugar level, in studies of diabetes treatment as the NICE-SUGAR study has done; improvement of blood sugar control may not always translate to better clinical results.
Finally, the rush to deploy difficult and resource-intensive protocols in ICU’s may be premature until there is a better understanding of the reasons that the NICE-SUGAR results differ so markedly from those of an earlier study by Van den Berghe et al. 2, which showed that tight control of blood sugar in critically ill hyperglycemic patients seemed to improve outcomes（…在明确原因之前，贸然推动复杂且消耗资源的规章指南还为时尚早…）. There are certainly differences in study design and target patient populations between these two studies, and the situation is further clouded by van den Berghe’s failure to replicate the results of her original study, which was done in surgical patients, in a subsequent study of critically ill medical patients.
Close analysis of these study differences, including examination of the results in various sub-groups, may give rise to important questions that need to be answered by further studies. For example, are outcomes after tight glucose control the same in those with pre-existing diabetes as in those without it? Does the number or severity of hypoglycemic episodes, or some other aspect of tight glucose control, impair the future counter-regulatory and autonomic nervous system responses to hypoglycemia in this patient population? What is the temporal relationship of hypoglycemia to death? Would the use of continuous glucose monitoring improve outcomes?
Aggressive outpatient management of hyperglycemia has been the hallmark of diabetes care for almost two decades since the DCCT4 and UKPDS5 studies showed reduced microvascular complications with such an approach. Potential benefits of tight glucose control in reducing macrovascular complications and death have been more difficult to demonstrate, with recent studies (ACCORD6, ADVANCE7, and VADT8) showing that such aggressive management of hyperglycemia can be associated with substantial risks and/or few benefits. 有哪些经典研究及其意义…
The Endocrine Society believes that we have entered an era of more nuanced and patient-appropriate recommendations as a result of these recent large, well-done outpatient and inpatient studies. We believe physicians should individually tailor their approach to glycemic control in their ICU patients, perhaps targeting glucose values between 144-180 mg/dl, until we better understand the reasons for these somewhat counterintuitive findings.1. The NICE-SUGAR Study Investigators. Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009;360:1283-1297.
2. Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in critically ill patients. N Engl J Med 2001; 345:1359-67.
3. Van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in the medical ICU. N Engl J Med 2006;354:449-461.
4. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986.
5. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with Sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 21998;352:837-853.
6. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-2559.
7. The ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-2572.
8. Duckworth, W, Abraira, C, Moritz, T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2009;360:129-139.
For further information, please contact Holly Whelan, Associate Director, Health Policy, at hwhelan@endo-society.org.
Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.
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多说一句，个人觉得专业委员会就应该像美国内分泌协会一样，及时的对业内重要进展作出回应和判断，为其下属成员提供最专业和权威的行动指南，可惜SCCM和ESICM目前还没有类似声明，可能他们觉得没必要，或者他们的委员也在”彻夜争吵”中…
参考阅读：jerryljw.blogspot.com/2009/03/nice-sugar-or-bad-sugar.html 台湾同行的…
不过读者也可以参照美国糖尿病协会（ADA）和美国临床内分泌医师协会（AACE）的就NICE SUGAR的联合公报，公报内容仍然认为(NICE-SUGAR) study should NOT lead to an abandonment of the concept of good glucose management in the hospital setting. Uncontrolled high blood glucose can lead to serious problems for hospitalized patients, such as dehydration and increased propensity to infection.
