美国医师协会指南不建议胰岛素强化治疗

ACP Guideline Discourages Intensive Insulin Therapy

美国医师协会指南不建议胰岛素强化治疗

February 14, 2011 — The American College of Physicians (ACP) has issued a new clinical guideline for glycemic control in hospitalized patients that discourages the use of intensive insulin therapy (IIT).

2011年2月14日—美国医师协会（ACP）发布了新的住院患者血糖控制临床指南，不再建议胰岛素强化治疗（IIT）。

The guideline is based on a systematic review, which concluded: "No consistent evidence demonstrates that IIT targeted to strict glycemic control compared with less strict glycemic control improves health outcomes in hospitalized patients. Furthermore, IIT is associated with increased risk for severe hypoglycemia."

该指南基于一个系统回顾推断：“没有一致的证据表明胰岛素强化治疗严格控制血糖能比较宽松的血糖控制可改善住院患者的预后，此外，胰岛素强化治疗与严重低血糖的风险增加有关。。“

The clinical practice guideline, published online February 14 in the Annals of Internal Medicine, recommends against "using intensive insulin therapy to strictly control blood glucose in non-surgical intensive care unit (SICU)/medical intensive care unit (MICU) patients with or without diabetes mellitus."

该临床实践指南在线发表在2月14日的内科医学年鉴上，该指南反对“在非外科重症监护病房（SICU）/内科重症监护病房（MICU）使用强化胰岛素治疗严格控制糖尿病患者或非糖尿病患者的血糖。“

The guideline also recommends against using IIT rather than conventional glucose control to normalize blood glucose in patients in the SICU/MICU, whether they have diabetes or not. Finally, the guideline recommends a target blood glucose level of 7.8 to 11.1 mmol/L (140 - 200 mg/dL) if insulin therapy is used in patients in the SICU/MICU.

该指南也反对在SICU/MICU的患者应用胰岛素强化治疗，仍然推荐传统的血糖控制方案，无论患者有无糖尿病。最后，指南建议SICU/MICU的患者使用胰岛素治疗的目标血糖水平为7.8~11.1 mmol / L（140- 200 mg/dL）。

Data supporting the new guideline were drawn from a systematic review by Devan Kansagara, MD, and colleagues. Their meta-analysis of 21 trials in ICU, perioperative care, myocardial infarction, and stroke or brain injury settings found that IIT did not improve short-term mortality, long-term mortality, infection rates, length of stay, or the need for renal replacement therapy. Furthermore, IIT was associated with a 6-fold increase in risk for severe hypoglycemia in all hospital settings.

支持新指南的数据来自Devan Kansagara博士及其同事的一项系统综述。他们对在ICU、围手术期、心肌梗死、卒中或脑损伤的患者中进行的21项试验进行了荟萃分析发现，强化血糖控制并没有改善短期死亡率、长期死亡率、感染率、住院天数或肾脏替代治疗。此外，在所有医疗机构中，强化血糖控制还伴随着严重低血糖的风险增加了6倍。

The ACP Clinical Guidelines Committee, chaired by Paul Shekelle, MD, PhD, used the data to shape the 3 recommendations for the use in IIT in hospitalized patients with or without diabetes.

美国医师协会临床指南委员会主席Paul Shekelle博士根据研究的数据修改了住院糖尿病患者或非住院患者胰岛素强化治疗的3项建议。

Current Results Consistent With NICE-SUGAR Trial

目前的结果与NICE-SUGAR试验的结果一致

The ACP paper marks another brake on the formerly fast rush to adopt tight glycemic control for critically ill adults. This followed a 2001 study by van den Berghe et al, who reported that targeting normoglycemia in ventilated patients in the SICU reduced the risk for in-hospital death by one third.

美国医师协会指南给先前如火如荼的重症病人采用胰岛素强化治疗又踩了刹车。在此之前van den Berghe等于2001年报告，将SICU机械通气的患者血糖控制正常可减少医院死亡三分之一的风险。

However, this result was not confirmed by the subsequent Normoglycemia in Intensive Care Evaluation — Survival Using Glucose Algorithm Regulation (NICE-SUGAR) randomized comparison of intensive vs conventional glucose control.

然而，这一结果并没有得到NICE-SUGAR研究随机比较强化血糖控制与传统血糖控制结果的证实。

Simon Finfer, FRCP, FJFICM, one of the NICE-SUGAR investigators, told Medscape Medical News that the new ACP guideline reinforces both the American Diabetes Association (ADA) guidelines for diabetes care in hospital (glucose target of 140 - 180 mg/dL, 7.8 - 10 mmol/L) and the similar Institute for Healthcare Improvement guidelines.

Simon Finfer是NICE-SUGAR研究者之一，他告诉Medscape医学新闻，新的ACP指南再次强调了美国糖尿病协会指南关于住院患者的控制目标（血糖目标140 - 180 mg/dL, 7.8 - 10 mmol/L）及相似的医疗改进研究所的指南。

ADA Weighs in on the ACP Guidelines

ADA和ACP指南基本一致

Sue Kirkman, MD, senior vice president , ADA, told Medscape Medical News that the ACP reviewers did a very thorough and systematic review of the data and that the new guideline is basically consistent with the ADA recommendations.

Sue Kirkman博士是ADA的高级副主席，告诉Medscape医学新闻说，ACP的作者们对数据做了非常详尽和系统的回顾，新指南基本与ADA的建议一致。

Dr. Kirkman said, "The upper limit of the range is higher than we'd recommend. It's not clear why they picked 200 mg/dL rather than 180 mg/dL, and 140 to 180 mg/dL was the target for the control group in the NICE-SUGAR study." Dr. Kirkman explained that 180 mg/dL is also the point at which the kidneys start to spill glucose. Theoretically, patients could get dehydrated above that level, but this would mostly be a risk at much more elevated blood glucose readings, she explained.

Kirkman博士说：“在这一范围内的上限高于我们以前ADA推荐的标准。目前还不清楚他们为什么选择200 mg/dL，而不是180 mg/dL，或者140~180 mg/dL以NICE-SUGAR研究的对照组作为血糖控制目标。”柯克曼博士解释说，180 mg/dL也是肾脏漏出葡萄糖的阈值。从理论上说，病人血糖超过这个水平可能会脱水，但血糖水平再升高会有较大风险，她解释说。

"In actuality, there isn't much difference between the 2 recommendations," Dr. Kirkman said.

The ACP guideline is expected to affect not only diabetes specialists but also hospitalists, critical care specialists, and primary care providers.

“实际上，在这两个建议之间并没有太大的差别”，博士柯克曼说。
ACP指南是希望不仅影响糖尿病专家，更想影响医院管理专家、、危重病专家和初级保健人员。

Dr. Kirkman said, "I think some may still want to aim for the lower range of the ADA recommendations (110 - 140 mg/dL) for some patients, such as post–coronary artery bypass graft patients in the ICU. The ACP statement and other guidelines, such as ADA's, acknowledge that severe hyperglycemia (>200 mg/dL) is certainly linked to adverse outcomes for hospitalized patients, so one would hope that the pendulum won't swing too far towards not being concerned with hyperglycemia."

Kirkman博士说：“我觉得有些专家可能还想在某些患者中降低ADA建议的控制范围（110~ 140 mg/dL），如ICU中冠状动脉旁路移植后的患者。在ACP和其他指南（如ADA）的立场中承认，严重高血糖（>200 mg/dL）肯定对住院的病人会带来不利的结果，所以人们希望钟摆摆动不会太远以免血糖过高。“

Both Dr. Finfer and Dr. Kirkman noted that the ACP guideline applies only to patients in the ICU.

Dr. Kirkman said, "By far the biggest unanswered question is what the goals should be for non-ICU patients, which is most patients in the hospital. Also, the links of hypoglycemia to adverse outcomes need to be better understood. Is this causative, or is it a marker for a sicker patient? Better systems to prevent hypoglycemia are needed."

Finfer博士和Kirkman博士均指出，ACP指南仅适用于ICU的病人。
Kirkman博士说，“目前最大的尚未回答的问题是对于非ICU的病人其目标该是多少，这些患者占住院患者的大多数。此外，低血糖与不良结局关联需要更深入的探讨。这是原因，还是病人病情加重的一个标志？我们需要防止低血糖更好的系统。”

Ann Intern Med. 2011;154:260-267, 268-282.