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[JAMA发表论文]:高血糖强化治疗与标准治疗对急性缺血性脑卒中患者功能预后的影响
2019年08月06日 时讯速递, 进展交流 暂无评论

Original Investigation | July 23/30, 2019

Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial

Karen C. Johnston, Askiel Bruno, Qi Pauls, et al

JAMA. 2019;322(4):326-335. doi:10.1001/jama.2019.9346

Abstract

Importance 背景

Hyperglycemia during acute ischemic stroke is common and is associated with worse outcomes. The efficacy of intensive treatment of hyperglycemia in this setting remains unknown.

急性缺血性卒中时高血糖非常普遍,且与不良预后相关。在这种情况下对于高血糖的强化治疗效果尚属未知。

Objectives 目的

To determine the efficacy of intensive treatment of hyperglycemia during acute ischemic stroke.

确定急性缺血性卒中时高血糖强化治疗的疗效。

Design, Setting, and Participants 设计、场景及研究对象

The Stroke Hyperglycemia Insulin Network Effort (SHINE) randomized clinical trial included adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or ≥150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018. The trial included 1151 patients who met eligibility criteria.

SHINE随机临床试验于2012年4月至2018年8月在美国63所医院进行,纳入急性缺血性卒中伴高血糖(糖尿病患者血糖水平>110 mg/dL,无糖尿病患者≥150 mg/dL)的成年患者。随访于2018年11月结束。试验纳入1151名符合入选标准的患者。

Interventions 干预措施

Patients were randomized to receive continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n = 581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n = 570) for up to 72 hours.

患者被随机分组,分别根据计算机决策支持工具进行持续静脉胰岛素治疗(目标血糖水平80-130 mg/dL [4.4-7.2 mmol/L];强化治疗组:n = 581)或根据方案皮下注射胰岛素(目标血糖水平80-179 mg/dL [4.4-9.9 mmol/L];标准治疗组:n = 570),疗程72小时。

Main Outcomes and Measures 主要预后指标

The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0 [no symptoms or completely recovered] to 6 [death]) that was adjusted for baseline stroke severity.

主要预后指标为良好预后患者比例,预后根据90天修订Rankin量表评分评估(卒中残疾量表,分值从0分[无临床症状或完全恢复]到6分[死亡]),并针对基线卒中严重程度进行校正。

Results 结果 

Among 1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 529 [46%] women, 920 [80%] with diabetes), 1118 (97%) completed the trial. Enrollment was stopped for futility based on prespecified interim analysis criteria. During treatment, the mean blood glucose level was 118 mg/dL (6.6 mmol/L) in the intensive treatment group and 179 mg/dL (9.9 mmol/L) in the standard treatment group. A favorable outcome occurred in 119 of 581 patients (20.5%) in the intensive treatment group and in 123 of 570 patients (21.6%) in the standard treatment group (adjusted relative risk, 0.97 [95% CI, 0.87 to 1.08], P = .55; unadjusted risk difference, −0.83% [95% CI, −5.72% to 4.06%]). Treatment was stopped early for hypoglycemia or other adverse events in 65 of 581 patients (11.2%) in the intensive treatment group and in 18 of 570 patients (3.2%) in the standard treatment group. Severe hypoglycemia occurred only among patients in the intensive treatment group (15/581 [2.6%]; risk difference, 2.58% [95% CI, 1.29% to 3.87%]).

总共1151名患者接受随机分组(平均年龄66岁[SD, 13.1 岁]; 529名 [46%] 女性,920名 [80%] 糖尿病患者),1118名 (97%) 完成试验。基于预先确定的中期分析标准,因治疗无效,提前终止患者入选。在治疗过程中,强化治疗组平均血糖水平为118 mg/dL (6.6 mmol/L),标准治疗组179 mg/dL (9.9 mmol/L)。强化治疗组581名患者中119名 (20.5%) 及标准治疗组570名患者中 123 名 (21.6%) 符合良好预后标准(校正相对危险度,0.97 [95% CI, 0.87 to 1.08], P = .55;未校正危险差异,−0.83% [95% CI, −5.72% to 4.06%])。强化治疗组581名患者中65名 (11.2%) 与标准治疗组570名患者中 18 名 (3.2%) 因低血糖或其他不良事件提前停止治疗。仅强化治疗组患者发生了严重低血糖(15/581 [2.6%]; 风险差异, 2.58% [95% CI, 1.29% to 3.87%])。

Conclusions and Relevance 结论与意义

Among patients with acute ischemic stroke and hyperglycemia, treatment with intensive vs standard glucose control for up to 72 hours did not result in a significant difference in favorable functional outcome at 90 days. These findings do not support using intensive glucose control in this setting.

对于伴有高血糖的急性缺血性卒中患者,疗程72小时的强化治疗与标准血糖控制不会对90天的良好功能预后造成显著差异。这些发现不支持在此种情况下采用强化血糖控制。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT01369069

评论[仅代表个人观点]

  • 我们是否永远在证实相关关系其实为因果关系的道理上失败?
  • 可能以下的观点仍然是正确的:对于危重病患者而言,一过性高血糖的危害远较低血糖小

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