低剂量（0.05 单位/千克/小时）与标准剂量（0.1 单位/千克/小时）胰岛素治疗小儿糖尿病酮症酸中毒：一项随机双盲对照试验。

Low-Dose (0.05 Unit/kg/hour) vs Standard-Dose (0.1 Unit/kg/hour) Insulin in the Management of Pediatric Diabetic Ketoacidosis: A Randomized Double-Blind Controlled Trial.

机构信息

Division of Pediatric Critical Care, Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry. Correspondence to: Dr R Rameshkumar, Associate Professor, Division of Pediatric Critical Care, Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605 006.

Division of Pediatric Critical Care, Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry.

出版信息

Indian Pediatr. 2021 Jul 15;58(7):617-623. Epub 2021 Feb 19.

PMID:33612484

Abstract

OBJECTIVE

To compare the efficacy of insulin infusion of 0.05 Unit/kg/hour vs 0.1 Unit/kg/hour in the management of pediatric diabetic ketoacidosis (DKA).

DESIGN

Randomized, double-blind controlled clinical trial.

SUBJECT

Pediatric critical care division of a tertiary care hospital from October, 2014 to July, 2018.

PARTICIPANTS

Children aged 12 years or younger with a diagnosis of DKA. Children with septic shock and those who had received insulin before enrollment were excluded.

INTERVENTION

Low-dose (0.05 Unit/kg/hour) vs. Standard-dose (0.1 Unit/kg/hour) insulin infusion.

OUTCOME MEASURES

The primary endpoint was time for resolution of DKA (pH ≥7.3, bicarbonate ≥15 mEq/L, beta-hydroxybutyrate <1 mmol/L). Secondary outcomes were the rate of fall in blood glucose until 250 mg/dL or less and the rate of complications (hypokalemia, hypoglycemia, and cerebral edema).

RESULTS

Sixty patients were analyzed on an intention-to-treat basis (Low-dose group: n=30; Standard-dose group: n=30). Mean (SD) time taken for the resolution of ketoacidosis was similar in both groups [22 (12) vs 23 (18.5) hours; P=0.92]. The adjusted hazard ratio (95% CI) of the resolution of ketoacidosis was lower in the low-dose group [0.40 (0.19 to 0.85); P=0.017]. Mean (SD) rate of blood glucose decrease until 250 mg/dL or less reached [56 (41) vs 64 (65) mg/dL/hour; P=0.41] and time to achieve the target [4.2 (3.1) vs 4.8 (3.3) hours; P=0.44] were similar in both groups. Hypokalemia [30% vs 43.3%; P=0.28] and hypoglycemia [3.3% vs 13.3%; P=0.35] were lower in low-dose group. No child had cerebral edema, and no mortality occurred.

CONCLUSIONS

Time for resolution of ketoacidosis was similar in the low-dose and standard-dose insulin with a lower rate of therapy-related complications in the low-dose group. Hence, low-dose insulin infusion can be a safer approach in the management of pediatric DKA.

摘要

目的

比较 0.05 单位/千克/小时与 0.1 单位/千克/小时胰岛素输注在儿科糖尿病酮症酸中毒（DKA）治疗中的疗效。

设计

随机、双盲对照临床试验。

研究对象

2014 年 10 月至 2018 年 7 月，三级保健医院儿科重症监护病房。

参与者

年龄在 12 岁以下且诊断为 DKA 的儿童。患有感染性休克和入组前已接受胰岛素治疗的儿童被排除在外。

干预

低剂量（0.05 单位/千克/小时）与标准剂量（0.1 单位/千克/小时）胰岛素输注。

结局测量

主要结局是 DKA 缓解时间（pH≥7.3、碳酸氢盐≥15 mEq/L、β-羟丁酸<1 mmol/L）。次要结局是血糖下降至 250mg/dL 或更低的速度和并发症发生率（低钾血症、低血糖和脑水肿）。

结果

基于意向治疗，对 60 名患者进行了分析（低剂量组：n=30；标准剂量组：n=30）。两组酸中毒缓解的平均（SD）时间相似[22（12）与 23（18.5）小时；P=0.92]。低剂量组的酸中毒缓解调整后的危险比（95%CI）较低[0.40（0.19 至 0.85）；P=0.017]。血糖下降至 250mg/dL 或更低的平均（SD）速率[56（41）与 64（65）mg/dL/hour；P=0.41]和达到目标的时间[4.2（3.1）与 4.8（3.3）小时；P=0.44]在两组之间相似。低钾血症[30%与 43.3%；P=0.28]和低血糖[3.3%与 13.3%；P=0.35]在低剂量组较低。没有儿童发生脑水肿，也没有死亡。