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Diabetes Care. 2021 Jul;44(7):1641-1646. doi: 10.2337/dc20-2856. Epub 2021 Jun 7.
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强化与非强化补充胰岛素联合基础-餐时胰岛素方案治疗 2 型糖尿病住院患者的疗效和安全性:一项随机临床研究。

Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study.

机构信息

Division of Endocrinology, Metabolism and Lipids, Emory University School of Medicine, Atlanta, GA.

Rollins School of Public Health, Emory University, Atlanta, GA.

出版信息

Diabetes Care. 2022 Oct 1;45(10):2217-2223. doi: 10.2337/dc21-1606.

DOI:10.2337/dc21-1606
PMID:35675498
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9643128/
Abstract

OBJECTIVE

Administration of supplemental sliding scale insulin for correction of hyperglycemia in non-intensive care unit (ICU) patients with type 2 diabetes is frequently used with basal-bolus insulin regimens. In this noninferiority randomized controlled trial we tested whether glycemic control is similar with and without aggressive sliding scale insulin treatment before meals and bedtime in patients treated with basal-bolus insulin regimens.

RESEARCH DESIGN AND METHODS

Patients with type 2 diabetes with admission blood glucose (BG) 140-400 mg/dL treated with basal-bolus insulin were randomized to intensive (correction for BG >140 mg/dL, n = 108) or to nonintensive (correction for BG >260 mg/dL, n = 107) administration of rapid-acting sliding scale insulin before meals and bedtime. The groups received the same amount of sliding scale insulin for BG >260 mg/dL. Primary outcome was difference in mean daily BG levels between the groups during hospitalization.

RESULTS

Mean daily BG in the nonintensive group was noninferior to BG in the intensive group with equivalence margin of 18 mg/dL (intensive 172 ± 38 mg/dL vs. nonintensive 173 ± 43 mg/dL, P = 0.001 for noninferiority). There were no differences in the proportion of target BG readings of 70-180 mg/dL, <70 or <54 mg/dL (hypoglycemia), or >350 mg/dL (severe hyperglycemia) or total, basal, or prandial insulin doses. Significantly fewer subjects received sliding scale insulin in the nonintensive (n = 36 [34%]) compared with the intensive (n = 98 [91%] [P < 0.0001]) group with no differences in sliding scale insulin doses between the groups among those who received sliding scale insulin (intensive 7 ± 4 units/day vs. nonintensive 8 ± 4 units/day, P = 0.34).

CONCLUSIONS

Among non-ICU patients with type 2 diabetes on optimal basal-bolus insulin regimen with moderate hyperglycemia (BG <260 mg/dL), a less intensive sliding scale insulin treatment did not significantly affect glycemic control.

摘要

目的

在接受基础-餐时胰岛素方案治疗的 2 型糖尿病非重症监护病房(ICU)患者中,经常使用补充短效胰岛素推注方案来纠正高血糖。在这项非劣效性随机对照试验中,我们检测了在接受基础-餐时胰岛素方案治疗的患者中,餐前和睡前积极使用短效胰岛素推注方案是否会对血糖控制产生影响。

方法和研究设计

将入院时血糖(BG)为 140-400mg/dL 的 2 型糖尿病患者随机分为强化组(BG>140mg/dL 时进行校正,n=108)和非强化组(BG>260mg/dL 时进行校正,n=107),分别接受餐前和睡前的快速起效短效胰岛素推注。两组在 BG>260mg/dL 时接受相同剂量的短效胰岛素推注。主要结局是住院期间两组患者的平均日 BG 水平差异。

结果

非强化组的平均日 BG 不劣于强化组,等效边界为 18mg/dL(强化组 172±38mg/dL 与非强化组 173±43mg/dL,P=0.001 表示非劣效性)。70-180mg/dL、<70mg/dL 或<54mg/dL(低血糖)、>350mg/dL(严重高血糖)或总、基础和餐时胰岛素剂量的目标 BG 读数比例均无差异。在非强化组(n=36 [34%])中,接受短效胰岛素推注的患者明显少于强化组(n=98 [91%])(P<0.0001),而在接受短效胰岛素推注的患者中,两组的短效胰岛素推注剂量无差异(强化组 7±4 单位/天,非强化组 8±4 单位/天,P=0.34)。

结论

在接受最佳基础-餐时胰岛素方案治疗且伴有中度高血糖(BG<260mg/dL)的非 ICU 2 型糖尿病患者中,采用较不积极的短效胰岛素推注方案不会显著影响血糖控制。