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目的 探讨模拟人工胰腺用于调控危重患者应激性高血糖的有效性和安全性.方法 采用前瞻性随机对照研究方法,以2015年1月1日至2017年6月30日上海市浦东新区浦南manbet官网登录 重症加强治疗病房(ICU)收治的72例应激性高血糖危重患者为研究对象〔年龄18~85岁,急性生理学与慢性健康状况评分系统Ⅱ(APACHEⅡ)评分>15分,连续2次以上随机血糖≥11.1 mmol/L,糖化血红蛋白(HbA1C)<0.065,3 d不能进食或仅接受肠外营养〕.按照随机数字表法将入选患者分为3组,其中模拟人工胰腺高强度组和低强度组采用由实时血糖监测系统(GRT系统)、闭环控制算法和微量注射泵组成的模拟人工胰腺,注射诺和灵R调控高血糖(高强度组取2/3用量,低强度组取1/3用量);优泌林组以优泌林70/30皮下注射调控高血糖.3组均采用GRT系统每10 min监测1次患者组织葡萄糖(相当于血糖)水平,测定患者入组24 h内空腹血浆应激激素(肾上腺素、皮质醇)水平和胰岛素抵抗指数(IRI);测定有效性指标(平均血糖、血糖变异系数、血糖达标率、血糖达标时间)、安全性指标(低血糖发生率)及6个月病死率.另选择同期健康管理科20例健康体检者作为对照(健康对照组).结果 共纳入合格病例60例,每组20例,3组患者性别、年龄、APACHEⅡ评分比较差异均无统计学意义;入组24 h 内血浆肾上腺素、皮质醇及IRI均显著高于健康对照组.优泌林组、低强度组及高强度组平均血糖依次下降(mmol/L:10.2±3.2、8.4±2.6、8.1±2.2),血糖达标率依次增高〔40.2%(3295/8196)、71.1% (5393/7585)、80.4% (6286/7818)〕,血糖达标时间依次缩短(h:49.1±5.8、24.6±4.6、17.5±4.2),低血糖发生率依次增高〔1.3%(108/8196)、2.8%(211/7585)、4.0%(313/7818)〕,差异均有统计学意义(均1=0.000),而血糖变异系数和6个月病死率差异均无统计学意义〔血糖变异系数:(29.4±3.7)%、(28.5±5.3)%、(26.1±4.6)%, 6个月病死率:55.0%、45.0%、40.0%,均1>0.05〕.结论 用模拟人工胰腺可安全有效地调控危重患者的应激性高血糖,以2/3用量诺和灵R的高强度调控效果更好;高频率GRT监测可及时发现低血糖并予以纠正.

Objective To explore efficacy and safety of simulated artificial pancreas in modulating stress hyperglycemia in critically ill patients. Methods A prospective randomized controlled study was performed. Seventy-two critically ill patients with stress hyperglycemia, aged 18-85 years, acute physiology and chronic health evaluationⅡ(APACHEⅡ) score over 15, two consecutive random blood glucose 11.1 mmol/L or higher, glycated hemoglobin (HbA1C) below 0.065, unable to eat food for 3 days after inclusion, or only accepting parenteral nutrition, admitted to intensive care unit (ICU) in Shanghai Punan Hospital of Pudong New District from January 1st, 2015 to June 30th, 2017 were enrolled. The patients were divided into three groups according to the random number table method, high-intensity group and low-intensity group were injected Novolin R (high-intensity group 2/3 dosage, low-intensity group 1/3 dosage) to modulate stress hyperglycemia by simulated artificial pancreas. Simulated artificial pancreas consisted of Guardian real time glucose monitoring system (GRT system), close-circle control algorithm and micro-pump;subcutaneous injection of Humulin 70/30 was applied to modulate stress hyperglycemia in humulin group. Real-time glucose levels of interstitial fluid in abdominal wall, equivalent to blood glucose levels, 10 minutes each time, were monitored by using of GRT system for all patients in three groups. Fasting serum levels of stress hormones including epinephrine and cortisol and insulin resistance index (IRI) were recorded within 24 hours after inclusion. Mean blood glucose, blood glucose variation coefficient, blood glucose target-reaching rate, blood glucose target-reaching time, hypoglycemia rate and 6-month mortality were measured. Twenty healthy adults from health administration department of the hospital were recruited as healthy control group. Results A total of 60 eligible critically ill patients were included in this study, each group with 20 patients. There was no significant difference in gender, age, APACHE Ⅱ scores among three groups. The levels of serum epinephrine, cortisol and IRI within 24 hours after inclusion in the three groups were significantly higher than those in healthy control group. The mean blood glucose levels of humulin group, low-intensity group, high-intensity group were decreased (mmol/L: 10.2±3.2, 8.4±2.6, 8.1±2.2), the blood glucose target-reaching rate were increased [40.2% (3 295/8 196), 71.1% (5 393/7 585), 80.4% (6 286/7 818)], the blood glucose target-reaching time were shortened (hours: 49.1±5.8, 24.6±4.6, 17.5±4.2), the hypoglycemia rates were increased respectively [1.3% (108/8 196), 2.8% (211/7 585), 4.0% (313/7 818)], with statistically significant differences (all 1 = 0.000). There was no significant difference in blood glucose variation coefficient and 6-month mortality among three groups [blood glucose variation coefficient: (29.4±3.7)%, (28.5±5.3)%, (26.1±4.6)%, 6-month mortality: 55.0%, 45.0%, 40.0%, all 1 > 0.05]. Conclusions Simulated artificial pancreas could effectively and safely modulate stress hyperglycemia in critically ill patients, high-intensity modulation could bring about better efficacy in the regulation of hyperglycemia. High-frequency blood glucose monitoring by using GRT system could promptly identify hypoglycemia and help it to be corrected.