摘要目的 观察血糖控制胰岛素用量调节卡尺对急危重症患者血糖集中趋势、波动性及低血糖发生率等的影响,并评价其应用价值.方法 采用前瞻性单盲随机平行对照干预性研究方法,选择2015年11月至2017年11月嘉兴市第一医院急诊及重症加强治疗病房(ICU)收治的100例合并明显高血糖需要胰岛素输注治疗的急危重症患者,并按随机数字表法分为卡尺组(使用专利产品血糖控制胰岛素用量调节卡尺调节方案)和常规组(采用常规胰岛素用量调节方案),每组50例.记录并比较两组患者性别、年龄、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)、序贯器官衰竭评分(SOFA)、入院主要疾病、影响血糖的主要因素(肝肾功能不全、降糖药物、糖皮质激素、机械通气、肠内营养、肠外营养、静脉葡萄糖使用等)、各时间节点的血糖值(使用胰岛素后12 h内每2 h测定1次,16～72 h每4 h测定1次)、血糖变异度(CV)、血糖不稳定指数(GLUGLI)、平均血糖波动幅度(GLUMAGE)、胰岛素用量、低血糖发生率、血糖值在目标范围内的比例、住院时间、人均住院费用及预后等指标.结果 剔除资料不全、中途退出等病例后,最终92例患者纳入分析,其中卡尺组47例,常规组45例.两组患者的性别构成、年龄、APACHEⅡ、SOFA、入院时是否存在感染、既往糖尿病史、糖化血红蛋白水平、入院时血糖、外科术后患者比例、入院主要疾病及影响血糖主要因素等资料比较差异均无统计学意义.卡尺组共获得1379次血糖测定值,常规组共获得1332次血糖测定值.卡尺组6～72 h各时间节点血糖均值明显低于常规组.与常规组比较,卡尺组GLUGLI、GLUMAGE明显降低〔GLUGLI:12.96(8.73,19.58)比23.27(13.07,44.61),GLUMAGE(mmol/L):0.66±0.22比0.87±0.28,均P<0.01〕,低血糖发生率有降低趋势〔8.51％(4/47)比15.56％(7/45),但P>0.05〕,血糖值在目标范围内的比例明显增高〔41.99％(579/1379)比27.18％(362/1332),P<0.01〕,而两组CV、胰岛素用量、低血糖比例差异均无统计学意义,且ICU住院时间、总住院时间、院内感染发生率、预后及人均费用差异也无统计学意义.结论 血糖控制胰岛素用量调节卡尺在对急危重症患者的血糖进行目标控制、减小血糖波动性及减少低血糖发生等方面有较好的实用价值.临床试验注册中国临床试验注册中心,ChiCTR1800015024.

abstractsObjective To observe the effects of insulin caliper for blood glucose control on glycemic central tendency, fluctuation and incidence of hypoglycemia, etc., in emergent and critical patients to evaluate its application value.Methods A prospective single-blinded randomized parallel controlled intervention study was conducted. One hundred patients with severe hyperglycemia requiring treatment with insulin infusion admitted to emergency department and intensive care unit (ICU) of the First Hospital of Jiaxing from November 2015 to November 2017 were enrolled, and they were divided into the caliper group (used patented product insulin calipers for blood glucose control to adjust insulin dose for blood glucose control) and the conventional group (used paper-based insulin dose modification scheme to adjust insulin dose for blood glucose control) on average by random number table, 50 in each group. The gender, age, acute physiology and chronic health evaluation Ⅱ(APACHEⅡ), sequential organ failure assessment (SOFA), the principal diseases, main factors affecting blood glucose (hepatic and renal insufficiency, hypoglycemic drugs, glucocorticoids, mechanical ventilation, enteral nutrition, parenteral nutrition, intravenous glucose use, etc.), blood glucose levels at each time node (once every 2 hours after insulin use and once every 4 hours after 16-72 hours), glycemic coefficient of variance (CV), glycemic lability index (GLUGLI) and mean amplitude of glycemic excursion (GLUMAGE), insulin dose, incidence of hypoglycemia, proportion of achieving the glucose control target at each time point, the length of ICU stay and hospitalization cost per patient were recorded and compared between the two groups.Results After excluding those with incomplete data and withdraw in the midway, 92 patients were enrolled in the analysis finally,47 in caliper group and 45 in conventional group. There were no significant differences in the incidence of the gender, age, APACHEⅡ, SOFA, presence of infection at admission, previous diabetes history, glycosylated hemoglobin level, blood glucose at admission, proportion of patients after surgery, major diseases at admission and major factors affecting blood glucose between the two groups. A total of 1379 blood glucose measurements were obtained in the caliper group and 1332 blood glucose measurements were obtained in the conventional group. The glycemic measurements in caliper group were significantly lower than that in conventional group at each time point from 6-72 hours. Compared with conventional group, GLUGLI and GLUMAGE were significantly decreased in the caliper group [GLUGLI: 12.96 (8.73, 19.58) vs. 23.27 (13.07, 44.61), GLUMAGE (mmol/L): 0.66±0.22 vs. 0.87±0.28, bothP< 0.01]; there was a tendency towards decreasing incidence of hypoglycemia in the caliper group [8.51％ (4/47) vs. 15.56％ (7/45)], but no statistical difference was found (P > 0.05); the proportion of achieving the glucose control target was significantly increased in the caliper group [41.99％ (579/1379) vs. 27.18％ (362/1332),P < 0.01]. There were no significant differences in glycemic CV, insulin dose, proportion of hypoglycemic measurements in total measurements, and the length of ICU stay, the length of hospital stay, incidence of nosocomial infection, patient prognosis and cost between the two groups.Conclusion For emergent and critical patients, insulin caliper for blood glucose control presents favorable application value for achieving glucose control target, reducing glycemic fluctuation, and lowering the incidence of hypoglycemia.Clinical trial registration China clinical trial registration center, ChiCTR1800015024