多参数追加建议在胰岛素泵强化治疗中的应用

Effectiveness and safety of multi-parameter bolus advisor in insulin-pump therapy among hospitalized patients with diabetes

目的 评估采用多参数追加建议的持续皮下胰岛素输注（CSⅡ）系统在临床应用中的安全性和有效性,以探讨多参数追加建议的临床应用价值.方法 2012年5月至2013年7月,将来自国内三甲综合医院内分泌病房的158例糖尿病患者,按2∶1∶1的比例随机分配至3组：多参数追加建议的持续皮下胰岛素输注（BA-CSⅡ）组、普通的持续皮下胰岛素输注（CO-CSⅡ）组和每日多次皮下胰岛素注射（MDI）组,用χ^2检验、Mann-Whitney U检验、Kruskal-WallisH检验比较3组患者住院治疗期间的血糖控制情况、不良事件及胰岛素用量的差异.结果 BA-CSⅡ组患者的餐后血糖达标率为78.1％ （50/64）,显著高于CO-CSⅡ组[52.3％ （23/44）,χ^2=7.955,P＜0.05]和MDI组[50.0％（18/36）,χ^2=8.375,P＜0.05],且出院时的餐后血糖水平显著低于CO-CSⅡ组[（7.8±2.0）比（9.1±2.8） mmol/L,Z=-2.301,P＜0.05]和MDI组[（7.8±2.0）比（9.1 ±2.2）mmol/L,Z=-2.920,P＜0.05].BA-CSⅡ组患者的低血糖（≤3.9 mmol/L）发生率和高血糖（≥10 mmol/L）人均发生频次均少于其他两组（P＞0.05）.3组患者住院期间的日平均胰岛素用量,BA-CSⅡ组低于MDI组[（44±17）比（56±27）U,P＞0.05],CO-CSⅡ组显著低于MDI组[（39±12）比（56±27）U,Z=-2.690,P＜0.05].与人院日相比,BA-CSⅡ组及CO-CSⅡ组患者出院日的胰岛素用量减少,而MDI组用量增加,但3组间差异无统计学意义（均P ＞0.05）.结论 采用多参数追加建议的CSⅡ进行胰岛素强化治疗,有利于餐后血糖达标,且不会增加胰岛素用量,同时有利于减少血糖波动.对于糖尿病住院患者,多参数追加建议的CSⅡ治疗方式能更安全有效地控制血糖.

Objective To assess the clinical safety and efficacy of multi-parameter bolus advisor in insulin pump therapy and explore clinical application value of the multi-parameter bolus advisor.Methods A total of 158 diabetic patients from endocrine departments of 10 tertiary comprehensive hospitals were randomly （2∶ 1∶1） assigned to three groups from May 2012 to July 2013,including therapy with insulin in the form of continuous subcutaneous insulin infusion （CSⅡ） with multi-parameter bolus advisor （BA-CSⅡ group）,common CSⅡ system （CO-CSⅡ group）,and multiple daily injection （MDI group）.The insulin dosage,blood glucose controlling,and incidence of hyperglycemia or hypoglycemia episodes during the hospitalization were compared and analyzed by chi-square test,Mann-Whitney U test and Kruskal-Wallis H test among the three groups.Results After treatment,the ratio of postprandial blood glucose reaching the individualized target in BA-CSⅡ group was significantly higher than CO-CSⅡ group （78.1% vs 52.3%,χ^2=7.955,P〈0.05） and MDI group （78.1% vs 50.0%,χ^2 =8.375,P〈0.05）,and postprandial blood glucose level of BA-CSⅡ group was remarkably lower than CO-CSⅡ group （（7.8 ± 2.0） vs （9.1 ± 2.8）mmol/L,Z=-2.301,P〈0.05） and MDI group （（7.8±2.0）vs （9.1 ±2.2）mmol/L,Z=-2.920,P 〈 0.05）.The incidence of hypoglycemia （blood glucose ≤ 3.9 mmol/L） and the per capita frequency of hyperglycemia （blood glucose≥ 10 mmol/L） in BA-CSⅡ group were lower than those in COCSⅡ group and MDI group,but there were no significant differences observed （P 〉 0.05）.Moreover,during the hospitalization,the average daily insulin dosage of BA-CSⅡ group was lower than that in MDI group （（44.4±17.0）vs （55.7 ±27.3） U,P〉0.05）,and that of CO-CSⅡ group （（39.3 ± 11.6）vs （55.7 ±27.3） U,Z=-2.690,P〈0.05） was significantly lower than that in MDI group,too.Compared with that of the hospital admission day,the insulin dosage of BA-CSⅡ group decreased more than CO-CSⅡ group on discharge day,whereas the insulin dosage of MDI group increased,and no obvious contrasts were found among three groups （all P 〉 0.05）.Conclusions The application of multi-parameter bolus advisor can improve postprandial glucose control in intensively treated diabetics,with less hypoglycemia risk and lower insulin dosage.Accordingly,automated bolus advisor was proven to be a safe and effective feature for insulin-pump system.