Use of insulin lispro in continuous subcutaneous insulin infusion treatment -: Results of a multicenter trial
Use of insulin lispro in continuous subcutaneous insulin infusion treatment -: Results of a multicenter trial
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DOI：
10.2337/diacare.22.5.784
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发表时间：
1999-05-01
期刊：
影响因子：
16.2
通讯作者：
Landgraf, R
中科院分区：
文献类型：
--
作者：
Renner, R;Pfútzner, A;Landgraf, R
目的-赖脯胰岛素是一种人胰岛素类似物，与常规人胰岛素相比起效更快，作用持续时间更短。在一项比较赖脯胰岛素和常规人胰岛素（均使用胰岛素泵）的开放随机交叉试验中，评估了赖脯胰岛素在连续皮下胰岛素输注（CSII）治疗中的疗效和耐受性。（60名男性，53名女性，年龄[平均值+/-SD] 37 +/-12岁，糖尿病病程19 +/-9年）参加了这项开放、随机交叉研究）：两种胰岛素均应用4个月，餐时胰岛素推注和进餐之间有适当的间隔（人胰岛素：30 min;赖脯胰岛素：0 min）。观察参数为HbA（1c），每日和餐后血糖曲线，不良事件，低血糖和高血糖事件的发生率，导管阻塞的数量，以及治疗满意度与国际验证questionnaire. RESULTS-患者控制良好，基线时平均HbA（1c）为7.24 +/-1.0%。HbA（1c）在两个治疗阶段均下降，但赖脯胰岛素治疗期间更好（赖脯胰岛素：6.8 +/-0.9%，常规人胰岛素：6.9 +/-1.0% Friedman秩和检验：餐后1h和2h血糖升高显著低于餐后1h和2h赖脯胰岛素（每餐P <0.001），与常规人胰岛素相比，每日血糖曲线更平稳，低血糖罕见率无显著差异（平均值+/-SD [中位数]：赖脯胰岛素12.4 +/-13.9 [8]，常规人胰岛素11.0 +/-11.2 [8]）、导管阻塞率（每个治疗组42起事件）以及不良事件的数量和类型。赖脯胰岛素治疗期间未观察到重度酮症酸中毒病例，而常规人胰岛素治疗期间报告了1例病例。当患者接受赖脯胰岛素治疗时，治疗满意度更好。结论-赖脯胰岛素是一种合适且非常方便的泵胰岛素，可改善CSII治疗期间的长期血糖控制。其安全性特征与常规人胰岛素无差异。
OBJECTIVE - Insulin lispro is an analog of human insulin with a faster onset and a shorter duration of action than regular human insulin. Efficacy and tolerability of insulin lispro in continuous subcutaneous insulin infusion (CSII) treatment were assessed in an open randomized crossover trial comparing insulin lispro and regular human insulin, both applied with insulin pumps.RESEARCH DESIGN AND METHODS - A total of 113 type 1 patients (60 male, 53 female, age [mean +/- SD] 37 +/- 12 years, duration of diabetes 19 +/- 9 years) participated in this open, randomized crossover stud): Both insulins were applied for 4 months each with the appropriate intervals between the prandial insulin bolus and the meal(human insulin: 30 min; lispro: 0 min). Observation parameters were HbA(1c), daily and postprandial blood glucose profiles, adverse events, rate of hypoglycemic and hyperglycemic events, number of catheter obstructions, and treatment satisfaction as assessed with an international validated questionnaire.RESULTS - The patients were well controlled with a mean HbA(1c) of 7.24 +/- 1.0% at baseline. HbA(1c) decreased in both treatment periods, but it was better during insulin lispro treatment (insulin lispro: 6.8 +/- 0.9%, regular human insulin: 6.9 +/- 1.0% Friedman's rank-sum test: P < 0.02), In addition, the 1-h and 2-h postprandial rises in blood glucose were significantly lower (P < 0.001 for each meal) with insulin lispro, resulting in smoother daily glucose profiles as compared with regular human insulin, No significant differences were reported for the rare of hypoglycemia (mean +/- SD [median]: insulin lispro 12.4 +/- 13.9 [8], regular human insulin 11.0 +/- 11.2 [8]), for the rate of catheter obstructions (42 events in each treatment arm), and for the number and type of adverse events. No severe case of ketoacidosis was seen during insulin lispro treatment, whereas one case was reported during therapy with regular human insulin. Treatment satisfaction was better when patients were treated with insulin lispro,CONCLUSIONS - Insulin lispro is a suitable and very convenient pump insulin that may result in an improvement of long-term glucose control during CSII treatment. Its safety profile does not differ from that of regular human insulin.