Mozdzan M, Ruxer J, Loba J, Siejka A, Markuszewski L
Department of Interventional Cardiology, Cardiodiabetology and Cardiac Rehabilitation, Medical University of Lódź ul. Wyszyńskiego 25a/4, 94-047 Lódź, Poland.
Adv Med Sci. 2006;51:133-6.
The aim of the study was to determine the safety of three intensive insulin therapy methods: multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII) and continuous intravenous insulin infusion (IVII) used in poorly controlled type 2 diabetic patients in hospital condition. The safety of these intensive insulin therapy methods was measured by the assessment of number and duration of symptomatic and symptomfree hypoglycaemic events with use of Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed).
The study comprised 90 type 2 diabetic patients treated with conventional insulin therapy based on a twice daily injections with mean glucose profile values > 14 mmol/l. The patients were randomized into three groups according to the method of insulin treatment. The first group was treated with MDI, the second group with CSII and the third with IVII. The glucose monitoring with the use of CGMS lasted 48 hours and was conducted on the second and on the third day of intensive insulin therapy. Glucose level below 3.5 mmol/l were recognized as hypoglycaemic episode. Intensive insulin treatment was continued until "near normoglycaemia" (glucose levels 4.5-10.0 mmol/l) was achieved and then conventional insulin therapy was readministrated.
Mean number of symptomatic hypoglycaemic events detected with CGMS was two times higher for MDI than for IVII (p = 0.04) and for CSII (p = 0.04). Number of symptomfree hypoglycaemic events detected with CGMS was higher for MDI than for IVII and CSII, but the differences were insignificant (NS). Mean duration of one symptomfree hypoglycaemic event detected with CGMS was longer in MDI than in CSII (p = 0.02) and IVII (p = 0.03). It was not observed significant differences in mean duration of one symptomatic hypoglycaemic episode between studied groups (NS).
The results of study suggest that CSII and IVII treatment is associated with essentially lower number of symptomatic hypoglycaemic events and shorter mean duration of one symptomfree hypoglycaemic event than MDI.
本研究旨在确定三种强化胰岛素治疗方法的安全性:多次皮下注射胰岛素(MDI)、持续皮下胰岛素输注(CSII)和持续静脉胰岛素输注(IVII),用于医院条件下血糖控制不佳的2型糖尿病患者。这些强化胰岛素治疗方法的安全性通过使用连续血糖监测系统(CGMS,美敦力MiniMed)评估有症状和无症状低血糖事件的数量和持续时间来衡量。
本研究包括90例接受基于每日两次注射的传统胰岛素治疗且平均血糖水平>14 mmol/l的2型糖尿病患者。根据胰岛素治疗方法将患者随机分为三组。第一组接受MDI治疗,第二组接受CSII治疗,第三组接受IVII治疗。使用CGMS进行血糖监测持续48小时,在强化胰岛素治疗的第二天和第三天进行。血糖水平低于3.5 mmol/l被视为低血糖发作。持续强化胰岛素治疗直至达到“接近正常血糖”(血糖水平4.5 - 10.0 mmol/l),然后重新给予传统胰岛素治疗。
CGMS检测到的有症状低血糖事件的平均数量,MDI组比IVII组高两倍(p = 0.04),也比CSII组高两倍(p = 0.04)。CGMS检测到的无症状低血糖事件数量,MDI组高于IVII组和CSII组,但差异无统计学意义(NS)。CGMS检测到的一次无症状低血糖事件的平均持续时间,MDI组比CSII组长(p = 0.02),也比IVII组长(p = 0.03)。研究组之间一次有症状低血糖发作的平均持续时间未观察到显著差异(NS)。
研究结果表明,与MDI相比,CSII和IVII治疗相关的有症状低血糖事件数量显著减少,一次无症状低血糖事件的平均持续时间更短