Bruttomesso D, Crazzolara D, Maran A, Costa S, Dal Pos M, Girelli A, Lepore G, Aragona M, Iori E, Valentini U, Del Prato S, Tiengo A, Buhr A, Trevisan R, Baritussio A
Department of Clinical and Experimental Medicine, Division of Metabolic Diseases, University of Padova, Padova, Italy.
Diabet Med. 2008 Mar;25(3):326-32. doi: 10.1111/j.1464-5491.2007.02365.x.
The superiority of continuous subcutaneous insulin infusion (CSII) over multiple daily injections (MDI) with glargine is uncertain. In this randomized cross-over study, we compared CSII and MDI with glargine in patients with Type 1 diabetes well controlled with CSII. The primary end-point was glucose variability.
Thirty-nine patients [38.1 +/- 9.3 years old (mean +/- sd), diabetes duration 16.6 +/- 8.2 years, glycated haemoglobin (HbA(1c)) 7.6 +/- 0.8%], already on CSII for at least 6 months, were randomly assigned to CSII with lispro or MDI with lispro and glargine. After 4 months they were switched to the alternative treatment. During the last month of each treatment blood glucose variability was analysed using glucose standard deviation, mean amplitude of glycaemic excursions (MAGE), lability index and average daily risk range (ADRR). As secondary end-points we analysed blood glucose profile, HbA(1c), number of episodes of hypo- and hyperglycaemia, lipid profile, free fatty acids (FFA), growth hormone and treatment satisfaction.
During CSII, glucose variability was 5-12% lower than during MDI with glargine. The difference was significant only before breakfast considering glucose standard deviation (P = 0.011), significant overall using MAGE (P = 0.016) and lability index (P = 0.005) and not significant using ADRR. Although HbA(1c) was similar during both treatments, during CSII blood glucose levels were significantly lower, hyperglycaemic episodes were fewer, daily insulin dose was less, FFA were lower and treatment satisfaction was greater than during MDI with glargine. The frequency of hypoglycaemic episodes was similar during both treatments.
During CSII, glucose variability is lower, glycaemic control better and treatment satisfaction higher than during MDI with glargine.
持续皮下胰岛素输注（CSII）相较于甘精胰岛素多次皮下注射（MDI）的优势尚不确定。在这项随机交叉研究中，我们比较了CSII与MDI联合甘精胰岛素在使用CSII良好控制的1型糖尿病患者中的效果。主要终点为血糖变异性。
39例患者[年龄38.1±9.3岁（均值±标准差），糖尿病病程16.6±8.2年，糖化血红蛋白（HbA1c）7.6±0.8%]，已使用CSII至少6个月，被随机分配至赖脯胰岛素CSII组或赖脯胰岛素与甘精胰岛素MDI组。4个月后，他们转换为另一种治疗方案。在每种治疗的最后一个月，使用血糖标准差、血糖波动幅度均值（MAGE）、不稳定指数和平均每日风险范围（ADRR）分析血糖变异性。作为次要终点，我们分析了血糖谱、HbA1c、低血糖和高血糖发作次数、血脂谱、游离脂肪酸（FFA）、生长激素和治疗满意度。
在CSII期间，血糖变异性比联合甘精胰岛素的MDI期间低5 - 12%。仅在早餐前考虑血糖标准差时差异有统计学意义（P = 0.011），使用MAGE（P = 0.016）和不稳定指数（P = 0.005）时总体差异有统计学意义，而使用ADRR时差异无统计学意义。尽管两种治疗期间HbA1c相似，但在CSII期间血糖水平显著更低，高血糖发作次数更少，每日胰岛素剂量更少，FFA更低，且治疗满意度高于联合甘精胰岛素的MDI。两种治疗期间低血糖发作频率相似。
与联合甘精胰岛素的MDI相比，CSII期间血糖变异性更低，血糖控制更好，治疗满意度更高。
