Mozzillo Enza, Franzese Adriana, Valerio Giuliana, Sepe Angela, De Simone Ilaria, Mazzarella Gianfranco, Ferri Pasqualina, Raia Valeria
Department of Pediatrics, Federico II University of Naples, Naples, Italy.
Pediatr Diabetes. 2009 May;10(3):162-7. doi: 10.1111/j.1399-5448.2008.00451.x. Epub 2009 Jan 14.
Diabetes increases morbidity and mortality in cystic fibrosis (CF) patients, but several studies indicate that also prediabetic status may have a potential impact on both nutrition and lung function.
To evaluate the effect of glargine on the clinical course in CF patients with early glucose derangements.
CF population was screened for glucose tolerance. CF patients with age >10 yr were screened with fasting hyperglycemia (FH). CF patients with age >10 yr without FH and those with age <10 yr with occasional FH were evaluated for glucose abnormalities on the basis of oral glucose tolerance test and/or continuous glucose monitoring system. All CF patients with glucose derangements were enrolled in an open clinical trial with glargine. Body mass index (BMI) z-score, forced expiratory volume in the first second (FEV(1)), number of acute pulmonary exacerbations and hemoglobin A1c, were as outcome measures at baseline and after 1 yr of treatment.
After 12 months of therapy, BMI z-score improved only in patients with baseline BMI z-score less than -1 (p = 0.017). An 8.8% increase in FEV(1) (p = 0.01) and 42% decrease in the number of pulmonary exacerbations (p = 0.003) were found in the whole group compared with previous 12 months of therapy.
Glargine could represent an innovative strategy to prevent lung disease progression in CF patients with early glucose derangements. Larger controlled trials are needed to better clarify the effects of insulin on clinical status in CF patients with early glucose derangements.
糖尿病会增加囊性纤维化(CF)患者的发病率和死亡率,但多项研究表明,糖尿病前期状态也可能对营养和肺功能产生潜在影响。
评估甘精胰岛素对早期血糖紊乱的CF患者临床病程的影响。
对CF人群进行葡萄糖耐量筛查。年龄>10岁的CF患者进行空腹血糖过高(FH)筛查。年龄>10岁无FH的CF患者以及年龄<10岁偶尔出现FH的患者,根据口服葡萄糖耐量试验和/或连续血糖监测系统评估血糖异常情况。所有血糖紊乱的CF患者均纳入甘精胰岛素开放临床试验。以体重指数(BMI)z评分、第1秒用力呼气量(FEV₁)、急性肺部加重发作次数和糖化血红蛋白A1c作为基线和治疗1年后的结局指标。
治疗12个月后,仅基线BMI z评分小于-1的患者BMI z评分有所改善(p = 0.017)。与前12个月的治疗相比,整个组的FEV₁增加了8.8%(p = 0.01),肺部加重发作次数减少了42%(p = 0.003)。
甘精胰岛素可能是预防早期血糖紊乱的CF患者肺部疾病进展的一种创新策略。需要更大规模的对照试验来更好地阐明胰岛素对早期血糖紊乱的CF患者临床状况的影响。