Tubiana-Rufi Nadia, Coutant Regis, Bloch Juliette, Munz-Licha Geraldine, Delcroix Christine, Montaud-Raguideau Nathalie, Ducrocq Rolande, Limal Jean-Marie, Czernichow Paul
Department of Pediatric Endocrinology and Diabetology, Hôpital Robert-Debré, Assistance Publique-Hôpitaux de Paris, France.
Horm Res. 2004;62(6):265-71. doi: 10.1159/000081703. Epub 2004 Oct 22.
To compare the safety, efficacy and management of insulin lispro (LP) with regular human insulin (RH) in young diabetic children treated with continuous subcutaneous insulin infusion (CSII).
27 very young diabetic children (age 4.6 +/- 2.2 years) treated with CSII participated in an open-label, randomized cross-over multicenter study comparing 2 periods of 16 weeks of CSII with LP or RH.
Mean daily basal rate was significantly higher during the LP period (p = 0.04). No differences were seen in changes in HbA1c levels, number of hypoglycemic events, cutaneous infections and catheter occlusions. There was no significant difference between the two treatments for preprandial and postprandial glucose values, although prandial glucose excursions tended to be lower with LP (significant at dinner, p = 0.01). Mean blood glucose levels were significantly higher at 0.00 and 3.00 a.m. during LP therapy (p < 0.05). No episode of ketoacidosis occurred during LP treatment. More parents indicated that LP made their own and the child's daily life easier (p = 0.02) and preferred LP (p = 0.01).
LP in CSII therapy in children is safe, as effective as RH, improved postprandial excursions, met the needs of young children in their daily life well, and gained their parents' satisfaction and preference. However, a shorter duration of LP resulted in hyperglycemia during the first part of the night, which must be compensated for by increasing nocturnal basal rates during this time.
比较赖脯胰岛素（LP）与常规人胰岛素（RH）在接受持续皮下胰岛素输注（CSII）治疗的糖尿病幼童中的安全性、有效性及管理情况。
27名接受CSII治疗的糖尿病幼童（年龄4.6±2.2岁）参与了一项开放标签、随机交叉多中心研究，比较了使用LP或RH进行16周CSII治疗的两个阶段。
LP治疗阶段的平均每日基础输注率显著更高（p = 0.04）。糖化血红蛋白（HbA1c）水平变化、低血糖事件数量、皮肤感染及导管堵塞情况均无差异。两种治疗方法在餐前和餐后血糖值方面无显著差异，不过LP治疗时餐后血糖波动往往更低（晚餐时差异显著，p = 0.01）。LP治疗期间凌晨0:00和3:00时的平均血糖水平显著更高（p < 0.05）。LP治疗期间未发生酮症酸中毒事件。更多家长表示LP使他们自己和孩子的日常生活更轻松（p = 0.02），且更倾向于LP（p = 0.01）。
CSII治疗中使用LP对儿童是安全的，与RH一样有效，可改善餐后血糖波动，很好地满足了幼儿日常生活需求，并获得了家长的满意和青睐。然而，LP治疗时间较短会导致夜间前半段出现高血糖，这必须通过在此期间增加夜间基础输注率来弥补。
