Rosenstock Julio, Nakano Masako, Silverman Bernard L, Sun Bin, de la Peña Amparo, Suri Ajit, Muchmore Douglas B
Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas 75230, USA.
Diabetes Technol Ther. 2007 Feb;9(1):80-8. doi: 10.1089/dia.2006.0042.
The Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system [AIR (a registered trademark of Alkermes, Inc., Cambridge, MA) Inhaled Insulin System] was designed to be easy to use. Training methods were compared in insulin-naive patients with type 2 diabetes.
Patients (n = 102) were randomized to standard or intensive training. With standard training, patients learned how to use the HIIP delivery system by reading directions for use (DFU) and trying on their own. Intensive training included orientation to the HIIP delivery system with individual coaching and inspiratory flow rate training. Both groups received preprandial HIIP + metformin with or without a thiazolidinedione for 4 weeks. Overall 2-h postprandial blood glucose (PPBG) excursion was the primary measure. Noninferiority was defined as the upper limit of the two-sided 95% confidence interval of the mean difference between groups being 1.2 < or = mmol/L.
Overall 2-h PPBG excursions (least squares mean +/- SE) at endpoint were -0.11 +/- 0.38 (standard training) and 0.23 +/- 0.36 (intensive training) mmol/L. The mean difference (standard minus intensive training) and two-sided 95% confidence interval were -0.35 (-1.02, 0.33) mmol/L. No statistically or clinically significant differences were observed between training methods in premeal, postmeal, or bedtime blood glucose values, HIIP doses at endpoint, or blood glucose values after a test meal. No discontinuations occurred because of difficulty of use or dislike of the HIIP system. DFU compliance was >90% in both training groups. There were no significant differences between training methods in safety measures.
The HIIP delivery system is easy to use, and most patients can learn to use it by reading the DFU without assistance from health care professionals.
礼来公司/阿尔克姆斯公司的人胰岛素吸入粉（HIIP）给药系统[AIR（阿尔克姆斯公司的注册商标，马萨诸塞州剑桥）吸入胰岛素系统]设计得易于使用。对2型糖尿病初治患者的培训方法进行了比较。
患者（n = 102）被随机分为标准培训组或强化培训组。标准培训时，患者通过阅读使用说明（DFU）并自行尝试来学习如何使用HIIP给药系统。强化培训包括在个人指导下熟悉HIIP给药系统以及吸气流量率训练。两组均接受餐前三甲双胍联合HIIP治疗，可加用或不加用噻唑烷二酮类药物，为期4周。总体餐后2小时血糖（PPBG）波动是主要测量指标。非劣效性定义为两组均值差异的双侧95%置信区间上限≤1.2 mmol/L。
终点时总体餐后2小时PPBG波动（最小二乘均值±标准误）分别为-0.11±0.38（标准培训组）和0.23±0.36（强化培训组）mmol/L。均值差异（标准培训组减去强化培训组）及双侧95%置信区间为-0.35（-1.02，0.33）mmol/L。在餐前、餐后或睡前血糖值、终点时的HIIP剂量或试验餐后血糖值方面，两种培训方法之间未观察到统计学或临床显著差异。未因使用困难或不喜欢HIIP系统而导致停药。两组培训中DFU依从性均>90%。在安全指标方面，两种培训方法之间无显著差异。
HIIP给药系统易于使用，大多数患者通过阅读DFU无需医护人员协助就能学会使用。
