Hayes Risa P, Muchmore Douglas, Schmitke Jennifer
Global Health Outcomes, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
Curr Med Res Opin. 2007 Feb;23(2):435-42. doi: 10.1185/030079906X167381.
To compare patient-reported outcomes and treatment preference between preprandial inhaled insulin and preprandial subcutaneous (SC) insulin in the context of a clinical trial of crossover design with a primary objective of comparing HbA(1C) between groups.
Multi-center, randomized, open-label, two-arm crossover trial conducted in the US and Canada with two 12-week periods comparing preference between preprandial human insulin inhalation powder (HIIP; AIR inhaled insulin) and preprandial SC insulin (regular human insulin or insulin lispro) in patients with type 1 diabetes. Patients received HIIP plus insulin glargine during period 1 and SC insulin plus insulin glargine during period 2, or the reverse sequence.
SF-36 Vitality Subscale, Diabetes Symptom Checklist-Revised subscales, Diabetes Treatment Satisfaction Questionnaire, Insulin Delivery System Questionnaire, HIIP-specific questionnaire, preference question.
Of 137 patients entered, 119 completed the study (54% female, mean age 40.9 +/- 12.4 years, mean HbA(1C) 8.1 +/- 1.0%). Patients had significantly greater treatment satisfaction and more positive evaluation of their insulin delivery system (easier to control blood sugar, less lifestyle impact) with HIIP than with SC insulin (all p < 0.01). Patients preferring HIIP (80%) were significantly more confident about (p = 0.005) and comfortable with (p = 0.003) using the system than those preferring SC insulin. Results may not be generalizable to all patients with type 1 diabetes.
Some patients desire alternatives to insulin injection. In this study 80% preferred HIIP to injected insulin. Other patients feel more comfortable with familiar insulin delivery. Healthcare providers should help patients find insulin delivery that corresponds to individual preferences.
在一项交叉设计的临床试验背景下，比较餐前吸入胰岛素与餐前皮下注射胰岛素的患者报告结局及治疗偏好，该试验的主要目的是比较组间糖化血红蛋白（HbA₁C）水平。
在美国和加拿大进行的多中心、随机、开放标签、双臂交叉试验，为期两个12周阶段，比较1型糖尿病患者对餐前人胰岛素吸入粉（HIIP；AIR吸入胰岛素）和餐前皮下注射胰岛素（常规人胰岛素或胰岛素赖脯胰岛素）的偏好。患者在第1阶段接受HIIP加甘精胰岛素，在第2阶段接受皮下注射胰岛素加甘精胰岛素，或相反顺序。
SF-36活力子量表、糖尿病症状清单修订子量表、糖尿病治疗满意度问卷、胰岛素给药系统问卷、HIIP特定问卷、偏好问题。
纳入的137例患者中，119例完成研究（女性占54%，平均年龄40.9±12.4岁，平均HbA₁C 8.1±1.0%）。与皮下注射胰岛素相比，患者使用HIIP时治疗满意度显著更高，对胰岛素给药系统的评价更积极（更容易控制血糖，对生活方式影响更小）（所有p<0.01）。与偏好皮下注射胰岛素的患者相比，偏好HIIP的患者（80%）对使用该系统更有信心（p = 0.005）且更舒适（p = 0.003）。结果可能不适用于所有1型糖尿病患者。
一些患者希望有胰岛素注射的替代方法。在本研究中，80%的患者更喜欢HIIP而非注射胰岛素。其他患者对熟悉的胰岛素给药方式感觉更舒适。医疗服务提供者应帮助患者找到符合个人偏好的胰岛素给药方式。
