Department of Sociology, Loyola University Maryland, Baltimore, Maryland, USA.
Diabetes Technol Ther. 2010 Jan;12(1):49-55. doi: 10.1089/dia.2009.0115.
This randomized controlled trial assessed the impact of Technosphere insulin (MannKind Corp., Valencia, CA) delivered via the MedTone inhaler (MannKind Corp.) on quality of life and treatment satisfaction in adults with type 2 diabetes.
Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Subjects completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Insulin Treatment Questionnaire [ITQ]) before starting insulin treatment and approximately 12 weeks later. The ITQ assesses Diabetes Worries, Perceptions of Insulin Therapy, and Inhaler Performance.
There was no significant change in any SF-36 factor or Diabetes Worries during the trial in either arm, and there were no significant between-arm differences in change on any of these measures. Perceptions of Insulin Therapy improved significantly during the trial in the active medication arm (effect size for composite measure = 0.56, P = 0.002) but not in the placebo arm; there were no significant between-arm differences in change. The majority of subjects gave positive ratings of Inhaler Performance on all items (median = 93% positive ratings).
In this study treatment with inhaled Technosphere insulin was well tolerated, clinically efficacious, and associated with positive patient-reported outcomes, including improved attitudes toward insulin therapy and high treatment satisfaction. This treatment strategy was implemented without a negative impact on health-related quality of life or worries about diabetes.
本随机对照试验评估了 Technosphere 胰岛素（MannKind 公司，加利福尼亚州瓦伦西亚）通过 MedTone 吸入器（MannKind 公司）给药对 2 型糖尿病成人患者生活质量和治疗满意度的影响。
受试者为 119 名初治胰岛素的患者，其起始糖化血红蛋白（HbA1c）＞6.5%：活性吸入胰岛素组 58 例，吸入安慰剂组 61 例（7 例（67%为男性；平均年龄 55 岁；平均确诊糖尿病病程 7 年）。在开始胰岛素治疗前和大约 12 周后，受试者完成了一项健康相关生活质量（SF-36）测量和一项治疗满意度（胰岛素治疗问卷 [ITQ]）测量。ITQ 评估了糖尿病担忧、胰岛素治疗认知和吸入器性能。
在试验期间，两组的任何 SF-36 因子或糖尿病担忧均无显著变化，并且这些指标的任何变化在两组之间均无显著差异。在活性药物组，胰岛素治疗认知在试验期间显著改善（综合测量的效应大小为 0.56，P=0.002），而在安慰剂组则没有显著改善；两组之间的变化没有显著差异。大多数患者对所有吸入器性能项目均给予了积极评价（中位数=93%的积极评价）。
在这项研究中，吸入 Technosphere 胰岛素治疗耐受性良好，具有临床疗效，并与积极的患者报告结果相关，包括改善对胰岛素治疗的态度和高治疗满意度。这种治疗策略的实施并未对健康相关生活质量或对糖尿病的担忧产生负面影响。
