Rubin Richard R, Peyrot Mark
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Curr Med Res Opin. 2007 Aug;23(8):1919-29. doi: 10.1185/030079907X210804.
This study was designed to assess treatment satisfaction in patients using pramlintide who had not previously achieved glycemic targets with insulin therapy alone. Assessment included the association between treatment satisfaction and clinical outcomes (changes in post-prandial glucose [PPG], glycosylated hemoglobin [HbA(1c)], weight, and insulin requirements).
In this open-label study 240 participants with type 1 diabetes and 160 participants with type 2 diabetes added pramlintide to their established insulin regimen. Mealtime insulin doses were subsequently adjusted to optimize glycemic control.
Seven-point glucose profiles, weight, and insulin requirements were obtained at baseline and months 1, 3, and 6; HbA(1c) levels were obtained at baseline and months 3 and 6. Participants completed a treatment satisfaction questionnaire (TSQ) at months 1, 3, and 6.
Participants rated the study treatment regimen including pramlintide significantly (p < 0.001) superior to their pre-study regimens in terms of 'glucose control', 'eating-weight control', and 'general benefits' at all three TSQ administrations. Regression analysis of treatment satisfaction at 6 months revealed several independent predictors (p < 0.05). Participants who were able to reach the maximum dosage of pramlintide per protocol, and those who experienced more reduction in PPG and insulin requirements during the study, reported higher satisfaction with glucose control and general benefits; those who lost more weight reported higher treatment satisfaction on all three TSQ measurements.
Greater satisfaction with the study regimen was reported on all treatment satisfaction factors at all three TSQ administrations, with all advantages representing large treatment effects. Treatment satisfaction was higher for patients who experienced better clinical outcomes (decreases in weight, insulin dose requirements, and PPG levels). Study limitations include the fact this was an open-label study.
本研究旨在评估使用普兰林肽的患者的治疗满意度，这些患者此前仅接受胰岛素治疗时未达到血糖目标。评估内容包括治疗满意度与临床结局（餐后血糖[PPG]、糖化血红蛋白[HbA(1c)]、体重和胰岛素需求量的变化）之间的关联。
在这项开放标签研究中，240名1型糖尿病患者和160名2型糖尿病患者在其既定的胰岛素治疗方案中添加了普兰林肽。随后调整餐时胰岛素剂量以优化血糖控制。
在基线、第1、3和6个月时获取七点血糖谱、体重和胰岛素需求量；在基线以及第3和6个月时获取HbA(1c)水平。参与者在第1、3和6个月时完成一份治疗满意度问卷（TSQ）。
在所有三次TSQ评估中，参与者对包括普兰林肽在内的研究治疗方案在“血糖控制”、“饮食-体重控制”和“总体益处”方面的评分均显著（p<0.001）高于其研究前的治疗方案。对6个月时治疗满意度的回归分析显示了几个独立预测因素（p<0.05）。能够按照方案达到普兰林肽最大剂量的参与者，以及在研究期间PPG和胰岛素需求量降低更多的参与者，对血糖控制和总体益处的满意度更高；体重减轻更多的参与者在所有三次TSQ测量中对治疗的满意度更高。
在所有三次TSQ评估中，所有治疗满意度因素对研究方案的满意度均更高，所有优势均代表较大的治疗效果。临床结局（体重、胰岛素剂量需求和PPG水平降低）更好的患者治疗满意度更高。研究局限性包括这是一项开放标签研究这一事实。
