Pfizer Inc, New York, N Y.
Diabetes Metab Syndr Obes. 2013;6:79-92. doi: 10.2147/DMSO.S37415. Epub 2013 Feb 8.
The purpose of this study was to characterize the burden of illness among adult subjects with painful diabetic peripheral neuropathy (pDPN) seeking treatment in the US.
This observational study recruited 112 subjects with pDPN during routine visits from general practitioner and specialist sites. Subjects completed a one-time questionnaire, which included demographics, symptom duration, health care resource use, out-of-pocket costs, employment status, and validated measures that assessed pain, functioning, sleep, anxiety and depression, health status, and productivity. Investigators completed a case report form based on a 6-month retrospective chart review to capture clinical information, pDPN-related treatments, and other pDPN-related health care resource use over the past 6 months. Annualized costs were extrapolated based on reported 6-month health care resource use.
The mean age of the subjects was 61.1 years, 52.7% were female, and 17.9% were in paid employment. The most common comorbid conditions were sleep disturbance/insomnia (43.8%), depressive symptoms (41.1%), and anxiety (35.7%). The mean pain severity score was 5.2 (0-10 scale), and 79.5% reported moderate or severe pain. The mean pain interference with function score was 5.0 (0-10 scale) overall, with 2.0 among mild, 5.1 among moderate, and 7.0 among severe. The mean Medical Outcomes Study sleep problems index score was 48.5 (0-100 scale). The mean health state utility score was 0.61. Among subjects employed for pay, mean overall work impairment was 43.6%. Across all subjects, mean overall activity impairment was 52.3%. In total, 81.3% were prescribed at least one medication for their pDPN; 50.9% reported taking at least one nonprescription medication. Adjusted mean annualized total direct and indirect costs per subject were $4841 and $9730, respectively. Outcomes related to pain interference with function, sleep, health status, activity impairment, prescription medication use, and direct and indirect costs were significantly worse among subjects with more severe pain (P < 0.0020).
Subjects with pDPN exhibited high pain levels, which were associated with poor sleep, function, and productivity. Health care resource utilization in pDPN was prevalent and costs increased with greater pain severity. The burden of pDPN was greater among subjects with greater pain severity.
本研究旨在描述寻求美国治疗的成年疼痛性糖尿病周围神经病变（pDPN）患者的疾病负担。
这项观察性研究从全科医生和专科医生处招募了 112 名患有 pDPN 的患者。患者完成了一次性问卷调查，其中包括人口统计学、症状持续时间、医疗资源使用、自付费用、就业状况以及评估疼痛、功能、睡眠、焦虑和抑郁、健康状况和生产力的经过验证的措施。调查员根据过去 6 个月的回顾性图表审查完成了病例报告表，以获取过去 6 个月内的临床信息、与 pDPN 相关的治疗以及其他与 pDPN 相关的医疗资源使用情况。根据报告的 6 个月医疗资源使用情况推断年度成本。
患者的平均年龄为 61.1 岁，52.7%为女性，17.9%有薪就业。最常见的合并症是睡眠障碍/失眠（43.8%）、抑郁症状（41.1%）和焦虑（35.7%）。平均疼痛严重程度评分为 5.2（0-10 分），79.5%报告中度或重度疼痛。总体而言，平均疼痛对功能的干扰评分为 5.0（0-10 分），轻度为 2.0，中度为 5.1，重度为 7.0。平均医疗结果研究睡眠问题指数评分为 48.5（0-100 分）。平均健康状态效用评分为 0.61。对于有薪就业的患者，总体工作障碍的平均程度为 43.6%。在所有患者中，总体活动障碍的平均程度为 52.3%。共有 81.3%的患者至少开具了一种治疗其 pDPN 的药物；50.9%的患者报告至少服用了一种非处方药物。每位患者的调整后平均年化直接和间接总成本分别为 4841 美元和 9730 美元。与疼痛对功能的干扰、睡眠、健康状况、活动障碍、处方药物使用以及直接和间接成本相关的结果在疼痛程度更严重的患者中明显更差（P < 0.0020）。
患有 pDPN 的患者表现出较高的疼痛水平，这与睡眠不佳、功能和生产力低下有关。pDPN 的医疗资源利用普遍存在，疼痛程度增加导致成本增加。疼痛程度更严重的患者的 pDPN 负担更大。
