Pfizer, Inc., New London, CT, USA Pfizer, Inc., New York, NY, USA.
Pain. 2010 May;149(2):194-201. doi: 10.1016/j.pain.2009.09.017. Epub 2010 Mar 19.
The current analysis compares changes in pain with changes in function and health status in individuals with painful diabetic peripheral neuropathy (DPN). The post hoc analysis is based on a 12week, multinational, placebo-controlled trial of pregabalin in which 401 patients were randomized to treatment. Study measures included the Brief Pain Inventory short-form (BPI-sf), EQ-5D and other patient-reported outcomes. Cutpoints were derived on the BPI-sf 0-10 average pain numeric rating scale [NRS] to classify pain grades of "mild" (1-3), moderate (4-6) and severe (7-10), adjusting for geographical regions where data were collected. Two different metrics were used to classify the importance of change in pain severity from baseline to 12weeks: changes in pain severity grades (defined by cutpoint categories) and percent reduction in the NRS (categories ranging from 0-9% to 50%). An improvement in one pain grade or a 30% reduction in the NRS served as determinants of a clinically important difference. Patients with a one-grade reduction in pain severity, either from "severe-to-moderate" or "moderate-to-mild," had a 3-point improvement the BPI-sf Pain Interference Index (PII; a composite measure of function); a reduction from "severe-to-mild" pain corresponded to a 6-point improvement in the PII. Similarly, a reduction in the NRS of 30% and 50% corresponded to a 3-point and a 5-point improvement in the PII, respectively. Changes in pain were also associated with changes in health status. Results suggest that patients whose pain is not reduced to a mild level of severity can still experience clinically important changes in function and health status.
当前的分析比较了患有痛性糖尿病周围神经病变(DPN)的个体中疼痛变化与功能和健康状况变化的关系。这一事后分析基于一项为期 12 周的、多国家参与的、普瑞巴林的安慰剂对照试验,该试验共纳入了 401 名患者。研究的评估指标包括简短疼痛量表简表(BPI-sf)、EQ-5D 和其他患者报告的结局。BPI-sf 0-10 平均疼痛数字评分量表(NRS)的切点是基于疼痛分级来定义的,分为“轻度”(1-3)、“中度”(4-6)和“重度”(7-10),并根据数据收集的地理位置进行了调整。使用了两种不同的指标来分类从基线到 12 周时疼痛严重程度的变化:疼痛严重程度分级的变化(通过切点类别定义)和 NRS 的百分比降低(类别范围从 0-9%至 50%)。疼痛严重程度改善一级或 NRS 降低 30%被定义为具有临床意义的差异。疼痛严重程度从“重度到中度”或“中度到轻度”降低一级的患者,BPI-sf 疼痛干扰指数(PII;功能的综合测量)会提高 3 分;从“重度”降到“轻度”的疼痛对应着 PII 提高 6 分。同样,NRS 降低 30%和 50%分别对应着 PII 提高 3 分和 5 分。疼痛的变化也与健康状况的变化相关。结果表明,疼痛未减轻至轻度严重程度的患者仍可能经历功能和健康状况的具有临床意义的变化。