United BioSource Corporation, Bethesda, MD 20814, USA.
Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27.
Patient-reported symptom scales are needed to evaluate treatments for gastroparesis. The Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) was developed to assess daily symptoms of gastroparesis. This study evaluated the validity and responsiveness of the GCSI-DD in patients with gastroparesis.
Symptomatic patients were started with a new treatment for gastroparesis. Patients completed the GCSI-DD each evening during a baseline week and for 8 weeks of treatment. Responders were defined based on patient and clinician global rating of change. Minimal important differences (MID) were estimated based on baseline to 4 week changes in symptoms scores for small improvements.
Of 69 patients participating, 46 had idiopathic, 19 diabetic, and four postfundoplication gastroparesis. Excellent test-retest reliability was seen for GCSI-DD scores, and there were significant correlations between GCSI-DD scores and clinician ratings of symptom severity. Responders to treatment reported improvements in nausea [effect size (ES) = 0.42, P < 0.001], postprandial fullness, ES = 0.83, P < 0.001), bloating (ES = 0.34, P < 0.001), early satiety (ES = 0.53, P < 0.001), but lower responses for upper abdominal pain (ES = 0.29), and vomiting (ES = 0.22; P = 0.119). MIDs were 0.55 for nausea, 0.97 for excessive fullness, 0.63 for bloating, 0.77 for postprandial fullness, and 0.30 for abdominal pain. A composite score of four symptoms (Composite-1; nausea, bloating, excessive fullness, postprandial fullness) had ES of 0.61 and MID of 0.73. Composite-2 score (nausea, early satiety, bloating, abdominal pain) had a lower ES of 0.47.
CONCLUSIONS & INFERENCES: Symptoms of early satiety, nausea, postprandial fullness, and bloating were responsive to treatment for gastroparesis. A composite of these symptoms also demonstrates validity and responsiveness to treatment for gastroparesis, and may represent an acceptable endpoint for evaluating the effectiveness of medical treatments in clinical trials for gastroparesis.
需要患者报告的症状量表来评估胃轻瘫的治疗效果。为了评估胃轻瘫患者的日常症状，开发了胃轻瘫综合症状指数-日常日记（GCSI-DD）。本研究旨在评估 GCSI-DD 在胃轻瘫患者中的有效性和反应性。
出现症状的患者开始接受新的胃轻瘫治疗。患者在基线周的每个晚上以及治疗的 8 周内完成 GCSI-DD。根据患者和临床医生对治疗变化的总体评价，将应答者定义为治疗有效。基于症状评分在基线至 4 周内的变化，来估计最小有意义差异（MID），以评估较小改善的变化。
在 69 名参与的患者中，46 名患有特发性胃轻瘫，19 名患有糖尿病性胃轻瘫，4 名患有胃手术后胃轻瘫。GCSI-DD 评分具有极好的重测信度，且 GCSI-DD 评分与临床医生对症状严重程度的评分之间存在显著相关性。治疗应答者报告恶心症状有所改善[效应量（ES）=0.42，P＜0.001]，餐后饱胀感[ES=0.83，P＜0.001]、腹胀[ES=0.34，P＜0.001]、早饱[ES=0.53，P＜0.001]，而中上腹痛[ES=0.29]和呕吐[ES=0.22；P=0.119]的反应较低。恶心的 MID 为 0.55，过度饱胀的 MID 为 0.97，腹胀的 MID 为 0.63，餐后饱胀的 MID 为 0.77，腹痛的 MID 为 0.30。四项症状的综合评分（Composite-1；恶心、腹胀、过度饱胀、餐后饱胀）的 ES 为 0.61，MID 为 0.73。综合评分 2（恶心、早饱、腹胀、腹痛）的 ES 较低，为 0.47。
早饱、恶心、餐后饱胀和腹胀等症状对胃轻瘫的治疗有反应。这些症状的综合评分也表现出对胃轻瘫治疗的有效性和反应性，可能代表评估临床试验中胃轻瘫药物治疗效果的可接受终点。
