Peura David A, Gudmundson Jeff, Siepman Nancy, Pilmer Betsy L, Freston James
University of Virginia Health Sciences Center, Charlottesville, VA 22908-0708, USA.
Dig Dis Sci. 2007 Apr;52(4):983-7. doi: 10.1007/s10620-006-9156-7. Epub 2007 Mar 7.
The aim of this study was to evaluate the reasons for trial exclusion among dyspeptic patients and estimate the proportion that may have benefited from proton pump inhibitor (PPI) therapy. Stringent inclusion criteria for enrollment in two multicenter functional dyspepsia trials included dyspepsia (predominant persistent/recurrent upper abdominal discomfort [UAD] during the prior 3 months) of at least moderate intensity during > or =30% of days during the prior 2 to 3 weeks. Exclusion criteria were mild/infrequent UAD; heartburn and UAD of equal frequency; predominant heartburn with UAD; endoscopic evidence of erosive esophagitis or Barrett's or gastric and/or duodenal erosions (>5) or ulcers; irritable bowel syndrome (IBS); other gastrointestinal diagnoses; or other "non-categorized" disorders. Of 2,588 screened patients, 1,667 were excluded. Excluded patients by category had mild/infrequent UAD (12.5%, n=324), heartburn and UAD of equal frequency (1.1%, n=29), predominant heartburn with UAD (11.6%, n=300), endoscopic evidence of erosive esophagitis or Barrett's (6.2%, n=160), gastric and/or duodenal erosions (1.4%, n=36), gastric and/or duodenal ulcers (2.0%, n=53), IBS (7%, n=180), "other" gastrointestinal diagnoses (2.8%, n=73), or other "non-categorized" disorders (19.8%, n=512). Fifty-four percent of patients (902/1,667) had symptoms/diagnoses that would be expected to improve with PPI therapy. Individuals with IBS, "other," or "non-categorized" disorders were considered to have symptoms unlikely to respond to PPI treatment. Empiric PPI treatment would be expected to provide symptom relief to the majority of dyspepsia sufferer who present in clinical practice. PPIs represent the best currently available therapy for acid-related disorders and should be considered the first-line management approach in patients with uninvestigated dyspepsia.
本研究的目的是评估消化不良患者试验排除的原因，并估计可能从质子泵抑制剂（PPI）治疗中获益的比例。两项多中心功能性消化不良试验严格的入组标准包括在之前2至3周内至少30%的天数里存在至少中度强度的消化不良（在前3个月内主要为持续性/复发性上腹部不适[UAD]）。排除标准为轻度/不频繁的UAD；烧心和UAD频率相同；以烧心为主伴有UAD；内镜检查有糜烂性食管炎或巴雷特食管或胃和/或十二指肠糜烂（>5处）或溃疡的证据；肠易激综合征（IBS）；其他胃肠道诊断；或其他“未分类”疾病。在2588名筛查患者中，1667名被排除。按类别排除的患者有轻度/不频繁的UAD（12.5%，n = 324）、烧心和UAD频率相同（1.1%，n = 29）、以烧心为主伴有UAD（11.6%，n = 300）、内镜检查有糜烂性食管炎或巴雷特食管的证据（6.2%，n = 160）、胃和/或十二指肠糜烂（1.4%，n = 36）、胃和/或十二指肠溃疡（2.0%，n = 53）、IBS（7%，n = 180）、“其他”胃肠道诊断（2.8%，n = 73）或其他“未分类”疾病（19.8%，n = 512）。54%的患者（902/1667）有预期会随PPI治疗改善的症状/诊断。患有IBS、“其他”或“未分类”疾病的个体被认为症状不太可能对PPI治疗有反应。经验性PPI治疗预期可为临床实践中出现的大多数消化不良患者缓解症状。PPI是目前治疗酸相关疾病的最佳可用疗法，对于未经调查的消化不良患者应被视为一线治疗方法。
