Institute of Cardiovascular and Medical Sciences, University of Glasgow, Gardiner Institute, Glasgow G11 6NT, UK.
Gut. 2011 Apr;60(4):442-8. doi: 10.1136/gut.2010.228064. Epub 2010 Dec 15.
In most patients undergoing endoscopy for upper gastrointestinal (GI) symptoms in the Western world, no macroscopic abnormality or evidence of Helicobacter pylori infection is identified. Following this negative investigation, proton pump inhibitor (PPI) therapy is usually prescribed. The aim of this study was to assess the value of such treatment compared with placebo and to identify predictors of response.
Prospective parallel randomised study.
Dyspepsia Research Clinic.
105 patients (49 men, median age 44 years, IQR 22) with normal endoscopy and H pylori negative with ongoing upper GI symptoms following 2-week run-in period. Intervention Full demographic symptom severity and characteristics were assessed and 24 h oesophageal pH metry and oesophageal manometry were performed prior to randomisation to 2 weeks of treatment with lansoprazole 30 mg/day or placebo (2:1), with reassessment of symptom severity during the second week of treatment.
50% reduction in Glasgow Dyspepsia Severity Score (GDSS).
According to intention to treat analysis, the response was 35.7% for the active group and 5.7% for the placebo group (p < 0001). The only non-invasive independent predictor of response to PPI in multivariable analysis was the patient's body mass index (BMI) (p = 0.003). The association of BMI with response to PPI was apparent across the full range of quartiles (p values for trend=0.01). BMI had a similar predictive value to either 24 h oesophageal pH metry or manometry. Predominant symptom and symptom subgroups were unhelpful in predicting the response to PPI. Including all pretreatment assessments, only BMI (p < 0.05) and lower oesophageal sphincter pressure (p < 0.05) were independent predictors of response.
The response to PPI therapy is likely to be related to underlying acid reflux. The strong predictive value of BMI is probably due to its association with underlying reflux disease and the fact that it is a more objective and reproducible measure than symptom characteristics. It is recommended that BMI should be measured in patients with upper GI symptoms. Trial Registration Number ISRCTN 32863375.
在大多数接受上消化道（GI）症状内镜检查的西方患者中，未发现宏观异常或幽门螺杆菌感染的证据。在进行了这种阴性检查后，通常会开具质子泵抑制剂（PPI）治疗。本研究的目的是评估这种治疗方法与安慰剂相比的价值，并确定反应的预测因素。
前瞻性平行随机研究。
消化不良研究诊所。
105 名患者（49 名男性，中位年龄 44 岁，IQR 22），在上消化道症状持续存在的情况下进行了 2 周的洗脱期后，进行了正常内镜检查和 H 螺杆菌阴性。干预措施 对所有患者进行全面的人口统计学症状严重程度和特征评估，并在随机分配至兰索拉唑 30mg/天或安慰剂（2:1）治疗 2 周之前，进行 24 小时食管 pH 测量和食管测压，在治疗的第二周评估症状严重程度。
格拉斯哥消化不良严重程度评分（GDSS）降低 50%。
根据意向治疗分析，活性组的反应率为 35.7%，安慰剂组为 5.7%（p<0.0001）。多变量分析中，预测 PPI 反应的唯一非侵入性独立预测因素是患者的体重指数（BMI）（p=0.003）。BMI 与 PPI 反应的关联在整个四分位数范围内均很明显（趋势检验 p 值=0.01）。BMI 对 24 小时食管 pH 测量或测压具有相似的预测价值。主要症状和症状亚组对 PPI 的反应无帮助。包括所有治疗前评估，只有 BMI（p<0.05）和食管下括约肌压力较低（p<0.05）是反应的独立预测因素。
PPI 治疗的反应可能与潜在的酸反流有关。BMI 的强烈预测价值可能归因于其与潜在反流性疾病的关联，以及它是一种比症状特征更客观和可重复的测量方法。建议在上消化道症状患者中测量 BMI。
ISRCTN32863375。
