Background and objective

Beyond its application for diagnostics in patients, esophagogastroduodenoscopy (EGD) is used to assess gastrointestinal drug effects in clinical trials, where the interpretation of any pathological findings depends on the respective background variability. The objective of this analysis was to characterize the occurrence of pathological findings in the upper gastrointestinal tract in symptom-free healthy individuals.

Methods

A baseline EGD was performed in clinically healthy individuals in three clinical trials aimed to assess gastrointestinal tolerability of drugs. Pathological findings were described by type (redness, erosion, ulcer or other), number, size and location, and by clinical relevance as assessed by the endoscopist. Characteristics of volunteers were tested as potential covariates.

Results

A total of 294 EGDs were assessed. Characteristics of individuals were as follows: 257 (87.4%) males, age (mean ± SD) 32.0 ± 8.1 years, body weight 76.0 ± 10.6 kg, body mass index (BMI) 24.0 ± 2.5 kg/m², 200 consumed alcohol, 250 (of 290 where this information was available) consumed caffeine and 39 (of 152) were smokers, 30 (of 151) tested positive for H. pylori. Any pathological finding was present in 79.6%. Clinically relevant findings occurred in 44.2%, mainly erosions (39.1%). Nine stomach ulcers were observed. Only age and BMI had a statistically significant relationship to overall pathological findings [age 3.4 years higher (p = 0.027), and BMI 1.6 kg/m² higher (p < 0.001); for clinically relevant vs no findings].

Conclusion

Upper gastrointestinal tract mucosal lesions, including those assessed as clinically relevant, are frequent in clinically healthy individuals, impeding the assessment of causality for both disease and drug effects on gastrointestinal health.

中文翻译：

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临床健康个体病理性上消化道内窥镜检查结果的频率和类型。

背景和目标

除了用于患者诊断之外，食管胃十二指肠镜检查（EGD）还用于评估临床试验中的胃肠道药物效应，其中对任何病理结果的解释取决于各自的背景变异性。该分析的目的是表征无症状健康个体上胃肠道病理结果的发生情况。

方法

在三项旨在评估药物胃肠道耐受性的临床试验中，对临床健康个体进行了基线 EGD。病理结果通过类型（发红、糜烂、溃疡或其他）、数量、大小和位置以及内窥镜医师评估的临床相关性进行描述。志愿者的特征作为潜在的协变量进行了测试。

结果

总共评估了 294 个 EGD。个体特征如下：257名（87.4％）男性，年龄（平均值±标准差）32.0±8.1岁，体重76.0±10.6公斤，体重指数（BMI）24.0±2.5公斤/米2，饮酒200^人， 250 人（在可获得此信息的 290 人中）摄入了咖啡因，39 人（在 152 人中）吸烟，30 人（在 151 人中）幽门螺杆菌检测呈阳性。79.6% 存在任何病理发现。44.2% 发生临床相关发现，主要是糜烂 (39.1%)。观察到九个胃溃疡。只有年龄和BMI与总体病理结果有统计学上的显着关系[年龄高3.4岁( p  = 0.027)，BMI高1.6 kg/m ^{2 (} p  < 0.001)；临床相关与无发现]。

结论

上胃肠道粘膜病变，包括那些被评估为临床相关的病变，在临床健康个体中很常见，这阻碍了疾病因果关系和药物对胃肠道健康影响的评估。