Johannessen T, Petersen H, Kristensen P, Kleveland P M, Dybdahl J, Sandvik A K, Brenna E, Waldum H
Department of Community Medicine and General Practice, University of Trondheim, Norway.
Scand J Prim Health Care. 1993 Mar;11(1):50-5. doi: 10.3109/02813439308994902.
During the waiting time for upper gastrointestinal endoscopy 165 patients with dyspepsia completed a questionnaire and a diary for daily measurements of the symptoms pain, heartburn, and global complaints. 23 patients (14%) had peptic ulcer disease (PUD), 18 oesophagitis (11%), and the rest were labelled nonulcer dyspepsia (NUD). NUD was further subdivided into ulcer-like, reflux-like, dysmotility, and essential NUD by means of predefined symptom profiles. 39 (24%) patients were on H2 receptor antagonist treatment. In general, the intensity of the daily symptoms was rather low, and except for a higher rating of heartburn in oesophagitis, there were no significant differences between PUD, oesophagitis, and NUD--treated or untreated. NUD patients with reflux-like dyspepsia had significantly more heartburn than the group with essential NUD; otherwise there were no differences between the subgroups of NUD. The individual daily ratings for abdominal pain, heartburn, and global symptoms varied by an average standard deviation of 64%, 97% and 47% of the mean values, respectively, and were independent of treatment or diagnoses. There was an approximately 40% probability that two successive days had different levels of symptoms. Only 10% of the patients showed stable symptoms, and the patients were completely symptom-free for 20% of the observation period. Symptoms in dyspepsia patients disclosed low intensity and high variability in this study. Such factors may be important sources of bias in clinical trials.
在上消化道内镜检查的等待期间,165例消化不良患者完成了一份问卷和一本日记,用于每日测量疼痛、烧心及整体不适等症状。23例患者(14%)患有消化性溃疡病(PUD),18例患有食管炎(11%),其余患者被诊断为非溃疡性消化不良(NUD)。NUD根据预先定义的症状特征进一步细分为溃疡样、反流样、动力障碍样和原发性NUD。39例(24%)患者正在接受H2受体拮抗剂治疗。总体而言,每日症状的强度较低,除食管炎患者的烧心评分较高外,PUD、食管炎和NUD患者(无论是否接受治疗)之间无显著差异。反流样消化不良的NUD患者烧心症状明显多于原发性NUD组;除此之外,NUD各亚组之间无差异。腹痛、烧心及整体症状的个体每日评分的平均标准差分别为平均值的64%、97%和47%,且与治疗或诊断无关。连续两天症状水平不同的概率约为40%。只有10%的患者症状稳定,在20%的观察期内患者完全无症状。本研究中,消化不良患者的症状强度较低且变异性较高。这些因素可能是临床试验中重要的偏倚来源。