Johannessen T, Fjøsne U, Kleveland P M, Halvorsen T, Kristensen P, Løge I, Hafstad P E, Sandbakken P, Petersen H
Dept. of Medicine, Trondheim Regional and University Hospital, Norway.
Scand J Gastroenterol. 1988 Apr;23(3):327-36. doi: 10.3109/00365528809093874.
The effect of cimetidine and placebo was examined in 123 patients with non-ulcer dyspepsia (NUD) by means of a 12-day multi-crossover model with 5 regular interchanges between cimetidine and placebo. The evaluation of effect in individual patients was based on the number of times cimetidine was associated with less symptoms than the preceding or following placebo period. If cimetidine had no effect, the probability of being defined as a cimetidine responder was 25%. In general, cimetidine was associated with less symptoms than placebo (p less than 0.0001). Forty patients were identified as cimetidine responders (R) and the remaining patients were termed non-responders (NR). Symptoms compatible with gastroesophageal reflux were significantly more frequent in R than in NR, whereas the opposite was true for symptoms of the irritable colon syndrome. The ability of symptoms selected by stepwise logistic regression to predict response to cimetidine showed at best a sensitivity of 75% and a specificity of about 65%. No differences were found between R and NR with regard to acid secretion, endoscopic and histologic findings, or the result of an acid perfusion test. The present study supports the existence of a subgroup of cimetidine responders among patients with NUD characterized by symptoms suggestive of gastroesophageal reflux disease in the absence of confirmatory objective evidence.
采用12天多交叉模型,在西咪替丁和安慰剂之间进行5次常规交替,对123例非溃疡性消化不良(NUD)患者研究了西咪替丁和安慰剂的效果。对个体患者效果的评估基于西咪替丁与安慰剂前一阶段或后一阶段相比症状减轻次数。如果西咪替丁无效,被定义为西咪替丁反应者的概率为25%。总体而言,西咪替丁与比安慰剂更少的症状相关(p<0.0001)。40例患者被确定为西咪替丁反应者(R),其余患者称为无反应者(NR)。与胃食管反流相符的症状在R组比NR组明显更常见,而肠易激综合征症状则相反。逐步逻辑回归选择的症状预测西咪替丁反应的能力,敏感性最高为75%,特异性约为65%。在酸分泌、内镜和组织学检查结果或酸灌注试验结果方面,R组和NR组之间未发现差异。本研究支持在无客观证据证实的情况下,以提示胃食管反流病症状为特征的NUD患者中存在西咪替丁反应者亚组。