Kleveland P M, Larsen S, Sandvik L, Kristensen P, Johannessen T, Hafstad P E, Sandbakken P, Løge I, Fjøsne U, Petersen H
Scand J Gastroenterol. 1985 Jan;20(1):19-24. doi: 10.3109/00365528509089627.
The symptomatic effect of cimetidine was examined in 27 patients with non-ulcer dyspepsia (NUD) by means of a multi-cross-over model (MCO model) for testing the symptomatic effect of drugs in individual patients. None of the patients showed an ulcer at the time, but 20 patients had evidence of previous peptic ulcer disease. The variant of the MCO model used included six treatment periods and three regular interchanges between cimetidine and placebo. Treatment periods lasted 2 or 4 days. The individual results were evaluated on the basis of the number of times (X score) cimetidine was associated with less symptoms than the preceding or following placebo. In general, cimetidine was associated with significantly (p less than 0.02) less symptoms than placebo. The X-score distribution was therefore skew in favour of high scores. Five patients showed the maximal X score of 5. The chance of getting an X score of 5 when cimetidine is not better than placebo is about 9%. Accordingly, the risk of being wrong when defining these five patients as cimetidine responders is 9%. The present study confirms that the MCO model may identify individual cimetidine responders among patients with NUD.
通过一种用于测试个体患者药物症状疗效的多交叉模型（MCO模型），对27例非溃疡性消化不良（NUD）患者西咪替丁的症状疗效进行了研究。当时所有患者均未出现溃疡，但有20例患者有既往消化性溃疡病史。所使用的MCO模型变体包括六个治疗期以及西咪替丁和安慰剂之间的三次常规交替。治疗期持续2天或4天。根据西咪替丁比前一次或后一次安慰剂症状更少的次数（X评分）来评估个体结果。总体而言，西咪替丁比安慰剂症状明显更少（p<0.02）。因此，X评分分布偏向高分。五名患者的X评分达到最大值5。当西咪替丁不比安慰剂更好时，获得X评分为5的概率约为9%。因此，将这五名患者定义为西咪替丁反应者时出错的风险为9%。本研究证实，MCO模型可在NUD患者中识别出个体西咪替丁反应者。
