Danielsson A, Ek B, Nyhlin H, Steen L
Ann Clin Res. 1980 Feb;12(1):4-12.
Fifty patients with active peptic ulcers on endoscopy were randomly allocated for treatment with placebo or cimetidine (1.0 g daily) over a period of four weeks. All patients had free access to antacids to relieve epigastric pain. In the cimetidine group a significantly higher proportion of the ulcers had healed (82.6% of the patients) compared with the placebo group (48.0%). There was poor correlation between the healing of the ulcer and dyspeptic symptoms in the placebo group. The results suggest that the presence of endoscopic duodenitis is to a great extent responsible for the dyspepsia. Cimetidine treatment, besides healing the ulcers, also improved the endoscopic duodenitis and the symptomatic state more than placebo treatment. No significant clinical side effects were observed. Chemical abnormalities were only noted with respect to serum creatinine. In the cimetidine group there was a statistically significant rise in serum creatinine, which was most apparent after two weeks of treatment. However, the increase was slight and not significant among the males, whereas in the case of the females there was a large and highly significant rise. The reason for this sex difference is at present unknown.
五十例经内镜检查确诊为活动性消化性溃疡的患者被随机分为两组,分别接受为期四周的安慰剂治疗或西咪替丁治疗(每日1.0克)。所有患者均可自由使用抗酸剂以缓解上腹部疼痛。与安慰剂组(48.0%)相比,西咪替丁组溃疡愈合的患者比例显著更高(82.6%)。在安慰剂组中,溃疡愈合与消化不良症状之间的相关性较差。结果表明,内镜下十二指肠炎症在很大程度上是导致消化不良的原因。与安慰剂治疗相比,西咪替丁治疗除了能治愈溃疡外,还能更有效地改善内镜下十二指肠炎症和症状状态。未观察到明显的临床副作用。仅在血清肌酐方面发现了化学异常。在西咪替丁组中,血清肌酐有统计学意义的升高,在治疗两周后最为明显。然而,这种升高在男性中轻微且无统计学意义,而在女性中则有大幅且高度显著的升高。目前尚不清楚这种性别差异的原因。