Bodemar G, Walan A
Lancet. 1978 Feb 25;1(8061):403-7. doi: 10.1016/s0140-6736(78)91200-x.
68 patients with chronic peptic ulcer took part in a double-blind trial in which 32 received the histamine H2-receptor antagonist cimetidine, (400 mg twice daily) and 36 received a placebo, for a year. 6 of those on cimetidine had an endoscopically proven recurrent ulcer within a mean of 7 months, while 30 of those on placebo had one after a mean of 4 months (P less than 0.0005). 1 patient on cimetidine had two recurrences compared with 12 patients on placebo (P less than 0.0005). No patient in the cimetidine group had complications compared to 4 patients in the placebo group, 2 of whom had melaena and haematemesis and 2 melaena alone (P less than 0.05). 15 patients on placebo and 1 on cimetidine were referred for surgery during the trial because of symptoms from their recurrent ulcers. Day and night ulcer pain and antacid consumption were significantly less, and general wellbeing better, in cimetidine group. The only probable side-effect of cimetidine was reversible drug-induced liver damage of hypersensitivity type in 1 patient.
68例慢性消化性溃疡患者参与了一项双盲试验,其中32例接受组胺H2受体拮抗剂西咪替丁(每日两次,每次400毫克)治疗,36例接受安慰剂治疗,为期一年。服用西咪替丁的患者中有6例在平均7个月内出现内镜证实的复发性溃疡,而服用安慰剂的患者中有30例在平均4个月后出现复发性溃疡(P<0.0005)。服用西咪替丁的患者中有1例出现两次复发,而服用安慰剂的患者中有12例出现两次复发(P<0.0005)。与安慰剂组的4例患者相比,西咪替丁组无患者出现并发症,安慰剂组的4例患者中,2例出现黑便和呕血,2例仅出现黑便(P<0.05)。在试验期间,15例服用安慰剂的患者和1例服用西咪替丁的患者因复发性溃疡症状而接受手术治疗。西咪替丁组的日夜溃疡疼痛和抗酸剂消耗量明显减少,总体健康状况更好。西咪替丁唯一可能的副作用是1例患者出现可逆性药物性超敏反应性肝损伤。