Lauritsen K, Rune S J, Bytzer P, Kelbaek H, Jensen K G, Rask-Madsen J, Bendtsen F, Linde J, Højlund M, Andersen H H
N Engl J Med. 1985 Apr 11;312(15):958-61. doi: 10.1056/NEJM198504113121505.
We conducted a double-blind randomized study of 132 patients to determine whether the new, investigational proton-pump inhibitor, omeprazole (30 mg per day), would accelerate healing and pain relief, as compared with cimetidine (1 g per day), in patients with duodenal ulcer. After two weeks of treatment, which was completed by all patients, the healing rates were 73 per cent in the omeprazole group and 46 per cent in the cimetidine group (P less than 0.01). After four weeks of treatment, which was completed by 118 patients, the corresponding figures were 92 and 74 per cent (P less than 0.05). In the omeprazole group 55 per cent of the patients were free of pain after the first week, as compared with 40 per cent of those treated with cimetidine (P greater than 0.05). No major clinical or biochemical side effects of omeprazole or cimetidine were noted. A six-month follow-up study revealed no significant difference between the recurrence rates after omeprazole and after cimetidine treatment. In May 1984 clinical trials with omeprazole were temporarily suspended, since a study of long-term toxicity in rats had shown the development of gastric carcinoid tumors.
我们对132例十二指肠溃疡患者进行了一项双盲随机研究，以确定新型试验性质子泵抑制剂奥美拉唑（每日30毫克）与西咪替丁（每日1克）相比，是否能加速溃疡愈合并缓解疼痛。在所有患者均完成的两周治疗后，奥美拉唑组的愈合率为73%，西咪替丁组为46%（P<0.01）。在118例患者完成的四周治疗后，相应数字分别为92%和74%（P<0.05）。奥美拉唑组在第一周后55%的患者疼痛消失，而西咪替丁治疗组为40%（P>0.05）。未观察到奥美拉唑或西咪替丁有重大临床或生化副作用。一项为期六个月的随访研究显示，奥美拉唑治疗后与西咪替丁治疗后的复发率无显著差异。1984年5月，奥美拉唑的临床试验暂时中止，因为一项对大鼠的长期毒性研究显示出现了胃类癌肿瘤。
