Sun H S, Choi K W, Yoon C M, Park K N, Min Y I, Lee S I, Chung J M, Yang U S
Catholic University, Seoul, Korea.
J Gastroenterol Hepatol. 1989;4 Suppl 2:69-74.
The healing efficacy of omeprazole was assessed in 57 Korean patients with endoscopically-proven gastric (GU) and/or prepyloric (PPU) ulcers of at least 5 mm diameter. Fifty-three patients presented with GU, two with PPU and two with both types of ulcer. The maximum ulcer diameter was 5-10 mm in 27 patients and greater than 10 mm in 30 patients. All patients received 20 mg of omeprazole each morning for 4-8 weeks depending on ulcer healing. Ulcer healing rates were comparable using both 'intention to treat' (IT) and 'per protocol' (PP) analyses. Following the IT approach 82% (47 of 57) of patients were healed at 4 weeks and 98% (56 of 57) at 8 weeks. Following the PP approach, the corresponding healing rates were 83% (44 of 53) and 98% (55 of 56), respectively. Smoking was found to have a significant effect on ulcer healing at 4 weeks (P = 0.03), with 96% (26 of 27) of non/occasional smokers healed versus only 69% (18 of 26) of daily/heavy smokers. Ulcer size did not have a significant effect on healing, however. Ulcer symptoms, reported by all patients at entry, disappeared rapidly after commencement of omeprazole therapy. Only four patients reported mild symptoms at 4 weeks and no symptoms were reported at 8 weeks. No clinically significant changes in haematology or clinical chemistry (other than a rise in leucocytes in one patient) and no serious adverse events were observed. In conclusion, omeprazole 20 mg each morning was found to be safe and highly effective for treatment of gastric and prepyloric ulcer in Korean patients, producing a 98% healing rate. Symptom relief was rapid and the drug was well tolerated.
在57例经内镜证实患有直径至少5毫米的胃溃疡（GU）和/或幽门管溃疡（PPU）的韩国患者中评估了奥美拉唑的愈合疗效。53例患者患有GU，2例患有PPU，2例同时患有两种类型的溃疡。27例患者的最大溃疡直径为5 - 10毫米，30例患者的最大溃疡直径大于10毫米。所有患者根据溃疡愈合情况，每天早晨服用20毫克奥美拉唑，疗程为4 - 8周。采用“意向性治疗”（IT）和“符合方案”（PP）分析，溃疡愈合率相当。按照IT方法，82%（57例中的47例）的患者在4周时愈合，98%（57例中的56例）在8周时愈合。按照PP方法，相应的愈合率分别为83%（53例中的44例）和98%（56例中的55例）。发现吸烟对4周时的溃疡愈合有显著影响（P = 0.03），96%（27例中的26例）的非/偶尔吸烟者愈合，而每日/重度吸烟者中只有69%（26例中的18例）愈合。然而，溃疡大小对愈合没有显著影响。所有患者在入组时报告的溃疡症状在开始使用奥美拉唑治疗后迅速消失。只有4例患者在4周时报告有轻微症状，8周时未报告有症状。未观察到血液学或临床化学方面有临床意义的变化（除1例患者白细胞升高外），也未观察到严重不良事件。总之，发现每天早晨服用20毫克奥美拉唑对韩国患者的胃溃疡和幽门管溃疡治疗安全且高效，愈合率达98%。症状缓解迅速，药物耐受性良好。
