Jorde R, Burhol P G, Hansen T
Gut. 1987 Apr;28(4):460-3. doi: 10.1136/gut.28.4.460.
After healing of a gastric ulcer, 53 patients were randomly allocated to either 12 months maintenance treatment with ranitidine 150 mg at night or an identical placebo. Fifty patients completed the trial. The patients were interviewed every third month. If symptoms indicated a relapse, endoscopy was done; and if an ulcer was found the maintenance trial was terminated. All remaining patients were endoscoped after one year. The accumulated relapse rate in the ranitidine group (36%) was significantly lower (p less than 0.01) than in the placebo group (76%), as also was the antacid consumption (p less than 0.01). Four of the six ulcers found at the final one year endoscopy were asymptomatic. In all but two of the 26 patients with relapse of symptoms an ulcer was found at endoscopy. The patients that suffered a recurrence had significantly (p less than 0.05) higher maximal acid output than those without ulcer recurrence. The time needed for healing of the relapse ulcers (four or eight weeks) corresponded to that needed for healing of the preinclusion ulcers. It is concluded that ranitidine 150 mg at night significantly reduces the gastric ulcer recurrence rate, and that relapsing ulcers are similar to the initial ones in healing response.
胃溃疡愈合后,53例患者被随机分为两组,一组接受每晚150毫克雷尼替丁的12个月维持治疗,另一组接受相同的安慰剂。50例患者完成了试验。每三个月对患者进行一次访谈。如果出现症状提示复发,则进行内镜检查;如果发现溃疡,则终止维持治疗试验。所有剩余患者在一年后进行内镜检查。雷尼替丁组的累积复发率(36%)显著低于安慰剂组(76%)(p<0.01),抗酸剂的消耗量也是如此(p<0.01)。在最后一年的内镜检查中发现的6例溃疡中有4例无症状。在26例症状复发的患者中,除2例之外,其余患者在内镜检查中均发现溃疡。复发患者的最大酸排量显著高于未复发溃疡的患者(p<0.05)。复发溃疡愈合所需时间(4周或8周)与纳入前溃疡愈合所需时间相当。结论是,每晚150毫克雷尼替丁可显著降低胃溃疡复发率,复发溃疡的愈合反应与初始溃疡相似。