Lauritsen K, Bytzer P, Hansen J, Bekker C, Rask-Madsen J
Scand J Gastroenterol. 1985 Jan;20(1):123-8. doi: 10.3109/00365528509089643.
One hundred and nineteen patients with endoscopically confirmed prepyloric (n = 59) or duodenal (n = 60) ulcer were stratified for ulcer location before entering a randomized double-blind trial comparing ranitidine (150 mg twice daily) and a potent liquid antacid (Novaluzid; 10 ml seven times daily, with a neutralizing capacity of 600 mmol H+). Fifty-four patients with prepyloric (26 receiving ranitidine) and 53 patients with duodenal ulcer (28 receiving ranitidine) completed the trial in accordance with the protocol. The 4 and 6 weeks' healing rates for prepyloric ulcers were 54%, 68%, and 61%, versus 69%, 79%, and 74% for the ranitidine, the antacid, and whole groups, respectively. For duodenal ulcers these figures were 89%, 84%, and 87%, versus 100%, 96%, and 98% for the ranitidine, antacid, and whole groups, respectively. Differences in healing rates between treatments were statistically insignificant within strata for ulcer type, but healing rates for prepyloric ulcers were significantly lower than for duodenal ulcers (p less than 0.002). A significant early pain relief was found in all groups, and side effects, including diarrhoea, were rare. In conclusion, these two ulcer treatment modalities appear to be equally effective in the short term. In addition, the data emphasize the need for proper stratification of prepyloric and duodenal ulcers in clinical trials of ulcer healing.
119例经内镜确诊为幽门管（n = 59）或十二指肠（n = 60）溃疡的患者，在进入一项比较雷尼替丁（每日2次，每次150 mg）和一种强效液体抗酸剂（诺瓦鲁西德；每日7次，每次10 ml，中和能力为600 mmol H⁺）的随机双盲试验之前，根据溃疡部位进行了分层。54例幽门管溃疡患者（26例接受雷尼替丁治疗）和53例十二指肠溃疡患者（28例接受雷尼替丁治疗）按照方案完成了试验。幽门管溃疡4周和6周的愈合率分别为54%、68%和61%，而雷尼替丁组、抗酸剂组和全组分别为69%、79%和74%。十二指肠溃疡的这些数字分别为89%、84%和87%，而雷尼替丁组、抗酸剂组和全组分别为100%、96%和98%。各治疗组之间的愈合率差异在溃疡类型分层内无统计学意义，但幽门管溃疡的愈合率显著低于十二指肠溃疡（p＜0.002）。所有组均发现有显著的早期疼痛缓解，包括腹泻在内的副作用很少见。总之，这两种溃疡治疗方式在短期内似乎同样有效。此外，数据强调在溃疡愈合的临床试验中对幽门管和十二指肠溃疡进行适当分层的必要性。
