Sontag S, Graham D Y, Belsito A, Weiss J, Farley A, Grunt R, Cohen N, Kinnear D, Davis W, Archambault A
N Engl J Med. 1984 Sep 13;311(11):689-93. doi: 10.1056/NEJM198409133111101.
Three hundred seventy patients with recently healed duodenal ulcer entered into a one-year, double-blind, randomized multicenter trial comparing placebo with three different dose schedules of cimetidine (200 mg twice a day, 300 mg twice a day, and 400 mg at bedtime) for the prevention of recurrent duodenal ulcer. By the end of one year, the cumulative symptomatic recurrence rate as demonstrated by endoscopy was similar for the patients receiving the three dosages of cimetidine (19 per cent, 15 per cent, and 13 per cent, respectively; not significant), whereas the placebo-treated group had a 34.7 per cent symptomatic recurrence rate (P less than 0.01 as compared with each cimetidine group). Cigarette smoking was found to be an important variable; among the placebo recipients ulcer recurrence was significantly more likely in smokers (72 per cent) than in nonsmokers (21 per cent, P less than 0.001). The frequency of ulcer recurrence in smokers was significantly reduced by treatment with cimetidine (from 72 per cent to 34 per cent, P less than 0.). Smokers who received cimetidine were at least as likely to have a recurrence as were nonsmokers who received placebo (34 per cent vs. 21 per cent, not significant). Thus, smoking appears to be a major factor in recurrence of duodenal ulcer, and in smokers, giving up smoking may be more important in the prevention of ulcer recurrences than administration of cimetidine.
370例近期十二指肠溃疡已愈合的患者进入了一项为期一年的双盲随机多中心试验,该试验比较了安慰剂与西咪替丁三种不同剂量方案(每日两次,每次200毫克;每日两次,每次300毫克;睡前400毫克)预防十二指肠溃疡复发的效果。到一年结束时,接受三种剂量西咪替丁治疗的患者经内镜检查显示的累积症状复发率相似(分别为19%、15%和13%,无显著差异),而接受安慰剂治疗的组症状复发率为34.7%(与各西咪替丁组相比,P<0.01)。发现吸烟是一个重要变量;在接受安慰剂的患者中,吸烟者溃疡复发的可能性显著高于不吸烟者(72%对21%,P<0.001)。西咪替丁治疗可显著降低吸烟者溃疡复发的频率(从72%降至34%,P<0.05)。接受西咪替丁治疗的吸烟者复发的可能性至少与接受安慰剂的不吸烟者相同(34%对21%,无显著差异)。因此,吸烟似乎是十二指肠溃疡复发的一个主要因素,对于吸烟者来说,戒烟在预防溃疡复发方面可能比服用西咪替丁更重要。