A randomized study of maintenance therapy with ranitidine to prevent the recurrence of duodenal ulcer.
A randomized study of maintenance therapy with ranitidine to prevent the recurrence of duodenal ulcer.
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雷尼替丁维持治疗预防十二指肠溃疡复发的随机研究。
DOI：
10.1056/nejm198904273201704
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发表时间：
1989
期刊：
影响因子：
--
通讯作者：
Walsh,JH
中科院分区：
文献类型：
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作者：
VanDeventer,GM;Elashoff,JD;Reedy,TJ;Schneidman,D;Walsh,JH
活动性十二指肠溃疡经药物治疗痊愈后，第二年的复发率相对较高。因此，我们招募了140名十二指肠溃疡痊愈患者，进行为期两年的随机双盲试验，比较维持性治疗(雷尼替丁，每晚150毫克)和安慰剂预防十二指肠溃疡复发的效果。我们每年进行内窥镜检查，当症状提示溃疡复发时。经验证，两组中的两组复发性溃疡都接受了开放标签雷尼替丁(150 mg，每天两次)治疗4或8周。溃疡在8周内愈合的患者恢复随机治疗。雷尼替丁预防治疗将溃疡复发率从安慰剂组的63%降低到雷尼替丁组的37%(P<；0.05)。雷尼替丁治疗将中位无溃疡间隔时间从一年延长至两年(P<；0.05)。一半的雷尼替丁组和四分之一的安慰剂组的首次溃疡复发是无症状的。雷尼替丁的预防治疗还将复发溃疡的发生率从安慰剂组的43%降低到21%，这些溃疡在八周内未愈合，正在出血，在胃内，或者在六个月内第二次复发溃疡。在进入研究时饮酒、吸烟、有溃疡病史或十二指肠瘢痕或糜烂的患者复发风险最大，预防性服用雷尼替丁获益最多。我们得出结论，雷尼替丁预防性治疗在预防十二指肠溃疡复发方面是有效的。(N Engl J Med 1989；320：1113-9)
After an active duodenal ulcer has healed in response to medical therapy, the rate of recurrence during the subsequent year is relatively high. We therefore enrolled 140 patients with healed duodenal ulcers in a two-year randomized, double-blind trial comparing maintenance therapy (ranitidine, 150 mg nightly) with placebo for the prevention of recurrent duodenal ulceration. We performed endoscopy annually and when symptoms suggested the recurrence of ulcers. Verified recurrent ulcers in either group were treated for four or eight weeks with open-label ranitidine (150 mg twice a day). Patients whose ulcers healed within eight weeks resumed randomized treatment.Prophylactic therapy with ranitidine reduced the rate of ulcer relapses from 63 percent in the placebo group to 37 percent in the ranitidine group (P<0.05). Treatment with ranitidine extended the median ulcer-free interval from one to two years (P<0.05). The first recurrences of ulcer were asymptomatic in half the ranitidine group and in a quarter of the placebo group. Prophylactic therapy with ranitidine also reduced the frequency of recurrent ulcers that were unhealed by eight weeks, that were bleeding, that were in the stomach, or that were the second recurrent ulcer within six months, from 43 percent in the placebo group to 21 percent. Patients who drank alcohol, smoked, had a history of ulcer disease, or had duodenal scarring or erosion at the time of entry into the study were at the greatest risk for recurrence and benefited the most from prophylactic ranitidine.We conclude that prophylactic treatment with ranitidine is effective in preventing the recurrence of duodenal ulceration. (N Engl J Med 1989; 320:1113–9.)