Hirschowitz B I
J Clin Gastroenterol. 1983;5 Suppl 1:115-22. doi: 10.1097/00004836-198312001-00011.
In duodenal ulcer, acid and pepsin in greater amounts and at higher concentration enter the duodenum and specific treatment should be directed towards correcting this abnormality. Such treatment is provided by the histamine H2-receptor antagonists. We discuss the first U.S. multicenter trial of the new nitrofuran-based antagonist, ranitidine, in which 382 patients were treated for 4 weeks with either ranitidine 150mg b.i.d. (195 pts.) or placebo (187); both groups were allowed to use antacid for pain. Those treated with ranitidine had significantly less pain and used less antacids than the placebo-treated patients; after 2 weeks, 37% vs 19% were healed, and after 4 weeks, 73% vs 45% were healed (p less than 0.01). After 4 weeks, 124 unhealed patients were randomized to ranitidine vs placebo for another 4 weeks. Ranitidine treatment again produced a greater healing rate (p less than 0.01), regardless of prior treatment. The 3 subsets of the data which contained more than 34 patients were analyzed separately. Each showed 1 or more significant deviations (type I and type II errors) from the overall study, which was in all respects similar to the aggregate results of all similar studies overseas. We emphasize the need for studies of adequate size.
在十二指肠溃疡中，大量且高浓度的胃酸和胃蛋白酶进入十二指肠，因此应针对纠正这种异常情况进行特异性治疗。组胺H2受体拮抗剂可提供此类治疗。我们讨论了新型硝基呋喃类拮抗剂雷尼替丁在美国进行的首个多中心试验，该试验中382例患者接受了为期4周的治疗，其中195例患者每日两次服用150mg雷尼替丁，187例患者服用安慰剂；两组患者均可使用抗酸剂缓解疼痛。与服用安慰剂的患者相比，服用雷尼替丁的患者疼痛明显减轻，抗酸剂使用量也更少；2周后，愈合率分别为37%和19%，4周后，愈合率分别为73%和45%（p<0.01）。4周后，124例未愈合的患者被随机分为雷尼替丁组和安慰剂组，再进行4周治疗。无论之前的治疗情况如何，雷尼替丁治疗再次产生了更高的愈合率（p<0.01）。对数据中包含超过34例患者的3个亚组分别进行了分析。每个亚组均显示出与总体研究存在1个或更多显著偏差（I型和II型错误），总体研究在各方面均与海外所有类似研究的汇总结果相似。我们强调进行足够规模研究的必要性。
