Hentschel E, Schütze K, Reichel W, Kerstan E, Kratochvil P, Brandstätter G, Judmaier G, Keohane P P
First Medical Dept., Hanusch Krankenhaus, Vienna, Austria.
Scand J Gastroenterol Suppl. 1987;136:84-8. doi: 10.3109/00365528709094491.
Nizatidine, a new H2-receptor antagonist, was compared with ranitidine in a double-blind, randomized, multicentre trial for the prevention of duodenal ulcer relapse. This is the interim analysis of 197 patients admitted to the study by 1 September 1985, having finished a 6-month treatment period by 1 March 1986. At night, 96 and 101 patients received 150 mg nizatidine and 150 mg ranitidine, respectively. Both groups were well matched for demographic data, duration and severity of ulcer disease. Calculating cumulative relapse rates by the life-table method of Cutler and Ederer, 18% on nizatidine and 13% on ranitidine had experienced a symptomatic or asymptomatic recurrence. The difference is not statistically significant. The symptomatic response was identical in both groups, 3/4 of the patients in both groups being free of any symptom over all 6 months. During maintenance treatment, 24% of the patients on nizatidine and 32% of those on ranitidine reported new symptoms, listed as 'adverse events'. However, none of these events was likely to be drug related. There was no difference between the two groups concerning the percentage change of laboratory variables from baseline to endpoint.
新型H2受体拮抗剂尼扎替丁与雷尼替丁在一项预防十二指肠溃疡复发的双盲、随机、多中心试验中进行了比较。这是对截至1985年9月1日入组研究且截至1986年3月1日完成6个月治疗期的197例患者的中期分析。夜间，分别有96例和101例患者接受150mg尼扎替丁和150mg雷尼替丁治疗。两组在人口统计学数据、溃疡病病程和严重程度方面匹配良好。采用卡特勒和埃德勒的寿命表法计算累积复发率，接受尼扎替丁治疗的患者中有18%出现有症状或无症状复发，接受雷尼替丁治疗的患者中有13%出现复发。差异无统计学意义。两组的症状反应相同，两组中3/4的患者在整个6个月期间均无任何症状。在维持治疗期间，接受尼扎替丁治疗的患者中有24%报告出现新症状，列为“不良事件”，接受雷尼替丁治疗的患者中有32%报告出现新症状。然而，这些事件均不太可能与药物有关。两组实验室指标从基线到终点的变化百分比无差异。
