Levendoglu H, Mehta B, Wait C, Reddy G, Hatcher C
Am J Gastroenterol. 1986 Dec;81(12):1167-70.
Forty-three patients with newly diagnosed duodenal ulcers were treated with a new histamine blocker, nizatidine, and with placebo. The incidence of complete endoscopic healing was 38, 74, and 82% in the nizatidine treated patients compared with 25, 37, and 50% in the placebo treated group after 2, 4, and 8 wk of treatment, respectively. Nizatidine was clearly more effective than placebo after 4 wk of treatment. The size of unhealed ulcers decreased more than 50% in 62, 50, and 50% in the nizatidine treated groups versus 27, 25, and 40% in the placebo treated groups after 2, 4, and 8 wk of treatment, respectively. The difference between the two was not statistically significant for any given period. There was a significant correlation between day pain relief and ulcer healing in both treatment groups. Nizatidine significantly improved day pain relief only after 8 wk of treatment (p less than 0.01). No patient developed any side effects as a result of nizatidine treatment, except that the serum creatinine level rose from 1.05 to 1.1 mg/100 ml but still remained within the normal accepted range. This study demonstrated that nizatidine at 150 mg po bid could be effectively used in the treatment of duodenal ulcer disease.
43例新诊断的十二指肠溃疡患者分别接受新型组胺阻滞剂尼扎替丁和安慰剂治疗。治疗2周、4周和8周后，尼扎替丁治疗组的内镜完全愈合率分别为38%、74%和82%，而安慰剂治疗组分别为25%、37%和50%。治疗4周后，尼扎替丁明显比安慰剂更有效。治疗2周、4周和8周后，尼扎替丁治疗组未愈合溃疡的大小分别减少超过50%（分别为62%、50%和50%），而安慰剂治疗组分别为27%、25%和40%。在任何给定时间段内，两组之间的差异均无统计学意义。两个治疗组的日间疼痛缓解与溃疡愈合之间均存在显著相关性。仅在治疗8周后，尼扎替丁显著改善了日间疼痛缓解情况（p<0.01）。除血清肌酐水平从1.05 mg/100 ml升至1.1 mg/100 ml但仍在正常可接受范围内外，没有患者因尼扎替丁治疗出现任何副作用。本研究表明，口服150 mg bid的尼扎替丁可有效用于治疗十二指肠溃疡病。
