Cerulli M A, Cloud M L, Offen W W, Chernish S M, Matsumoto C
Section of Gastroenterology, Brooklyn Hospital-Caledonian Hospital, New York.
Scand J Gastroenterol Suppl. 1987;136:79-83. doi: 10.3109/00365528709094490.
A new H2-receptor antagonist, nizatidine (150 mg h.s.), was compared with placebo as maintenance therapy in a randomized, parallel, double-blind, one-year study of 513 patients with recently healed duodenal ulcer. Endoscopies were performed at 0, 3, 6, and 12 months and at unscheduled times if symptoms of active peptic ulcer disease were present. Cumulative ulcer recurrence rates for nizatidine and placebo were 13 versus 40% at 3 months, 24 versus 57% at 6 months, and 34 versus 64% at 12 months. The differences were significant (p less than 0.001) at each treatment period. Smokers in both treatment groups had significantly greater recurrence rates than non-smokers. Symptoms of peptic ulcer disease were significantly less in nizatidine-treated patients in the first 3 months of treatment. Adverse events, including those related to peptic ulcer disease, occurred more frequently in placebo-treated patients. Nizatidine proved to be safe and effective in preventing recurrences of duodenal ulcer.
在一项针对513例近期十二指肠溃疡已愈合患者的随机、平行、双盲、为期一年的研究中，将一种新型H2受体拮抗剂尼扎替丁（每晚150毫克）与安慰剂作为维持疗法进行了比较。在0、3、6和12个月时进行内镜检查，如有活动性消化性溃疡疾病症状则在非预定时间进行检查。尼扎替丁组和安慰剂组的累积溃疡复发率在3个月时分别为13%和40%，6个月时分别为24%和57%，12个月时分别为34%和64%。在每个治疗期，差异均具有统计学意义（p<0.001）。两个治疗组中的吸烟者复发率均显著高于非吸烟者。在治疗的前3个月，接受尼扎替丁治疗的患者消化性溃疡疾病症状明显较少。不良事件，包括与消化性溃疡疾病相关的事件，在接受安慰剂治疗的患者中更频繁发生。事实证明，尼扎替丁在预防十二指肠溃疡复发方面安全有效。
