Gitlin N, McCullough A J, Smith J L, Mantell G, Berman R
Gastroenterology. 1987 Jan;92(1):48-53. doi: 10.1016/0016-5085(87)90838-9.
The efficacy and safety of famotidine, a potent new long-acting H2-receptor antagonist, was compared with placebo in a multicenter, double-blind, randomized, placebo-controlled study in the United States. A total of 384 patients with endoscopically proven acute duodenal ulcer disease were enrolled. Patients received either famotidine or a placebo. The patients receiving famotidine were treated with one of three dose regimens, 40 mg h.s., 40 mg b.i.d., or 20 mg b.i.d. Patients were reassessed by endoscopy at 2, 4, and 8 wk if ulcer healing had not occurred sooner. A diary was kept to record the duration and intensity of the day and night pain and the amount of Gelusil antacid (Parke-Davis, Morris Plains, N.J.) ingested. Three hundred sixty-three patients met the evaluation criteria. The results revealed a 4-wk healing rate of 70%, 75%, 67%, and 31% for the famotidine 40 mg h.s., 40 mg b.i.d., 20 mg b.i.d., and placebo groups, respectively. The 8-wk healing rates for the same respective groups were 83%, 82%, 82%, 45%. Ulcer pain and antacid consumption occurred less often in the famotidine groups. The clinical and laboratory safety profile of the famotidine groups was similar to that of the placebo group. Famotidine appears to be an effective and safe once-a-day therapy for the treatment of acute duodenal ulcer disease. The recommended dosage is 40 mg h.s.
在美国进行的一项多中心、双盲、随机、安慰剂对照研究中，将新型强效长效H2受体拮抗剂法莫替丁的疗效和安全性与安慰剂进行了比较。共有384例经内镜证实患有急性十二指肠溃疡病的患者入组。患者分别接受法莫替丁或安慰剂治疗。接受法莫替丁治疗的患者采用三种剂量方案之一进行治疗，即每晚40毫克、每日两次40毫克或每日两次20毫克。如果溃疡未在更早时间愈合，则在第2、4和8周通过内镜对患者进行重新评估。记录一本日记，以记录昼夜疼痛的持续时间和强度以及摄入的氢氧化铝镁抗酸剂（新泽西州莫里斯平尔斯帕尔克 - 戴维斯公司生产）的量。363例患者符合评估标准。结果显示，法莫替丁每晚40毫克组、每日两次40毫克组、每日两次20毫克组和安慰剂组的4周愈合率分别为70%、75%、67%和31%。相同各组的8周愈合率分别为83%、82%、82%、45%。法莫替丁组溃疡疼痛和抗酸剂消耗量出现得较少。法莫替丁组的临床和实验室安全性概况与安慰剂组相似。法莫替丁似乎是一种有效且安全的每日一次治疗急性十二指肠溃疡病的疗法。推荐剂量为每晚40毫克。
