Marks I N, Wright J P
S Afr Med J. 1987 Jul 4;72(1):18-20.
One hundred and thirty-two patients with endoscopically confirmed duodenal ulcers were entered into a 4-6-week double-blind trial of famotidine (Fm) and ranitidine (Rn). Seventy patients were randomised to Fm 40 mg at night and Rn placebo and 62 to Rn 300 mg at night and Fm placebo. Gelusil tablets were allowed for ulcer pain, and diary cards were issued. Clinical evaluations were carried out on entry and at 2 and 4 weeks, and endoscopy was repeated at 4 weeks. Patients with an unhealed ulcer at 4 weeks were continued on the same treatment for another 2 weeks and further endoscopy was carried out at 6 weeks. The groups were comparable with respect to age, sex, duration of the most recent attack, initial ulcer size and smoking, but the duration of disease tended to be longer in the Rn-treated group (P less than 0.05). Of the patients available for analysis, 75% of the Fm-treated and 78% of the Rn-treated patients were healed at 4 weeks and 91% of patients in both treatment groups were healed at 6 weeks. Gelusil consumption and symptomatic responses were comparable in the two groups, and no side-effects were noted apart from mild dizziness in 1 patient after a single Fm tablet. The mean initial size of ulcers healed at 4 weeks was significantly less than that of ulcers which were unhealed at 4 weeks (P less than 0.01), and the healing rate among smokers was significantly lower than that among non-smokers--48 of 72 patients (67%) and 41 of 45 (91%) respectively (P less than 0.01). The study shows that Fm 40 mg at night is as effective as Rn 300 mg in duodenal ulcer healing.
132例经内镜确诊为十二指肠溃疡的患者进入了一项为期4 - 6周的法莫替丁(Fm)和雷尼替丁(Rn)双盲试验。70例患者被随机分为每晚服用40毫克Fm及Rn安慰剂组,62例患者被随机分为每晚服用300毫克Rn及Fm安慰剂组。允许使用氢氧化铝凝胶片缓解溃疡疼痛,并发放日记卡。在入组时、2周和4周进行临床评估,4周时重复进行内镜检查。4周时溃疡未愈合的患者继续接受相同治疗2周,并在6周时再次进行内镜检查。两组在年龄、性别、最近一次发作的持续时间、初始溃疡大小和吸烟情况方面具有可比性,但Rn治疗组的病程往往更长(P小于0.05)。在可供分析的患者中,Fm治疗组75%的患者和Rn治疗组78%的患者在4周时溃疡愈合,两个治疗组91%的患者在6周时愈合。两组的氢氧化铝凝胶消耗量和症状反应相当,除1例患者服用1片Fm后出现轻度头晕外,未观察到副作用。4周时愈合的溃疡平均初始大小明显小于4周时未愈合的溃疡(P小于0.01),吸烟者的愈合率明显低于非吸烟者——72例患者中的48例(67%)和45例中的41例(91%)(P小于0.01)。该研究表明,每晚服用40毫克Fm在十二指肠溃疡愈合方面与服用300毫克Rn一样有效。