Jean F, Bonnefond A, Gislon J, Kloeti G, Libeskind M, Petite J P, Rautureau J, Roberti A, Zeitoun P
Rev Med Interne. 1985 Jun;6(3):321-6. doi: 10.1016/s0248-8663(85)80125-9.
Relapse rates were studied in one hundred patients in a multicentric, randomized trial during and after maintenance therapy comparing sucralfate, cimetidine and placebo. These patients were previously treated by cimetidine for peptic ulcer and were considered cured after endoscopic examination. Outpatients were randomly assigned to a 6 month maintenance treatment with either cimetidine (600 mg daily), sucralfate (300 mg daily) or a placebo. All patients underwent endoscopic evaluation after 3 and 6 months of therapy. A clinical évaluation was performed 6 months after all treatment had ceased. Clinical and endoscopic results proved the significant superiority of both sucralfate and cimetidine over the placebo. Remission rates with sucralfate were respectively 80,4 p. 100 after 6 months and 68,5 p. 100 after 12 months. These results were slightly superior to those observed with cimetidine (69,3 p. 100 and 61,3 p. 100). However, this difference is not statistically significant. Results for the placebo group were 47,9 p. 100 and 37,7 p. 100. Sucralfate is an effective medication in preventing the recurrence of peptic ulcer. Its pharmacological action, its few side effects and its effectiveness seem to make this medication very interesting in treating the ulcerous disease.
在一项多中心随机试验中,对100例患者在维持治疗期间及之后的复发率进行了研究,比较了硫糖铝、西咪替丁和安慰剂。这些患者先前因消化性溃疡接受过西咪替丁治疗,经内镜检查后被认为已治愈。门诊患者被随机分配接受为期6个月的维持治疗,治疗药物分别为西咪替丁(每日600毫克)、硫糖铝(每日300毫克)或安慰剂。所有患者在治疗3个月和6个月后均接受了内镜评估。在所有治疗结束6个月后进行了临床评估。临床和内镜检查结果证明,硫糖铝和西咪替丁均显著优于安慰剂。硫糖铝治疗6个月后的缓解率分别为80.4%,12个月后为68.5%。这些结果略优于西咪替丁组(分别为69.3%和61.3%)。然而,这种差异无统计学意义。安慰剂组的结果分别为47.9%和37.7%。硫糖铝是预防消化性溃疡复发的有效药物。其药理作用、较少的副作用以及有效性似乎使其成为治疗溃疡病的理想药物。