Euler A R, Krawiec J, Odes H, Gilat T, Garcia L, Rachmilewitz D, Gabryelewicz A, Gibinski K, Bass D, Barbara L
Upjohn Company, Kalamazoo, MI 49001.
Am J Gastroenterol. 1990 Feb;85(2):145-9.
Six hundred and thirty patients were enrolled in a randomized double-blind placebo-controlled trial evaluating two arbaprostil dosages (25 micrograms and 50 micrograms) qid for 4 wk for the treatment of acute duodenal ulcers. The healing rates in the placebo, 25-micrograms, and 50-micrograms treatment groups were 39%, 51%, and 60%, respectively. Smoking was found to adversely affect the healing rates in all the treatment groups. Pain severity was less with either arbaprostil treatment. The only side effect found was diarrhea: 10%, 14%, and 32% in the placebo, 25-micrograms, and 50-micrograms treatment groups, respectively. Severe diarrhea occurred in 1% of those patients who received the 50-micrograms dosage regimen, but in none of the other two groups. Arbaprostil at these two dosage levels, when given for 4 wk, appears to be a safe and efficacious agent for the treatment of acute duodenal ulcers.
630名患者参与了一项随机双盲安慰剂对照试验,该试验评估了两种阿巴前列素剂量(25微克和50微克),每日4次,持续4周用于治疗急性十二指肠溃疡。安慰剂组、25微克治疗组和50微克治疗组的愈合率分别为39%、51%和60%。研究发现,吸烟对所有治疗组的愈合率均有不利影响。两种阿巴前列素治疗的疼痛严重程度均较低。唯一发现的副作用是腹泻:安慰剂组、25微克治疗组和50微克治疗组的腹泻发生率分别为10%、14%和32%。接受50微克剂量方案的患者中有1%发生了严重腹泻,但其他两组均未出现。这两种剂量水平的阿巴前列素,服用4周时,似乎是治疗急性十二指肠溃疡的一种安全有效的药物。