Gustavsson S, Adami H O, Lööf L, Nyberg A, Nyrén O
Lancet. 1983 Jul 16;2(8342):124-5. doi: 10.1016/s0140-6736(83)90114-9.
In a double-blind, dose-comparative trial, 32 patients with duodenal ulcer were assigned to receive either 20 mg/day or 60 mg/day omeprazole for 4 weeks. The 2-week healing frequency of 100% in the 60 mg/day group was significantly higher than that in the 20 mg/day group (63%). After 4 weeks all ulcers but one in the 20 mg/day group were healed (93% healing frequency). In both groups transient and mostly slight rises in serum alanine aminotransferase levels were observed (total 10 patients). One patient in the 20 mg/day group was withdrawn because of a pronounced rise in serum alanine aminotransferase on day 8. The reason for these liver reactions is not clear, but exclusion of a causal relation with omeprazole treatment must precede further clinical evaluation of this drug.
在一项双盲、剂量对比试验中,32例十二指肠溃疡患者被分配接受每日20毫克或60毫克奥美拉唑治疗,为期4周。60毫克/天组的2周愈合率为100%,显著高于20毫克/天组(63%)。4周后,20毫克/天组除1例溃疡外全部愈合(愈合率93%)。两组均观察到血清丙氨酸转氨酶水平短暂且大多轻微升高(共10例患者)。20毫克/天组的1例患者因第8天血清丙氨酸转氨酶显著升高而退出试验。这些肝脏反应的原因尚不清楚,但在对该药物进行进一步临床评估之前,必须排除与奥美拉唑治疗的因果关系。