Labenz J, Gyenes E, Rühl G H, Börsch G
Department of Internal Medicine, Elisabeth-Hospital, Academic Teaching Hospital, University of Essen, GHS, Germany.
Am J Gastroenterol. 1993 Apr;88(4):491-5.
In five subsequent open clinical studies, 180 patients with Helicobacter pylori (HP)-associated ulcer disease (n = 163) or severe functional dyspepsia (n = 17) requiring therapy were treated with either 40 mg omeprazole plus 4 x 500 mg amoxicillin suspension for 1 wk (group I, n = 35), 2 x 40 mg omeprazole plus 4 x 500 mg amoxicillin for 1 wk (group II, n = 50), 2 x 20 mg omeprazole plus 4 x 500 mg amoxicillin for 2 wk (group III, n = 62), 2 x 20 mg omeprazole (day 1-14) and 4 x 500 mg amoxicillin (day 8-14) (group IV, n = 22) or with 2 x 20 mg omeprazole for 2 wk (group V, n = 11). The HP eradication rates determined with a biopsy urease test, microscopy of a mucosal smear, specific culture, and histology after modified GIEMSA staining in the 5th wk after discontinuation of study medication were 61.3% in group I, 61.7% in group II, 82.8% in group III, 28.6% in group IV, and 0% in group V. Apart from clinical insignificant pharyngeal paresthesias (n = 6), nine patients (5.7%) with combined therapy complained of important side effects (stomatitis: n = 3, diarrhea: n = 3, allergic exanthema: n = 3) that led to termination of amoxicillin treatment in four cases (2.5%). We conclude that omeprazole-enhanced amoxicillin antibiosis is a simple and effective approach to the eradication of HP colonization.
在随后的五项开放性临床研究中,180例患有幽门螺杆菌(HP)相关性溃疡病(n = 163)或需要治疗的严重功能性消化不良(n = 17)的患者,接受了以下治疗:40 mg奥美拉唑加4×500 mg阿莫西林混悬液治疗1周(I组,n = 35);2×40 mg奥美拉唑加4×500 mg阿莫西林治疗1周(II组,n = 50);2×20 mg奥美拉唑加4×500 mg阿莫西林治疗2周(III组,n = 62);2×20 mg奥美拉唑(第1 - 14天)和4×500 mg阿莫西林(第8 - 14天)(IV组,n = 22);或2×20 mg奥美拉唑治疗2周(V组,n = 11)。在停用研究药物后的第5周,通过活检尿素酶试验、黏膜涂片显微镜检查、特异性培养以及改良吉姆萨染色后的组织学检查确定的HP根除率分别为:I组61.3%,II组61.7%,III组82.8%,IV组28.6%,V组0%。除了临床意义不大的咽部感觉异常(n = 6)外,9例(5.7%)联合治疗的患者抱怨有严重副作用(口腔炎:n = 3,腹泻:n = 3,过敏性皮疹:n = 3),其中4例(2.5%)因副作用导致阿莫西林治疗终止。我们得出结论,奥美拉唑增强阿莫西林抗菌作用是根除HP定植的一种简单有效的方法。