Garza González E, Giasi González E, Martínez Vázquez M A, Pérez Pérez G I, González G M, Maldonado Garza H J, Bosques Padilla F J
Departamento de Microbiología. Facultad de Medicina, Universidad Autónoma de Nuevo León, México.
Rev Esp Enferm Dig. 2007 Feb;99(2):71-5. doi: 10.4321/s1130-01082007000200002.
to assess the efficacy of rabeprazole (RPZ), amoxicillin (Am), and clarithromycin (Cla) (7 vs. 14 days) in the eradication of H. pylori, and to determine the effect of strain-specific antibiotic resistance and host CYP2C19 status.
first, we determined the CYP2C19 status of 100 healthy subjects to establish a sample size for the clinical trial. Then, 59 H. pylori-infected patients were randomized to receive RPZ (20 mg daily) plus Cla (500 mg b.d.) and Am (1,000 mg b.d.) for 7 vs. 14 days. The MIC for Am and Cla were determined using the agar dilution method. The CYP2C19 genotype was determined by the PCR-RFLP method.
In the per-protocol analysis (PP) eradication rates were 89.7 and 72% for the 7- and 14-day groups (p = 0.159). In the intention to-treat analysis (ITT) eradication rates were 86.7 and 62.1% in the 7- and 14-day groups, respectively (p = 0.06). None of the strains was resistant to Am, and 4 strains were resistant to Cla: 3 (11.1%) in the 14-day group and 1 (4%) in the 7-day group. Neither strain-specific antibiotic resistance nor host CYP2C19 status influenced eradication rates.
both 7- and 14-day therapies were effective for H. pylori eradication. Strain resistance and CYP2C19 status do not seem to influence eradication rates in the studied population.
评估雷贝拉唑(RPZ)、阿莫西林(Am)和克拉霉素(Cla)(7天与14天疗程)根除幽门螺杆菌的疗效,并确定菌株特异性抗生素耐药性和宿主细胞色素P450 2C19(CYP2C19)状态的影响。
首先,我们测定了100名健康受试者的CYP2C19状态,以确定临床试验的样本量。然后,59例幽门螺杆菌感染患者被随机分为两组,分别接受RPZ(每日20 mg)加Cla(每日2次,每次500 mg)和Am(每日2次,每次1000 mg)治疗7天或14天。采用琼脂稀释法测定Am和Cla的最低抑菌浓度(MIC)。通过聚合酶链反应-限制性片段长度多态性(PCR-RFLP)方法测定CYP2C19基因型。
在符合方案分析(PP)中,7天和14天治疗组的根除率分别为89.7%和72%(p = 0.159)。在意向性分析(ITT)中,7天和14天治疗组的根除率分别为86.7%和62.1%(p = 0.06)。所有菌株对Am均无耐药性,4株对Cla耐药:14天治疗组3株(11.1%),7天治疗组1株(4%)。菌株特异性抗生素耐药性和宿主CYP2C19状态均未影响根除率。
7天和14天的治疗方案对根除幽门螺杆菌均有效。在所研究的人群中,菌株耐药性和CYP2C19状态似乎不影响根除率。