Felga Guilherme, Silva Fernando Marcuz, Barbuti Ricardo Correa, Navarro-Rodriguez Tomas, Zaterka Schlioma, Eisig Jaime Natan
School of Medicine, University of São Paulo, São Paulo, Brazil.
J Infect Dev Ctries. 2010 Nov 24;4(11):712-6. doi: 10.3855/jidc.911.
The scheme proton pump inhibitor/amoxicillin/clarithromycin (PPI/AC) is still the first-line treatment for Helicobacter pylori (H. pylori) infections despite evidence suggesting its failure in up to 20% to 30% of patients.
This study involved 493 patients who were prescribed omeprazole (20 mg twice a day) or another proton pump inhibitor in equivalent dosage, amoxicillin (1 g twice a day), and clarithromycin (500 mg twice a day) for seven days. Efficacy was determined by negative urease test and absence of H. pylori on gastric biopsy samples twelve weeks after the end of treatment. Safety was defined according to the adverse effects reported. Mean age of the patients was (± SD) 48.96 ± 13, and demographic and clinical data were recorded for correlation with treatment outcomes.
Out of 493 patients, 316 (64.1%) presented duodenal ulcer, 111 (22.5%) gastric ulcer, and 66 (14.4%) simultaneous gastric and duodenal ulcers. Additionally, 267 (54.2%) patients had at least one risk factor for peptic ulcer disease, smoking being the most common (99 [36.5%]). Successful eradication was achieved in 408 patients. The eradication rates per protocol, and according to the intention to treat, were 88.8% and 82.7%, respectively. Of 164 (35.5%) patients who presented adverse effects, 100 (61%) reported them as mild and only six (3.7%) patients had to discontinue treatment. Previous use of tobacco and non-steroid anti-inflammatory drugs was the only risk factor for treatment failure (P = 0.00).
PPI/AC is still a valuable and remarkably tolerable option for first-line H. pylori eradication in Brazil.
尽管有证据表明质子泵抑制剂/阿莫西林/克拉霉素(PPI/AC)方案在高达20%至30%的患者中治疗失败,但它仍是幽门螺杆菌(H. pylori)感染的一线治疗方案。
本研究纳入了493例患者,他们被给予奥美拉唑(20毫克,每日两次)或同等剂量的另一种质子泵抑制剂、阿莫西林(1克,每日两次)和克拉霉素(500毫克,每日两次),疗程为7天。治疗结束12周后,通过尿素酶试验阴性和胃活检样本中无幽门螺杆菌来确定疗效。根据报告的不良反应来定义安全性。患者的平均年龄为(±标准差)48.96±13岁,并记录了人口统计学和临床数据以与治疗结果进行相关性分析。
在493例患者中,316例(64.1%)患有十二指肠溃疡,111例(22.5%)患有胃溃疡,66例(14.4%)同时患有胃溃疡和十二指肠溃疡。此外,267例(54.2%)患者至少有一项消化性溃疡疾病的危险因素,吸烟是最常见的(99例[36.5%])。408例患者实现了成功根除。按方案分析和意向性分析的根除率分别为88.8%和82.7%。在出现不良反应的164例(35.5%)患者中,100例(61%)报告为轻度,只有6例(3.7%)患者不得不停止治疗。既往使用烟草和非甾体抗炎药是治疗失败的唯一危险因素(P = 0.00)。
在巴西,PPI/AC仍然是一线根除幽门螺杆菌的有价值且耐受性良好的选择。