Warrington Emanuel, López-Román Orlando, Tirado Montijo Rafael, Urbina Rafael, Cruz-Correa Marcia, Toro Doris H
VA Caribbean Healthcare System, San Juan, Puerto Rico.
University of Puerto Rico Comprehensive Cancer Center, San Juan, Puerto Rico.
P R Health Sci J. 2016 Dec;35(4):203-208.
Helicobacter pylori is a bacterial pathogen associated with chronic gastritis, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa associated lymphoid tissue lymphoma. Current treatment guidelines support a 7- to 14-day, triple-drug protocol consisting of a proton-pump inhibitor (PPI), clarithromycin, and either amoxicillin or an imidazole. The initial eradication rates for this regimen were 80 to 90%. Nevertheless its effectiveness has declined as the antibiotic resistance to clarithromycin and metronidazole has emerged. In Puerto Rico the reported resistance of H. pylori to clarithromycin is 16% and to metronidazole, 3.7%. Sequential therapy for H. pylori eradication, 5 days of treatment with a PPI and amoxicillin followed by 5 days of treatment with the PPI and 2 other antibiotics (clarithromycin and an imidazole), was introduced as an effective alternate regimen. This is a prospective clinical trial intended to compare the efficacy of first-line, standard 10-day tripledrug therapy with those of both 10- and 14-day sequential therapy in eradicating H. pylori at the San Juan Veterans Affairs Hospital in a population that is naïve to previous treatment.
This was a prospective, open-label, randomized clinical trial.
Based on the intention-to-treat analysis, the eradication rate was 83.7% (72 of 86 patients) in the standard triple-therapy group, 80.0% (68/85) in the 10- day sequential-therapy group, and 79.1% (68/86) in the 14-day sequential-therapy group. There were no significant statistical differences between the eradication rates among therapies.
Sequential-therapy treatment regimens are not better than standard triple therapy for the eradication of H. pylori infection, regardless of the treatment duration.
幽门螺杆菌是一种与慢性胃炎、消化性溃疡病、胃腺癌以及胃黏膜相关淋巴组织淋巴瘤相关的细菌病原体。当前的治疗指南支持采用一种为期7至14天的三联药物方案，该方案由一种质子泵抑制剂（PPI）、克拉霉素以及阿莫西林或一种咪唑类药物组成。该方案的初始根除率为80%至90%。然而，随着对克拉霉素和甲硝唑的抗生素耐药性出现，其有效性有所下降。在波多黎各，据报道幽门螺杆菌对克拉霉素的耐药率为16%，对甲硝唑的耐药率为3.7%。用于根除幽门螺杆菌的序贯疗法，即先用PPI和阿莫西林治疗5天，然后再用PPI和另外两种抗生素（克拉霉素和一种咪唑类药物）治疗5天，作为一种有效的替代方案被引入。这是一项前瞻性临床试验，旨在比较在圣胡安退伍军人事务医院对既往未接受过治疗的人群中，一线标准10天三联药物疗法与10天和14天序贯疗法根除幽门螺杆菌的疗效。
这是一项前瞻性、开放标签、随机临床试验。
基于意向性分析，标准三联疗法组的根除率为83.7%（86例患者中的72例），10天序贯疗法组为80.0%（68/85），14天序贯疗法组为79.1%（68/86）。各疗法之间的根除率无显著统计学差异。
无论治疗时长如何，序贯疗法治疗方案在根除幽门螺杆菌感染方面并不优于标准三联疗法。
