14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial

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• 作者：Dr E Robert Greenberg MD^a ; ^b ; ^{e.r.greenberg@dartmouth.edu"" rel=""nofollow} ; Garnet L Anderson PhD^a ; ^b ; Douglas R Morgan MD^c ; Javier Torres PhD^d ; William D Chey MD^e ; Luis Eduardo Bravo MD^f ; Ricardo L Dominguez MD^g ; Catterina Ferreccio MD^h ; Rolando Herrero MDⁱ ; ^j ; Eduardo C Lazcano-Ponce MD^k ; Marí ; a Mercedes Meza-Montenegro PhD^l ; Rodolfo Peñ ; a PhD^m ; Edgar M Peñ ; a MD^m ; Eduardo Salazar-Martí ; nez PhD^k ; Pelayo Correa MDⁿ ; Marí ; a Elena Martí ; nez PhD^o ; Manuel Valdivieso MD^p ; Gary E Goodman MD^b ; ^q ; John J Crowley PhD^a ; Laurence H Baker DO^p
• 刊名：The Lancet
• 出版年：2011
• 出版时间：6 August 2011-12 August 2011
• 年：2011
• 卷：378
• 期：9790
• 页码：507-514
• 全文大小：173 K

文摘

<h3 class=""h3"">Summaryh3><h4 class=""h4"">Backgroundh3>Evidence from Europe, Asia, and North America suggests that standard three-drug regimens of a proton-pump inhibitor plus amoxicillin and clarithromycin are significantly less effective for eradication of Helicobacter pylori infection than are 5-day concomitant and 10-day sequential four-drug regimens that include a nitroimidazole. These four-drug regimens also entail fewer antibiotic doses than do three-drug regimens and thus could be suitable for eradication programmes in low-resource settings. Few studies in Latin America have been done, where the burden of H pylori-associated diseases is high. We therefore did a randomised trial in Latin America comparing the effectiveness of four-drug regimens given concomitantly or sequentially with that of a standard 14-day regimen of triple therapy.<h4 class=""h4"">Methodsh3>

Between September, 2009, and June, 2010, we did a randomised trial of empiric 14-day triple, 5-day concomitant, and 10-day sequential therapies for H pylori in seven Latin American sites: Chile, Colombia, Costa Rica, Honduras, Nicaragua, and Mexico (two sites). Participants aged 21–65 years who tested positive for H pylori by a urea breath test were randomly assigned by a central computer using a dynamic balancing procedure to: 14 days of lansoprazole, amoxicillin, and clarithromycin (standard therapy); 5 days of lansoprazole, amoxicillin, clarithromycin, and metronidazole (concomitant therapy); or 5 days of lansoprazole and amoxicillin followed by 5 days of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Eradication was assessed by urea breath test 6–8 weeks after randomisation. The trial was not masked. Our primary outcome was probablity of H pylori eradication. Our analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, registration number NCT01061437.<h4 class=""h4"">Findingsh3>

1463 participants aged 21–65 years were randomly allocated a treatment: 488 were treated with 14-day standard therapy, 489 with 5-day concomitant therapy, and 486 with 10-day sequential therapy. The probability of eradication with standard therapy was 82·2 % (401 of 488), which was 8·6 % higher (95 % adjusted CI 2·6–14·5) than with concomitant therapy (73·6 % [360 of 489]) and 5·6 % higher (–0·04 % to 11·6) than with sequential therapy (76·5 % [372 of 486]). Neither four-drug regimen was significantly better than standard triple therapy in any of the seven sites.<h4 class=""h4"">Interpretationh3>

Standard 14-day triple-drug therapy is preferable to 5-day concomitant or 10-day sequential four-drug regimens as empiric therapy for H pylori infection in diverse Latin American populations.<h4 class=""h4"">Fundingh3>

Bill & Melinda Gates Foundation, US National Institutes of Health.