Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial.
Background: Whether concomitant therapy is superior to bismuth quadruple therapy or 14-day triple therapy for the first-line treatment of Helicobacter pylori infection remains poorly understood. We aimed to compare the efficacy and safety of 10-day concomitant therapy, 10-day bismuth quadruple thera...
| Publicado en: | Lancet Vol. 388; no. 10058; pp. 2355 - 2366 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Lancet
11/12/2016
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=119481941&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 119481941 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01406736 LAN jtl: Lancet issn: 01406736 maglogo: N pubinfo: dt: 11/12/2016 vid: 388 iid: 10058 pid: 1297 pub: Lancet place: Philadelphia, Pennsylvania artinfo: ui: 119481941 119481941 NLM27769562 119481941 10.1016/S0140-6736(16)31409-X NLM27769562 119481941 ppf: 2355 ppct: 11 formats: tig: atl: Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. aug: au: Jyh-Ming Liou Yu-Jen Fang Chieh-Chang Chen Ming-Jong Bair Chi-Yang Chang Yi-Chia Lee Mei-Jyh Chen Chien-Chuan Chen Cheng-Hao Tseng Yao-Chun Hsu Ji-Yuh Lee Tsung-Hua Yang Jiing-Chyuan Luo Chun-Chao Chang Chi-Yi Chen Po-Yueh Chen Chia-Tung Shun Wen-Feng Hsu Wen-Hao Hu Yen-Nien Chen affil: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. sug: subj: Drug Administration Schedule Helicobacter Pylori Drug Effects Helicobacter Infections Drug Therapy Drug Therapy, Combination Statistics and Numerical Data Organometallic Compounds Administration and Dosage Antacids Administration and Dosage Antibiotics Administration and Dosage Amoxicillin Therapeutic Use Lansoprazole Therapeutic Use Human Urea Metabolism Antacids Therapeutic Use Clarithromycin Therapeutic Use Breath Tests Organometallic Compounds Therapeutic Use Taiwan Proton Pump Inhibitors Therapeutic Use Clarithromycin Administration and Dosage Middle Age Lansoprazole Administration and Dosage Male Metronidazole Administration and Dosage Antibiotics Therapeutic Use Metronidazole Therapeutic Use Tetracycline Administration and Dosage Amoxicillin Administration and Dosage Proton Pump Inhibitors Administration and Dosage Tetracycline Therapeutic Use Female Validation Studies Comparative Studies Evaluation Research Multicenter Studies Middle Aged: 45-64 years Male Female ab: Background: Whether concomitant therapy is superior to bismuth quadruple therapy or 14-day triple therapy for the first-line treatment of Helicobacter pylori infection remains poorly understood. We aimed to compare the efficacy and safety of 10-day concomitant therapy, 10-day bismuth quadruple therapy, and 14-day triple therapy in the first-line treatment of H pylori.Methods: In this multicentre, open-label, randomised trial, we recruited adult patients (aged >20 years) with H pylori infection from nine medical centres in Taiwan. Patients who had at least two positive tests from the rapid urease test, histology, culture, or serology or who had a single positive 13C-urea breath test for gastric cancer screening were eligible for enrolment. Patients were randomly assigned (1:1:1) to either concomitant therapy (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily) for 10 days; bismuth quadruple therapy (bismuth tripotassium dicitrate 300 mg four times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day) for 10 days; or triple therapy (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily) for 14 days. A computer-generated permuted block randomisation sequence with a block size of 6 was used for randomisation, and the sequence was concealed in an opaque envelope until the intervention was assigned. Investigators were masked to treatment allocation. The primary outcome was the eradication frequency of H pylori with first-line therapy assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01906879.Findings: Between July 17, 2013, and April 20, 2016, 5454 patients were screened for eligibility. Of these, 1620 patients were randomly assigned in this study. The eradication frequencies were 90·4% (488/540 [95% CI 87·6-92·6]) for 10-day bismuth quadruple therapy, 85·9% (464/540 [82·7-88·6]) for 10-day concomitant therapy, and 83·7% (452/540 [80·4-86·6]) for 14-day triple therapy in the intention-to-treat analysis. 10-day bismuth quadruple therapy was superior to 14-day triple therapy (difference 6·7% [95% CI 2·7-10·7, p=0·001), but not 10-day concomitant therapy. 10-day concomitant therapy was not superior to 14-day triple therapy. The frequency of adverse events was 67% (358/533) in patients treated with 10-day bismuth quadruple therapy, 58% (309/535) in patients treated with 10-day concomitant therapy, and 47% (252/535) in patients treated with 14-day triple therapy.Interpretation: Bismuth quadruple therapy is preferable to 14-day triple therapy in the first-line treatment in the face of rising prevalence of clarithromycin resistance. Concomitant therapy given for 10 days might not be optimum and a longer treatment length should be considered.Funding: National Taiwan University Hospital and Ministry of Science and Technology of Taiwan. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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