14 day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: a multicentre, non-inferiority, randomized trialстатья из журнала
Аннотация: Whether extending the treatment length and the use of high-dose esomeprazole may optimize the efficacy of Helicobacter pylori eradication remains unknown.To compare the efficacy and tolerability of optimized 14 day sequential therapy and 10 day bismuth quadruple therapy containing high-dose esomeprazole in first-line therapy.We recruited 620 adult patients (≥20 years of age) with H. pylori infection naive to treatment in this multicentre, open-label, randomized trial. Patients were randomly assigned to receive 14 day sequential therapy or 10 day bismuth quadruple therapy, both containing esomeprazole 40 mg twice daily. Those who failed after 14 day sequential therapy received rescue therapy with 10 day bismuth quadruple therapy and vice versa. Our primary outcome was the eradication rate in the first-line therapy. Antibiotic susceptibility was determined. ClinicalTrials.gov: NCT03156855.The eradication rates of 14 day sequential therapy and 10 day bismuth quadruple therapy were 91.3% (283 of 310, 95% CI 87.4%-94.1%) and 91.6% (284 of 310, 95% CI 87.8%-94.3%) in the ITT analysis, respectively (difference -0.3%, 95% CI -4.7% to 4.4%, P = 0.886). However, the frequencies of adverse effects were significantly higher in patients treated with 10 day bismuth quadruple therapy than those treated with 14 day sequential therapy (74.4% versus 36.7% P < 0.0001). The eradication rate of 14 day sequential therapy in strains with and without 23S ribosomal RNA mutation was 80% (24 of 30) and 99% (193 of 195), respectively (P < 0.0001).Optimized 14 day sequential therapy was non-inferior to, but better tolerated than 10 day bismuth quadruple therapy and both may be used in first-line treatment in populations with low to intermediate clarithromycin resistance.
Год издания: 2018
Авторы: Jyh‐Ming Liou, Chieh‐Chang Chen, Yu‐Jen Fang, Po‐Yueh Chen, Chi-Yang Chang, Chu‐Kuang Chou, Mei‐Jyh Chen, Cheng‐Hao Tseng, Ji‐Yuh Lee, Tsung‐Hua Yang, Min‐Chin Chiu, Jian-Jyun Yu, Chia‐Chi Kuo, Jiing‐Chyuan Luo, Wen‐Feng Hsu, Wenhao Hu, Min‐Horn Tsai, Jaw‐Town Lin, Chia‐Tung Shun, Gary Twu, Lee Yi-Chia, Ming‐Jong Bair, Ming-Shiang Wu, Jyh‐Ming Liou, Lee Yi-Chia, Jaw‐Town Lin, Chun‐Ying Wu, Jeng–Yih Wu, Ching‐Chow Chen, Chun‐Hung Lin, Yu-Ren Fang, Ming‐Jong Bair, Jiing‐Chyuan Luo, Ming-Shiang Wu, Tsu‐Yao Cheng, Ping‐Huei Tseng, Han‐Mo Chiu, Chun‐Chao Chang, Chien-Chun Yu, Min‐Chin Chiu, Yen-Nien Chen, Wenhao Hu, Chu‐Kuang Chou, Chi‐Ming Tai, Ching‐Tai Lee, Wen‐Lun Wang, Wen-Shiung Chang
Издательство: Oxford University Press
Источник: Journal of Antimicrobial Chemotherapy
Ключевые слова: Helicobacter pylori-related gastroenterology studies, Gastroesophageal reflux and treatments, Gastric Cancer Management and Outcomes
Другие ссылки: Journal of Antimicrobial Chemotherapy (PDF)
Journal of Antimicrobial Chemotherapy (HTML)
PubMed (HTML)
Journal of Antimicrobial Chemotherapy (HTML)
PubMed (HTML)
Открытый доступ: bronze
Том: 73
Выпуск: 9
Страницы: 2510–2518