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Is tailored therapy based on antibiotic susceptibility effective ? A multicenter, open-label, randomized trial |
Jie Pan1, Zhengchao Shi2, Dingsai Lin3, Ningmin Yang4, Fei Meng4, Lang Lin5, Zhencheng Jin6, Qingjie Zhou1, Jiansheng Wu7, Jianzhong Zhang8,9( ), Youming Li10() |
1. Wenzhou Central Hospital, Wenzhou 325000, China
2. The People’s Hospital of Ruian, Wenzhou 325200, China
3. The Second People’s Hospital of Cangnan, Wenzhou 325802, China
4. Zhiyuan Inspection Medical Institute, Hangzhou 310009, China
5. The First People’s Hospital of Cangnan, Wenzhou 325800, China
6. The First People’s Hospital of Pingyang, Wenzhou 325400, China
7. The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China
8. State Key Laboratory of Infectious Disease Prevention and Control, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing 102206, China
9. National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China
10. The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China |
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Abstract An effective eradication therapy of Helicobacter pylori (H. pylori) should be used for the first time. In this study, we assessed whether tailored therapy based on antibiotic susceptibility testing is more effective than traditional therapy. We also evaluated the factors that cause treatment failure in high-resistance areas. For this multicenter trial, we recruited 467 H. pylori-positive patients. The patients were randomly assigned to receive tailored triple therapy (TATT), tailored bismuth-containing quadruple therapy (TABQT), or traditional bismuth-containing quadruple therapy (TRBQT). For the TATT and TABQT groups, antibiotic selection proceeded via susceptibility testing using an agar-dilution test. The patients in the TRBQT group were given amoxicillin, clarithromycin, esomeprazole, and bismuth. Successful eradication was defined as a negative 13C-urea breath test at least eight weeks after the treatment ended. Susceptibility testing was conducted using an agar-dilution test. The eradication rate was examined via intention-to-treat (ITT) and per-protocol (PP) analyses. The clarithromycin, levofloxacin, and metronidazole resistance rates were 26.12%, 28.69%, and 96.79%, respectively. Resistance against amoxicillin and furazolidone was rare. The eradication rates for TATT, TRBQT, and TABQT were 67.32%, 63.69%, and 85.99% in the ITT analysis (P<0.001) and 74.64%, 68.49%, and 91.22% in the PP analysis (P<0.001), respectively. The efficacy of TABQT was affected by clarithromycin resistance, and bismuth exerted a direct influence on TATT failure. TABQT was the most efficacious regimen for use in high-resistance regions, especially among clarithromycin-susceptible patients.
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| Keywords
tailored triple therapy
tailored bismuth-containing quadruple therapy
traditional bismuth-containing quadruple therapy
antibiotic susceptibility testing
eradication rates
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Corresponding Author(s):
Jianzhong Zhang,Youming Li
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Just Accepted Date: 24 October 2019
Online First Date: 02 January 2020
Issue Date: 02 March 2020
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