Levofloxacin+Tetracycline Quadruple Regimen for Eradication of Helicobacter pylori: A Multicenter Multinational Randomized Controlled Trial.
Background: The ideal combination regimen for Helicobacter pylori (HP) eradication has not yet been determined and the success rate of HP eradication has been extensively reduced worldwide due to increasing antibiotic resistance. So this multinational multicenter randomized controlled trial was desi...
| Publicado en: | Middle East Journal of Digestive Diseases Vol. 15; no. 1; pp. 12 - 19 |
|---|---|
| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Iranian Association of Gastroenterology & Hepatology
Jan2023
|
| 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=163833502&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 163833502 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 20085230 BG4K jtl: Middle East Journal of Digestive Diseases issn: 20085230 maglogo: N pubinfo: dt: Jan2023 vid: 15 iid: 1 pid: 70725 pub: Iranian Association of Gastroenterology & Hepatology artinfo: ui: 163833502 163833502 163833502 10.34172/mejdd.2023.314 163833502 ppf: 12 ppct: 7 formats: fmt: @attributes: type: P tig: atl: Levofloxacin+Tetracycline Quadruple Regimen for Eradication of Helicobacter pylori: A Multicenter Multinational Randomized Controlled Trial. aug: au: Alavinejad, Pezhman Nayebi, Morteza Parsi, Abazar Abdelsameea, Eman Ahmed, Mohammed Hussien Hormati, Ahmad Dao Viet Hang Modarres, Mehdi Pezeshgi Cheraghian, Bahman Baghaee, Siamak Ara, Tahmine Farbod Quang Trung Tran Behl, Nitin Shanker Hashemi, Seyed Jalal Alboraie, Mohammed Salman, Saif Nha, Le Patai, Árpád V. Hajiani, Eskandar Abravesh, Ali Akbar affil: Alimentary Tract Research Center, Imam Khomeini Hospital Clinical Research Development Unit, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran sug: subj: Helicobacter Infections Drug Therapy Disease Eradication Ofloxacin Therapeutic Use Tetracycline Therapeutic Use Drug Therapy, Combination Treatment Outcomes Drug Efficacy Clarithromycin Therapeutic Use Amoxicillin Therapeutic Use Human Multicenter Studies Randomized Controlled Trials Random Assignment Tertiary Health Care Male Female Adult Middle Age Comparative Studies Pantoprazole Sodium Therapeutic Use Adolescence Aged Aged, 80 and Over Adult: 19-44 years Middle Aged: 45-64 years Adolescent: 13-18 years Aged: 65+ years Aged, 80 & over Male Female ab: Background: The ideal combination regimen for Helicobacter pylori (HP) eradication has not yet been determined and the success rate of HP eradication has been extensively reduced worldwide due to increasing antibiotic resistance. So this multinational multicenter randomized controlled trial was designed to evaluate the efficacy of tetracycline + levofloxacin for HP eradication. Methods: During a 6-month period, all of the cases with HP infection in eight referral tertiary centers of three countries were included and randomly allocated to receive either tetracycline + levofloxacin or clarithromycin plus amoxicillin quadruple regimen for two weeks. For all of the participants, pantoprazole was continued for 4 more weeks and after one to two weeks of off-therapy, they underwent urea breath test C13 to prove eradication. Results: Overall 788 patients were included (358 male (45.4%), average age 44.2 years). They were diagnosed as having non-ulcer dyspepsia (516 cases, 65.5%), peptic ulcer disease (PUD) (234 cases, 29.69%), and intestinal metaplasia (38 cases, 4.8%). Racially 63.1% were Caucasian, 14.5% Arab, 15.6% African, and 6.1% Asian. The participants were randomly allocated to groups A and B to receive either tetracycline + levofloxacin or clarithromycin. Among groups A and B in intention to treat (ITT) and per protocol (PP) analysis, 75.2% & 82.1% (285 cases) and 67.5% & 70.1% (276 cases) of participants achieved eradication, respectively (P = 0.0001). The complete compliance rate in groups A and B were 84.4% and 83.6%, respectively. During the study, 33.5% of the participants in group A (127 cases) reported side effects while the complication rate among group B was 27.9% (114 cases, P = 0.041). The most common complaints among groups A and B were nausea and vomiting (12.6% & 9.3%) and abdominal pain (4.48% & 2.68%), respectively. The rate of severe complications that caused discontinuation of medication in groups A and B were 2.1% and 1.46%, respectively (P = 679). In subgroup analysis, the eradication rates of tetracycline+levofloxacin among patients with non-ulcer dyspepsia, PUD, and intestinal metaplasia were 79.4%, 88.1%, and 73.9%, respectively. These figures in group B (clarithromycin base) were 71.3%, 67.6%, and 61.5% respectively (P = 0.0001, 0.0001, and 0.043). Conclusion: Overall, the combination of tetracycline+levofloxacin is more efficient for HP eradication in comparison with clarithromycin+amoxicillin despite more complication rate. In areas with a high rate of resistance to clarithromycin, this therapeutic regimen could be an ideal choice for HP eradication, especially among those who were diagnosed with PUD. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|