PMID- 29596646
OWN - NLM
STAT- MEDLINE
DCOM- 20190916
LR  - 20190916
IS  - 1460-2091 (Electronic)
IS  - 0305-7453 (Linking)
VI  - 73
IP  - 6
DP  - 2018 Jun 1
TI  - New single capsule of bismuth, metronidazole and tetracycline given with 
      omeprazole versus quadruple therapy consisting of bismuth, omeprazole, 
      amoxicillin and clarithromycin for eradication of Helicobacter pylori in duodenal 
      ulcer patients: a Chinese prospective, randomized, multicentre trial.
PG  - 1681-1687
LID - 10.1093/jac/dky056 [doi]
AB  - OBJECTIVES: To assess the efficacy and safety of omeprazole given with the new 
      single capsule of bismuth, metronidazole and tetracycline (OBMT) compared with 
      quadruple treatment consisting of omeprazole, bismuth, amoxicillin and 
      clarithromycin (OBAC) for Helicobacter pylori eradication in duodenal ulcer 
      patients. METHODS: This single-blind, randomized multicentre trial was conducted 
      in 10 tertiary hospitals in China between January 2013 and April 2014. Patients 
      were randomized to receive 10 days of OBMT therapy or 10 days of OBAC therapy. 
      Our primary outcome was the H. pylori eradication rate, confirmed by negative 
      [13C]urea breath tests 20-25 days after the end of omeprazole maintenance. 
      Antibiotic resistance was determined by Etest. This study is registered with 
      ClinicalTrials.gov, number ChiCTR-TRC-13003143. RESULTS: One hundred and 
      ninety-two patients received OBMT therapy and 192 received OBAC therapy. There 
      was no significant difference between the eradication rates achieved by OBMT and 
      OBAC in either the ITT analysis (86.46% versus 87.50%, P = 0.762) or the PP 
      analysis (94.58% versus 93.06%, P = 0.563). The efficacies of OBMT and OBAC were 
      not affected by metronidazole or clarithromycin resistance. Treatment-emergent 
      adverse events (TEAEs) for both treatments were similar; gastrointestinal and CNS 
      symptoms were the most commonly reported. CONCLUSIONS: The new single-capsule 
      OBMT quadruple therapy is as effective and well tolerated as the widely used OBAC 
      therapy for treatment of H. pylori in clinical practice in China. In addition, 
      this OBMT therapy largely overcomes H. pylori metronidazole and clarithromycin 
      resistance.
FAU - Xie, Yong
AU  - Xie Y
AD  - Department of Gastroenterology, The First Affiliated Hospital of Nanchang 
      University, Nanchang, Jiangxi, China.
FAU - Pan, Xiaolin
AU  - Pan X
AD  - Department of Gastroenterology, The First Affiliated Hospital of Nanchang 
      University, Nanchang, Jiangxi, China.
FAU - Li, Yan
AU  - Li Y
AD  - Department of Gastroenterology, Shengjing Hospital of China Medical University, 
      Shenyang, Liaoning, China.
FAU - Wang, Huahong
AU  - Wang H
AD  - Department of Gastroenterology, Peking University First Hospital, Beijing, China.
FAU - Du, Yiqi
AU  - Du Y
AD  - Department of Gastroenterology, Changhai Hospital of Second Military Medical 
      University, Shanghai, China.
FAU - Xu, Jianming
AU  - Xu J
AD  - Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical 
      University, Hefei, Anhui, China.
FAU - Wang, Jiangbin
AU  - Wang J
AD  - Department of Gastroenterology, China-Japan Union Hospital of Jilin University, 
      Changchun, Jilin, China.
FAU - Zeng, Zhirong
AU  - Zeng Z
AD  - Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, Guangdong, China.
FAU - Chen, Ye
AU  - Chen Y
AD  - Department of Gastroenterology, Nanfang Hospital of Southern Medical University, 
      Guangzhou, Guangdong, China.
FAU - Zhang, Guoxin
AU  - Zhang G
AD  - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical 
      University, Nanjing, Jiangsu, China.
FAU - Wu, Kaichun
AU  - Wu K
AD  - Department of Gastroenterology, Xijing Hospital of Fourth Military Medical 
      University, Xi'an, Shanxi, China.
FAU - Liu, Dongsheng
AU  - Liu D
AD  - Department of Gastroenterology, The First Affiliated Hospital of Nanchang 
      University, Nanchang, Jiangxi, China.
FAU - Lv, Nonghua
AU  - Lv N
AD  - Department of Gastroenterology, The First Affiliated Hospital of Nanchang 
      University, Nanchang, Jiangxi, China.
LA  - eng
SI  - ChiCTR/ChiCTR-TRC-13003143
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - J Antimicrob Chemother
JT  - The Journal of antimicrobial chemotherapy
JID - 7513617
RN  - 0 (Antacids)
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Capsules)
RN  - 140QMO216E (Metronidazole)
RN  - 804826J2HU (Amoxicillin)
RN  - F8VB5M810T (Tetracycline)
RN  - H1250JIK0A (Clarithromycin)
RN  - KG60484QX9 (Omeprazole)
RN  - U015TT5I8H (Bismuth)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Amoxicillin/administration & dosage/therapeutic use
MH  - Antacids/*administration & dosage/*therapeutic use
MH  - Anti-Bacterial Agents/*administration & dosage/*therapeutic use
MH  - Bismuth/administration & dosage/therapeutic use
MH  - Capsules/administration & dosage
MH  - China
MH  - Clarithromycin/administration & dosage/therapeutic use
MH  - Drug Therapy, Combination
MH  - Duodenal Ulcer/*drug therapy
MH  - Female
MH  - Helicobacter Infections/*drug therapy
MH  - Helicobacter pylori/drug effects
MH  - Humans
MH  - Male
MH  - Metronidazole/administration & dosage/therapeutic use
MH  - Middle Aged
MH  - Omeprazole/administration & dosage/therapeutic use
MH  - Prospective Studies
MH  - Tetracycline/administration & dosage/therapeutic use
MH  - Young Adult
EDAT- 2018/03/30 06:00
MHDA- 2019/09/17 06:00
CRDT- 2018/03/30 06:00
PHST- 2017/10/08 00:00 [received]
PHST- 2018/01/28 00:00 [accepted]
PHST- 2018/03/30 06:00 [pubmed]
PHST- 2019/09/17 06:00 [medline]
PHST- 2018/03/30 06:00 [entrez]
AID - 4955233 [pii]
AID - 10.1093/jac/dky056 [doi]
PST - ppublish
SO  - J Antimicrob Chemother. 2018 Jun 1;73(6):1681-1687. doi: 10.1093/jac/dky056.