Efficacy and safety of sequential therapy versus standard triple therapy in Helicobacter pylori eradication in Kashmir India: a randomized comparative trial

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• 作者：Gul Javid (1)
  Showkat Ali Zargar (1)
  Khurshid Bhat (1)
  Bashir Ahmad Khan (1)
  Ghulam Nabi Yatoo (1)
  Ghulam Mohamad Gulzar (1)
  Altaf Hussain Shah (1)
  Jaswinder Singh Sodhi (1)
  Mushtaq Ahmad Khan (1)
  Abid Shoukat (1)
  Riyaz U Saif (1)
  
• 关键词：Antimicrobial resistance ; Compliance ; Peptic ulcer ; Side effects
• 刊名：Indian Journal of Gastroenterology
• 出版年：2013
• 出版时间：May 2013
• 年：2013
• 卷：32
• 期：3
• 页码：190-194
• 全文大小：130KB
• 参考文献：1. Graham DY, Adam E, Reddy GT, et al. Sero epidemiology of / Helicobacter pylori infection in India. Comparison of developing and developed countries. Dig Dis Sci. 1991;36:1084-. CrossRef
  2. Graham DY, Yamaoka Y. Ethical considerations of comparing sequential and traditional anti- / Helicobacter therapy. Ann Intern Med. 2007;147:434-. CrossRef
  3. Suerbaum S, Michetti P. / Helicobacter pylori infection. N Engl J Med. 2002;347:1175-6. CrossRef
  4. Laheij RJ, Rossum LG, Jansen JB, Straatman H, Verbeek AL. Evaluation of treatment regimens to cure / Helicobacter pylori infection a meta-analysis. Aliment Pharmacol Ther. 1999;13:857-4. CrossRef
  5. Perri F, Villani MR, Festa V, Quitadamo M, Andriulli A. Predictors of failure of / Helicobacter pylori eradication with the standard ‘Maastricht triple therapy- Aliment Pharmacol Ther. 2001;15:1023-. CrossRef
  6. Bigard MA, Delchier JC, Riachi G, Thiabult P, Barthelemy P. One-week triple therapy using omeprazole, amoxicillin and clarithromycin for the eradication of / Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of Omeprazole and clarithromycin. Aliment Pharmacol Ther. 1998;12:383-. CrossRef
  7. Calvet X, Ducons J, Guardiola J, et al. One-week triple versus quadruple therapy for / Helicobacter pylori infection—a randomized trial. Aliment Pharmacol Ther. 2002;16:1261-. CrossRef
  8. Deltenre M, Jonas C, van Gossum M, Buset M, Otero J, De Koster E. Omeprazole based antimicrobial therapies: results in 198 / Helicobacter pylori-positive patients. Eur J Gastroenterol Hepatol. 1995;7 suppl 1:S39-4.
  9. Vakil N. / Helicobacter pylori eradication: sequential and traditional therapy. Gastroenterol Hepatol. 2009;3:59-4.
  10. Ramakrishan BS. / Helicobacter pylori infection in India: the case against eradication. Indian J Gastroenterol. 2006;25:25-.
  11. Thyagarajan SP, Ray P, Das BK, et al. Geographical difference in antimicrobial resistance pattern of / Helicobacter pylori clinical isolates from Indian patients: multicenteric study. J Gastroenterol Hepatol. 2003;18:1373-. CrossRef
  12. Datta S, Chattopadhyay S, Patra R, et al. Most / Helicobacter pylori strains of Kolkata in India are resistant to metronidazole but susceptible to other drugs commonly used for eradication and ulcer therapy. Aliment Pharmacol Ther. 2005;22:51-. CrossRef
  13. Fuccio L, Minardi ME, Zagari RM, Grilli D, Magrini N, Bazzoli F. Meta-analysis: duration of first-line proton-pump inhibitor based triple therapy for / Helicobacter pylori eradication. Ann Intern Med. 2007;147:553-2. CrossRef
  14. Zullo A, De Francesco V, Hassan C, Morini S, Vaira D. The sequential therapy regimen for / Helicobacter pylori eradication: a pooled-data analysis. Gut. 2007;56:1353-. CrossRef
  15. Zullo A, Hassan C, Morini S, et al. Sequential therapy for / H. pylori an ‘aberrant-therapy for general use. Dig Liver Dis. 2004;36:852-. CrossRef
  16. Vaira D, Zullo A, Vakil N, et al. Sequential therapy versus standard triple-drug therapy for / Helicobacter pylori eradication. A randomized trial. Ann Intern Med. 2007;146:556-3. CrossRef
  17. De Francesco V, Zullo A, Margiotta M, et al. Sequential treatment for / Helicobacter pylori does not share the risk factors of triple therapy failure. Aliment Pharmacol Ther. 2004;19:407-4. CrossRef
  18. Zullo A, Rinaldi V, Winn S, et al. A new highly effective short-term therapy schedule for / Helicobacter pylori eradication. Aliment Pharmacol Ther. 2000;14:715-. CrossRef
  19. De Francesco V, Zullo A, Hassan C, et al. Two new treatment regimens for / Helicobacter pylori eradication: a randomized study. Dig Liver Dis. 2001;33:676-. CrossRef
  20. Newcombe RG, Altman DG. Proportion and their differences. In: Altman DG, Machin D, Trevor NB, Newcombe RG (eds). Statistics with Confidences, 2nd ed. London: BMJ Books; 2000. pp 45-6.
  21. Kim YS, Kim SJ, Yoon JH, et al. Randomised clinical trial: the efficacy of a 10-day sequential therapy vs. a 14-day standard proton pump inhibitor-based triple therapy for / Helicobacter pylori in Korea. Aliment Pharmacol Ther. 2011;34:1098-05. CrossRef
  22. Uygun A, Kadayifci A, Yesilova Z, Safali M, Ilgan S, Karaeren N. Comparison of sequential and standard triple-drug regimen for / Helicobacter pylori eradication: a 14-day, open-label, randomized, prospective, parallel-arm study in adult patients with nonulcer dyspepsia. Clin Ther. 2008;30:528-4. CrossRef
  23. Park HG, Jung MK, Jung JT, et al. Randomised clinical trial: a comparative study of 10-day sequential therapy with 7-day standard triple therapy for / Helicobacter pylori infection in na?ve patients. Aliment Pharmacol Ther. 2012;35:56-5. CrossRef
  24. Laine L, Fennerty MB, Osato M, et al. Esomeprazole based / Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. Am J Gastroenterol. 2000;95:3393-. CrossRef
  25. Vakil N, Lanza F, Schwartz H, Barth J. Seven-day therapy for / Helicobacter pylori in the United States. Aliment Pharmacol Ther. 2004;20:99-07. CrossRef
  26. Greenberg ER, Anderson GL, Morgan DR, et al. 14-Day triple, 5-day concomitant, and 10-day sequential therapies for / Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011;378:507-4. CrossRef
  27. Duck WM, Sobel J, Pruckler JM, et al. Antimicrobial resistance incidence and risk factors among / Helicobacter pylori-infected persons. United States Emerg Infect Dis. 2004;10:1088-4. CrossRef
  28. Thyagarajan SP, Ray P, Das BK, et al. Geographical difference in antimicrobial resistance pattern of / Helicobacter pylori clinical isolates from Indian patients: multicentric study. J Gastroenterol Hepatol. 2003;18:1373-. CrossRef
  29. Bhatia V, Ahuja V, Das B, Bal C, Sharma MP. Use of imidazole-based eradication regimens for / Helicobacter pylori should be abandoned in North India regardless of in vitro antibiotic sensitivity. J Gastroenterol Hepatol. 2004;19:619-5. CrossRef
  30. De Francesco V, Margiotta M, Zullo A, et al. Clarithromycin-resistant genotypes and eradication of / Helicobacter pylori. Ann Intern Med. 2006;144:94-00. CrossRef
  31. Castro Fernández M, Sánchez Mu?oz D, García Díaz E, Galán Jurado MV, Rodríguez AC. Diagnosis of / Helicobacter pylori infection using urease rapid test in patients with bleeding duodenal ulcer: influence of endoscopic signs and simultaneous corporal and antral biopsies. Rev Esp Enferm Dig. 2004;96:599-02.
  32. Archimandritis A, Tzivras M, Sougioultzis S, et al. Rapid urease test is less sensitive than histology in diagnosing / Helicobacter pylori infection in patients with non-variceal upper gastrointestinal bleeding. J Gastroenterol Hepatol. 2000;15:369-3. CrossRef
  
• 作者单位：Gul Javid (1)
  Showkat Ali Zargar (1)
  Khurshid Bhat (1)
  Bashir Ahmad Khan (1)
  Ghulam Nabi Yatoo (1)
  Ghulam Mohamad Gulzar (1)
  Altaf Hussain Shah (1)
  Jaswinder Singh Sodhi (1)
  Mushtaq Ahmad Khan (1)
  Abid Shoukat (1)
  Riyaz U Saif (1)
  
  1. Department of Gastroenterology, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, 190 011, India
  

文摘

Background Increasing resistance against Helicobacter pylori has resulted in reduced eradication rates. Objective This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. Patients Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. Intervention Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40?mg, clarithromycin 500?mg and amoxicillin 1?g each administered twice daily) for 10?days and 138 received sequential regimen (pantoprazole 40?mg plus amoxicillin 1?g twice daily for 5?days followed by 40?mg pantoprazole, 500?mg clarithromycin, and 500?mg tinidazole each administered twice daily for 5?days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning. Results The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9?%, p--.005; difference, 14.1?% [95?% CI, 6.5-9?%] and per protocol analysis (84.6 % vs. 67.4?%, p--.002; difference, 17.2?% [95?% CI, 8.5-3.5?%]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. Limitation Cultures were not performed. Loss to follow up was 5.2?% in standard therapy and 6.5?% in sequential therapy. Conclusion Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.