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EFFICACY OF THE BISMUTH-CONTAINING QUADRUPLE REGIMEN (EBMT) in patients with H pylori- related chronic gastritis Dang Ngoc Quy Hue Tran Van Huy Nguyen Thanh Hai Hue Univesity of Medicine and Pharmacy ThongNhat – DongNai General Hospital CONTENT BACKGROUND AIMS SUBJECTS AND METHODS RESULTS - DISCUSSION CONCLUSION - SUGGESTION 1.BACKGROUND • H pylori- related chromic gastritis the strongest risk factor for gastric cancer Maastricht IV & V: eradication of H pylori = primary prevention of GC Challenges: +++ • increased quickly rate of resistance of H pylori • Correa, P (1992) Cancer research 52: 6735-6740 • Fallone, C A., et al (2016), The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults, Gastroenterology • Malfertheiner, P., et al (2012, 2016), Management of Helicobacter pylori infection the Maastricht IV, V Gut 1.BACKGROUND Resistant rate (%) Author Resistance Year CLR Bình T.T LFX MTZ 2008 33.0 18.4 69.9 Phan Trung Nam 2012-2013 42.9 30.2 84.6 44.6 39.5 61.5 Đặng Ngọc Quý Huệ 2013 71.6 64.1 30.6 29.2 TET AMX ≥2 ABX CLR+MTZ 24.3 5.8 0.0 67.9 67.4 69.2 - 1.8 0.0 7.7 abx 45.6 - - - CLR+LFX 22.4 1.BACKGROUND • Maastricht IV (2012), V (2016), Toronto (2016): bismuth – containing quadruple therapy (PBMT) first-line empirical treatment and after the first eradication failure • Data about eradication rates of PBMT in Vietnam: still limited • Fallone, C A., et al (2016), The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults, Gastroenterology • Malfertheiner, P., et al (2012, 2016), Management of Helicobacter pylori infection the Maastricht IV, V Gut AIMS To evaluate Helicobacter pylori eradication rate To determine the rate of side effects To access the rate of medication compliance of bismuth-containing quadruple regimen (EBMT) in patients with chronic gastritis H pylori (+) 3.SUBJECTS AND METHODS • STUDY DESIGN Prospective, uncontrolled clinical trial • POPULATION Outpatient with gastroduodenal disease followed up at Gastroenterology clinics, in Thong Nhat – Dong Nai General Hospital 3.PATIENTS • INCLUSION CRITERIA Signs, symptoms of gastroduodenal disease Endoscopy: purely gastritis Histology: chronic gastritis Diagnosis in H pylori infected by ≥ tests (+): RUT (+) + 100% 1/3 - Antrum biopsy specimen - Corpus biopsy specimen H pylori (+) - Culture 3.PATIENTS • EXCLUSION CRITERIA Used: Antibiotics, Bismuth < wks; anti-secretory agents < wks Medical history: Coagulation disorders, allergy to any drugs Chronic disease: heart failure, renal failure, cirrhosis, chronic pulmonary disease Laboratory test: PLT < 100 K/L ALT > 60UI/L (male), > 38 UI/L (female) Gastric histopathology with cancer cells ERADICATION REGIMEN • ERADICATION REGIMEN EBMT 10 days: Esomeprazol 40 mg, b.i.d; 30 mins before meal Tripotassium dicitrato Bismuthate 600 mg, b.i.d; 30 mins before meal Metronidazole 250 mg, q.i.d Tetracycline 500 mg, q.i.d 10 4.DEMOGRAPHIC VARIABLES Mean age Female (%) Dore [1] 52 62.33 Laine [2] 47±13 38 Malfertheiner [3] 48.53±14.64 48 Our study 38.70± 10.47 42.77 Author • Our study: purely chronic gastritis, included nạve patients or after ≥ one eradication failure • Other studies: imflammation, ulcers and other gastroduodenal disease, naïve patients (1) Dore, M P., et al (2011), Helicobacter, 16(4), pp.295-300 (2) Laine, L., et al (2003), Am J Gastroenterol, 98(3), pp.562-567 (3) Malfertheiner, P., (2011), Lancet, 377(9769), pp.905-913 15 4.HISTORY OF TREATMEN H PYLORI 16 4.SUCCESSFUL OF H PYLORI ERADICATION RATE RESULTS OF H PYLORI ERADICATION POPULATION ITT (n = 166) PP (n = 150) Cases (%) CI 95% Cases (%) CI 95% Overall 134 (80.72) 73.89 – 86.43 134 (89.33) 83.26 – 93.78 Naïve patients 97 (79.51) 71.25 – 86.28 97 (90.65) 83.48 – 95.43 22 (91.67) 73.00 – 98.97 22 (91.67) 73.00 – 98.97 15 (75.00) 50.90 – 91.34 15 (78.95) 54.43 – 93.95 After 1st eradication failure After ≥ eradication failures 17 4.RATE OF FIRST H.PYLORI ERADICATION NAÏVE PATIENTS RESULTS OF H PYLORI ERADICATION Author ITT (%) PP (%) Dore [1] 92 95 Laine [2] 87.7 92.5 94 98 79.51 90.65 O’Morain [3] Our study •Don’t know clearly the importance of H pylori eradication •Be afraid of endoscopy after H pylori treatment •Choose urea breath test (1) Dore, M P., et al (2011), Helicobacter, 16(4), pp.295-300 (2) Laine, L., et al (2003), Am J Gastroenterol, 98(3), pp.562-567 (3) O'Morain, et al (2003), Aliment Pharmacol Ther, 17(3), pp.415-420 18 4.RATE OF H PYLORI ERADICATION AFTER 1ST ERADICATION FAILURE Author RESULTS OF H PYLORI ERADICATION ITT (%) PP (%) T T Trung [1] 93.3 95.7 Kuo [2] 79.7 90.8 91.67 91.67 Our study •Successful eradication: T T Trung > Our study > Kuo •Result of Kuo’s study after 1st eradication failure (ITT 79.7 and PP 90.8%) is the same as the first eradication result in our study (79.51 and 90.65%) given up treament (1) Trần Thiện Trung (2009), Y học Tp Hồ Chí Minh, 13(Phụ số 1), tr.11-17 (2) Kuo, C H., et al (2013), J Antimicrob Chemother, 68(1), pp.222-228 19 4.RATE OF H PYLORI ERADICATION AFTER ≥ ERADICATION FAILURES Author Gisbert Our study RESULTS OF H PYLORI ERADICATION ITT (%) PP (%) 65 67 75.00 78.95 •Gisbert: •Treatment duration varied from to 14 days •Variable doses of Tetracycline Metronidazole (1) Gisbert, J P., (2014), Dig Dis Sci, 59(2), pp.383-389 20 ... Author ITT (%) PP (%) Dore [1] 92 95 Laine [2] 87.7 92.5 94 98 79.51 90.65 O’Morain [3] Our study •Don’t know clearly the importance of H pylori eradication •Be afraid of endoscopy after H pylori... patient Treatment EBMT D1-D10 FLOW – CHART OF THE STUDY patients excluded: lost to follow-up 16 patients excluded : -3 side effects -1 unrelieved disease -2 compliance