2 drhue vdd mạn do hp 2eng ebmt 251116

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
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CONTENT
1. BACKGROUND
2. AIMS
3. SUBJECTS AND METHODS
4. RESULTS - DISCUSSION
5. CONCLUSION - SUGGESTION

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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.

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• 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

2 abx 45.6

-

-

-

CLR+LFX
22.4
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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.
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• Malfertheiner, P., et al (2012, 2016), Management of Helicobacter pylori infection--the Maastricht IV, V. Gut.


2. 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 (+)

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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.

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3.PATIENTS
• INCLUSION CRITERIA
 Signs, symptoms of gastroduodenal disease.
 Endoscopy: purely gastritis.
 Histology: chronic gastritis.
 Diagnosis in H. pylori infected by ≥ 2 tests (+):
RUT (+) +
100%

1/3

- Antrum biopsy specimen

- Corpus biopsy specimen

H. pylori (+)

- Culture
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3.PATIENTS
• EXCLUSION CRITERIA
 Used: Antibiotics, Bismuth < 4 wks; anti-secretory agents < 2 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.

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3. 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.
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3.FOLLOW – UP
• EVALUATE MEDICATION COMPLIANCE AND SIDE EFFECTS, DAY 1-14:


follow – up side effects of therapy



patient compliance

 patient taking rightly, using ≥ 80% delivered - drugs.

 degree of compliance:
- Low level compliance: ≥ 80-90%
- High level compliance: ≥ 91-100% (completely 100%).

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3.FOLLOW – UP
• ASSESSMENT METHODS OF ERADICATION, WEEK 4 – 8 AFTER
STOPPING TREATMENT COURSE:
 Repeat endoscopy with both tests:


RUT



Histological examination

 Successful eradication of H. pylori = ALL of three tests (-):

 RUT (-) + corpus biopsy (-) + antrum biopsy (-).

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177 patient
Agreed to participate in the
study

8 patients excluded:
-7 pts ALT > 2 times ULN
-1 pts PLT <100 K/L

169 patient
Treatment EBMT D1-D10

FLOW – CHART
OF THE STUDY

3 patients excluded:
lost to follow-up
16 patients excluded :
-3 side effects
-1 unrelieved disease
-2 compliance <80%
-3 no endoscopy
-1 test H. pylori another
hospital
-1 used antibiotic for
different disease
-1 took more drugs at
day2 due to fever
-3 got out of the area
-1 lost to follow-up

ITT

PP

166 patient
Have information after
≥ 1 dose of treatment

150 patient
Complete research

Success rate
of
eradication

Failure rate
of
eradication

D11-D14: Evaluate
side effects, and
medication compliance
D40-D56 (Week 4–8
after stopping
treatment course):
Repeat endoscopy

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4.RESULTS - DISCUSSION
From 3/2014 to 1/2016: 166 patients

Mean age ± SD:

38.70 ± 10.47
•Minimum: 17
•Maximum: 73

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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 naïve
patients or after ≥ one eradication failure.
• Other studies: imflammation, ulcers and other
gastroduodenal disease, nạve 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.

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4.HISTORY OF TREATMEN H. PYLORI

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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 ≥ 2 eradication
failures

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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.

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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 bản số 1), tr.11-17.
(2) Kuo, C. H., et al (2013), J Antimicrob Chemother, 68(1), pp.222-228

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4.RATE OF H. PYLORI ERADICATION

AFTER ≥ 2 ERADICATION FAILURES

Author
Gisbert
Our study

RESULTS OF H. PYLORI ERADICATION
ITT (%)

PP (%)

65

67

75.00

78.95

•Gisbert:
•Treatment duration varied from 7 to 14 days.
•Variable doses of Tetracycline và Metronidazole.
(1) Gisbert, J. P., (2014), Dig Dis Sci, 59(2), pp.383-389

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