INTRODUCTION test provides accurate and sensitive diagnosis

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INTRODUCTION

Helicobacter pylor is spiral in form with a flagellum, gram-negative,
microaerophilic bacterium in the human gastric mucosa, It is supposed to be the
most common bacterial infection and a leading risk factor for developing
gastric cancer in50% – 75% of the population all over the world also it is
associated with upper gastrointestinal diseases, including peptic ulcer disease
(gastric and duodenal), chronic gastritis, gastric cancer associated lymphoid
tissue lymphoma.( Lee HS. Histopathologic Diagnosis of H. pylori Infection). Helicobacter pylori: Springer;
2016: 119-27. Testing for H. pylori is highly recommended in patients with ; Active
peptic ulcer disease , After resection of early gastric cancer, Dyspepsia
undergoing upper endoscopy ,Gastric MALT lymphoma, History of peptic ulcer
disease, Idiopathic thrombocytopenic purpura (ITP),Unexplained iron deficiency
anemia, Family history of gastric cancer , Hyperplastic gastric polyps and Lymphocytic
gastritis. Transmission could be via feco-oral or mouth to mouth. Not all
infected individuals with H. pylori have the same symptoms the reasons due to
variation in the bacterial virulence and host risk factors. 90-95% of patients
with duodenal ulcers and seventy percent 
of gastric ulcers are associated with H. pylori infections. Recently,
reviews and and statistical analysis revealed that extra gastric diseases are
also associated with H. pylori infections, such as unexplained iron deficiency
anemia, idiopathic thrombocytopenic purpura ITP, unexplained vitamin B12
deficiency (megaloblastic anemia) , and the association of CagA -positive HP
strains with ischemic heart diseases IHD . ( Vítor JM, Vale FF.)

 Urea breath test :Urea breath test is considered the
gold standard method of diagnosis in both pre- and post-eradicated cases. It is
non-invasive, simple, highly accurate, but expensive ,  has a sensitivity of 96-100% and specificity
of 100% , also is  the most reliable
method of diagnosing HP infection in pre- and post-eradicated cases (
Osaki T, Mabe K, Hanawa
T, Kamiya S. Urease-positive bacteria in the stomach induce a false-positive
reaction in a urea breath test for diagnosis of Helicobacter pylori )

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Stool
antigen test

The stool antigen
test provides accurate and sensitive diagnosis in pre- and post-treatment cases
of H. pylori infections. A 4-8 week post -treatment evaluation has excellent
result but an evaluation <4 weeks post-treatment after PPI gives false results. (Lario S, Ramirez-Lazaro MJ, Montserrat A, Quilez ME, Junquera F, Martinez-Bauer E, et al. Diagnostic accuracy of three monoclonal stool tests in a large series of untreated Helicobacter pylori infected patients..)  IgG serology  Serum antigen marker immunoglobulin G antibodies serology is a very simple and available test for diagnosis of H. pylori infection. Positive results denotes that the patient has developed the infection but remains positive after eradication. However, it does not give false negative results in patients taking PPIs or antibiotics  so it is an excellent negative test as an exclusion of infection. (Marchildon PA, Sugiyama T, Fukada Y, Peacock JS, Asaka M, Shimoyama T, et al. Evaluation of the effects of strain-specific antigen variation ) Rapid urease test (RUT) RUT is a characteristic urease reaction done on a fresh biopsy. It is simple and rapid, with very good sensitivity and adequacy , even in post-treatment  cases. The sensitivity varies from 90-95% and specificity varies from 91-100%. However it also gives false positive results in non-helicobacter urease producing organisms and in patients with achlorhydria. (Calvet X,Montserrat A, Lario S, Ramírez-Lázaro MJ, Quesada M, et al. Accuracy of diagnostic tests for Helicobacter pylor.) Histology Histology using geimsa stained biopsy remains the gold standard for diagnosis with a sensitivity and specificity more than 95%. Immunostaining helps to increase the sensitivity to 100% and specitivity to 98 to 99%. (Buharideen S, Waduge R, Ratnatunga C. Evaluation of histology as a Helicobacter pylori detection methods.) Culture and sensitivity The role of culture and sensitivity has a gargantuan and leading role in increasing H. pylori eradication as it not only diagnoses H. pylori infection but also guides clinicians on using the appropriate treatment regimen according to the sensitivities of drugs in specific regions where antibiotic resistance is high and that is the AIM OF THIS PILOT THAT WE WILL APPLY TO PATIENTS IN AGOUZA HOSPITAL. AVAILABLE DRUG THERAPIES used in eradication. (Kim SG, , Kim CG, et al. Guidelines for the diagnosis and treatment of Helicobacter pylori infection  ) Standard therapy Standard triple therapy (PPI+ amoxicillin+ clarithromycin) for 7 days is the worldwide followed first line treatment regimen. However, IT fails in up to 30% of cases due to increased resistance to clarithromycin. (Yoon H, Kim N, Lee BH, Hwangt al. Moxifloxacin? Containing Triple Therapy as Second?Line Treatment for Helicobacter pylori Infection: Effect of Treatment Duration and Antibiotic Resistance on the Eradication Rate.) Sequential therapy Clarithromycin-based sequential therapy (lansoprazole, amoxicillin bid*5d, followed by lansoprazole, clarithromycin, metronidazole bid*5d).  Clarithromycin/tinidazole based sequential therapy (omeprazole 20 mg, amoxicillin 1 gm bid*5d, followed by omeprazole 20 mg, clarithromycin 500 mg, tinidazole 500 mg bid* 5d) . Esmoprazole/levofloxacin based sequential therapy (esomeprazole 40 mg+ amoxicillin 1 mg bid*5d followed by esomeprazole 40 mg+ levofloxacin 240 mg+ metronidazole 500 mg bid*5d) showed a higher eradication rate of >95%.  Moxifloxacin-based  sequential therapy (Rebeprazole
20 mg+ amoxicillin 1 gm bid*7d followed by Rebeprazole 20 mg+ metronidazole 500
mg+ moxifloxacin 400 mg bid*7d)

 Concomitant therapy  four drugs are concomitantly given for 7-14 days. (esomeprazole, 40 mg; amoxicillin 1gm, clarithromycin, 500 mg;
metronidazole, 500 mg) bid*10 days. 7 days of concomitant therapy (pantoprazole, 40 mg; amoxicillin, 1 mg;
clarithromycin, 500 mg; metronidazole, 500 mg bid) . 7- day concomitant therapy (Rebeprazole, amoxicillin, clarithromycin, metronidazole)  . omeprazole, 20 mg; amoxicillin, 1 gm;
clarithromycin, 500 mg; and tinidazole, 500 mg for 14 days concomitant therapy .

 Hybrid therapy:  hybrid therapy of omeprazole, 20
mg, and amoxicillin, 1 gm twice daily for 7 days,followed by omeprazole, 20 mg;
clarithromycin, 500 mg; and tinidazole, 500 mg twice daily for
another 7 days . hybrid therapy of esomeprazole, 40 mg, and amoxicillin, 1 gm, twice daily for 14 days plus
clarithromycin, 500 mg, and metronidazole, 500 mg, twice daily for the final 7
days (Zullo A, et al. Concomitant, sequential, and hybrid therapy for H. pylori
eradication: a pilot study. Clinics and research in hepatology and gastroenterology.)

 Rescue therapy :Rescue triple therapy (ecabet sodium, 2 gm; lansoprazole, 30 mg; amoxicillin,
750 mg bid) for 2 weeks. Rescue quadruple
therapy that is tetracycline-based, RRMB (Rebeprazole, rifabutin, minocycline,
bismuth subcitrate)(Furuta T, Furukawa K, et al. Triple therapy with ecabet
sodium, amoxicillin and lansoprazole for 2 weeks as the rescue regimen for H.
pylori infection)  RRMB regimen
can be an option in those who have failed at least 2 previous triple regimens. Rescue quadruple  therapy  (rebeprazole, 
20  mg amoxicillin 1  gm; 
bismuth  subcitrate 220  mg ,furazolidone, 100 mg bid*14 days or
furazolidone, 10mg tid *7 days)

REGIMENS THERAPIES ACCORDING TO THE
RECENT GUIDELINES  (Malfertheiner ,
Atherton J, Axon AT, Bazzoli F, et al. Management of Helicobacter pylori
infection.)

1st line regimen therapies include; 
in high resistant areas to clarithromycin   we can use Bismuth quadruple
therapy referred to as PBMT PPI + Bismuth + Metronidazole +
Tetracycline or Concomitant quadruple therapy
referred to as PAMC PPI + Amoxicillin + Metronidazole + Clarithromycin
The challenge of Helicobacter pylori resistance to
antibiotics: the comeback of bismuth-based quadruple therapy.).  In areas of low resistance to clarithromycin, The
following are the preferred clarithromycin triple therapy regimens: Clarithromycin
triple therapy (referred to as PAC PPI + Amoxicillin + Clarithromycin or PMC
PPI +Metronidazole + Clarithromycin for 14 days The following are alternatives
in case of failure of at least 2 previous first-line regimens: (Zagari RM,
Romano, Annibale B, et al. Guidelines for the management of Helicobacter pylori
infection)

1.PAM (PPI +
Amoxicillin + Metronidazole) for 14 days 
PPI:  omeprazole 20 mg BID or an
equivalent dose of an alternate PPI , Amoxicillin 1000 mg BID, Metronidazole
500 mg BID

2. Sequential therapy :PPI:  omeprazole 20 mg BID or an equivalent dose of
an alternate PPI for five to seven days, Amoxicillin 1000 mg BID for five to
seven days, Followed by PMC  for five to
seven days (Jung SM, Cheung DY, Kim JI, Kim I,
Seong H. Comparing the Efficacy of Concomitant Therapy with Sequential Therapy
as the First-Line Therapy of Helicobacter pylori Eradication)

3.Hybrid therapy :
PPI:  omeprazole 20 mg BID or an
equivalent dose of an alternate PPI for seven days ,Amoxicillin 1000 mg BID for
seven days Followed by PAMC  for seven
days

4. Levofloxacin triple therapy for ten to
14 days : PPI:  omeprazole 20 mg BID or
an equivalent dose of an alternate PPI, Amoxicillin 1000 mg BID,Levofloxacin
500 mg QD (Yoon H, Kim N, Lee BH, Hwang TJ, Lee DH, Park YS, et
levofloxacin? Containing Triple Therapy as Second?Line Treatment for Helicobacter
pylori Infection: Effect of Treatment Duration and Antibiotic Resistance on the
Eradication Rate )

5. Levofloxacin sequential therapy :PPI:  omeprazole 20 mg to 40 mg BID or an
equivalent dose of an alternate PPI for five to seven days, Amoxicillin 1000 mg
BID for five to seven days, Followed by five to seven days of:PPI:  omeprazole 20 mg to 40 mg BID or an
equivalent dose of an alternate PPI,Amoxicillin 1000 mg BID, Levofloxacin 500
mg QD, Metronidazole 500 mg BID

6.LOAD therapy (Levofloxacin
+ Omeprazole +alinia( nitazoxanide) + Doxycycline) therapy for seven to ten
days. (Basu ,rishnaswamy N, Flynn M. A randomized study
comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple
therapy for the eradication of Helicobacter pylori. The American journal of
gastroenterology)

II. Materials And Methods

 All patients undergoing endoscopy
for whatever reason in the agoza hospital, will be the test subjects of the
pilot . All the biopsy samples from gastric and duedunal lesions will be
gathered altogether in a filter soaked with normal saline and without
application of formalin followed by conventional tissue processing using  hematoxylin
with eosin staining, In addition, Geimsa staining will be applied to confirm
the presence of helicobacter Pylori . Biopsies confirmed positive to
helicobacter pylori infection will be processed for culture and sensitivity

III. Aim of the pilot: to overcome
the problem of Antibiotic resistance and eradication failure , by applying the
culture and sensitivity testing ,before any medical approach will allow to use
the most appropriate eradication regimen from the start .The high rate of clarithromycin resistance  made us prevent  its 
empirical  use  in standard triple anti-H pylori  regimens. resistance  rates 
of  metronidazole  and clarithromycin are significantly
elevating allover wide world followed by levofloxacin. Therefore, the
culture-guided therapy for H. pylori is currently mandatory specifically in
well-known antibiotic resistant countries.

IV. INCLUSION CRITERIA: these
conditions will determine the candidate patients

1.     
Patients with long term
dyspepsia especially those who developed alarming signs as cachexia

2.     
All patients undergoing
endoscopy are not diagnosed or known to be infected with helicobacter pylori

3.     
Patients wheather
received  PPI or antibiotic therapy or
both and the patients whom didn’t take any therapy will be included

4.     
Patients providing full
consent

5.     
Biopsies will be mainly
taken from the antrum of the stomach and the 1st part of duodenum

6.     
Full medical examination
along lab investigations as CBC ,liver and renal function tests

7.     
Age of the patients will
range from late twenties up to early fifties, pediatrics and geriatrics will be
excluded.

REFRENCES

1.   Vítor JM, Vale FF. Alternative therapies for
Helicobacter pylori: Immunology & Medical Microbiology.

2. Choi YJ: Diagnosis of
H. pylori Infection

3.   Helicobacter, Group CC. Gastric cancer and
Helicobacter pylori 2015

4.   Kim SG, Jung HK et al. Guidelines for the
diagnosis and treatment of Helicobacter pylori infection  2017

5.   Tonkic , Mégraud F. Epidemiology and
diagnosis of Helicobacter pylori infection 2008

6.   Hun Van Der Merwe S. World gastroenterology
organisation global guideline of gastrointestinal and liver disease. 2009

7.   Zhang Yang Y, et al. Seroepidemiology of
Helicobacter pylori infection. World journal of gastroenterology

8.   Kato M,  Recent knowledge of the relationship between
Helicobacter pylori and gastric cancer and recent progress of gastroendoscopic
diagnosis and treatment for gastric cancer. Japanese journal of clinical
oncology.

9.   Lee S-Y. Current progress toward eradicating
Helicobacter pylori , differences in the 2013 revised guidelines between China,
Japan, and South Korea. World journal of gastroenterology. 2014

10.Cancer Research UK:
Information resource center 2004.

 11
.Suzuki , Wakai K, et

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