EFFICACY AND SAFETY OF GEMIFLOXACIN CONTAINING TREATMENT REGIMEN IN FIRST-LINE TREATMENT OF HELICOBACTER PYLORI.

•In eradication treatment of H. pylori gemifloxacin containing triple treatment regimen was as effective as bismuth containing quadruple treatment. •Drug adverse effects were fewer and milder in the gemifloxacin group. •Since treatment period was shorter and pills to be taken were fewer compared to quadruple treatment, patient compliance was significantly higher in the gemifloxacin group. Background - After eradication of Helicobacter pylori (H. pylori) chronic gastritis will resolve, complications due to H. pylori infection and recurrence of infection will be prevented. Objective - To determine efficacy and safety of gemifloxacin containing treatment regimen in first line treatment of H. pylori with comparison to bismuth containing quadruple therapy. Methods - This retrospective study was conducted in a tertiary care university hospital between January 2018 and January 2021 with 410 participants who were diagnosed to have H. pylori infection with biopsies obtained during upper gastrointestinal system endoscopy. Patients were distributed into two groups according to their first-line treatment regimens. First group patients were treated with amoxicillin, gemifloxacin and pantoprazole and second group patients were treated with amoxicillin, metronidazole, bismuth subcitrate and pantoprazole for seven days. Results - Intention to treat and per protocol ratios for gemifloxacin containing regimen were 90.0% and 91.2%, while quadruple treatment has these ratios as 91.7% and 93.8% respectively. Treatment success rate in both regimens were similar. But adverse effects were lower and patient compliance were better in patients who had gemifloxacin containing treatment (P<0.001). Conclusion - Gemifloxacin containing treatment regimen is as effective as bismuth containing quadruple treatment regimen for H. pylori infection and patient compliance is better in this group. Gemifloxacin containing treatment regimens may be novel and effective alternatives for eradication of H. pylori infection.

Efetividade e segurança do regime de tratamento contendo gemifloxacino no tratamento de primeira linha para Helicobacter pylori / Efficacy and safety of gemifloxacin containing treatment regimen in first-line treatment of helicobacter pylori

ABSTRACT Background: After eradication of Helicobacter pylori (H. pylori) chronic gastritis will resolve, complications due to H. pylori infection and recurrence of infection will be prevented. Objective: To determine efficacy and safety of gemifloxacin containing treatment regimen in first line treatment of H. pylori with comparison to bismuth containing quadruple therapy. Methods: This retrospective study was conducted in a tertiary care university hospital between January 2018 and January 2021 with 410 participants who were diagnosed to have H. pylori infection with biopsies obtained during upper gastrointestinal system endoscopy. Patients were distributed into two groups according to their first-line treatment regimens. First group patients were treated with amoxicillin, gemifloxacin and pantoprazole and second group patients were treated with amoxicillin, metronidazole, bismuth subcitrate and pantoprazole for seven days. Results: Intention to treat and per protocol ratios for gemifloxacin containing regimen were 90.0% and 91.2%, while quadruple treatment has these ratios as 91.7% and 93.8% respectively. Treatment success rate in both regimens were similar. But adverse effects were lower and patient compliance were better in patients who had gemifloxacin containing treatment (P<0.001). Conclusion: Gemifloxacin containing treatment regimen is as effective as bismuth containing quadruple treatment regimen for H. pylori infection and patient compliance is better in this group. Gemifloxacin containing treatment regimens may be novel and effective alternatives for eradication of H. pylori infection.

RESUMO Contexto: Após a erradicação do Helicobacter pylori (HP), a gastrite crônica será resolvida, as complicações devido à infecção por HP e a recorrência da infecção serão prevenidas. Objetivo: Determinar a eficácia e segurança do regime de tratamento contendo gemifloxacino no tratamento de primeira linha do HP, em comparação com a terapia quádrupla contendo bismuto. Métodos: Este estudo prospectivo foi conduzido em um hospital universitário de atendimento terciário entre janeiro de 2018 e janeiro de 2021, com 410 participantes diagnosticados com infecção por HP, obtidos por meio de biópsias durante a endoscopia do sistema gastrointestinal superior. Os pacientes foram divididos em dois grupos de acordo com seus regimes de tratamento de primeira linha. Os pacientes do primeiro grupo foram tratados com amoxicilina, gemifloxacino e pantoprazol, e os pacientes do segundo grupo foram tratados com amoxicilina, metronidazol, subcitrato de bismuto e pantoprazol por 7 dias. Resultados: As taxas de intenção de tratar e por protocolo para o regime contendo gemifloxacino foram de 90,0% e 91,2%, enquanto o tratamento quádruplo apresentou essas taxas como 91,7% e 93,8%, respectivamente. A taxa de sucesso do tratamento em ambos os regimes foi similar. No entanto, os efeitos adversos foram menores e a adesão dos pacientes foi melhor nos que receberam o tratamento contendo gemifloxacino (P<0,001). Conclusão: O regime de tratamento contendo gemifloxacino é tão eficaz quanto o regime de tratamento quádruplo contendo bismuto para a infecção por HP, e a adesão dos pacientes é melhor neste grupo. Os regimes de tratamento contendo gemifloxacino podem ser alternativas novas e eficazes para a erradicação da infecção por HP.

Safety of peginterferon alfa-2a (40KD) treatment in patients with chronic hepatitis B infection: an observational, multicenter, open label, non-interventional study in Turkish patients.

BACKGROUND/AIMS: Pegylated alfa interferon is the only immunomodulatory drug licensed for hepatitis B. We evaluated the safety and tolerability of peginterferon alfa-2a (40KD) in patients with chronic hepatitis B. MATERIALS AND METHODS: A total of 113 chronic hepatitis B patients under peginterferon alfa-2a (40KD; 180 µg/week) treatment were included in this multicenter, open label, non-interventional study, and 66 patients completed the follow-up period. Vital signs, physical examination and laboratory findings, concomitant medications, and adverse events were recorded. A Quality of Life questionnaire (Short Form-36) was performed twice, at the beginning and at the end of the study. RESULTS: There was no significant difference between initial and last visits in terms of physical examination findings and Short Form-36 scores. A total of 27 adverse events were reported in 15 patients (22.7%), with most of them being mild in intensity (70.4%). The rates of the adverse events were similar in the monotherapy and combination therapy groups (peginterferon alfa-2a + lamivudine, peginterferon alfa-2a + adefovir or peginterferon alfa-2a + entecavir therapy groups), at 23.7% and 14.3%, respectively. The dosage of peginterferon had to be reduced in 3 patients (4.5%) due to thrombocytopenia. Overall patient compliance to treatment was detected as 85.9%. CONCLUSIONS: Based on the lack of serious adverse events and absence of impairment in Quality of Life, peginterferon alfa-2a (40KD, 180 µg/week, subcutaneously) treatment for 48 weeks led to a high level of patient compliance and was associated with a high degree of safety and tolerability for the treatment of adult patients with chronic hepatitis B in real-life practice.

Delayed presentation of post-traumatic diaphragmatic hernia with gastric volvulus: a case report.

Post-traumatic diaphragmatic hernia complicated by gastric volvulus may manifest immediately or several years after the incident. Delayed presentation of traumatic diaphragmatic hernia with gastric volvulus is relatively unusual. We report a 28-year-old male patient who admitted with gastric volvulus due to traumatic diaphragmatic hernia after sustaining a knife wound to the left lower chest one year before presentation. The patient has been followed without any symptom for two years since the diaphragmatic hernia was repaired by primary suture plication.

Cerebral sinus thrombosis in a patient with active ulcerative colitis and double heterozygosity for Factor V Leiden and prothrombin gene mutations.

Inflammatory bowel diseases are associated with increased risk for thrombotic complications, In patients with ulcerative colitis (UC) cerebral sinus venous thrombosis (CSVT) is an extremely rare complication. We report a patient with active UC and CSVT. The patient was heterozygous for Factor V Leiden and G20210A prothrombin gene mutations without other identifiable precipitating factors. This patient highlights the need for investigating the patients with UC with thrombotic complications for other thrombophilic states.

The spectrum of FMF mutations and genotypes in the referrals to molecular genetic laboratory at Kirikkale University in Turkey.

Familial Mediterranean Fever (FMF) is an autosomal recessive genetic disorder characterised by recurrent and self-limited abdominal pain, synovitis and pleuritis. MEFV gene mutations are responsible from the disease and its protein product, pyrin or marenostrin, plays an essential role in the regulation of the inflammatory reactions. MEFV gene contains 10 exons and most of the mutations have been found on the last exon. Up to date, 152 mutations and polymorpisms have been reported inwhere V726A, M694V, M694I, M680I and E148Q are the most common mutations. In this study, MEFV allele frequencies of 136 individuals (60 from Pediatry, 76 from Internal Medicine) have been evaluated, and compared with each other. Asymptomatic individuals with FMF family history (4 from Pediatry, 6 from Internal Medicine) were excluded from the analysis. The prominent mutations indicated in the Pediatry group are V726A, M694V and M680I (G/C) and with the allele frequency of 0.06, 0.05 and 0.04 respectively while they were E148Q, M694V, M680I (G/C) in the Internal Medicine group with the allele frequency of 0.12, 0.08 and 0.04. The E148Q mutation is significantly overrepresented in the adult referrals (P = 0.02). Mutation on both alleles was observed in only 12% of cases. Overall mutation frequency was low, seen in 26.2% (66/252). However, when only diagnosed patients were analyzed it is 72.7% (16/22). It is also interesting that 63% of individuals are female that there may be sex influence on FMF phenotype.

Diffuse plane xanthomatosis in a patient with Budd-Chiari syndrome and monoclonal gammopathy.

Diffuse plane xanthomas are characterized by the presence of yellowish plaques on the eyelids, neck, upper trunk, buttocks, and flexural folds. Histology shows foamy histiocytes in the dermis. Approximately half of the cases are associated with lymphoproliferative disorders. Budd-Chiari syndrome is an uncommon condition induced by thrombotic or nonthrombotic obstruction of hepatic venous outflow. We present a case of diffuse plane xanthoma in a 62-year-old man who developed normolipemic plane xanthomas coinciding with Budd-Chiari syndrome and monoclonal gammopathy. We review the English-language literature regarding the rare association of xanthomas and Budd-Chiari syndrome.

Celiac disease prevalence in patients with iron deficiency anemia of obscure origin.

BACKGROUND/AIMS: Anemia, especially due to iron deficiency, is a frequent feature in celiac disease. In this study, we aimed to define the prevalence of celiac disease in Turkish patients with iron deficiency anemia of obscure origin. METHODS: One thousand four hundred and eighty-six consecutive patients with iron deficiency anemia were evaluated for etiology. Of those, 77 patients were found to have iron deficiency anemia of obscure origin. Sera from 77 patients with iron deficiency anemia of obscure origin and 119 healthy controls were tested for IgA and IgG tissue transglutaminase (tTG) antibodies by ELISA. Endoscopic mucosal biopsies were taken from the second part of the duodenum in these patients. Histopathologic examination results of patients were stratified according to Marsh classification. RESULTS: IgA and IgG class anti-tTG antibodies were found positive in 6 (7.8%) and 3 (3.9%) patients with iron deficiency anemia of obscure origin, respectively. Three patients had only IgA anti-tTG and 3 had both IgA and IgG anti-tTG antibodies. In the control group, 1 subject was positive for both IgA and IgG anti-tTG antibodies (0.7%). Six patients (7.8%) and 1 control subject (0.8%) had histopathologic findings of celiac disease (p=0.02). CONCLUSIONS: Patients with iron deficiency anemia of obscure origin had increased prevalence of celiac disease. Our study results suggest that serological screening may be recommended for early detection of celiac disease in patients with iron deficiency anemia of obscure origin.

Does the urinary excretion of alpha1-microglobulin and albumin predict clinical disease activity in ulcerative colitis?

INTRODUCTION: There remains some difficulty in determining disease activity during the development of inflammatory bowel disease (IBD). The excretion levels of some inflammatory response molecules increase as a result of the onset of this disease. We studied urinary alfa-1-microglobulin (alpha1-MG) and albumin levels in patients with active and inactive ulcerative colitis (UC) and investigated whether we could use these parameters as an activity index. METHODS: The study was carried out at Gazi University Faculty of Medicine, Nephrology and Gastroenterology Departments, between December 2003 and March 2006. In total, 35 patients (male/female: 16/19, mean age: 38.3+/-2.4 years) and 13 healthy controls (male/female: 6/7, mean age: 35.8+/-2.8 years) were enrolled in the study. Nineteen patients had symptoms of active disease and the remaining 16 patients had inactive disease. RESULTS: There was a significant difference in serum C-reactive protein (CRP), urinary albumin excretion, and alpha1-MG excretion levels between patients and controls. Patients with active disease had significantly higher serum CRP and alpha1-MG levels than those with inactive disease and controls. Patients with active disease had higher microalbuminuria levels than inactive patients, but this difference was not statistically significant. Urinary albumin and alpha1-MG excretion did not correlate with serum CRP levels. CONCLUSION: The present study suggests that, as with CRP, urinary levels of albumin and alpha1-MG increase during the active period of UC. During the inactive period, concentrations of these parameters are comparable to controls. The measurement of alpha1-MG and/or microalbuminuria could provide information on disease severity and response to treatment.

Prevalence of coeliac disease in patients with autoimmune thyroiditis in a Turkish population.

AIM: To investigate the prevalence of coeliac disease in a series of Turkish patients with autoimmune thyroiditis. METHODS: Sera from 136 consecutive patients with newly diagnosed autoimmune thyroiditis and 119 healthy blood donors were tested for IgA tissue transglutaminase antibody with enzyme-linked immunosorbent assay. Endoscopic mucosal biopsy from the second part of duodenum was performed in patients with positive antibody test. RESULTS: Eight patients (5.9%) and one control subject (0.8%) were positive for IgA tissue transglutaminase antibody (OR: 7.38, 95% CI: 0.91-59.85, P = 0.04). Six patients and one control agreed to take biopsies. Histopathological examination revealed changes classified as Marsh IIIa in one, Marsh II in one, Marsh I in two, and Marsh 0 in two patients with autoimmune throiditis, and Marsh I in one blood donor. CONCLUSION: Turkish patients with autoimmune thyroiditis have an increased risk of coeliac disease and serological screening may be useful for early detection of coeliac disease in these patients. Our findings need to be confirmed in a larger series of patients.

Prevalence of occult hepatitis B and hepatitis C virus infections in Turkish hemodialysis patients.

BACKGROUND AND OBJECTIVE: Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections are important causes of morbidity and mortality in maintenance hemodialysis patients. Although their exact prevalence is not known, HBV and HCV viral infections and occult viral hepatitis are frequent in these patients. This study aimed to determine the prevalence of occult HBV and HCV infections in maintenance hemodialysis patients. MATERIALS AND METHODS: One hundred and eighty-eight end-stage renal disease patients on maintenance hemodialysis (100 male, mean age 49+/-29 [16-80] years, and mean duration of hemodialysis 98+/-66 [12-228] months) were enrolled in this study. Serological markers for HBV and HCV were determined with immunoenzymatic assay (ELISA) by using commercial diagnostic kits (Access and BioRad, Beckman-Coulter). HCV-RNA (Cobas Amplicor HCV kit) and HBV-DNA (Artus GmbH HBV kit) were determined quantitatively by polymerase chain reaction. RESULTS: Among the patients screened, 25 (13.3%) had HBV infection alone and 38 (20.2%) had HCV infection alone, while seven (3.7%) had dual infection of both viruses. Serological markers for occult hepatitis B and occult hepatitis C were positive in five (2.7%) and nine (4.8%) of the patients, respectively. Isolated anti-HBc was positive in 12 (6.4%) of all patients, three (7.9%) of the patients with anti-HCV and two (40%) of the patients with occult hepatitis B. Isolated anti-HBc positivity was more frequent in patients with occult hepatitis B than in those without (40% [2/5] vs. 5.5% [10/183], p=0.002). None of the patients with HCV had occult hepatitis B. CONCLUSIONS: Both occult and non-occult forms of HCV infection are more prevalent than HBV infection in hemodialysis patients. Especially the patients with isolated anti-HBc positivity should be tested for probable occult hepatitis B infection.

Evaluation of gallbladder motility in patients with irritable bowel syndrome.

BACKGROUND: Abnormalities involving smooth muscle function in different systems of the body have been reported in irritable bowel syndrome (IBS). There are a few studies on gallbladder function in this disorder with conflicting results. OBJECTIVES: To investigate the motility of gallbladder in patients with IBS. PATIENTS AND METHODS: Forty-eight patients (15 male and 33 female) with IBS and 48 healthy volunteers (15 male and 33 female) were included into the study. Thirty-four patients (70.8%) had constipation predominant and 14 patients (29.2%) had diarrhoea predominant type of IBS. Fasting and postprandial gallbladder volumes were studied using real time ultrasonography and ejection fraction (EF) of gallbladder was calculated. RESULTS: While fasting gallbladder volume (FGV) was similar between IBS and control groups (18.0 +/- 4.0 ml vs. 17.8 +/- 4.9 ml, p >0.05), postprandial gallbladder volume (PGV) was lower in IBS group than in the control group (5.5 +/- 1.4 ml vs. 6.2 +/- 1.9 ml, p = 0.03). Accordingly, the mean EF of gallbladders was found to be higher in IBS group than in the control group (69.1% vs. 64.1%, p = 0.0001). There were no difference in FGV, PGV and EF of gallbladders between constipation predominant and diarrhoea predominant IBS patients (p >0.05). CONCLUSION: The results of this study indicated that IBS patients have increased emptying of gallbladder compared to healthy subjects.

Vitamin E treatment in patients with nonalcoholic steatohepatitis: A six-month, open-label study of sixteen patients.

BACKGROUND: Free radicals have a pivotal role in the pathogenesis of nonalcoholic steatohepatitis (NASH). Decreasing oxidative stress might have beneficial effects on the biochemical and histologic progression of this disease. OBJECTIVE: We aimed to determine the therapeutic effect of vitamin E, a potent antioxidant, on liver enzymes and histology in NASH. METHODS: This 6-month, open-label study was conducted at the Departments of Gastroenterology and Pathology, Gazi University School of Medicine (Ankara, Turkey). Patients aged 18 to 70 years with biopsy-proven NASH were included in the study. All patients received vitamin E 800 U/d in 2 divided doses, orally (capsules) for 6 months. Patients were not advised to change their exercise or dietary habits. Body mass index (BMI) was calculated at months 0 (baseline) and 6. Histologic scoring of steatosis, necroinflammatory grade, and fibrosis stage was performed at 0 and 6 months. Liver enzyme activities (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and gamma-glutamyltransferase [GGT]) were monitored monthly. Control biopsy specimens were obtained at the end of the treatment. All of the liver biopsies were read by a single pathologist (G.A.) who was blinded to the clinical, laboratory, and histopathologic data, as well as the sequence of liver biopsies. Assessments of compliance and tolerability of treatment were performed using a pill count and patient interview, respectively, at the end of each month. RESULTS: Sixteen patients (12 men, 4 women; mean [SD] age, 45.5 [6.9] years [range, 37-60 years]) were enrolled. All patients completed 6 months of treatment. Mean BMI did not change significantly from baseline. Significant improvements in mean (SD) serum liver enzyme activities were observed at 6 months compared with baseline (ALT: 38.6 [16.3] U/L vs 84.8 [22.1] U/L, respectively, P = 0.001; AST: 29.8 [15.4] U/L vs 46.0 [16.0] U/L, respectively, P = 0.001; ALP: 154.6 [64.1] U/L vs 211.5 [70.4] U/L, respectively, P= 0.011; and GGT: 49.8 [38.5] U/L vs 64.7 [54.4] U/L, respectively, P = 0.002), as well as in total cholesterol level (176.2 [42.0] mg/dL vs 199.6 [60.6] mg/dL; P = 0.02). Posttreatment liver biopsy was available in 13 patients (81%). Significant improvements in the mean (SD) scores of steatosis (1.46 [0.66] vs 2.43 [0.62]; P = 0.002) and necroinflammatory grade (0.84 [0.24] vs 1.31 [0.51]; P= 0.006) were observed at 6 months compared with baseline, respectively. However, no significant change was noted in the mean (SD) score of fibrosis stage (0.77 [0.33] vs 1.12 [0.59], respectively). None of the patients reported any adverse effects. CONCLUSION: In this small, 6-month, open-label study, vitamin E treatment was safe and well tolerated and led to potential biochemical and histologic improvements (except in fibrosis) in patients with NASH.