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BACKGROUND AND AIMS: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. METHODS: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. RESULTS: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29-99% in <50 years to 60-99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. CONCLUSION: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.
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BACKGROUND & AIMS: After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. METHODS: This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology-Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. RESULTS: Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin-bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. CONCLUSIONS: Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin-bismuth quadruple therapy, 14-day tetracycline-bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.
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Infecções por Helicobacter , Helicobacter pylori , Quinolonas , Adulto , Amoxicilina , Antibacterianos/uso terapêutico , Bismuto , Claritromicina/uso terapêutico , Quimioterapia Combinada , Infecções por Helicobacter/tratamento farmacológico , Humanos , Levofloxacino , Moxifloxacina/uso terapêutico , Penicilinas/efeitos adversos , Estudos Prospectivos , Inibidores da Bomba de Prótons , Quinolonas/uso terapêutico , Sistema de Registros , Tetraciclina/uso terapêuticoRESUMO
INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management." METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.
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Antibacterianos/efeitos adversos , Bismuto/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Infecções por Helicobacter/tratamento farmacológico , Inibidores da Bomba de Prótons/efeitos adversos , Antibacterianos/uso terapêutico , Bismuto/uso terapêutico , Quimioterapia Combinada , Europa (Continente)/epidemiologia , Feminino , Infecções por Helicobacter/epidemiologia , Helicobacter pylori , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/uso terapêutico , Sistema de RegistrosRESUMO
Helicobacter pylori is the most prevalent infection worldwide, while non-alcoholic fatty liver disease emerged as the most frequent liver disease. The common occurrence can be either by chance or due to certain pathogenetic factors. Epidemiologic studies revealed that the risk of non-alcoholic liver disease is increased in patients infected with Helicobacter pylori. DNA fragments of Helicobacter pylori were rarely identified in human samples of liver carcinoma and fatty liver. Helicobacter pylori could influence the development of non-alcoholic fatty liver either by hormonal (ghrelin? gastrin? insulin?), or by effect of pro-inflammatory cytokines (interleukin 1 and 8, tumor necrosis factor É, interferon É£) and by changes of gut microbiome as well. Probiotic supplementation could improve some clinical parameters of non-alcoholic fatty liver disease and eradication rates of Helicobacter pylori. Regimens used for eradication can be safely administered, although non-alcoholic fatty liver increases the risk of drug-induced liver damage. Controlled studies of the effect of eradication on the development and progression of non-alcoholic fatty liver are warranted.
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Infecções por Helicobacter/complicações , Helicobacter pylori , Hepatopatia Gordurosa não Alcoólica/complicações , Infecções por Helicobacter/fisiopatologia , Humanos , Hepatopatia Gordurosa não Alcoólica/fisiopatologiaRESUMO
The subject of Helicobacter pylori continues to elicit worldwide interest in many research fields. Epidemiological data suggest that the prevalence of the infection is decreasing in Western/developed countries and even in some developing regions, but this is masked by the high prevalence in the most populous regions. Chronic gastritis, caused invariably by the bacterium, was again classified in Kyoto and Helicobacter pylori-associated gastritis was included as a distinct entity. The prevalence of peptic ulcers is decreasing, but bleeding ulcers are a challenging problem, with stable mortality levels even in the endoscopic era. With the extended use of endoscopy, gastric polyps (GP) have become more prevalent: some are associated with the infection, some are not. Autoimmune and Helicobacter-induced gastritis can share common pathogenetic mechanisms. Gastric cancer (GC) is ranked highly on mortality lists worldwide. Its surgical treatment has registered some progress though. Little, if any improvement has been achieved in the medical treatment of advanced GC. With proper organization, GC seems a preventable disease. In spite of many guidelines, the Pan-European registry of Helicobacter pylori management shows that eradication rates obtained in many places are suboptimal. A new therapeutic regimen was compiled with promising pilot results. The results obtained with vonaprazan are limited to Asia. New avenues of both antibiotic and non-antibiotic treatments are expected to accelerate the eradication of this ulcerogenic and carcinogenic bacterium.
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Duodenopatias/microbiologia , Neoplasias Duodenais/microbiologia , Infecções por Helicobacter/complicações , Helicobacter pylori , Gastropatias/microbiologia , Neoplasias Gástricas/microbiologia , HumanosRESUMO
BACKGROUND: Some gastric cancers are Epstein-Barr virus associated. AIM: To assess the prevalence of Helicobacter pylori and viral co-infection in benign upper digestive diseases. METHODS: One hundred and four outpatients were included in a prospective endoscopic-serologic study. Epstein-Barr virus immunoglobulin G (IgG), immunoglobulin M and viral capsid antigen titres were assayed with an ELISA test. Helicobacter pylori was determined by the modified Giemsa stain and by IgG-chemiluminescence. RESULTS: The overall prevalence of Helicobacter pylori was 56.7%. Duodenal ulcer patients were infected in 72.5 % of the cases, with the prevalence being 33.3% in functional dyspepsia (p = 0.0008) and 25.8% in reflux patients (p = 0.0001). Epstein-Barr virus IgG was detected in 70.1% of the whole group, 75% of duodenal ulcer patients, 51.2% of functional dyspepsia patients (p = 0.04) and 51.6% of the reflux disease cases (p = 0.04). Co-infection with both agents was detected in 60% of duodenal ulcer patients, 18.1% of functional dyspepsia (p = 0.00014) and 12.9% of reflux disease patients (p = 0.00012). Anti-viral IgG titre displayed a 31.7 ± 3.0 cut-off index in duodenal ulcer, 20.5 ± 3.5 in functional dyspepsia (p = 0.01) and 21.4 ± 3.6 in reflux cases (p = 0.03). CONCLUSIONS: Both Helicobacter pylori and Epstein-Barr virus, and co-infection with these agents, were significantly more prevalent in duodenal ulcer patients than in dyspeptic/reflux patients.
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Carbonic anhydrase (CA, EC 4.2.1.1) inhibitors (CAIs) started to be used in the treatment of peptic ulcers in the 1970s, and for more than two decades, a group led by Ioan Puscas used them for this purpose, assuming that by inhibiting the gastric mucosa CA isoforms, hydrochloric acid secretion is decreased. Although acetazolamide and other sulfonamide CAIs are indeed effective in healing ulcers, the inhibition of CA isoforms in other organs than the stomach led to a number of serious side effects which made this treatment obsolete when the histamine H2 receptor antagonists and the proton pump inhibitors became available. Decades later, in 2002, it has been discovered that Helicobacter pylori, the bacterial pathogen responsible for gastric ulcers and cancers, encodes for two CAs, one belonging to the α-class and the other one to the ß-class of these enzymes. These enzymes are crucial for the life cycle of the bacterium and its acclimation within the highly acidic environment of the stomach. Inhibition of the two bacterial CAs with sulfonamides such as acetazolamide, a low-nanomolar H. pylori CAI, is lethal for the pathogen, which explains why these compounds were clinically efficient as anti-ulcer drugs. Thus, the approach promoted by Ioan Puscas for treating this disease was a good one although the rationale behind it was wrong. In this review, we present a historical overview of the sulfonamide CAIs as anti-ulcer agents, in memoriam of the scientist who was in the first line of this research trend.
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Antiulcerosos/história , Antiulcerosos/uso terapêutico , Inibidores da Anidrase Carbônica/história , Inibidores da Anidrase Carbônica/uso terapêutico , Úlcera Péptica/tratamento farmacológico , Úlcera Péptica/história , Animais , Antiulcerosos/química , Inibidores da Anidrase Carbônica/química , Helicobacter pylori/efeitos dos fármacos , Helicobacter pylori/enzimologia , História do Século XX , Humanos , Úlcera Péptica/microbiologia , Sulfonamidas/química , Sulfonamidas/história , Sulfonamidas/uso terapêuticoRESUMO
BACKGROUND: The urea breath test (UBT) is one of the most accurate methods of assessing Helicobacter pylori status. The predictive value of the test is, however, uncertain. This study was a serial, prospective analysis of the change over time of UBT values after first-, second- and third-line treatments of patients with failed eradication therapy. METHODS: One hundred thirty-four duodenal ulcer patients with persisting H. pylori infection after first-line triple therapy were enrolled in a cross-over manner to receive either pantoprazole (40 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg) or ranitidine bismuth citrate (400 mg twice daily), metronidazole (250 mg twice daily), and clarithromycin (500 mg twice daily) for 7 days. Forty-one patients with failed second-line treatment were randomized to receive third-line quadruple therapies with pantoprazole + amoxicillin and tetracycline (500 mg four times daily) and either nitrofurantoin (100 mg three times daily) or bismuth subsalicylate (120 mg four times daily). Breath tests were performed 6 weeks after therapy. The delta(13)CO(2) values ( per thousand) after primary, secondary, and tertiary treatment were analyzed, and the correlation between pretreatment values and the rate of H. pylori eradication was assessed. RESULTS: In patients with successful second-line treatment, UBT values decreased from 12.4 per thousand [confidence interval (CI), 9.7-15.7)] to 2.8 per thousand (CI, 0.9-2.5) (P=0.001), and in those with persistent infection, they increased from 13.2 per thousand (CI, 7.3-19.1) to 19.2 per thousand (CI, 13.4-25.0) (P=0.03). After a failed quadruple regimen, UBT values increased from 19.3 per thousand (CI, 16.2-22.4) to 25.8 per thousand (CI, 19.8-312.8) (P=0.03). The correlation between the pretreatment UBT values and the rate of eradication was negative for both second- and third-line therapies. CONCLUSIONS: Serial assessment showed that UBT values after successive treatments showed a marked tendency to increase over time in failed cases. The significance of this phenomenon must be further studied. It might indicate increased colonization, ongoing resistance, or urease gene overexpression. Higher pretreatment UBT values were associated with lower (<60%) eradication rates. In these cases, alternative/rescue therapies should be chosen.
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Testes Respiratórios , Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori , 2-Piridinilmetilsulfinilbenzimidazóis/uso terapêutico , Adulto , Anti-Infecciosos/uso terapêutico , Bismuto/uso terapêutico , Claritromicina/uso terapêutico , Estudos Cross-Over , Quimioterapia Combinada , Feminino , Humanos , Masculino , Metronidazol/uso terapêutico , Pessoa de Meia-Idade , Pantoprazol , Inibidores da Bomba de Prótons , Ranitidina/análogos & derivados , Ranitidina/uso terapêutico , Ureia/análiseRESUMO
Several aspects of Helicobacter pylori eradication have been meta-analyzed; however, nitrofuran-based therapies constitute an exception. The aim of this study was the systematic review and meta-analysis of the effect of furazolidone- and nitrofurantoin-based regimens in the eradication of infection. Studies evaluating the effects of nitrofurans on H. pylori were identified from Medline, EMBASE, the Cochrane Controlled Trials Register and congress abstracts. The studies were classified into groups based on first-, second- and third-line regimens. The pooled eradication rates and combined odd ratios of the individual studies were calculated and compared with the published meta-analysis. The factors influencing the efficiency of the regimens were also analyzed. Side-effects of nitrofuran-based regimens were also analyzed. The pooled eradication rate of primary proton pump inhibitor-based regimens containing furazolidone was 76.3% (CI 67.8-84.2). The odds ratio for furazolidone-based regimens versus standard triple therapies was 2.34 (CI 0.76-3.92). Ranitidine bismuth citrate + furazolidone-based triple regimens were equally efficient (83.5%, CI 74.0-93.0, P = 0.06 versus triple therapies). Schedules including a H(2) antagonist + furazolidone + one other antibiotic achieved pooled eradication rates of 79.9% (CI 67.8-89.9, P = 0.04). Bismuth-based triple therapies achieved 84.5% (CI 72.6-93.0, P = 0.002). Primary quadruple regimens containing furazolidone were superior to triple therapies (83.4%, CI 69.7-92.3, P = 0.01). Second-line schedules containing furazolidone obtained eradication rates of 76.1% (CI 66.4-85.0, P = 0.28 versus primary regimens). Third-line 'rescue' therapies were efficient in 65.5% of the cases (CI 56.3-75.5, P = 0.0001). Side-effects of the regimens containing furazolidone were more frequent than in standard therapies (P = 0.02). The combined odds ratio of side-effects for furazolidone-based versus standard therapies was 0.74 (CI 0.32-1.98). The duration of treatment, but not the furazolidone dose, influenced the treatment outcome. Primary triple regimens containing furazolidone are slightly less efficient than the standard primary combinations; primary quadruple regimens were more efficient than triple therapies. Furazolidone is also efficient as a component of second-line or rescue therapies.
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Anti-Infecciosos Locais/uso terapêutico , Furazolidona/uso terapêutico , Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori , Antiulcerosos/uso terapêutico , Bismuto/uso terapêutico , Quimioterapia Combinada , Antagonistas dos Receptores H2 da Histamina/uso terapêutico , Humanos , Inibidores da Bomba de Prótons/uso terapêutico , Ranitidina/análogos & derivados , Ranitidina/uso terapêuticoRESUMO
AIM: To meta-analyse the European abstracts presented between 1997-2004 at the European H pylori Study Group, United European Gastroenterology Week meetings and World Congresses of Gastroenterology. METHODS: The abstracts of randomized/controlled prospective studies were classified into groups based on first-line eradication schedules. The quality of the abstracts was checked by a validated score system. The pooled eradication rates (PER) and combined odds ratios (OR) were calculated and compared with the published meta-analyses. RESULTS: The PER of proton pump inhibitor-based (PPI) one week triple therapies was 81.4% (confidence interval, 95% CI: 78.5-84.5). Ranitidine bismuth citrate-based (RBC) triple regimens have an efficiency rate of 78.5% (95% CI: 70.5%-84.3%) (P = 0.28 vs PPI). The OR for PPI effect vs RBC regimens was 1.1 (95% CI: 0.92-1.30). H(2) receptor antagonist-based triple therapies achieved 64.1% (95% CI: 52.6-75.6) (P = 0.02 < 0.05 vs PPI), the OR vs PPI regimens was 1.55 (95% CI: 0.72-3.78). PPI-based double combinations were less efficient than triple regimens (PER: 55.0%, OR: 4.90, 95% CI: 2.36-9.70). Quadruple regimens were successful in 82.6% (95% CI: 76.0-89.7), the OR vs triple therapies was 0.80 (0.62-1.03). Clarithromycin + amoxicillin or nitroimidazole combinations were efficient in 80.5% (95% CI: 77.2-84.2) and 83.8% (95% CI: 81.7-85.9), respectively. Amoxicillin + nitromidazole therapies eradicated the infection in 73.5% (66.6-78.5) (P = 0.01 < 0.05 vs clarithromycin-based regimens). CONCLUSION: PPI/RBC-based triple therapies achieved comparable results with the meta-analyses. H(2)-receptor antagonists and PPI-based double combinations were less efficient. Triple and quadruple regimens were equally effective. Clarithromycin + either amoxicillin or nitroimidazole containing regimens were more effective than amoxicillin + nitroimidazole combinations. High quality congress abstracts constitutes a valuable pool of data which is suitable for meta-analytical workup.
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Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/terapia , Helicobacter pylori/metabolismo , Anti-Infecciosos/metabolismo , Bismuto/farmacologia , Quimioterapia Combinada , Europa (Continente) , Humanos , Bombas de Próton/metabolismo , Ranitidina/análogos & derivados , Ranitidina/farmacologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Quality of life (QOL) is impaired in functional dyspepsia (FD). Little is known about the effects of different therapies on the QOL profile in patients with this condition. OBJECTIVES: The aims of this study were to measure baseline QOL in patients with FD and to assess changes in QOL over time associated with Helicobacter pylori eradication and prokinetic treatment. The primary and secondary end points were the improvement in QOL 6 weeks and 1 year after successful eradication of the infection or prokinetic therapy. METHODS: This 1-year, single-center, prospective, open-label, controlled, parallel-group trial was conducted at the Department of Gastroenterology, Ferencvdros Health Centre, Budapest, Hungary. The Functional Digestive Disorder Quality of Life (FDDQoL) Questionnaire (MAPI Research Institute, Lyon, France) was translated and validated previously in Hungarian. Male and female subjects aged 20 to 60 years were enrolled and classified as H pylori positive (HP+), H pylori negative (HP-) with FD, or healthy (control group). The HP+ patients received pantoprazole 40 mg BID + amoxicillin 1000 mg BID + clarithromycin 500 mg BID for 7 days, followed by on-demand ranitidine (150-300 mg/d) for 1 year. The HP- patients received the prokinetic cisapride 10 mg TID for 1 month, followed by on-demand cisapride (10-20 mg/d) for 1 year. The FDDQoL questionnaire was completed by all 3 groups on enrollment, at 6 weeks, and 1 year. RESULTS: A total of 101 HP+ patients, 98 HP- patients, and 123 healthy controls were included in the study (185 women, 137 men; mean age, 39.0 ears). The mean (SD) baseline QOL scores were significantly lower in the HP+ group (53.3 [9.6]; 95% CI, 54.4-58.2) and the HP- groups (50.0 [9.8]; 95% CI, 58.0-62.0) compared with that in healthy controls (76.2 [8.7]; 95% CI, 74.6-77.8) (both, P < 0.001). Analysis of the short-term domain scores found that the HP+ group had significantly decreased scores in 6 of 8 domains: daily activities (P = 0.005), anxiety level (P = 0.02), diet (P = 0.008), sleep (P < 0.001), discomfort (P = 0.004), and disease control (P = 0.02); the HP- group had significantly decreased scores in 5 of 8 domains: daily activities (P < 0.001), diet (P = 0.004), sleep (P = 0.005), discomfort (P < 0.001), and disease control (P = 0.02). Eradication of the infection was successful in 77/101 (76.2%) of the patients on intent-to-treat analysis and 77/94 (81.9%) on per-protocol analysis. Eradication was associated with an increase in mean (SD) QOL score to 70.8 (10.7) at 6 weeks (95% CI, 63.3-73.2; P < 0.001 vs baseline) and to 75.3 (9.3) at 1 year (95% CI, 73.2-77.5; P= 0.05 vs 6 weeks). In the HP- group, the QOL score increased to 73.3 (9.7) (95% CI, 71.3-75.4; P < 0.001 vs baseline) at 6 weeks of cisapride treatment and to 76.5 (8.5) at 1 year (95% CI, 74.5-78.4; P = 0.06 vs 6 weeks). Most of the impaired domain scores improved significantly after both treatments. The short-term effect size was 1.48 in HP+ and 1.35 in HP- patients. Adverse events (AEs) occurred in 22 (21.8%) patients in the HP+ group (nausea, 8 [7.9%] patients; diarrhea, 5 [5.0%]; loss of appetite, 5 [5.0%]; stomatitis, 5 [5.0%]; abdominal pain, 4 [4.0%]; bloating, 4 [4.0%]; headache, 4 [4.0%]; vomiting, 4 [4.0%]; constipation, 3 [3.0%]; and vaginitis, 3 [3.0%]). In HP- cases, AEs occurred in 9 (9.2%) patients (abdominal cramps, 7 [7.1%]; diarrhea, 4 [4.1%]; and nausea, 3 [3.1%]). CONCLUSION: In this study in patients with FD and healthy controls, eradication of H pylori infection in infected patients and cisapride treatment in uninfected patients reversed low QOL scores during the 1-year follow-up period.
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Acetazolamida/uso terapêutico , Inibidores da Anidrase Carbônica/uso terapêutico , Anidrases Carbônicas/efeitos dos fármacos , Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori/enzimologia , Acetazolamida/administração & dosagem , Inibidores da Anidrase Carbônica/administração & dosagem , Anidrases Carbônicas/metabolismo , Infecções por Helicobacter/microbiologia , Helicobacter pylori/efeitos dos fármacos , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Following standard first-line triple therapies for Helicobacter pylori infection, up to 20% of patients require further eradication. OBJECTIVE: The aim of this study was to assess the effects of second-line triple therapies and third-line quadruple therapies for the eradication of H pylori. METHODS: This 7-week, prospective, crossover, controlled, second- and third-line trial was conducted at the Department of Gastroenterology, Ferencváros Health Center (Budapest, Hungary). Patients aged 18 to 80 years with duodenal ulcers and an H pylori infection resistant to first-line triple therapy (pantoprazole 40 mg BID + amoxicillin 1000 mg BID + clarithromycin 500 mg BID [PAC] given as tablets) received a different triple therapy regimen (ranitidine bismuth citrate 400 mg BID + metronidazole 500 mg BID + clarithromycin 500 mg BID [RBC-MC]) for 7 days (group 1A), and nonresponders after RBC + 2 antimicrobials received the pantoprazole-based regimen (group 1B). After secondary failure, patients were randomized to receive quadruple therapies: pantoprazole, amoxicillin, tetracycline, and either nitrofurantoin or bismuth subsalicylate (groups 2A and 2B). RESULTS: One hundred thirty-four patients were enrolled in the second-line study (56 men, 78 women; mean [SD] age, 51.1 [12.4] years; group 1A, 68 patients; group 1B, 66 patients). Subsequently, 41 (30.6%) of these patients were randomized to receive quadruple therapies. Using intent-to-treat (ITT) analysis, the eradication rates did not differ significantly (60.3% and 65.2% in groups 1A and 1B, respectively; 61.9% and 55.0% in groups 2A and 2B, respectively). Perprotocol eradication rates did not differ significantly (66.1% and 68.3% in groups 1A and 1B, respectively); however, the rates were significantly different in group 2A (66.7%) versus group 2B (55.5%) (P = 0.03).
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The aim of this study was to compare in an open, controlled and prospective trial the efficacy of one-week regimen using either lansoprazole (2 x 30 mg) + 2 x 500 mg metronidazole + 2 x 250 mg clarithromycin (group I, 60 cases) or ranitidine bismuth citrate (2 x 400 mg) + 2 x 500 mg metronidazole + 2 x 250 mg clarithromycin (group II, 61 cases) on the eradication of Hp infection in duodenal ulcer patients. The diagnosis was stated endoscopically. Hp infection was confirmed from 2 antral + 2 corporeal biopsies by the modified Giemsa stain and rapid urease test. After eradication the patients were given on-demand treatment with 30 mg lansoprazole (group I) or 2 x 150 mg ranitidine (group II). Control 13C-urea breath test was performed 4-6 weeks after eradication. On intention to treat basis, Hp was eradicated in 78.3% (confidence interval, CI: 67.6-89.1%) in group I and 78.7% (CI: 68.1-89.2%) in group II (p > 0.05). Per protocol eradication rates were 92.1% (CI: 84.5-99.7%) in group I and 90.5 (CI: 82.4-98.6%) in group II (p > 0.05). Side effects were recorded in 13.5% in group I and 18.3% of cases in group II. Short term triple therapies using either lansoprazole or ranitidine bismuth citrate + 2 antimicrobials were effective and safe in the eradication of Hp in duodenal ulcer patients.