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1.
Isr Med Assoc J ; 23(1): 38-42, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33443341

RESUMEN

BACKGROUND: The antibiotic resistance profile of Helicobacter pylori (H. pylori) is constantly changing. Up-to-date and reliable data for the effectiveness of first-line H. pylori treatment protocols are necessary to provide evidence-based best-practice guidelines. OBJECTIVES: To determine the effectiveness, compliance and safety of first-line treatment for H. pylori in Israel. METHODS: An observational, prospective, multicenter study was conducted in tertiary referral centers in Israel, as part of the European registry on H. pylori management (Hp-EuReg). H. pylori-infected patients were included from 2013 to March 2020. Data collected included demographics, clinical data, diagnostic tests, previous eradication attempts, current treatment, compliance, adverse events, and treatment outcome result. RESULTS: In total, 242 patients were registered, including 121 (50%) who received first-line therapy, 41% of these individuals received clarithromycin based triple therapy and 58.9% received a four-drug regimen. The overall effectiveness of first-line therapy was 85% and 86% by modified intention-to-treat and per protocol analyses, respectively. The effectiveness of both sequential and concomitant therapies was 100% while clarithromycin-based triple therapy achieved an eradication rate of 79%. Treatment eradication was higher among patients who received high dose proton pump inhibitor (PPI) compared to those treated with low dose PPI (100% vs. 81.5% respectively, P < 0.01). No difference in treatment effectiveness was found between 7-, 10-, and 14-day treatment. CONCLUSIONS: The effectiveness of clarithromycin-based triple therapy is suboptimal. First-line treatment of H. pylori infection should consist of four drugs, including high dose PPI, according to international guidelines.


Asunto(s)
Antibacterianos , Claritromicina/administración & dosificación , Infecciones por Helicobacter , Helicobacter pylori/efectos de los fármacos , Inhibidores de la Bomba de Protones/administración & dosificación , Antibacterianos/administración & dosificación , Antibacterianos/clasificación , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada/métodos , Quimioterapia Combinada/estadística & datos numéricos , Femenino , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/tratamiento farmacológico , Infecciones por Helicobacter/epidemiología , Humanos , Israel/epidemiología , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Sistema de Registros/estadística & datos numéricos , Retratamiento/métodos , Retratamiento/estadística & datos numéricos , Resultado del Tratamiento
2.
PLoS One ; 15(12): e0244500, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33378403

RESUMEN

BACKGROUND: The primary objective of this study was to compare concomitant and hybrid therapy in the first line eradication treatment of Helicobacter pylori infection in Split-Dalmatia County, Croatia, in which clarithromycin resistance is above 20%. The secondary objective of the study was to determine and compare compliance and adverse events rate between these therapeutic protocols. MATERIALS AND METHODS: In an open-label, randomised clinical trial 140 patients total with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 g, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or hybrid (esomeprazole 40 mg and amoxicillin 1 g twice daily during 14 days with adding metronidazole 500 mg and clarithromycin 500 mg twice daily, in the last 7 days,) treatment group. RESULTS: Eradication rates for concomitant group and hybrid therapy group were 84.1% (58/69) and 83.1% (59/71) respectively in the intention-to-treat analysis and 96.7% (58/60) and 95.2% (59/62) in per-protocol analysis. There was no significant difference between the groups (ITT analysis: P = 0.878; PP analysis: P = 0.675). Adverse events were more frequent in the concomitant group (33.3% vs 18.3%, P = 0.043). There was no difference among groups regarding compliance rate. CONCLUSION: Hybrid therapy has similar eradication rate as concomitant therapy, with lower adverse events rate. In the era of increasing antibiotic resistance, eradication regime with less antibiotic's usage, as hybrid therapy, should be reasonable first line treatment choice for H. pylori infection. Clinical Trials, gov: NCT03572777.


Asunto(s)
Antibacterianos/administración & dosificación , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/aislamiento & purificación , Inhibidores de la Bomba de Protones/administración & dosificación , Anciano , Amoxicilina/administración & dosificación , Amoxicilina/efectos adversos , Antibacterianos/efectos adversos , Claritromicina/administración & dosificación , Claritromicina/efectos adversos , Croacia , Esquema de Medicación , Farmacorresistencia Bacteriana , Quimioterapia Combinada/métodos , Esomeprazol/administración & dosificación , Esomeprazol/efectos adversos , Femenino , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/microbiología , Helicobacter pylori/efectos de los fármacos , Humanos , Masculino , Metronidazol/administración & dosificación , Metronidazol/efectos adversos , Persona de Mediana Edad , Estudios Prospectivos , Inhibidores de la Bomba de Protones/efectos adversos , Resultado del Tratamiento
3.
Medicine (Baltimore) ; 99(38): e22137, 2020 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-32957336

RESUMEN

BACKGROUND: Helicobacter pylori (HP) infection causes many diseases, such as peptic ulcers, gastritis and gastric cancer, and MALToma. It has been gradually accepted that all HP-infected patients should be treated because HP is regarded as an infection. Therefore, the importance of selecting the optimal treatment regimen has increased. Although the 14-day standard triple therapy (STT) is recommended in the current guidelines, prolonging treatment duration is controversial in real practice because of inconsistent results from previous data and the risk of adverse effects. Additionally, the effect of STT using ilaprazole has not been reported until now. We aimed to compare the eradication rate between 7 and 10 days STT using ilaprazole. METHODS: A prospective randomized controlled trial was conducted, which was divided into 2 treatment groups: the control group was 7 days of STT, and the test group was 10 days of STT. The eradication regimen was 10 mg ilaprazole, 500 mg clarithromycin, and 1000 mg amoxicillin twice daily. We included patients who were diagnosed with positive results of H pylori examination. We compared the HP eradication rate according to treatment duration, CYP2C19 subtype and endoscopic diagnosis. RESULTS: We enrolled a total of 254 patients consisting of 127 patients in each treatment arm. The eradication rates of the control and test groups were 65.4% (82/127) and 74.8% (95/127), respectively, in the intention-to-treat analysis (P = .1). In the per-protocol analysis, 70.3% (83/118) and 82.6% (94/115) were eradicated in each group, which was statistically significant (P = .027). The CYP2C19 subtype was examined in 230 patients. The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (P = .704). CONCLUSION: Ten-day STT was more effective than 7-day STT for HP eradication. The eradication rate was not affected by the CYP2C19 genotype.


Asunto(s)
2-Piridinilmetilsulfinilbencimidazoles/administración & dosificación , Amoxicilina/administración & dosificación , Antibacterianos/administración & dosificación , Claritromicina/administración & dosificación , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/efectos de los fármacos , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
4.
N Z Med J ; 133(1512): 22-30, 2020 04 03.
Artículo en Inglés | MEDLINE | ID: mdl-32242175

RESUMEN

AIMS: To assess a persuasive multimodel approach to decreasing unnecessary intravenous (IV) clarithromycin use for community-acquired pneumonia (CAP) in Canterbury District Health Board (CDHB) hospitals. METHODS: In December 2013, CDHB guidelines for empiric treatment of CAP changed to prioritise oral azithromycin over IV clarithromycin. The multimodel approach we used to implement this change included obtaining stakeholder agreement, improved guidelines access, education and pharmacist support. The impact of the intervention was evaluated by comparing macrolide usage and expenditure for the four years pre- and post-intervention. RESULTS: Mean annual clarithromycin IV use decreased by 72% from 6.4 to 1.8 defined daily doses (DDDs) per 1,000 occupied bed days (OBDs) post-intervention, while oral azithromycin increased by 833% (4.2 to 39.2 DDDs per 1,000 OBDs). Concurrently, oral clarithromycin use decreased by 91% (32.9 to 2.9 DDDs per 1,000 OBDs), and roxithromycin by 71% (17.0 to 5.0 DDDs per 1,000 OBDs). Mean annual total macrolide use decreased by 21% (68.2 to 53.9 DDDs per 1,000 OBDs), while expenditure decreased by 69% mainly through avoided IV administration. CONCLUSIONS: A persuasive multimodel approach to support adoption of CAP guidelines produced a sustained decrease in IV clarithromycin use, which may have clinical benefits such as reduced occurrence of catheter-related complications.


Asunto(s)
Antibacterianos/administración & dosificación , Programas de Optimización del Uso de los Antimicrobianos/normas , Azitromicina/administración & dosificación , Claritromicina/administración & dosificación , Infecciones Comunitarias Adquiridas/tratamiento farmacológico , Neumonía/tratamiento farmacológico , Administración Intravenosa , Administración Oral , Antibacterianos/economía , Programas de Optimización del Uso de los Antimicrobianos/economía , Azitromicina/economía , Claritromicina/economía , Formas de Dosificación , Adhesión a Directriz , Hospitales , Humanos , Nueva Zelanda
5.
J Gastroenterol Hepatol ; 35(10): 1731-1737, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32167605

RESUMEN

BACKGROUND AND AIM: Concomitant therapy is a recommended first-line treatment for Helicobacter pylori infection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. This study aims to test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pylori infection. METHODS: Helicobacter pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment. RESULTS: Helicobacter pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, -4.0% to 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2% vs 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125). CONCLUSIONS: Fourteen-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H. pylori infection. However, reverse hybrid therapy has fewer adverse events compared with concomitant therapy.


Asunto(s)
Amoxicilina/administración & dosificación , Antibacterianos/administración & dosificación , Claritromicina/administración & dosificación , Dexlansoprazol/administración & dosificación , Gastritis/tratamiento farmacológico , Gastritis/microbiología , Infecciones por Helicobacter , Helicobacter pylori , Metronidazol/administración & dosificación , Adulto , Anciano , Amoxicilina/efectos adversos , Antibacterianos/efectos adversos , Claritromicina/efectos adversos , Dexlansoprazol/efectos adversos , Esquema de Medicación , Quimioterapia Combinada/métodos , Femenino , Humanos , Masculino , Metronidazol/efectos adversos , Persona de Mediana Edad , Resultado del Tratamiento
6.
Georgian Med News ; (298): 128-132, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32141865

RESUMEN

Experimental modeling of dysbacterioses associated with antibiotics is an urgent issue of morphological studies. The present paper was aimed at the detection and study of the primordial forms of Peyer's patches developed in the small intestine of albino rats after administration of clarithromycin. 30 mature albino male rats weighing 200.0 ± 20.0 g were involved into the experiment. Antibiotic was administered to the rodents as a supplement to food during their two-meals-a-day feeding. Areas of the small intestine with Peyer's patches have been studied. Serial paraffin sections have been analyzed using the "Konus" light microscope. Morphometric characteristics of the tissue structures were obtained using the Sigeta X 1 mm / 100 Div.x0.01mm stage micrometer. Administration of clarithromycin caused a significant increase in the amount of Peyer's patches, the appearance in the mucous membrane of newly formed aggregated lymphoid nodules, being the primordial forms of Peyer's patches, the appearance of which can be explained by only one factor, namely, impaired microbiocenosis in the small intestine under the influence of the broad-spectrum antibacterial drug, clarithromycin, which has immunotropic effect.


Asunto(s)
Antibacterianos/administración & dosificación , Claritromicina/administración & dosificación , Intestino Delgado/efectos de los fármacos , Ganglios Linfáticos Agregados , Animales , Antibacterianos/efectos adversos , Claritromicina/efectos adversos , Desarrollo Embrionario , Intestino Delgado/metabolismo , Masculino , Ratas
7.
Lancet ; 395(10232): 1259-1267, 2020 04 18.
Artículo en Inglés | MEDLINE | ID: mdl-32171422

RESUMEN

BACKGROUND: Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions. METHODS: We did an open-label, non-inferiority, randomised (1:1 with blocks of six), multicentre, phase 3 clinical trial comparing fully oral RC8 with RS8 in patients with early, limited Buruli ulcer lesions. There were four trial sites in hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè). Participants were included if they were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (caterories I and II) no larger than 10 cm in diameter. The trial was open label, and neither the investigators who took measurements of the lesions nor the attending doctors were masked to treatment assignment. The primary clinical endpoint was lesion healing (ie, full epithelialisation or stable scar) without recurrence at 52 weeks after start of antimicrobial therapy. The primary endpoint and safety were assessed in the intention-to-treat population. A sample size of 332 participants was calculated to detect inferiority of RC8 by a margin of 12%. This study was registered with ClinicalTrials.gov, NCT01659437. FINDINGS: Between Jan 1, 2013, and Dec 31, 2017, participants were recruited to the trial. We stopped recruitment after 310 participants. Median age of participants was 14 years (IQR 10-29) and 153 (52%) were female. 297 patients had PCR-confirmed Buruli ulcer; 151 (51%) were assigned to RS8 treatment, and 146 (49%) received oral RC8 treatment. In the RS8 group, lesions healed in 144 (95%, 95% CI 91 to 98) of 151 patients, whereas lesions healed in 140 (96%, 91 to 99) of 146 patients in the RC8 group. The difference in proportion, -0·5% (-5·2 to 4·2), was not significantly greater than zero (p=0·59), showing that RC8 treatment is non-inferior to RS8 treatment for lesion healing at 52 weeks. Treatment-related adverse events were recorded in 20 (13%) patients receiving RS8 and in nine (7%) patients receiving RC8. Most adverse events were grade 1-2, but one (1%) patient receiving RS8 developed serious ototoxicity and ended treatment after 6 weeks. No patients needed surgical resection. Four patients (two in each study group) had skin grafts. INTERPRETATION: Fully oral RC8 regimen was non-inferior to RS8 for treatment of early, limited Buruli ulcer and was associated with fewer adverse events. Therefore, we propose that fully oral RC8 should be the preferred therapy for early, limited lesions of Buruli ulcer. FUNDING: WHO with additional support from MAP International, American Leprosy Missions, Fondation Raoul Follereau France, Buruli ulcer Groningen Foundation, Sanofi-Pasteur, and BuruliVac.


Asunto(s)
Úlcera de Buruli/tratamiento farmacológico , Claritromicina/administración & dosificación , Rifampin/administración & dosificación , Estreptomicina/administración & dosificación , Administración Oral , Adolescente , Adulto , Antibacterianos , Benin , Niño , Claritromicina/efectos adversos , Preparaciones de Acción Retardada/administración & dosificación , Preparaciones de Acción Retardada/efectos adversos , Quimioterapia Combinada , Femenino , Ghana , Humanos , Masculino , Rifampin/efectos adversos , Estreptomicina/efectos adversos , Cicatrización de Heridas/efectos de los fármacos , Adulto Joven
8.
Zhonghua Er Ke Za Zhi ; 58(1): 41-45, 2020 Jan 02.
Artículo en Chino | MEDLINE | ID: mdl-31905475

RESUMEN

Objective: To evaluate the effectiveness of eradication therapy based on Helicobacter pylori (Hp) susceptibility and CYP2C19 genotype in children with refractory Hp infection. Methods: In this prospective observational cohort study, 156 children with Hp refractory to amoxicillin+clarithromycin+omeprazole triple regimen in Baoding Children's Hospital from December 2017 to May 2018 were enrolled. Ninety-two of them underwent Hp culture and CYP2C19 detection. Seventy-five cases with positive Hp culture were defined as culture successful group and were treated according to Hp susceptibility and CYP2C19 genotype. Seventeen cases with negative Hp culture were defined as culture failed group and were treated only based on the results of CYP2C19 genotype. Sixty-four children who did not have Hp culture and CYP2C19 gene testing were defined as the empirical eradication therapy group and were treated with quadruple regimen (amoxicillin+metronidazole+omeprazole+bismuth). Bacterial resistance, CYP2C19 polymorphism and therapeutic effectiveness between the three groups were compared using chi-square test. Results: Among the 75 positive Hp culture results, 72 (96%) were resistant to clarithromycin, 3 (4%) were resistant to metronidazole, 5 (7%) were resistant to levofloxacin, 5 (7%) were resistant to rifampicin, 1 (1%) was resistant to tetracycline, and none was resistant to amoxicillin and furazolidone. The CYP2C19 polymorphism in 92 patients showed that 43 (47%) were extensive metabolizer (EM), 9 (10%) were poor metabolizer (PM), and 40 (43%) were intermediate metabolizer (IM). In terms of the effectiveness, eradication rate in the culture successful group,culture failed group and empirical eradication therapy group were 99% (74/75), 88% (15/17) and 72% (46/64), respectively (χ(2)=21.325, P<0.05). The eradication rate in the culture successful group was significantly higher than that in empirical eradication therapy group (χ(2)=21.005, P<0.05), while there was no difference between empirical eradication therapy group and culture failed group (χ(2)=1.154, P=0.283). Conclusion: Eradication regimen based on bacterial susceptibility and CYP2C19 genotype should be considered in children with refractory Hp infection.


Asunto(s)
Citocromo P-450 CYP2C19/genética , Quimioterapia Combinada , Infecciones por Helicobacter/tratamiento farmacológico , Infecciones por Helicobacter/genética , Helicobacter pylori/efectos de los fármacos , Helicobacter pylori/genética , Omeprazol/uso terapéutico , Amoxicilina/uso terapéutico , Antibacterianos/uso terapéutico , Bismuto/uso terapéutico , Niño , Claritromicina/administración & dosificación , Claritromicina/uso terapéutico , Estudios de Cohortes , Resistencia a Medicamentos/genética , Femenino , Genotipo , Helicobacter pylori/aislamiento & purificación , Humanos , Masculino , Metronidazol/uso terapéutico , Omeprazol/administración & dosificación , Polimorfismo Genético , Estudios Prospectivos , Resultado del Tratamiento
9.
J Gastroenterol Hepatol ; 35(4): 617-623, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31758571

RESUMEN

BACKGROUND AND AIM: There is little published research to examine the best approach to the management of Helicobacter pylori in Myanmar. This study aimed to determine the relative efficacy and tolerability of sequential eradication therapy compared to Myanmar's current recommendation of a concomitant four drug regimen. METHODS: Patients were screened for H. pylori using monoclonal Stool Antigen Testing (SAT). Those testing positive were randomized 1:1 to receive receive Myanmar's first-line regimen of 14 days of concomitant rabeprazole, clarithromycin, amoxycillin and tinidazole (140 pills, cost US$23) or 10 days of sequential rabeprazole, clarithromycin, amoxycillin and tinidazole (60 pills, cost US$10). Adherence and adverse effects were recorded, and the efficacy of the regimens assessed with repeat SAT. RESULTS: Of the 1011 patients screened for H. pylori infection, 313 (31%) tested positive. There was no statistical difference in the cure rates of the two regimens in either intention-to-treat: 128/157 (82%; 95% confidence interval (CI): 75-87%) receiving sequential therapy versus 123/156 (79%; 95% CI: 72-85%) receiving concomitant therapy (P = 0.55) or per-protocol analysis: 125/131 (95%; 95% CI: 90-98) receiving sequential therapy versus 121/130 (93%; 95% CI: 87-96) receiving concomitant therapy (P = 0.42). Side effects of therapy were reported in 54/157 (47%) patients taking sequential therapy compared with 62/156 (53%) taking concomitant therapy, but this difference did not reach statistical significance (P = 0.33). CONCLUSIONS: In this high-burden, resource-poor setting, less expensive sequential therapy was as effective and as well tolerated as the currently recommended concomitant four drug regimen for eradication of H. pylori.


Asunto(s)
Amoxicilina/administración & dosificación , Claritromicina/administración & dosificación , Gastritis/tratamiento farmacológico , Gastritis/microbiología , Infecciones por Helicobacter , Helicobacter pylori , Rabeprazol/administración & dosificación , Tinidazol/administración & dosificación , Amoxicilina/efectos adversos , Amoxicilina/economía , Claritromicina/efectos adversos , Claritromicina/economía , Costos de los Medicamentos , Quimioterapia Combinada/economía , Mianmar , Rabeprazol/efectos adversos , Rabeprazol/economía , Tinidazol/efectos adversos , Tinidazol/economía , Resultado del Tratamiento
10.
J Gastroenterol Hepatol ; 35(4): 609-616, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31677184

RESUMEN

BACKGROUND AND AIM: The aim of this study is to identify gastric cancer burden in Indigenous Taiwanese peoples and conduct a project to evaluate how to reduce the disparities most effectively in Indigenous communities. METHODS: First, we quantified the health disparities in gastric cancer in Indigenous peoples using data from the cancer registries during the period of 2006-2014. Second, we identified parameters that might be associated with Helicobacter pylori infection or help identify a good eradication strategy. RESULTS: Gastric cancer incidence (24.4 vs 12.3 per 100 000 person-years) and mortality rates (15.8 vs 6.8 per 100 000 person-years) were higher in Indigenous than in non-Indigenous, with 2.19-fold (95% confidence interval [CI]: 2.06-2.33) and 2.47-fold (2.28-2.67) increased risk, respectively. In Indigenous communities, H. pylori infection was more prevalent in Indigenous than in non-Indigenous (59.4% vs 31.5%, P < 0.01). Regression analyses consistently showed that either the mountain or plain Indigenous had 1.89-fold (95% CI: 1.34-2.66) and 1.73-fold (95% CI: 1.24-2.41) increased risk for H. pylori infection, respectively, as compared with non-Indigenous, adjusting for other baseline characteristics. The high infection rates were similarly seen in young, middle-aged, and older adults. Program eradication rates using clarithromycin-based triple therapy were suboptimal (73.7%, 95% CI: 70.0-77.4%); the habits of smoking (1.70-fold, 95% CI: 1.01-2.39) and betel nut chewing (1.54-fold, 95% CI: 0.93-2.16) were associated with the higher risk of treatment failure. CONCLUSION: Gastric cancer burden is higher in Indigenous Taiwanese peoples than in their non-Indigenous counterparts. Eliminating the prevalent risk factor of H. pylori infection is a top priority to reduce this health disparity.


Asunto(s)
Claritromicina/administración & dosificación , Costo de Enfermedad , Gastritis/tratamiento farmacológico , Gastritis/microbiología , Disparidades en Atención de Salud , Infecciones por Helicobacter , Helicobacter pylori , Pueblos Indígenas/estadística & datos numéricos , Neoplasias Gástricas/prevención & control , Areca/efectos adversos , Quimioterapia Combinada , Gastritis/complicaciones , Gastritis/epidemiología , Incidencia , Prevalencia , Factores de Riesgo , Fumar/efectos adversos , Neoplasias Gástricas/epidemiología , Neoplasias Gástricas/etiología , Neoplasias Gástricas/mortalidad , Taiwán/epidemiología
12.
Arch Pharm Res ; 42(12): 1101-1106, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31820397

RESUMEN

Zolpidem is extensively metabolized by CYP3A4, CYP2C9 and CYP1A2. Previous studies demonstrated that pharmacokinetics of zolpidem was affected by CYP inhibitors, but not by short-term treatment of clarithromycin. The objective of this study was to investigate the effects of steady-state clarithromycin on the pharmacokinetics of zolpidem in healthy subjects. In the control phase, 33 subjects received a single dose of zolpidem (5 mg). One week later, in the clarithromycin phase, the subjects received clarithromycin (500 mg) twice daily for 5 days to reach steady state concentrations, followed by zolpidem (5 mg) and clarithromycin (500 mg). In each phase, plasma concentrations of zolpidem were evaluated up to 12 h after drug administration by using liquid chromatography-tandem mass spectrometry method. In the clarithromycin phase, mean total area under the curve of zolpidem (AUCinf) was 1.62-fold higher and the time to reach peak plasma concentration of zolpidem (tmax) was prolonged by 1.95-fold compared to the control phase. In addition, elimination half-life (t1/2) of zolpidem was 1.40-fold longer during co-administration with clarithromycin and its apparent oral clearance (CL/F) was 36.2% lower with clarithromycin administration. The experimental data demonstrate the significant pharmacokinetic interaction between zolpidem and clarithromycin at steady-state.


Asunto(s)
Claritromicina/sangre , Claritromicina/farmacocinética , Zolpidem/sangre , Zolpidem/farmacocinética , Administración Oral , Adulto , Claritromicina/administración & dosificación , Combinación de Medicamentos , Voluntarios Sanos , Humanos , Masculino , República de Corea , Adulto Joven , Zolpidem/administración & dosificación
13.
Respir Med ; 158: 67-69, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31605924

RESUMEN

INTRODUCTION: The details of the practice of treating nontuberculous mycobacterial pulmonary disease (NTMPD) have not been studied in Japan. METHODS: We studied a random sample of 2% (184) of the 9,200 patients with incident NTM-PD in 2010 who received standard three-drug therapy for at least some of their treatment between 2010 and 2014. RESULTS: The median duration of the standard treatment period was 248 days (IQR 56-540 days). Although 59% of the patients were treated with standard therapy for more than 6 months, only 41% were treated for 12 months. Fifty-three patients (29%) initiated treatment with substandard regimen, and 18 (34%) of those patients received treatment regimens that can lead to the development of macrolide resistance (MR)(CLR monotherapy or CLR + RIF). Furthermore, initially, 184 receiving the standard treatment, 49 patients (27%) eventually deviated from it, and 31 patients (63%) received regimens increasing the risk of developing MR. The sporadic administration of macrolide monotherapy was observed before and after the administration of the standard treatment for 50 patients (27.7%) and 41 patients (27.2%), respectively. CONCLUSIONS: Approximately 60% of the treated patients did not continue the standard regimen for more than 12 months and 42% were at risk for developing MR before and after receiving the standard treatment. It is important to educate physicians and patients about the correct and safe management of NTMPD.


Asunto(s)
Claritromicina/administración & dosificación , Etambutol/administración & dosificación , Infecciones por Mycobacterium no Tuberculosas/tratamiento farmacológico , Etambutol/efectos adversos , Femenino , Humanos , Masculino , Factores de Tiempo
14.
Expert Opin Drug Saf ; 18(12): 1255-1261, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31646920

RESUMEN

Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, idiopathic thrombocytopenic purpura, history of endoscopic treatment of early gastric cancer, and gastritis were enrolled. Patients received vonoprazan 20 mg, amoxicillin (AMPC) 750 mg, and clarithromycin (CAM) 200-400 mg twice daily for 7 days for the first-line eradication. For the second-line eradication, vonoprazan, AMPC, and metronidazole (MTZ) 250 mg were administered. The incidence of adverse drug reactions (ADRs) and eradication rates were evaluated.Results: The incidences of ADRs with vonoprazan/AMPC/CAM and vonoprazan/AMPC/MTZ were 3.22% (16/497) and 1.89% (1/53), respectively. Commonly reported ADRs were diarrhea, nausea, dysgeusia, feces soft, and rash. The eradication rates of the first-line therapy and the second-line therapy were 91.24% (427/468) and 95.45% (42/44), respectively. No notable differences in ADRs and eradication rates were observed when stratified by patient demographic characteristics.Conclusion: No new safety concerns were observed, and the effectiveness of vonoprazan-based triple therapy was confirmed in routine clinical practice.Trial registration: This study is registered at the Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI-153003).


Asunto(s)
Antibacterianos/administración & dosificación , Infecciones por Helicobacter/tratamiento farmacológico , Inhibidores de la Bomba de Protones/administración & dosificación , Pirroles/administración & dosificación , Sulfonamidas/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Amoxicilina/administración & dosificación , Antibacterianos/efectos adversos , Claritromicina/administración & dosificación , Quimioterapia Combinada , Femenino , Helicobacter pylori/aislamiento & purificación , Humanos , Masculino , Metronidazol/administración & dosificación , Persona de Mediana Edad , Vigilancia de Productos Comercializados , Estudios Prospectivos , Inhibidores de la Bomba de Protones/efectos adversos , Pirroles/efectos adversos , Sulfonamidas/efectos adversos , Adulto Joven
15.
Lancet Infect Dis ; 19(10): 1109-1120, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31559966

RESUMEN

BACKGROUND: In first-line treatment of Helicobacter pylori, we have previously shown that the eradication frequency was 83·7% (95% CI 80·4-86·6) for triple therapy for 14 days (T14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily), 85·9% (82·7-88·6) for concomitant therapy for 10 days (C10; lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily), and 90·4% (87·6-92·6) for bismuth quadruple therapy for 10 days (BQ10; bismuth tripotassium dicitrate 300 mg four times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day). In this follow-up study, we assess short-term and long-term effects of these therapies on the gut microbiota, antibiotic resistance, and metabolic parameters. METHODS: This was a multicentre, open-label, randomised trial done at nine medical centres in Taiwan. Adult patients (>20 years) with documented H pylori infection were randomly assigned (1:1:1, with block sizes of six) to receive T14, C10, or BQ10. We assessed long-term outcomes (reinfection frequency, changes in the gut microbiota, antibiotic resistance, and metabolic parameters) in patients with available data, excluding all protocol violators and those with unknown post-treatment H pylori status. Faecal samples were collected before treatment and 2 weeks, 2 months, and at least 1 year after eradication therapy. Amplification of the V3 and V4 hypervariable regions of the 16S rRNA was done followed by high-throughput sequencing. Susceptibility testing for faecal Escherichia coli and Klebsiella pneumoniae was done. This trial is complete and registered with ClinicalTrials.gov, NCT01906879. FINDINGS: Between July 17, 2013, and April 20, 2016, 1620 participants were randomly assigned to the three treatment groups (540 [33%] per group). 1214 (75%) attended 1-year follow-up and are included in this analysis. Compared with baseline, alpha diversity was significantly reduced 2 weeks after T14 (p=0·0002), C10 (p<0·0001), and BQ10 (p<0·0001) treatment. Beta diversity was also significantly altered 2 weeks after T14 (p=0·0010), C10 (p=0·0001), and BQ10 (p=0·0001). Alpha diversity and beta diversity were restored at week 8 (p=0·14 and p=0·918, respectively) and 1 year (p=0·14 and p=0·918) after T14, but were not fully recovered at week 8 and after 1 year in patients treated with C10 (p=0·0001 and p=0·013 at week 8; p=0·019 and p=0·064 at 1 year) and BQ10 (p<0·0001 and p=0·0002; p=0·001 and p=0·029). A transient increase at week 2 after T14 and C10 of the resistance rates of E coli to ampicillin-sulbactam (12% [15/127] to 66% [38/58] for T14, 7% [10/135] to 64% [28/44] for C10), cefazolin (13% [16/127] to 43% [25/58] for T14, 10% [13/135] to 41% [18/44] for C10), cefmetazole (8% [10/127] to 26% [15/58] for T14, 4% [5/135] to 18% [8/44] for C10), levofloxacin (8% [10/127] to 35% [20/58] for T14, 7% [10/135] to 32% [14/44] for C10), gentamicin (13% [19/146] to 47% [27/58] for T14, 15% [22/149] to 45% [20/44] for C10), and trimethoprim-sulfamethoxazole (33% [48/146] to 86% [50/58] for T14, 28% [42/148] to 86% [38/44] for C10; p<0·05 in paired samples in the above analyses) returned to basal state at week 8 and after 1 year. Although bodyweight and body-mass index slightly increased, there were significant improvements in metabolic parameters, with a decrease in insulin resistance, triglycerides, and LDL and an increase in HDL. Overall, there was no significant change in the prevalence of metabolic syndrome at week 8 and 1 year after T14, C10, and BQ10. INTERPRETATION: Eradication of H pylori infection has minimal disruption of the microbiota, no effect on antibiotic resistance of E coli, and some positive effects on metabolic parameters. Collectively, these results lend support to the long-term safety of H pylori eradication therapy. FUNDING: National Taiwan University Hospital and Ministry of Science and Technology of Taiwan.


Asunto(s)
Índice de Masa Corporal , Erradicación de la Enfermedad/métodos , Farmacorresistencia Microbiana/efectos de los fármacos , Microbioma Gastrointestinal/efectos de los fármacos , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/efectos de los fármacos , Síndrome Metabólico/epidemiología , Adulto , Anciano , Amoxicilina/administración & dosificación , Amoxicilina/uso terapéutico , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Claritromicina/administración & dosificación , Claritromicina/uso terapéutico , Esquema de Medicación , Quimioterapia Combinada , Escherichia coli/efectos de los fármacos , Femenino , Estudios de Seguimiento , Infecciones por Helicobacter/microbiología , Infecciones por Helicobacter/prevención & control , Humanos , Lansoprazol/administración & dosificación , Lansoprazol/uso terapéutico , Masculino , Metronidazol/administración & dosificación , Metronidazol/uso terapéutico , Persona de Mediana Edad , Compuestos Organometálicos/administración & dosificación , Compuestos Organometálicos/uso terapéutico , Prevalencia , Tetraciclina/administración & dosificación , Tetraciclina/uso terapéutico
16.
Gut Liver ; 13(5): 531-540, 2019 09 15.
Artículo en Inglés | MEDLINE | ID: mdl-31505907

RESUMEN

Background/Aims: This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population. Methods: Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Results: A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms. Conclusions: The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.


Asunto(s)
Antibacterianos/administración & dosificación , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori , Inhibidores de la Bomba de Protones/administración & dosificación , Amoxicilina/administración & dosificación , Claritromicina/administración & dosificación , Erradicación de la Enfermedad/métodos , Esquema de Medicación , Quimioterapia Combinada , Femenino , Infecciones por Helicobacter/prevención & control , Humanos , Lansoprazol/administración & dosificación , Masculino , Cumplimiento de la Medicación , Metronidazol/administración & dosificación , Persona de Mediana Edad , Estudios Prospectivos , República de Corea , Resultado del Tratamiento
17.
Indian J Gastroenterol ; 38(4): 325-331, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-31520370

RESUMEN

INTRODUCTION: Resistance to commonly used antibiotics against Helicobacter pylori (H. pylori) is increasing rapidly leading to lower success of traditional triple therapy to eradicate H. pylori infection. So, search for a new regimen as the first-line therapy of H. pylori infection is needed. AIM: In this study, we compared the efficacy of 14-day concomitant therapy and 14-day triple therapy for the eradication of H. pylori infection. METHOD: In this open-labeled prospective trial, patients with H. pylori infection were randomized to concomitant therapy (pantoprazole 80 mg, amoxicillin 2000 mg, clarithromycin 1000 mg, and metronidazole 1000 mg daily in divided doses) and triple therapy (pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in divided doses). Duration of treatment was 14 days. Gastric biopsy was done 10-12 weeks after completion of therapy to confirm H. pylori eradication. RESULT: The eradication rate achieved with the concomitant therapy was significantly greater than that obtained with the triple therapy. Per-protocol eradication rates of concomitant and triple therapy were 77% and 58.3% (p = 0.028), respectively. Intention-to-treat eradication rates of concomitant and triple therapy were 70.1% and 49.3% (p = 0.013), respectively. Both the treatment regimens were well tolerated. CONCLUSION: Although the rate of eradication of H. pylori infection with  concomitant therapy was higher than that with triple therapy, the rate of concomitant therapy was still less than expected.


Asunto(s)
Antibacterianos/administración & dosificación , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/efectos de los fármacos , Adulto , Amoxicilina/administración & dosificación , Claritromicina/administración & dosificación , Esquema de Medicación , Quimioterapia Combinada , Femenino , Infecciones por Helicobacter/microbiología , Humanos , Masculino , Metronidazol/administración & dosificación , Persona de Mediana Edad , Pantoprazol/administración & dosificación , Estudios Prospectivos , Resultado del Tratamiento
18.
BMC Microbiol ; 19(1): 176, 2019 08 05.
Artículo en Inglés | MEDLINE | ID: mdl-31382897

RESUMEN

BACKGROUND: Clarithromycin-resistance is becoming a global health concern in the treatment of Helicobacter pylori (H. pylori). The mutant prevention concentration (MPC) represent the propensities of antimicrobial agents to select resistant mutants. The concentration range between the minimum inhibitory concentration (MIC) and the MPC is defined as mutant selection window (MSW). In this study, we aimed to determine the cause of increasing clarithromycin resistance by investigating the MSW for clinical isolates of H. pylori. RESULTS: A retrospective subgroup, which included 68 clarithromycin-sensitive H. pylori strains, was selected from a double-blind trial. The MICs and MPCs were determined using agar plate assays. Genotypic tests were performed using Sanger sequencing. All isolates were wild-type, and 33.82% (23/68) had a 0.016 mg/L MIC, 45.59% (31/68) had a 0.031 mg/L MIC, 16.18% (11/68) had a 0.062 ≤ MIC ≤ 0.125 mg/L, and 4.41% (3/68) had a 0.25 mg/L MIC. The MPC50/90 (mg/L) of the isolates were: 0.062/0.125, 0.125/0.5, 0.25/0.25 and 1/2, respectively. The MPCs showed a moderate correlation with the MICs (rs = 0.65, P < 0.0001). Using published data and MPC90, we calculated the time inside the MSW (TMSW) for low- and high-dose (200 or 500 mg bid) clarithromycin that were 6 and 0 h, 24 and 4 h, 15 and 2 h, 5 and 17 h for the strains with MICs (mg/L) of 0.016, 0.031, 0.062-0.125, and 0.25, respectively. CONCLUSIONS: This study showed that in the clarithromycin-sensitive clinical isolates of H. pylori, low-dose clarithromycin may lead to decreased drug sensitivity or even clarithromycin resistance; strains with a 0.25 mg/L MIC display a high risk of treatment failure.


Asunto(s)
Claritromicina/farmacología , Farmacorresistencia Bacteriana/efectos de los fármacos , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori , Antibacterianos/administración & dosificación , Antibacterianos/farmacología , Claritromicina/administración & dosificación , Método Doble Ciego , Helicobacter pylori/efectos de los fármacos , Helicobacter pylori/aislamiento & purificación , Humanos , Pruebas de Sensibilidad Microbiana , Estudios Retrospectivos
19.
BMJ Case Rep ; 12(8)2019 Aug 28.
Artículo en Inglés | MEDLINE | ID: mdl-31466974
20.
PLoS One ; 14(8): e0221349, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31419266

RESUMEN

BACKGROUND: Extra-gastric manifestation of Helicobacter pylori infection involves systemic inflammation, which results in the production of several cytokines. Only a few clinical trials have investigated the effect of H. pylori eradication therapy on lipid metabolism in the infected patients with chronic gastritis. We aimed to evaluate the effect of H. pylori eradication therapy on lipid metabolism in a Japanese population with chronic gastritis. METHODS: One hundred and sixty-three patients with H. pylori-associated chronic gastritis were enrolled in this study between June 2015 and March 2017. They underwent H. pylori eradication therapy; the effects of the therapy were assessed by the urea breath test performed at least 4 weeks after the therapy. After confirming H. pylori eradication, the health screening examination was repeated between May 2016 and August 2018. The clinical parameters were compared before and after the administration of the eradication therapy. RESULTS: The mean age of the enrolled patients was 56.7 years, and the mean follow-up duration was 514.7 days. Weight, body mass index, and obesity index were significantly increased post-eradication therapy compared to those pre-eradication therapy. White blood cell and platelet counts were significantly decreased, and high density lipoprotein cholesterol (HDL) level was significantly increased (P = 0.001), while low density lipoprotein cholesterol (LDL), total cholesterol, and triglycerides levels were not altered significantly. Hence, the LDL/HDL ratio was significantly decreased. CONCLUSIONS: This study reported that H. pylori eradication therapy increase the HDL levels in the infected patients with chronic gastritis. Hence, the LDL/HDL ratio, which is used to evaluate the risk of atherosclerosis, was significantly decreased post-eradication therapy compared to that pre-eradication therapy.


Asunto(s)
Antibacterianos/administración & dosificación , HDL-Colesterol/sangre , Gastritis/tratamiento farmacológico , Infecciones por Helicobacter/tratamiento farmacológico , Metabolismo de los Lípidos/efectos de los fármacos , Inhibidores de la Bomba de Protones/administración & dosificación , Anciano , Amoxicilina/administración & dosificación , Aterosclerosis/sangre , Aterosclerosis/diagnóstico , HDL-Colesterol/metabolismo , Claritromicina/administración & dosificación , Quimioterapia Combinada/métodos , Femenino , Gastritis/sangre , Gastritis/microbiología , Infecciones por Helicobacter/sangre , Infecciones por Helicobacter/microbiología , Helicobacter pylori/efectos de los fármacos , Helicobacter pylori/aislamiento & purificación , Humanos , Masculino , Persona de Mediana Edad , Pirroles/administración & dosificación , Estudios Retrospectivos , Sulfonamidas/administración & dosificación , Resultado del Tratamiento
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