Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients.

INTRODUCTION AND OBJECTIVES: quadruple therapy with bismuth is recommended as a first line treatment for Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the compliance, adverse effects and effectiveness of this treatment with the new galenic three-in-one capsule formulation containing bismuth subcitrate, metronidazole and tetracycline (Pylera®). METHODS: a prospective, non-controlled, single center observational study was performed in a cohort of 200 consecutive patients with an untreated H. pylori infection; 58% were female. The subjects were treated for ten days with Pylera® of three capsules four times daily with meals and a proton pump inhibitor taken before breakfast and dinner. The Pylera® capsule contains 140 mg of bismuth subcitrate, 125 mg of metronidazole and 125 mg of tetracycline. The compliance and adverse effects of the treatment were evaluated via telephone contact and via an interview during the clinical revision. Eradication of infection was controlled for at least four weeks after treatment termination via the urea breath test, the stool antigen test with monoclonal antibodies or by histology. RESULTS: treatment compliance was observed in 96% (192/200) of the patients. Only 28.5% (57/200) of the patients experienced adverse effects, which led to abandoning the treatment in only seven subjects. Severe adverse effects developed in only one case due to Clostridium difficile infection. The effectiveness based on intention to treat was 91.5% (183/200, 95% CI: 87.1-96.8) and per protocol was 95.2% (182/191, 95% CI: 90.9-98.9). CONCLUSIONS: in our experience, Pylera® is an effective and safe treatment that should be considered as a first line therapeutic option for the eradication of H. pylori infection.

Modulation of faecal metagenome in Crohn's disease: Role of microRNAs as biomarkers.

BACKGROUND: The gut microbiota plays a key role in the maintenance of intestinal homeostasis and the development and activation of the host immune system. It has been shown that commensal bacterial species can regulate the expression of host genes. 16S rRNA gene sequencing has shown that the microbiota in inflammatory bowel disease (IBD) is abnormal and characterized by reduced diversity. MicroRNAs (miRNAs) have been explored as biomarkers and therapeutic targets, since they are able to regulate specific genes associated with Crohn's disease (CD). In this work, we aim to investigate the composition of gut microbiota of active treatment-naïve adult CD patients, with miRNA profile from gut microbiota. AIM: To investigate the composition of gut microbiota of active treatment-naïve adult CD patients, with miRNA profile from gut microbiota. METHODS: Patients attending the outpatient clinics at Valme University Hospital without relevant co-morbidities were matched according to age and gender. Faecal samples of new-onset CD patients, free of treatment, and healthy controls were collected. Faecal samples were homogenized, and DNA was amplified by PCR using primers directed to the 16S bacterial rRNA gene. Pyrosequencing was performed using GS-Junior platform. For sequence analysis, MG-RAST server with the database Ribosomal Project was used. MiRNA profile and their relative abundance were analyzed by quantitative PCR. RESULTS: Microbial community was characterized using 16S rRNA gene sequencing in 29 samples (n = 13 CD patients, and n = 16 healthy controls). The mean Shannon diversity was higher in the healthy control population compared to CD group (5.5 vs 3.7). A reduction in Firmicutes and an increase in Bacteroidetes were found. Clostridia class was also significantly reduced in CD. Principal components analysis showed a grouping pattern, identified in most of the subjects in both groups, showing a marked difference between control and CD groups. A functional metabolic study showed that a lower metabolism of carbohydrates (P = 0.000) was found in CD group, while the metabolism of lipids was increased. In CD patients, three miRNAs were induced in affected mucosa: mir-144 (6.2 ± 1.3 fold), mir-519 (21.8 ± 3.1) and mir-211 (2.3 ± 0.4). CONCLUSION: Changes in microbial function in active non-treated CD subjects and three miRNAs in affected vs non-affected mucosa have been found. miRNAs profile may serve as a biomarker.

Cumplimiento, efectos adversos y efectividad del tratamiento cuádruple con bismuto (Pylera(R)) como tratamiento erradicador de primera línea en 200 pacientes con infección por Helicobacter pylori / Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera(R)) to eradicate Helicobacter pylori infection in 200 patients

Introducción y objetivos: la cuádruple terapia con bismuto se recomienda como primera línea de tratamiento de la infección por Helicobacter pylori (H. pylori). El objetivo del estudio es valorar el cumplimiento, los efectos adversos y la efectividad de este tratamiento con la nueva forma galénica de cápsulas que contienen subcitrato de bismuto, metronidazol y tetraciclinas (Pylera(R)). Métodos: estudio observacional, prospectivo, unicéntrico, no controlado. Se incluyen 200 pacientes consecutivos, el 58% mujeres, con infección por H. pylori y sin tratamiento erradicador previo, tratados durante diez días con Pylera(R) (tres cápsulas cuatro veces al día con las comidas) asociado a un inhibidor de la bomba de protones antes de desayuno y cena. La cápsula de Pylera(R) contiene 140 mg de subcitrato de bismuto, 125 mg de metronidazol y 125 mg de tetraciclina. El cumplimiento y los efectos adversos del tratamiento se valoran mediante contacto telefónico y entrevista en la revisión clínica. El control de erradicación se realiza, al menos, tras cuatro semanas de finalizado el tratamiento, mediante la prueba del aliento con urea, la prueba de antígenos fecales con anticuerpos monoclonales o por histología. Resultados: a) cumplimiento del tratamiento en el 96% (192/200) de los pacientes; b) efectos adversos en el 28,5% (57/200) de los pacientes, motivando en siete casos el abandono del tratamiento y con gravedad en un solo caso por infección por Clostridium difficile; y c) efectividad por intención de tratamiento (183/200) del 91,5% (IC 95%: 87,1-96,8) y por protocolo (182/191) del 95,2% (IC 95%: 90,9-98,9). Conclusiones: el tratamiento con Pylera(R), en nuestra experiencia, es efectivo y seguro, debiéndose considerar como una opción terapéutica de primera línea en la erradicación de la infección por Helicobacter pylori

Introduction and objectives: quadruple therapy with bismuth is recommended as a first line treatment for Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the compliance, adverse effects and effectiveness of this treatment with the new galenic three-in-one capsule formulation containing bismuth subcitrate, metronidazole and tetracycline (Pylera(R)). Methods: a prospective, non-controlled, single center observational study was performed in a cohort of 200 consecutive patients with an untreated H. pylori infection; 58% were female. The subjects were treated for ten days with Pylera(R) of three capsules four times daily with meals and a proton pump inhibitor taken before breakfast and dinner. The Pylera(R) capsule contains 140 mg of bismuth subcitrate, 125 mg of metronidazole and 125 mg of tetracycline. The compliance and adverse effects of the treatment were evaluated via telephone contact and via an interview during the clinical revision. Eradication of infection was controlled for at least four weeks after treatment termination via the urea breath test, the stool antigen test with monoclonal antibodies or by histology. Results: treatment compliance was observed in 96% (192/200) of the patients. Only 28.5% (57/200) of the patients experienced adverse effects, which led to abandoning the treatment in only seven subjects. Severe adverse effects developed in only one case due to Clostridium difficile infection. The effectiveness based on intention to treat was 91.5% (183/200, 95% CI: 87.1-96.8) and per protocol was 95.2% (182/191, 95% CI: 90.9-98.9). Conclusions: in our experience, Pylera(R) is an effective and safe treatment that should be considered as a first line therapeutic option for the eradication of H. pylori infection

Daño hepático inducido por dronedarona. Descripción de un caso clínico / Dronedarone-induced liver injury. A case report

No disponible