Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients
| Autor: | Rocío Llorca Fernández, Manuel Castro Fernández, Teresa Romero García, Manuel Pabón Jaén, Alma Keco Huerga, Eloísa Lamas Rojas, Lourdes Grande Santamaría, María Rojas Feria |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent First line Urea breath test Capsules Single Center Linea Helicobacter Infections Medication Adherence 03 medical and health sciences Young Adult 0302 clinical medicine Anti-Infective Agents Metronidazole medicine Organometallic Compounds Humans Prospective Studies Adverse effect Aged Gynecology Aged 80 and over biology medicine.diagnostic_test Helicobacter pylori business.industry Gastroenterology General Medicine Middle Aged Tetracycline biology.organism_classification Drug Combinations Treatment Outcome Bismuth Subcitrate 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Female business medicine.drug |
| Zdroj: | Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva. 111(6) |
| ISSN: | 1130-0108 |
| Popis: | espanolIntroduccion y objetivos: la cuadruple terapia con bismuto se recomienda como primera linea de tratamiento de la infeccion 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 galenica de capsulas que contienen subcitrato de bismuto, metronidazol y tetraciclinas (Pylera®). Metodos: estudio observacional, prospectivo, unicentrico, no controlado. Se incluyen 200 pacientes consecutivos, el 58% mujeres, con infeccion por H. pylori y sin tratamiento erradicador previo, tratados durante diez dias con Pylera® (tres capsulas cuatro veces al dia con las comidas) asociado a un inhibidor de la bomba de protones antes de desayuno y cena. La capsula de Pylera® 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 telefonico y entrevista en la revision clinica. El control de erradicacion se realiza, al menos, tras cuatro semanas de finalizado el tratamiento, mediante la prueba del aliento con urea, la prueba de antigenos fecales con anticuerpos monoclonales o por histologia. 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 infeccion por Clostridium difficile; y c) efectividad por intencion 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®, en nuestra experiencia, es efectivo y seguro, debiendose considerar como una opcion terapeutica de primera linea en la erradicacion de la infeccion por Helicobacter pylori. EnglishIntroduction 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|