Evaluación de la efectividad del renikan: extracto del pelargonium sidoides estandarizado EPs7630 en el tratmiento de las infecciones de las vías respiratorias superiores de etiología viral / Evaluation of the effectiveness of renikan: standardized extract of Pelargonium sidoides tratmiento EPs7630 in infections of the upper respiratory tract viral etiology

Las infecciones respiratorias, uno de los síndromes más frecuentes a nivel comunitario pueden ser de dos tipos: infecciones del tracto respiratorio superior o inferior. En su gran mayoría son inicadas por una infección viral transformando el terreno vulnerable a la sobre infección bacteriana. Hasta 2/3 de los pacientes son tratados desde el inicio de los síntomas con antibióticos, aunque este tratamiento no influye positivamente sobre el curso de la enfermedad. Renikan, fitofármaco extraído de la raíz del Pelargonium Sidoides, posee un triple mecanismo de acción: antiviral, antibacteriano y mucolítico, antiviral, porque activa los mecanismos de defensa antivirales orgánicos, antibacetriano, por su actividad bacteriostática directa e indirecta, y mucolítico, por sus propiedades secretomotoras y expectorantes. El objetivo fue comprobar la efectividad y tolerabilidad de Renikan en el tratamiento de las infecciones respiratorias. Diseño abierto y multicéntrico. Se seleccionaron niños de 6 a12 años y adultos de cualquier sexo o raza, con infecciones del tracto respiratorio superior. A los cuales se le suministró Renikan durante 7 días continuos, se evaluó: evolución de los síntomas, necesidad de uso de antibióticos y la escala de resultados integraticos IMOs. Ingreason un total 305 pacientes, 156 adultos y 149 niños distribuidos en tres grupos de estudio: Rinosinusitis, 97 pacientes, los cuales presentaron mejoría de sus síntomas en un 86% en los adultos y no utilizaron antibióticos en un 86%; los niños mejoraron en un 80%, y no usaron antibióticos en 91%. En el caso de las Amigdalitis hubo 108 pacientes con una mejoría sintomatológica en adultos del 92% y en los niños el 89%, no antibióticoterapia en el 86% de los adultos y 93% de los niños. El uso de Renikan en pacientes con infecciones del tracto respiratorio superior, demuestra ser seguro y efecivo tanto en adultos como en niños mayores de 6 años

Respiratory tract infections are the most common syndromes at community, there are two types: upper and lower respiratory tract infections. The vast majoritary are stared by a viral infection transforming the land vulnerable into a bacterial infection. The 2/3 o patients is treated from the onset of symptoms with antibiotics, although it is known that this treatment not positively influences the course of the disease. Renikan, herbal extrated fron the root of pelargonium sidoides has a threefold mechanism of action: antibiotic and mucolytic, antiviral, because it activates the natural antiviral mechanism of defense; antibacterial, due to its direct and indirect bacterostatic action and mucolytic, owing to its secretomotory and expectorant properties. To test the effectiveness and tolerability of renikan in the treatment of respiratory infections. Open desing, multicenter study. We selected children 6-12 years'age and adults of any sex orrance with upper respiratory tract infecctions. Theyreceived renikan for 7 consecutive days, changes in symptoms; necessity of antibiotic use and the integrative medicine outcome scale (IMOS) were evaluated. Of total of 305 patients, 156 adults and 149 children were divided into three groups: 97 rhinosinusitis patients, who showed symptoms improvement in 86% of adults and 91% of children, in 108 tonsillitis patients, an improvement of symptoms was found in 92% of adults and 89% of children, no antibiotic use were in 86% of adults and 93% of children, and, in a third group consistng of 100 patients with bronchitis, improvement was report in 98% od adults and in 73% of children, no antibiotics were used in 88% of adults and 96% of children. The use of concomitant therapy decreasedin 50% of cases and only 0.02% of patients had adverse events. The use of renikan use in patients with upper respiratory tract infections was shown to be safe and effective in both adults and children over 6 years of age

Evaluation of medicine package inserts: a study of two cases of Pelargonium sidoides D.C. phytomedicines / Avaliação de bulas de medicamentos: um estudo de dois casos de Pelargonium sidoides DC fitoterápicos

In order for a phytotherapeutic drug be approved and sold in Brazil, it must be registered with the National Sanitary Surveillance Agency (ANVISA), where the quality, safety and efficacy of the product are carefully appraised. In addition, the drug must also meet a number of criteria one of which is the adequacy of the package inserts. Therefore, the aim of this study was to appraise the package inserts of all phytotherapeutic drugs produced using a standardized extract of Pelargonium sidoides, which were registered and available from Brazilian pharmacies. This checking was to ascertain whether these inserts fulfilled the requirements stipulated by RDC 140/03. The information required under RDC 140/03 was appraised through a previously devised standard form. Evaluation of the package inserts revealed that neither of the two brands fully met the requirements of the legislation. Manufacturer 'A' met only 37.0 percent of the requirements satisfactorily, while 16.0 percent of the information was considered unsatisfactory and 47.0 percent of the information was absent. Regarding manufacturer 'B', 64.2 percent of the analyzed requirements were considered satisfactory, while 16.0 percent were considered unsatisfactory and 19.8 percent of the information was absent. A package insert should contain information about medicine for consumers, pharmacists and doctors. However, the results obtained in this study showed that the information presented in the package insert of both medicines was unsatisfactory, and in many cases, violates the legislation.

Para que um medicamento fitoterápico seja comercializado no Brasil, este deve ser registrado junto à ANVISA, onde são avaliados todos os aspectos referentes à qualidade, segurança e eficácia do produto, além de verificar se estes atendem alguns requisitos, sendo um deles a adequação da bula. Por esta razão, neste estudo foram avaliadas as bulas de todos os fitoterápicos elaborados à base do extrato padronizado de Pelargonium sidoides, registrados e disponíveis no mercado brasileiro, com o intuito de verificar se estas atendem aos requisitos exigidos pela RDC 140/03. No presente trabalho, as informações exigidas pela RDC 140/03 foram avaliadas através de um formulário padrão previamente elaborado. Após avaliação das bulas pode ser verificado que nenhuma das duas marcas atendia por completo as exigências da legislação, sendo que o fabricante "A" atendeu apenas 37,0 por cento dos requisitos exigidos de forma satisfatória, enquanto 16,0 por cento das informações foram consideradas insatisfatórias e em 47,0 por cento as informações estavam ausentes. Com relação ao fabricante "B", 64,2 por cento dos itens analisados foram considerados satisfatórios, enquanto 16,0 por cento foram considerados insatisfatório e em 19,8 por cento as informações estavam ausentes. A bula deveria conter informações sobre o medicamento para consumidores, farmacêuticos e médicos, no entanto, os resultados obtidos neste estudo mostram que as informações apresentadas nas bulas foram insatisfatórias, e em muitos casos, violavam a legislação vigente.