Review of the efficacy and safety of over-the-counter medicine

;Os medicamentos isentos de prescrição são disponíveis sem prescrição médica devido a sua efetividade e segurança, para tratar sintomas e males menores. O objetivo deste trabalho é revisar a disponibilidade e qualidade das revisões sistemáticas publicadas sobre medicamentos isentos de prescrição, identificando os grupos para os quais há lacunas de evidência. Foram identificados artigos publicados através da ;Cochrane Database of Systematic Review; e MEDLINE (via PubMed) desde o início da base até maio de 2012, utilizando os termos ";nonprescription drugs;," ";over the counter;," ";OTC;". Foram procurados artigos que descrevessem revisão sistemática abordando a eficácia e segurança dos medicamentos dispensados sem prescrição, de acordo com as listas publicadas pela ;Association of the European Self-Medication Industry; e no Brasil, nas condições clínicas constantes na lista de Grupos e Indicações Terapêuticas Especificadas. Foram incluídos 49 artigos, 18 artigos eram de qualidade moderada e 31 de alta qualidade. 74,5% dos estudos demonstraram eficácia favorável ao uso do medicamento avaliado. Dos 24 estudos que avaliaram segurança, 21% mostraram evidência desfavorável ao uso do medicamento. No geral, a evidência encontrada nos estudos incluídos nesta revisão é favorável ao uso dos medicamentos avaliados. Entretanto, há grupos terapêuticos para os quais há lacunas na evidência.;Over-the-counter medicines are available without prescription because of their safety and effectiveness, to treat minor ailments and symptoms. The objective of the study was to analyze the availability and quality of systematic reviews published about nonprescription medicines, identifying the groups for which there are gaps in evidence. We identified published articles through the Cochrane Database of Systematic Review and MEDLINE, from the start of the database until May 2012, using the search terms "nonprescription drugs," "over the counter," and "OTC." We searched for articles that describe systematic reviews addressing the efficacy and safety of drugs dispensed without a prescription, according to the lists published by the Association of the European Self-Medication Industry and in Brazil, in the clinical conditions listed in Groups and Specified Therapeutic Indications. We included 49 articles, 18 articles were of moderate quality and 31 of high quality. Of the studies, 74.5% demonstrated efficacy in favor of the use of drugs evaluated. Of the 24 studies that evaluated safety, 21% showed evidence unfavorable to the drug. Overall, the evidence found in the studies included in the overview is favorable to the use of the drugs evaluated. However, there are gaps in evidence for some therapy groups

Systematic review and meta-analysis of the efficacy and safety of amfepramone and mazindol as a monotherapy for the treatment of obese or overweight patients

The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term

Hyperpigmentant activity of leaves and flowers extracts of Pyrostegia venusta on murine B16F10 melanoma

AbstractEthnopharmacological relevancePyrostegia venusta is a native Brazilian plant which has a variety of uses in traditional folk medicine including the treatment of vitiligo. However, its effectiveness on melanogenesis is not yet elucidated.Aim of the studyThis study aimed to investigate the melanogenic activity of hydroalcoholic extracts from the leaves and flowers of P. venusta on murine B16F10 melanoma cells.Materials and methodsDifferent concentrations of the hydroalcoholic extracts of flowers and leaves of P. venusta were evaluated in trials of spontaneous melanin content (4 days), and cell viability by the MTT assay in murine B16F10 cells, and in the mushroom tyrosinase activity in vitro.ResultsBoth extracts, leaves (0.1; 0.3; 1 and 3μg/mL) and flowers (0.03 and 0.1μg/mL) increased the melanin content in a concentration dependent manner after 4 days of incubation on melanoma cells. Leaves extract promoted enhancement of melanogenesis with maximum effect of 33.3±3% (3μg/mL), and the flower extract increased in 23.4±3% (0.1μg/mL). The cell viability test using MTT showed that in the same tested concentrations of both extracts no cell death was detected. Actually, either extract was not able to cause any change in the tyrosinase activity. HPLC analysis of P. venusta extracts found 0.09% and 1.08% of allantoin on leaves and flowers extracts, respectively.ConclusionsThe leaves and flowers extracts of P. venusta stimulates B16F10 melanogenesis at very low concentrations. These findings support the folk medicinal use of P. venusta on the treatment of hypopigmentation diseases, such as vitiligo

BIOLOGIC MEDICINES FOR MODERATE TO SEVERE PSORIASIS – A REVIEW OF CLINICAL EVIDENCE

A psoríase é uma doença autoimune, hiperproliferativa e crônica que se manifesta de várias maneiras, levando a alterações importantes principalmente na pele e nas articulações acometendo cerca de 0,1 a 3% da população mundial.  Os medicamentos biológicos surgem como alternativa terapêutica, apresentando resultados promissores de eficácia e segurança para o tratamento dessa doença. Trata-se de medicamentos que modificam sistemicamente a resposta imunológica na psoríase. Como a doença tem origem em processos inflamatórios de células T (notadamente células Th1 e Th17) que levam à hiperproliferação celular, os biológicos atuam mediando as interações específicas das células T com o antígeno, no bloqueio das interações intercelulares, no desvio da ativação do sistema imune, ou inibindo diretamente citocinas inflamatórias que desencadeiam ou exacerbam a resposta imunológica e proliferativa. Este artigo é uma revisão de literatura sobre eficácia e segurança de medicamentos imunobiológicos utilizados no tratamento da psoríase moderada a grave

ADVERSE DRUG EVENTS: A REVIEW OF CONCEPTS

Para um planejamento de farmacovigilância ser bem sucedido, os termos utilizados para segurança no uso dos medicamentos precisam ser cuidadosamente definidos, visto que as classificações adotadas atualmente são bastante confusas e limitadas. Nesse sentido, o presente artigo tem como objetivo descrever as principais definições de eventos adversos a medicamentos e seus componentes, a fim de esclarecer pontos importantes sobre a segurança no uso de medicamentos e auxiliar no acompanhamento, prevenção, diagnóstico e resolução de eventos adversos relacionados ao uso de medicamentos. Os resultados demonstram que atualmente existe uma grande diversidade de definições diferentes ligadas à segurança do paciente relacionada com os medicamentos. Torna-se evidente a necessidade de padronização dos termos e definições utilizados no que diz respeito à segurança no uso de medicamentos.

Modulation of gene expression in mice treated with sugar and whey protein isolate / Modulação da expressão gênica em camundongos tratados com açúcar e isolado de proteína de soro de leite

This study compared the effects of three different types of diets (regular diet, high in sugar diet and high in sugar plus whey protein isolate supplementation diet) in mice. After 3 months, gene expression in liver and in adipose tissue was measured. We found that diets influenced in gene expression, but not supplementation. However, supplementation showed an anorectic effect, and protected animals from hepatic steatosis. In addition, the diets did not influence the myeloperoxidase activity in the adipose tissue, showing little influence on the infiltration of white cells in this tissue

Topical antiinflammatory activity and chemical composition of the epicuticular wax from the leaves of Eugenia beaurepaireana (Myrtaceae)

In order to verify the topical antiinflammatory effect of epicuticular wax from leaves of Eugenia beaurepaireana, it was tested in mice croton oil-induced inflammation. Our findings show that topical application of Eugenia beaurepaireana epicuticular wax was significantly active in inhibiting both oedema (Inhibitory dose 50 % (ID50) = 0.31 (0.26 - 0.39) mg.ear -1, inhibition = 79 ± 6 %) and tissue myeloperoxidase activity (indicative of polymorphonuclear leukocytes influx) (ID50 =0.34 (0.20 - 0.41) mg.ear -1, inhibition = 77 ± 4 %) in mice ear treated with croton oil. Two main compounds were detected on epicuticular wax of E. beaurepaireana. These compounds were identified as α- and β-amyrin by flame ionization detection (GC-FID) and spectroscopic methods (IR, NMR ¹H and 13C). In conclusion, the results indicate a topical antiinflammatory activity for the Eugenia specie studied and, that, at least in part, α- and β-amyrin are responsible for this activity.A atividade antiinflamatória tópica da cera epicuticular das folhas de Eugenia beaurepaireana foi avaliada pelo modelo do edema de orelha induzido pelo óleo de cróton em camundongos. Os resultados do estudo mostram que a aplicação tópica da cera epicuticular de Eugenia beaurepaireana inibiu significativamente a formação do edema (Dose inibitória 50 % (DI50) = 0,31 (0,26 - 0,39) mg.orelha-1, inibição = 79 ± 6 %) e a atividade da mieloperoxidase tissular (indicativo do influxo de leucócitos polimorfonucleares) (DI50 =0,34 (0,20 - 0,41) mg.orelha-1, inibição = 77 ± 4 %) em camundongos tratados com o óleo de cróton. Dois compostos majoritários foram detectados e isolados da cera epicuticular de E. beaurepaireana. Estes compostos foram identificados como os triterpenos α-amirina e β-amirina, através de técnicas cromatográficas (CG-FID) e espectroscópicas (IV, RMN ¹H e 13C). Em conclusão, os resultados indicam que a espécie E. beaurepaireana apresenta um efeito antiinflamatório tópico relevante, sendo os compostos α-amirina e β-amirina responsáveis, pelo menos em parte, por esta atividade

Combretum leprosum Mart. (Combretaceae): Potential as an antiproliferative and anti-inflammatory agent

AbstractEthnopharmacological relevanceCombretum leprosum is a species that is popularly used in Brazil as a healing agent to treat skin problems and lesions. In this study we investigated the possible potential of this extract to treat inflammatory and hyperproliferative skin conditions.Materials and methodsClassical models of skin inflammation such as TPA- and croton oil-induced mouse ear oedema were applied in order to verify the potential topical anti-inflammatory activity of the ethanolic extract from flowers of Combretum leprosum.ResultsTopical application of ethanolic extract promoted a dose-dependent inhibition of phorbol ester-induced ear oedema, reduced myeloperoxidase activity and IL-6 tissue levels with inhibition comparable to dexamethasone (positive control). Histological and immunohistochemical analysis revealed that ethanolic extract also suppressed cell infiltration. Ethanolic extract altered inflammatory parameters on a chronic skin inflammation model induced by repeated applications of croton oil, decreasing ear oedema, epidermal hyperproliferation and cell infiltration. In addition, immunohistochemical analysis showed that the extract decreased PCNA expression on the epidermis.ConclusionTaken together, these results suggest that the extract from flowers of Combretum leprosum could be considered as a new potential tool for the treatment of several skin inflammatory diseases since it reversed the skin inflammatory and hyperproliferative process in a very significant manner. Further investigations are needed in order to verify the cellular mechanism and safety of Combretum leprosum extract

Avaliação econômica das anticitocinas adalimumabe, etanercepte e infliximabe no tratamento da artrite reumatoide no Estado do Paraná = Economic evaluation of anticitokines adalimumab, etanercept and infliximab for treatment of rheumatoid arthritis in Paraná State, Brazil

This study aimed to perform an economic evaluation of anticytokines adalimumab (ADA), etanercept (ETA) and infliximab (IFX) for the treatment of rheumatoid arthritis in the State of Parana, in Brazil, in the perspective of the Brazilian Unified Health System. Data on efficacy and safety of treatment were collected in literature, and costs were calculated on the amounts spent by the Government for each treatment. A Markov model was performed to get the cost-effectiveness of each treatment. The incremental cost-effectiveness relationship (ICER) compared to a standard treatment was also calculated for each anticytokine. Sensitivity analysis and discount rates were applied. In assessing cost-effectiveness we found the following values (cost at R$per QALY): 511,633.00, 437,486.00 and 657,593.00 (respectively for ADA, ETA and IFX). The ICER (R$ per QALY) was 628,124.00, 509,974.00 and 965,927.00 (for ADA, ETA and IFX). In the sensitivity analysis, ETA and ADA showed similar values. It is for public managers and physicians the choice for each patient, among the treatments available