"Real-world" effectiveness of methylphenidate in improving the academic achievement of Attention-Deficit Hyperactivity Disorder diagnosed students-A systematic review.

WHAT IS KNOWN AND OBJECTIVE: Attention-deficit hyperactivity disorder (ADHD) symptoms usually impairs academic achievement and can trigger the onset of medication. Methylphenidate is a drug widely prescribed to treat ADHD. However, systematic reviews of randomized clinical trials suggest that it does not lead to great improvements in academic performance. Thus, we aimed to evaluate the evidence on the "real-world" effectiveness of methylphenidate in improving the academic achievement of ADHD students. METHODS: We conducted a systematic review of observational studies retrieved from five electronic databases, besides a manual search and search in grey literature. Studies evaluating treatment with methylphenidate compared to no treatment or other pharmacological/non-pharmacological alternatives used in ADHD were included. The risk of bias of the selected studies was assessed using adapted versions of the Newcastle-Ottawa Scale. RESULTS AND DISCUSSION: Nine studies (from ten reports) were included in the review: four cohorts, two before-and-after designs and three cross-sectional studies. They involved 12,269 children and adolescents aged 6-18 years. The doses of methylphenidate ranged from 10 to 72 mg/day, and the duration of the treatment from 2.6 months to 4.25 years. Five of these studies concluded that methylphenidate improves academic performance. However, three of the four lowest-bias risk studies concluded that the drug is ineffective. Five studies assessed the long-term use of methylphenidate, and four of them concluded that it does not result in better outcomes in the school setting. Most included studies had considerable limitations and significant heterogeneity regarding methodological design and academic performance measurement criteria. WHAT IS NEW AND CONCLUSION: Although some studies indicate that the short-term use of methylphenidate may improve outcomes in the school environment, the available evidence does not support the establishment of adequate conclusions about the real benefits of methylphenidate in the academic improvement of ADHD students.

A eficácia do ácido tranexâmico tópico no tratamento do melasma: evidências clínicas / Efficacy of topical tranexamic acid in the treatment of melasma: clinical evidence

Introdução: o melasma é uma desordem hiperpigmentar adquirida, crônica, clinicamente caracterizada como máculas acastanhadas com contornos irregulares e limites claros. O tratamento apresenta diferentes modalidades que incluem a eliminação de possíveis fatores causais, como o uso de protetor solar, além de agentes despigmentantes. O ácido tranexâmico, fármaco tradicionalmente antifibrinolítico, tem sido utilizado nas lesões do melasma devido ao seu efeito hipopigmentador e também na prevenção da hiperpigmentação induzida por UV. Objetivo: realizar uma investigação qualitativa bibliográfica acerca do mecanismo de ação do ácido tranexâmico e sua eficácia no tratamento tópico do melasma, baseada em evidências clínicas. Metodologia: foi realizada uma busca nas bases Pubmed e Embase limitada aos últimos 10 anos, na língua inglesa, utilizando os termos 'melasma' e 'tranexamic acid'. Resultados: foram encontrados sete ensaios clínicos que avaliaram a eficácia do ácido tranexâmico em formulações tópicas com concentração variando de 2 a 5%. O AT exerce seu mecanismo de ação bloqueando reversivelmente a conversão de plasminogênio em plasmina. Como os ativadores de plasminogênio são gerados pelos queratinócitos, o ácido tranexâmico afeta a função dos queratinócitos. Conclusão: o ácido tranexamico mostrou-se seguro e promissor no tratamento de melasma, tanto em comparação ao placebo quanto em relação a outros despigmentantes, sendo bem tolerado e sem ocorrências de reações adversas severas. Contudo, ensaios clinicos controlados e randomizados com avaliação em larga escala e estudos observacionais de longo prazo são necessários para que a terapia a longo prazo e a ação em combinação a outras terapias e outros medicamentos fiquem bem esclarecidos.

Introduction: melasma is an acquired hyperpigmentation disorder, chronic, clinically characterized as brownish macules with irregular contours and clear boundaries. The treatment presents different modalities that include the elimination of possible causal factors, like the use of sunscreen, besides depigmenting agents. Tranexamic acid, a traditional antifibrinolytic drug, has been used in the lesions of melasma due to its hypopigmenting effect and also in the prevention of UV-induced hyperpigmentation. Objective: to conduct a qualitative bibliographic investigation about the mechanism of action of tranexamic acid and its efficacy in the topical treatment of melasma, based on clinical evidence. Methodology: a search was peformed in the Pubmed database limited to the last 10 years, in the English language, using the terms 'melasma' and 'tranexamic acid'. Results: we found seven clinical trials evaluating the efficacy of tranexamic acid in topical formulations with concentrations ranging from 2 to 5%. AT exerts its mechanism of action by reversibly blocking the conversion of plasminogen to plasmin. As plasminogen activators are generated by keratinocytes, tranexamic acid affects the function of keratinocytes. Conclusion: tranexamic acid was safe and promising in the treatment of melasma, both compared to placebo as compared to other lighteners, being well tolerated and without incidents of severe adverse reactions. However, controlled and randomized clinical trials with large-scale evaluation and long-term observational studies are necessary for long-term therapy and action in combination with other therapies and other medications can be well understood.

[High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit]. / A alta prevalência de prescrições de medicamentos off-label e não licenciados em unidade de terapia intensiva pediátrica Brasileira.

OBJECTIVE: To describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital METHODS: Cross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária - Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software. RESULTS: We analysed 1,054 prescription items for 73 patients. Females predominated (52%), and the patients' age ranged from 0 to 16 years. Among the prescribed items, 23.4% were off-label, 12.6% were unlicensed, 1.4% were both off-label and unlicensed, 86% had at least one item off-label, and 67% had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents. CONCLUSION: The current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.

A alta prevalência de prescrições de medicamentos off-label e não licenciados em unidade de terapia intensiva pediátrica brasileira / High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit

OBJETIVO: Descrever o uso e determinar a prevalência de medicamentos de uso off-label enão licenciados em prescrições na unidade de terapia intensiva pediátrica de um hospital no sudeste do Brasil. MÉTODOS: Estudo transversal envolvendo os pacientes internados na unidade de terapia intensiva pediátrica durante o período de maio de 2008 a janeiro de 2009. A classificação quanto aos critérios de aprovação da Agência de Vigilância Sanitária (Anvisa) foi baseada em seu bulário eletrônico e no Dicionário de Especialidades Farmacêuticas e as análises realizadas no software R. RESULTADOS: Foram analisados 1.054 itens de prescrição de 73 pacientes. O gênero feminino foi o mais frequente (52 por cento) e a idade dos pacientes variou de zero a 16 anos. Observou-se que 23,4 por cento dos medicamentos foram prescritos de modo off-label, 12,6 por cento não licenciados e 1,4 por cento foram classificados em ambas as razões; 86 por cento receberam ao menos um item de uso off-label e 67 por cento ao menos um item de uso não licenciado. Os grupos terapêuticos mais prescritos foram os antibacterianos de uso sistêmico, os analgésicos, psicolépticos e antiasmáticos. CONCLUSÃO: Os resultados do presente trabalho confirmam a alta prevalência do uso off-label e não licenciados dos medicamentos em unidade de terapia intensiva pediátrica.

OBJECTIVE: To describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital METHODS: Cross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária - Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software. RESULTS: We analysed 1,054 prescription items for 73 patients. Females predominated (52 percent), and the patients' age ranged from 0 to 16 years. Among the prescribed items, 23.4 percent were off-label, 12.6 percent were unlicensed, 1.4 percent were both off-label and unlicensed, 86 percent had at least one item off-label, and 67 percent had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents. CONCLUSION: The current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.