Conception and first results of a cross-sectional national study on the demography, disease characteristics and socioeconomics status of the Portuguese patients with multiple sclerosis : the PORT-MS study

RESUMO: Introdução e objetivos: Não existia um estudo multicêntrico que descrevesse as características dos doentes com EM, da doença em si, ou do seu tratamento, em Portugal.Métodos: Doentes McDonald 2010 positivos foram sequencialmente recrutados em 7 centros entre Maio e Novembro 2014. Aplicou-se um Caderno de Recolha de Dados incidindo na demografia, doença, educação e emprego (estudo PORT-MS). Resultados: 561 doentes incluídos. Primeiros sintomas aos 30,2±10,5 anos (RRMS 29,2±10, PPMS 39,4±11,7, p<0,001); diagnóstico 3,2±5,3 anos depois (RRMS 3,0±5,1, PPMS 4,9±2,5, p=0,002); tempo de doença após diagnóstico 9,4±7,2 anos (semelhante RRMS no diagnóstico e PPMS); idade atual 42,9±12,4 anos (grupo RRMS no diagnóstico 42,0±12,1, PPMS 52,5±11,3, p<0,001); EDSS atual 2,5 (RRMS 2.0, PPMS 6.0); proporção feminino:masculino é 2,5:1 (RRMS semelhante, PPMS 1,1:1, p<0,05); no diagnóstico RRMS 90,6%, SPMS 0,9%, PPMS 8,6%; 9,5% dos RRMS encontravam-se em SP na inclusão (nomeadamente os com mais idade no diagnóstico e/ou atualidade ou tempo de doença mais prolongado). PPMS mais frequente em doentes diagnosticados mais tardiamente (p<0,001), onde aumenta também ligeiramente a proporção de mulheres na PPMS. Nas últimas décadas: novos casos mostram estabilidade na proporção de géneros e tipos de doença; idade nos primeiros sintomas e no diagnóstico aumentou ligeiramente, tempo entre eles diminuiu ligeiramente. Proporção sob DMT (Maio 2014): global 84,5%; atualmente RRMS 90,4%; SPMS 70,8%; PPMS 36,8%; progressivas agregadas 48%. Tipo de DMT, amostra global: interferões 56,5%, GA 18,4%, Natalizumab 11,6%, Fingolimod 9,7%. Global: economicamente ativos 61,5%, desemprego 13,5%, 74,1% dos não activos estão reformados por doença. Gravidezes após diagnóstico em 15% mulheres. Casos com história familiar positiva 7,8%. Discussão e conclusões: Incluída cerca de 10% da população portuguesa. Resultados congruentes com dados internacionais. Elevada proporção sob DMT, mesmo EDSS alto e formas progressivas. Terapêuticas de segunda linha sub representadas. Doentes jovens e com doença ligeira com vida económica ativa; restantes essencialmente reformados por doença.---------------- ABSTRACT : Background/aims: In Portugal, there wasn’t a multicentric study on the general characteristics (demography, disease milestones, DMT, socioeconomic status) of Multiple Sclerosis patients. Methods: Patients fulfilling McDonald 2010 criteria were sequentially recruited from May to November 2014 in 7 centers and data was systematically collected. Results: 561 patients included. First symptoms occurred at 30,2±10,5 years-old (RRMS 29,2±10, PPMS 39,4±11,7, p<0,001); diagnosis 3,2±5,3 years later (RRMS 3,0±5,1, PPMS 4,9±2,5, p=0,002); 9,4±7,2 years elapsed since diagnosis (similar for those is RRMS at diagnosis and PPMS); current age 42,9±12,4 years-old (group RRMS at diagnosis 42,0±12,1, PPMS 52,5±11,3, p<0,001); current EDSS 2,5 (RRMS 2.0, PPMS 6.0); females to males 2,5:1 (RRMS similar, PPMS 1,1:1, p<0,05); at diagnosis RRMS 90,6%, SPMS 0,9%, PPMS 8,6%; 9,5% of RRMS reached SP at inclusion (those older at diagnosis, in actuality, or with longer follow-up). PPMS more frequente in patients diagnosed at older ages (p<0,001), also slight increase in females. Along the last decades: new cases have showed stable proportions of gender and disease types; age at first symptoms and diagnosis slightly increased, time between them slightly decreased. Proportion on DMT (May 2014): 84,5% of all; 90,4% of currently in RRMS; 70,8% of SPMS; 36,8% of PPMS; 48% of progressive forms together. Type of DMT, all patients: interferons 56,5%, Glatiramer Acetate 18,4%, Natalizumab 11,6%, Fingolimod 9,7%. Economically active 61,5% of all, unemployment 13,5%, 74,1% of non-active are retired due to disease. Females pregnant after diagnosis 15%. Positive family cases in 7,8%. Discussion/Conclusions: 10% of the national MS population collected. Data generally consistente with international reports. Proportion under DMT relatively high in all disease types, but second line therapies underrepresented. Young patients with mild disease have an active economic life. Those not active are essentially retired due to disease.

Novel antibiotic-loaded orthopaedic bone cements: insights on drug release profiles and biocompatibility

Acrylic bone cement (BC) is widely used as an anchor of artificial joints. Bacterial infection due to biofilm formation and inflammation are common and difficult to treat problems associated with commercial available BC formulations. Research on novel BC compositions is urgently needed. The main objective of this thesis was to develop a new biocompatible antibiotic-loaded BC with improved release profile. To achieve that aim several additives were incorporated, as an antibiotic (levofloxacin) to combat bacterial growth, an anti-inflammatory drug (diclofenac) to decrease the inflammatory process and two well-known and broadly used biopolymers, alginate and chitosan in order to increase matrix porosity, and in this way to intensify the amount of released drug. Novel BC formulations were tested in order to find the most suitable one that had potential to proceed to clinical application. Numerous tests were conducted as: a) evaluation of drug release profiles in different biomimetic media, b) mechanical and surface studies, c) microbiological activity testing against Staphylococcus aureus and d) in vitro biocompatibility assays (fibroblasts and osteoblasts). In general, the addition of biopolymers increased drug release, didn’t compromised BC mechanical properties and increased BC hydrophilicity. Microbiological testing revealed that Lev[BC]Chi was the only matrix that reduced significantly biofilm formation. On the contrary, alginate and diclofenac loading into BC seemed to increase biofilm growth. Biocompatibility studies showed some decrease in cell viability, in particularly on osteoblasts, mainly due to the high amounts of released drugs. In conclusion, the present work has shown that the matrix with more potential to proceed in further investigations was Lev[BC]Chi. Other conditions (namely additives and drugs concentrations) should be evaluated with the other tested BC matrices before being discharged.

Implementation of a pilot project for the treatment and prevention of substance abuse in children and adolescents : strengthening families for parents and youths 12-16

RESUMO: Antecendentes: Uma avaliação dos serviços de abuso de substâncias em Barbados identificou a necessidade de programas e serviços que são projetados especificamente para crianças e adolescentes. Objetivo: Realizar programa com base em evidências para reduzir a incidência de abuso de drogas entre crianças e adolescentes por meio do fortalecimento da unidade familiar através de parentalidade positiva, de maior funcionamento familiar e de resistência dos jovens. Método: Dois projetos-piloto foram realizadas com base no programa "Fortalecer as Famílias para Pais e Jovens de 12 a 16 anos (SFPY). O programa de nove semanas foi empregado como uma intervenção para criar laços familiares mais fortes, aumentar a resistência dos jovens e reduzir o abuso de drogas entre crianças e adolescentes de idades de 11 a 16 anos. A decisão foi tomada para incluir participantes de 11 anos desde que as crianças possam estar no primeiro ano da escola secundária nessa idade. IMPLEMENTATION OF SUBSTANCE ABUSE PILOT PROJECT FOR CHILDREN AND ADOLESCENTS 5 Resultados: Quinze famílias participaram em dois projetos-piloto e a avaliação final mostrou que os jovens após o programa, geralmente tornaram-se mais positivos sobre o seu lugar na unidade familiar e sentiram que sua participação no programa foi benéfica. Os pais, da mesma forma, relataram que eles conquistaram, com o programa uma relação mais positiva, uma melhor compreensão das necessidades, e consciência das mudanças de desenvolvimento de seus jovens. Desta forma, considera-se que o programa atingiu o resultado desejado de criar unidades familiares mais fortes. Conclusão: O Projeto Piloto “SFPY” foi bem sucedido em fazer pais e jovens mais conscientes de suas necessidades individuais e de responsabilidades dentro da unidade familiar. Como resultado, o relacionamentos das respectivas famílias melhorou. Estudos baseados em evidências têm demonstrado que um relação familiar mais forte diminui a incidência de uso e abuso de drogas na população adolescente, aumentando os fatores de proteção e diminuindo os fatores de risco. A implementação do programa, que foi desenvolvido e testado no ambiente norte-americano, demonstrou que era transferível para a sociedade de Barbados. No entanto, seu impacto total só pode ser determinado através de um estudo comparativo envolvendo um grupo de controle e / ou uma intervenção alternativa ao abuso de substâncias. Portanto, é recomendável que um estudo comparativo da intervenção SFPY deve envolver uma amostra representativa de adolescentes que estão em estágio de desenvolvimento anterior mais cedo. Evidências já demonstram que o programa é mais eficaz, com impacto mais longo sobre os jovens que participam em uma idade maisABSTRACT:Background: An evaluation of substance abuse services in Barbados has identified the need for programmes and services that are specifically designed for children and adolescents. Aim: To conduct an evidence-based programme to reduce the incidence of substance abuse among children and adolescents by strengthening the family unit through positive parenting, enhanced family functioning and youth resilience. Method: Two pilot projects were conducted based on the ‘Strengthening Families for Parents and Youths 12– 16’ (SFPY) programme. The nine-week programme was employed as an intervention to create stronger family connections, increase youth resiliency and reduce drug abuse among children and adolescents between the ages of 11 to 16. The decision was made to include participants from age 11 since children may be in the first year of secondary school at this age. IMPLEMENTATION OF SUBSTANCE ABUSE PILOT PROJECT FOR CHILDREN AND ADOLESCENTS 3 Results: Fifteen families participated in two pilot projects and an evaluation conducted at the conclusion showed that the youth were generally more positive about their perceived place in the family unit and felt that the being in the programme was generally beneficial. The parents similarly reported they had a more positive relationship with their youths and also had a better understanding of their needs, and an awareness of their developmental changes. This affirmed that the programme had achieved its desired outcome to create stronger family units. Conclusion: The SFPY Pilot Project was successful in making parents and youths more aware of their individual needs and responsibilities within the family unit. As a result relationships within their respective families were strengthened. Evidence-based studies have shown that enhanced family functioning decreases the incidence of substance use and abuse in the adolescent population by increasing protective factors and decreasing risk factors. The implementation of the programme, which was developed and tested in the North American environment, demonstrated that it was transferable to the Barbadian society. However, its full impact can only be determined through a comparative study involving a control group and/or an alternative substance abuse intervention. It is therefore recommended that a comparative study of the SFPY intervention should be delivered to a representative sample of adolescents who are at an earlier developmental stage. Evidence has shown that the programme is more effective, with longer impact on youths who participate at a younger age.