ABSTRACT
La Medicina Natural y Tradicional ha entrado en una nueva etapa de desarrollo con el incremento en la demanda de sus alternativas terapéuticas. Se realizó una investigación descriptiva transversal, mediante la cual se identificaron las necesidades de aprendizaje de 20 médicos, entre especialistas y residentes de Medicina Natural y Tradicional, acerca de los aspectos básicos de ensayos clínicos. Existe desconocimiento acerca de las fases y pilares fundamentales de un ensayo clínico y los aspectos éticos importantes al ser una investigación en seres humanos, por lo que demuestra la falta de capacitación que existe sobre el tema. Es imprescindible fomentar una cultura de ensayos clínicos en los médicos que se desempeñan en el área de la Medicina Natural y Tradicional. Esto permitiría elevar la calidad y rapidez con que se desarrollan estos estudios en Cuba.
The Natural and Traditional Medicine has entered a new developmental stage with the increase in the requests of its therapeutic alternatives. We carried out a crossed descriptive research, through which we identified the learning necessities of 20 doctors, between specialist and residents of Traditional and Natural Medicine, about the main aspects of clinical researches. There is a lack of knowledge on the main phases and bases of a clinical research and on the important ethical aspects for being a research in human beings, showing the lack of knowledge on the theme. It is unavoidable to promote a culture of clinical researches among the doctors working in the area of Traditional and Natural Medicine. This will allow increasing the quality and speed of these researches development in Cuba.
Subject(s)
Humans , Health Knowledge, Attitudes, Practice , Education, Medical, Continuing , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Clinical Trials, Phase IV as Topic , Medicine, Traditional , Epidemiology, Descriptive , Cross-Sectional StudiesABSTRACT
O objetivo da revisão foi analisar aspectos conceituais e operacionais de sistemas de vigilância de eventos adversos pós-vacina. Foram incluídos artigos disponíveis em formato eletrônico, publicados entre 1985 e 2009, selecionados nas bases Medline/PubMed, com as palavras-chave: "adverse events following vaccine", "adverse events following vaccine surveillance", "post-marketing surveillance" e "safety vaccine" e "Phase IV clinical trials", e excluídos aqueles com foco em tipos específicos desses eventos. Foram apontados os principais aspectos que justificam a importância dos eventos adversos pós-vacina em saúde pública, os instrumentos que garantem a segurança das vacinas e as finalidades, atributos, tipos, interpretações de dados, limitações e novos desafios da vigilância de eventos adversos pós-vacina, bem como estratégias para aumentar sua sensibilidade. A revisão é concluída com desafios para os próximos anos, visando à segurança e confiabilidade dos programas de vacinação.
El objetivo de la revisión fue analizar aspectos conceptuales y operacionales de sistemas de vigilancia de eventos adversos post vacuna. Fueron incluidos artículos disponibles en formato electrónico, publicados entre 1985 y 2009, seleccionados en las bases PubMed/Medline, con las palabras clave: "vigilancia de eventos adversos post vacuna", "vigilancia post comercialización", "seguridad de vacunas" y "estudios de Fase IV", y excluidos aquellos con foco en tipos específicos de tales eventos. Se señalaron los principales aspectos que justifican la importancia de los eventos adversos post vacuna en salud pública, los instrumentos que garantizan la seguridad de las vacunas y las finalidades, atributos, tipos, interpretaciones de datos, limitaciones y nuevos desafíos de la vigilancia de eventos adversos post vacuna, así como estrategias para aumentar su sensibilidad. Se concluye con desafíos para los próximos años, buscando seguridad y confiabilidad de los programas de vacunación.
Subject(s)
Clinical Trials, Phase IV as Topic , Immunization Programs , Vaccines/adverse effects , Product Surveillance, PostmarketingABSTRACT
As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.
Subject(s)
Humans , Clinical Trials, Phase IV as Topic , Medicine, Chinese Traditional , Product Surveillance, Postmarketing , Research DesignABSTRACT
Background Conventional antipsychotics have relatively moderate efficacy against schizophrenic negative symptoms and are associated with significant adverse events. Objectives To assess the clinical safety and efficacy of Solian[R] [amisulpride], an atypical antipsychotic agent of the benzamide family. Patients and methods: This is an 8-week cohort study including adults with schizophrenia. Daily dose was between 400 and 800 mg. Safety was measured as the cumulative risk of adverse events and efficacy as the physician's global assessment of global improvement on an ordinal scale from 0 to 6. An efficacy index, a composite measure of both safety and efficacy, was also measured on an ordinal scale from 16 the worst to 1 the best. Results Fifty-seven patients were included. Eight patients [14%] experienced at least one adverse event during the trial, mainly extra-pyramidal symptoms [EPS]. None required treatment discontinuation and none was qualified as serious. Four required corrective treatment and six resolved during the 8-week follow-up. On the Global Improvement scale 31.6% of patients were very much or much improved on D14 and 81.8% on D56. 25.5% of subjects achieved complete remission over the study period. Improvement reflected also on the efficacy index, decreasing from 8.2 [SD: 3.1] on D14 to 3.4 [SD: 2.9] on D56. Conclusion: Amisulpride, in addition to its well-established efficacy in schizophrenic patients, offers a particularly good safety profile
Subject(s)
Humans , Male , Female , Schizophrenia/drug therapy , Antipsychotic Agents/pharmacology , Benzamides/analogs & derivatives , Clinical Trials, Phase IV as TopicABSTRACT
Nas últimas duas décadas houve vários avanços no tratamento farmacológico da depressäo. Entretanto, ainda se tem necessidade de antidepressivos mais efetivos e mais bem tolerados. O propósito deste artigo é revisar os métodos d investigaçäo clínica de psicofármacos, especialmente os antidepressivos. Säo descritos os fundamentos e as principais diretrizes para a avaliaçäo dos antidepressivos. O objetivo principal é propiciar ao psiquiatra näo familiarizado com metodoligia um referencial para a interpretaçäo de estudos clínicos de antidepressivos