RESUMO
BACKGROUND: Allergen exposure chambers (AECs) are clinical facilities allowing for controlled exposure of subjects to allergens in an enclosed environment. AECs have contributed towards characterizing the pathophysiology of respiratory allergic diseases and the pharmacological properties of new therapies. In addition, they are complementary to and offer some advantages over traditional multicentre field trials for evaluation of novel therapeutics. To date, AEC studies conducted have been monocentric and have followed protocols unique to each centre. Because there are technical differences among AECs, it may be necessary to define parameters to standardize the AECs so that studies may be extrapolated for driving basic immunological research and for marketing authorization purposes by regulatory authorities. METHODS: For this task force initiative of the European Academy of Allergy and Clinical Immunology (EAACI), experts from academia and regulatory agencies met with chamber operators to list technical, clinical and regulatory unmet needs as well as the prerequisites for clinical validation. RESULTS: The latter covered the validation process, standardization of challenges and outcomes, intra- and interchamber variability and reproducibility, in addition to comparability with field trials and specifics of paediatric trials and regulatory issues. CONCLUSION: This EAACI Position Paper aims to harmonize current concepts in AECs and to project unmet needs with the intent to enhance progress towards use of these facilities in determining safety and efficacy of new therapeutics in the future.
Assuntos
Alérgenos/imunologia , Dessensibilização Imunológica/métodos , Ambiente Controlado , Exposição por Inalação , Dessensibilização Imunológica/normas , Dessensibilização Imunológica/tendências , Política de Saúde , Humanos , Hipersensibilidade/imunologia , Hipersensibilidade/terapia , Exposição por Inalação/efeitos adversos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: This study was designed to assess the association between personality disorders, personality traits, impulsive violence, and suicide. METHOD: Personality disorders and traits in 43 adolescent suicide victims and 43 community controls were assessed from the parents, using semistructured interviews and self-report forms. RESULTS: Probable or definite personality disorders were more common in suicide victims than in controls, particularly Cluster B (impulsive-dramatic) and C type (avoidant-dependent) disorders. Suicide victims also showed greater scores on lifetime aggression, even after controlling for differences in psychopathology between suicides and controls. CONCLUSIONS: Personality disorders and the tendency to engage in impulsive violence are critical risk factors for completed suicide.
Assuntos
Comportamento Impulsivo/psicologia , Desenvolvimento da Personalidade , Transtornos da Personalidade/psicologia , Suicídio/psicologia , Violência , Adolescente , Feminino , Humanos , Comportamento Impulsivo/diagnóstico , Comportamento Impulsivo/terapia , Masculino , Pennsylvania , Determinação da Personalidade , Transtornos da Personalidade/diagnóstico , Transtornos da Personalidade/terapia , Fatores de Risco , Prevenção do SuicídioRESUMO
OBJECTIVE: A family study of DSM-III-R personality disorders was conducted in the families of 66 clinically referred adolescents to examine the validity of personality disorder diagnoses in adolescents. METHOD: Semistructured interviews of Axis I and II disorders, including the Structured Clinical Interview for DSM-III-R Personality Disorders, were used to directly interview 66 clinically referred adolescents and their adult first-degree family members, combining family study and family history data. RESULTS: The relatives of adolescents with avoidant personality disorder had an increased prevalence of avoidant and cluster A (schizoid, schizotypal, and paranoid) personality disorders. The relatives of adolescents with borderline personality disorder demonstrated increased rates of borderline and avoidant personality disorders, even after adjusting for comorbidity. CONCLUSIONS: The results of this study support the validity of Axis II diagnoses, particularly avoidant and borderline disorders, in adolescents.
Assuntos
Filho de Pais com Deficiência/psicologia , Desenvolvimento da Personalidade , Transtornos da Personalidade/genética , Adolescente , Adulto , Transtorno da Personalidade Borderline/diagnóstico , Transtorno da Personalidade Borderline/genética , Transtorno da Personalidade Borderline/psicologia , Feminino , Humanos , Masculino , Transtornos da Personalidade/diagnóstico , Transtornos da Personalidade/psicologia , Escalas de Graduação Psiquiátrica , Fatores de RiscoRESUMO
Inpatient suicide attempters (n = 37) were compared with never-suicidal psychiatric controls (n = 29) with respect to prevalence and severity of personality disorder, history of aggression and assaultive behavior, and other measures of impulsive violence. Attempters, compared with controls, were more likely to show evidence of personality disorder or trait, particularly those of the borderline type. Attempters showed greater number of borderline symptoms than did controls, even after removing the item relating to suicidality. There were no differences between the groups with respect to lifetime history of aggression, history of assaultive behavior, or self-report measures of a tendency to impulsive aggression. Those attempters with personality disorder were much more likely to have made a previous attempt. The apparently high prevalence of personality disorder among adolescent inpatient suicide attempters indicates that the social impairment associated with personality disorder be viewed as an important aspect of treatment.