O uso do Canabidiol no Brasil e o posicionamento do Órgão Regulador / The use of Cannabidiol in Brazil and positioning of the National Regulator Organ / El uso del cannabidiol en Brasil y el posicionamiento de la Junta Nacional Reguladora

O artigo apresenta a posição dos estudiosos do canabidiol, acerca de seu uso terapêutico, bem como analisa o posicionamento do Órgão Regulador Nacional, a Agência Nacional de Vigilância Sanitária (Anvisa) e os acórdãos do Tribunal de Justiça do Estado de São Paulo (TJSP) e o Tribunal Regional Federal da 3a Região (TRF3a), acerca do fornecimento de tal substância no Brasil, nos anos 2014 e 2015. Foi realizada pesquisa exploratória do uso do canabidiol para fins clínicos, de normativas da Anvisa que tratem sobre o tema; e de acórdãos no banco de dados do TJSP e TRF3a. Os achados revelaram que estudos e decisões judiciais guardaram relação quanto aos fundamentos e que o órgão regulador apresentou, no tempo estudado, alteração de posicionamento.

En este artículo se presenta la posición de los estudiosos acerca del uso terapéutico del cannabidiol y analiza el posicionamiento de la Junta Nacional Reguladora, la Agencia Nacional de Vigilancia Sanitaria (Anvisa) y las sentencias del Tribunal del Estado de São Paulo (TJSP) y el Tribunal Regional Federal de la 3a Región (TRF3a) relativo a la concesión de la sustancia en Brasil, en los años 2014 y 2015. Se realizó la investigación exploratoria del uso de cannabidiol con fines clínicos, de acuerdo con los reglamentos de la Anvisa y resoluciones judiciales en la base de datos del TJSP y TRF3a. Los resultados revelaron que los estudios y las decisiones de los tribunales estaban relacionados con fundamentos que la Junta Nacional Reguladora presentó, en este periodo, para cambiar su posición.

This article presents the position of the cannabidiol the scholars about its therapeutic use as well as analyzes the positioning National Regulator Organ, the National Health Surveillance Agency (Anvisa) and the judgments of the Court of the State of São Paulo (TJSP) and the Federal Regional Court of the 3rd Region (TRF3a) concerning the provision of such substance in Brazil, during the years 2014 and 2015. An exploratory study of cannabidiol use for clinical purposes, Anvisa's normative and the judgments in the database of TJSP and TRF3a that deals on the subject was performed. The findings revealed that studies and court decisions that bear relation to the fundamentals that the regulator organ presented in the studied time to change its position.

Human histologic evaluation of a six-year-old threaded implant retrieved from a subject with osteoporosis.

AIM: The aim of this case report was to present the evaluation of the bone-to-implant contact in an implant retrieved from a subject with osteoporosis after six years of load. BACKGROUND: Systemic conditions associated with osteoporosis have been postulated to contribute to the severity of alveolar bone loss. The increase in human life expectancy, the increased number of elderly subjects who are partially or totally edentulous, and the use of dental implants for oral habilitation in subjects with osteoporosis has raised several questions. REPORT: A 68-year-old woman with postmenopausal osteoporosis received a prosthetic evaluation of an implant-supported restoration. Histologically, the peri-implant bone appeared healthy. The peri-implant bone appeared in close contact with the implant surface, whereas marrow spaces could be detected in other areas along with prominently stained cement lines. The mean of bone-to-implant contact was 62.51+1.96. CONCLUSION: The results of the evaluation of the dental implant reported here suggest the presence of osteoporosis may not be a contra-indication for implant placement at least after osseointegration has already been established.

Histologic evaluation of early human bone response to different implant surfaces.

BACKGROUND: Studies have demonstrated that roughened dental implant surfaces show firmer bone fixation and an increased percentage of bone-to-implant contact (BIC%) compared to commercially pure titanium-surface (machined) implants. Therefore, the purpose of this study was to evaluate the influence of implant-surface topography on human bone tissue after 2 months of unloaded healing. METHODS: Fourteen subjects with a mean age of 46.87 +/- 9.45 years received two microimplants each (2.5 mm in diameter and 6 mm in length), one test (sandblasted acid-etched surface) and one control (machined surface), either in the mandible or in the maxilla. After a healing period of 2 months, the microimplants and surrounding tissues were removed with a trephine bur and prepared for histologic analysis. RESULTS: All microimplants, except for one of the controls, were clinically stable after the healing period. Histometric evaluation indicated that the mean BIC% was 23.08% +/- 11.95% and 42.83% +/- 9.80% for machined and rough microimplant surfaces, respectively (P = 0.0005). The bone area within the threads was also higher for sandblasted-surface implants (P = 0.0005). The mean percentage of bone density did not differ between the two groups (P = 0.578). CONCLUSION: Data from the present histological study suggest that the sandblasted acid-etched implant provides a better human bone tissue response than machined implants under unloaded conditions after a healing period of 2 months.