Prevalence of errors causing events allegedly attributable to vaccination/immunization: systematic review and meta-analysis / Prevalencia de errores causantes de acontecimientos supuestamente atribuibles a la vacunación/inmunización: revisión sistemática y metanálisis / Prevalência de erros que causaram eventos supostamente atribuíveis à vacinação/imunização: revisão sistemática e metanálise

ABSTRACT Objective: To identify the prevalence of errors that caused events supposedly attributable to vaccination or immunization. Method: Systematic literature review with meta-analysis carried out on the Medline, Cochrane Library, Cinahl, Web of Science, Lilacs, Scopus; Embase; Open Grey; Google Scholar; and Grey Lit databases; with studies that presented the prevalence of immunization errors that caused events or that provided data that allowed this indicator to be calculated. Results: We evaluated 11 articles published between 2010 and 2021, indicating a prevalence of 0.044 errors per 10,000 doses administered (n=762; CI95%: 0.026 - 0.075; I2 = 99%, p < 0.01). The prevalence was higher in children under 5 (0.334 / 10,000 doses; n=14). The predominant events were fever, local pain, edema and redness. Conclusion: A low prevalence of errors causing events was identified. However, events supposedly attributable to vaccination or immunization can contribute to vaccine hesitancy and, consequently, have an impact on vaccination coverage.

RESUMEN Objetivo: Identificar la prevalencia de errores que causaron eventos supuestamente atribuibles a la vacunación o inmunización. Método: Revisión sistemática de la literatura con metaanálisis realizada en las bases de datos Medline, Cochrane Library, Cinahl, Web of Science, Lilacs, Scopus; Embase; Open Grey; Google Scholar; y Grey Lit; con estudios que presentaran la prevalencia de errores de inmunización que causaron eventos o que aportaran datos que permitieran calcular este indicador. Resultados: Se evaluaron 11 artículos publicados entre 2010 y 2021, indicando una prevalencia de 0,044 errores por cada 10.000 dosis administradas (n=762; IC95%: 0,026 - 0,075; I2 = 99%, p < 0,01). La prevalencia fue mayor en niños menores de 5 años (0,334 / 10.000 dosis; n=14). Los eventos predominantes fueron fiebre, dolor local, edema y enrojecimiento. Conclusión: Se identificó una baja prevalencia de eventos causantes de errores. Sin embargo, los eventos supuestamente atribuibles a la vacunación o inmunización pueden contribuir a la indecisión sobre la vacunación y, en consecuencia, repercutir en la cobertura vacunal.

RESUMO Objetivo: Identificar a prevalência de erros que causaram eventos supostamente atribuíveis à vacinação ou imunização. Método: Revisão sistemática da literatura com metanálise realizada nas bases Medline, Cochrane Library, Cinahl, Web of Science, Lilacs, Scopus; Embase; Open Grey; Google Scholar; e Grey Lit; com estudos que apresentassem prevalência de erros de imunização que causaram eventos ou que disponibilizassem dados que permitissem o cálculo deste indicador. Resultados: Avaliou-se 11 artigos publicados entre 2010 e 2021, apontando prevalência de 0,044 erros por 10.000 doses administradas (n=762; IC95%: 0,026 - 0,075; I2= 99%, p < 0,01). A prevalência foi maior em crianças menores de 5 anos (0,334 / 10.000 doses; n=14). Quanto aos eventos, predominou-se: febre, dor local, edema, rubor. Conclusão: Identificou-se uma prevalência baixa de erros que causaram eventos. Entretanto, os eventos supostamente atribuíveis à vacinação ou imunização podem contribuir para a hesitação vacinal e, consequentemente, impactar nas coberturas vacinais.

Spray-drying of casein/pectin bioconjugate microcapsules containing grape (Vitis labrusca) by-product extract.

Novel microcapsules containing grape peel by-product extract were obtained. In this pursuit, complex coacervation of casein/pectin bioconjugate and spray-drying were combined. We have investigated the role of the dispersion feed rate (FR), drying air inlet temperature (IT) and drying air flow rate (AR) in the drying yield, microencapsulation efficiency, total polyphenols and anthocyanins contents, antioxidant activity, and morphology of the products. Also, the first-order degradation kinetics of the phytochemicals for both the extract and dried microcapsules was assessed and compared. The loss on the phytochemicals during spray-drying was attenuated in up to 88%, and the IT was the main factor affecting the particle properties. The polyphenols on the extract interacted with the polymers, influencing the assemble of the bioconjugate and the particle's features. Such microencapsulation strategy enhanced the thermal stability of the phytochemicals and rendered biocompatible and biodegradable products of which the nutraceutical and cosmeceutical application may have potential.

Can parabens be added to cosmetics without posing a risk to human health? A systematic review of its toxic effects Pode adicionar parabenos a cosméticos sem risco para a saúde humana? Uma revisão sistemática de seus efeitos tóxicos

Objective: To summarize evidence regarding the toxic potential of administering parabenscontaining cosmetics in humans. Methods: The systematic review followed the methodology proposed in Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA). Electronic searches of the PubMed, Virtual Health Library (BVS), and Science Direct databases were performed between October 1st and 31st, 2018. No language restriction was determined. Original articles reporting observational, in vitro and in silico studies of toxicity caused by parabens in human or human cells were considered for eligibility. Two independent reviewers performed data extraction and assessed the methodological quality and risk of bias of articles by using the Downs & Black Scale. Score levels greater than 70% were assumed to reflect good methodological quality. The Kappa coefficient was calculated. Results: A total of 254 studies were found. Following the eligibility evaluation, 22 studies were included for the qualitative synthesis. The concordance between the reviewers was substantial (Kappa coefficient = 0.650). The meaningful reported outcomes were: high concentrations of parabens in the body; apoptosis damage to sperm DNA; oxidative stress; DNA damage; irritative potential; interference in the control of adipogenesis; estrogenic activity; genotoxicity; necrosis; role in carcinogenesis of breast cancer; harmful effects on human skin when exposed to the sun; stimulation of oncogenes expression; and interference with DNA transcription. Despite most included articles presenting appreciable methodological quality, remarkable limitations were observed and the mechanisms by which parabens exert toxicity on humans remained unclear. Conclusions: The accumulation of parabens in the human organism following repeated cosmetics administration on the skin is noteworthy. However overall, the evidence so far does not make it possible to determine whether, and in what extent, the use of paraben-containing cosmetics can disturb human health. Further investigations are still required for clarifying these issues.

Novel Eudragit® -based polymeric nanoparticles for sustained release of simvastatin

This paper reports on the development of nanoparticles aiming at the in vitro controlled release of simvastatin (SVT). The nanoparticles were prepared by the nanoprecipitation method with polymers Eudragit® FS30D (EDGFS) or Eudragit® NE30D (EDGNE). EDGFS+SVT nanoparticles showed mean size of 148.8 nm and entrapment efficiency of 76.4%, whereas EDGNE+SVT nanoparticles showed mean size of 105.0 nm and entrapment efficiency of 103.2%. Infrared absorption spectra demonstrated that SVT incorporated into the polymer matrix, especially EDGNE. Similarly, the differential scanning calorimeter (DSC) curve presented no endothermic peak of fusion, indicating that the system is amorphous and the drug is not in the crystalline state. The maintenance of SVT in the amorphous state may favors its solubilization in the target release sites. In the in vitro dissolution assay, the SVT incorporated into the EDGFS+SVT nanoparticles showed a rapid initial release, which may be related to the pH of the dissolution medium used. Regarding the EDGNE+SVT nanoparticles, the in vitro release occurred in a bimodal behavior, i.e., an initial "burst" followed by a sustained delivery, with the kinetics of drug release following Baker-Lonsdale's mathematical model. All these features suggest the nanoparticulate system's potential to modulate SVT delivery and enhance its bioavailability.

In vitro safety and efficacy evaluations of a complex botanical mixture of Eugenia dysenterica DC. (Myrtaceae): Prospects for developing a new dermocosmetic product.

In the context of developing a new natural product-based cosmetic, the in vitro efficacy and safety evaluations of a complex botanical mixture based on Eugenia dysenterica leaf hydroalcoholic extract (EDE) (2.5-1000µg/mL) were carried out. Chromatographic analysis demonstrated the presence of the tannin (ellagic acid) and flavonoids (quercetin and gallic acid) which characterize the EDE as a polyphenol-rich mixture. Using HFF-1 fibroblasts, it was shown that EDE promoted cell regeneration after UVA exposure. It also led to the inhibition of the collagenase, elastase and tyrosinase enzymes, which are involved in skin-related disorders. In terms of toxicological evaluation, the EDE was classified as non-phototoxic through the 3T3 Neutral Red Uptake Phototoxicity Test (OECD N° 432, 2004) and non-eye irritant by Bovine Corneal Opacity and Permeability (OECD N° 437, 2013) assay, in conjunction with corneal histomorphometric analysis. Furthermore, the EDE has no skin sensitization potential as demonstrated by a two-out-of-three prediction model [protein-binding/haptenization (OECD N° 442C, 2015), keratinocyte and dendritic cell activations]. In addition, it was shown that the EDE seems to be non-genotoxic through the cytokinesis-block micronucleus assay (OECD N° 487, 2014) using HepG2 cells. When considered together, these findings support the use of EDE botanical mixture in cosmetic/pharmaceutical products.

Chemical variability of the essential oils from fruits of Pterodon emarginatus in the Brazilian Cerrado

Pterodon emarginatus Vogel, Fabaceae, is a tree species commonly known as "sucupira-branca". It is a popular medicinal plant in the Brazilian cerrado (Savanna). This study investigates the chemical variability of the essential oils from fruits of P. emarginatus. The fruits were collected from five sites in the Brazilian Cerrado and their essential oils were analyzed by GC/MS. The results obtained by Principal Component and Cluster Analysis identified two groups: cluster I containing β-caryophyllene and δ-elemene and cluster II containing α-copaene, β-cubebene, allo-aromadendrene, α-cubebene and γ-muurulene. The Canonical Discriminant Analysis was used to differentiate between clusters on the basis of essential oil composition. The results showed high variability in the composition of the essential oils from fruits of P. emarginatus, contributing to studies of domestication of this species.