Conservação de peças anatômicas em cloreto de sódio: um estudo com produto de fecundação / Conservation of anatomical parts in sodium chloride: a study with fertilization product / Conservación de partes anatómicas en cloruro sódico: un estudio con producto de fertilización

Introdução: Os materiais de origem humana geralmente são conservados em formaldeído, para possibilitar o estudo da anatomia humana, tal conservante possui baixo custo e boa fixação, contudo é toxico. Diante do exposto é necessário, o estudo de outros métodos de conservação, menos prejudiciais, como a solução de NaCl 30%. Objetivo: Comparar a conservação de peças anatômicas em solução de NaCl à 30% e formaldeído a 10%. Método: Pesquisa experimental, exploratória e descritiva, realizada com dois produtos de abortamento, no laboratório de anatomia de uma universidade pública, no estado do Paraná/BR. Foi realizada fixação em solução de formol 10%, em seguida uma amostra foi lavado em água corrente e armazenado em solução de NaCl à 30%. Após 6 meses da conservação em solução salina, foram coletadas amostras, estas foram submetidas a análise de crescimento bacteriano. Avaliou-se tonalidade e turgor cutâneo, odor e peso, bem como crescimento bacteriano. O estudo seguiu os preceitos éticos (CAAE: 53740121.9.0000.9247). Resultados: Foram realizadas observações após 24h, 7, 30, 60, 90 e 180 dias. O feto em solução de NaCl não possui odor, e diminuição do turgor da pele. Ambas a amostras não apresentaram crescimento bacteriano. Considerações finais: A solução de NaCl a 30% desidrata a pele, mas não altera significativamente a forma e estrutura, ainda não possui odor e nem toxicidade, o que garante benefícios a saúde de quem os manipula, bem como tal concentração de NaCl inibe de forma efetiva o crescimento bacteriano nos tecidos e na própria solução, se demostrando eficaz na conservação.

Introduction: The materials of human origin are usually preserved in formaldehyde, to enable the study of human anatomy, this preservative has low cost and good fixation, however it is toxic. Therefore, it is necessary to study other less harmful preservation methods, such as 30% NaCl solution. Objective: To compare the preservation of anatomical specimens in 30% NaCl solution and 10% formaldehyde solution. Method: Experimental, exploratory and descriptive research, carried out with two abortion products, in the anatomy laboratory of a public university, in the state of Paraná/BR. Fixation in 10% formaldehyde solution was performed, after which a sample was washed in running water and stored in a 30% NaCl solution. After 6 months of preservation in saline solution, samples were collected and submitted to bacterial growth analysis. Skin tone and turgor, odor, weight, and bacterial growth were evaluated. The study followed the ethical precepts (CAAE: 53740121.9.0000.9247). Results: Observations were made after 24h, 7, 30, 60, 90 and 180 days. The fetus in NaCl solution had no odor, and decreased skin turgor. Both samples showed no bacterial growth. Final considerations: The 30% NaCl solution dehydrates the skin, but does not alter significantly the shape and structure, and also has no odor or toxicity, which guarantees health benefits to those who handle them, and such concentration of NaCl inhibits effectively the bacterial growth in the tissues and in the solution itself, proving to be effective in conservation.

Introducción: Los materiales de origen humano suelen conservarse en formol, para posibilitar el estudio de la anatomía humana, este conservante tiene bajo coste y buena fijación, sin embargo es tóxico. Por ello, es necesario estudiar otros métodos de conservación menos nocivos, como la solución de NaCl al 30%. Objetivo: Comparar la conservación de especímenes anatómicos en solución de NaCl al 30% y en solución de formaldehído al 10%. Método: Investigación experimental, exploratoria y descriptiva, realizada con dos abortos, en el laboratorio de anatomía de una universidad pública, en el estado de Paraná/BR. Fue realizada fijación en solución de formaldehído al 10%, después de lo cual la muestra fue lavada en agua corriente y almacenada en solución de NaCl al 30%. Tras 6 meses de conservación en solución salina, se recogieron las muestras y se sometieron a análisis de crecimiento bacteriano. Se evaluaron el tono y la turgencia de la piel, el olor, el peso y el crecimiento bacteriano. El estudio siguió los preceptos éticos (CAAE: 53740121.9.0000.9247). Resultados: Las observaciones se realizaron después de 24h, 7, 30, 60, 90 y 180 días. El feto en solución de NaCl no tenía olor, y la turgencia de la piel disminuyó. Ambas muestras no mostraron crecimiento bacteriano. Consideraciones finales: La solución de NaCl al 30% deshidrata la piel, pero no altera significativamente la forma y estructura, además no tiene olor ni toxicidad, lo que garantiza beneficios para la salud de quienes los manipulan, y dicha concentración de NaCl inhibe eficazmente el crecimiento bacteriano en los tejidos y en la propia solución, demostrando ser eficaz en la conservación.

Captopril oral solution for pediatric use: formulation, stability study and palatability assessment in vivo

Abstract he aim of this work was to develop an oral solution of captopril at 5 mg/mL preservative-free. Two formulations were prepared, one containing sweetener (formulation 1) and the other without this excipient (formulation 2). The results found of validation parameters from analytical method performed by HPLC for captopril were, linearity 0.9998, the limit of detection 15.71 µg/mL, the limit of quantification 47.60 µg/mL, repeatability 1.05%, intermediate precision 2.42%, accuracy intraday 101,53%, accuracy inter-day 99.85%. Moreover, the results found for captopril disulfide were, linearity 0.9999, limit of detection 0.65 µg/mL, limit of quantification 1.96 µg/mL, repeatability 2.28%, intermediate precision 1.51%, accuracy intraday 101.36%, accuracy inter-day 100.29%. The appearance of formulations was clear and colorless, pH measures were 3.12 and 3.04, dosage of captopril and captopril disulfide were 99.45% and 99.82%, 0.24% and 0.12% for formulation 1 and formulation 2, respectively. The stability study demonstrated that the concentration of captopril and captopril disulfide in the formulations was > 90% and below 3%, respectively. The in vivo palatability study in animals and humans showed that Formulation 1 containing the sweetener had better acceptance. Thus, the sweetener was able to improve the unpleasant taste of the formulation

High rate of sensitization to Kathon CG, detected by patch tests in patients with suspected allergic contact dermatitis

Abstract Background: Kathon CG, a combination of methylchloroisothiazolinone and methylisothiazolinone, is widely used as preservative in cosmetics, as well in household cleaning products, industrial products such as paints and glues. It has emerged as an important sensitizing agent in allergic contact dermatitis. Objectives: This study evaluated the reactivity to this substance in patients subjected to patch tests at the Dermatology Institute in Bauru, São Paulo from 2015 to 2017 and its correlation with other preservatives, the professional activity and location of the lesions. Methods: The patients were submitted to standard series of epicutaneous tests, standardized by the Brazilian Group Studies on Contact Dermatitis. Results: Out the 267 patients tested, 192 presented positivity to at least one substance and 29 of the patients (15.10%) presented reaction to Kathon CG, with predominance of the female gender (n = 27); main professional activity associated with Kathon CG sensibilization was cleaning (17.24%), followed by aesthetic areas (13.79%) and health care (10.34%). The most prevalent sensitizations among the substances tested were nickel sulphate (56.3%), followed by cobalt chloride (23.4%), neomycin (18.2%), potassium dichromate (17.7%), thimerosal (14.5%), formaldehyde (13.2%), paraphenylenediamine (9.3%), and fragrance mix (8.3%). Study limitations: We do not have data from patients that were submitted to patch test a decade ago in order to confront to current data and establish whether or no sensitization to Kathon CG has increased. Conclusion: High positivity to Kathon CG corroborates the recent findings in the literature, suggesting more attention to concentration of this substance, used in cosmetics and products for domestic use.

Effectiveness of using preservative-free artificial tears versus preserved lubricants for the treatment of dry eyes: a systematic review / Eficácia do uso de colírios sem preservativos comparados com colírios com preservativos no tratamento do olho seco: uma revisão sistemática

ABSTRACT This systematic review aimed to assess the effectiveness of using preservative-free artificial tears versus preserved lubricants for the treatment of dry eyes in Universidade Federal de Alagoas (PROSPERO 2018 CRD42018089933). Online databases were searched (LILACS, EMBASE, MEDLINE, and CENTRAL) from inception to April 2018; references from included papers were also searched. The following keywords were used: lubricants OR artificial tears OR artificial tears, lubricants AND dry eye OR dry eye syndrome OR syndromes, dry eye OR dry eyes. Among the 2028 electronic search results, 29 full papers were retrieved and four were considered relevant. The number of participants from these studies ranged from 15 to 76. Meta-analysis was possible for the following outcomes: score of symptoms according to the Ocular Surface Disease Index - Allergan (OSDI), tear secretion rate using the Schirmer test, tear evaporation rate using the tear film breakup time test, burning, foreign body sensation, and photophobia. No statistically significant difference was observed between the two groups, and no side effects were attributed to the interventions. Evidence proving that preservative-free artificial tears are more effective than preserved artificial tears is lacking.

RESUMO Esta revisão sistemática teve como objetivo avaliar a eficácia do uso de lágrimas artificiais sem conservantes em comparação com lubrificantes preservados no tratamento do olho seco na Universidade Federal de Alagoas (PROSPERO 2018 CRD42018089933). As bases de dados online foram pesquisadas (LILACS, EMBASE, MEDLINE e CENTRAL) desde o início até abril de 2018; referências de artigos incluídos também foram pesquisadas. Foram utilizados os seguintes descritores: lubrificantes OU lágrimas artificiais OU lágrimas artificiais, lubrificantes E olho seco OU síndrome do olho seco OU síndromes, olho seco OU olhos secos. Dos 2028 resultados de busca eletrônica, 29 artigos completos foram recuperados, e quatro foram considerados relevantes. O número de participantes desses estudos variou de 15 e 76. A meta-análise foi possível para as seguintes variáveis: escore de desfecho dos sintomas de acordo com o Índice de Doença da Superfície Ocular - Allergan (OSDI), taxa de secreção lacrimal pelo teste de Schirmer, taxa de evaporação lacrimal usando o teste de tempo de ruptura do filme lacrimal, queimação, sensação de corpo estranho e fotofobia. Nenhuma diferença estatisticamente significativa foi observada entre os dois grupos, e nenhum efeito adverso foi atribuído às intervenções. Evidências provando que as lágrimas artificiais sem conservantes são mais eficazes do que as lágrimas artificiais preservadas estão faltando.

Effects of benzalkonium chloride and cyclosporine applied topically to rabbit conjunctiva: a histomorphometric study / Efeitos do uso tópico do conservante cloreto de benzalcônio e ciclosporina na conjuntiva de coelhos: estudo histomorfométrico

ABSTRACT Purpose: Chronic instillation of benzalkonium chloride, a preservative, has inflammatory effects on the ocular surface. However, addition of the anti-inflammatory agent cyclosporine to a therapeutic protocol may mitigate these effects. This study compared the toxic effects of a 0.1% benzalkonium chloride solution and the possible protective effect of 0.05% cyclosporine when applied topically to the rabbit conjunctiva. Methods: Fifteen age- and weight-matched, female New Zealand white rabbits were categorized into three groups and treated for 30 consecutive days. Group 1, 2, and 3 - benzalkonium chloride received 0.1% every 24 h, 0.05% cyclosporine every 6 h, and both treatments, respectively. In each rabbit, the left eye was subjected to treatment and the right eye was a control. The rabbits were euthanized at after the experiment. Goblet cells and blood vessels were then enumerated in conjunctival tissues stained with periodic acid-Schiff and hematoxylin-eosin, respectively. Differences between treated and untreated eyes and between groups were compared using the t-test and analysis of variance. Results: Benzalkonium chloride treatment, with and without cyclosporine, significantly reduced (p≤0.05) in the number of goblet cells in treatment eyes compared with that in respective control eyes. Alternatively, adding cyclosporine to benzalkonium chloride did not prevent the loss of conjunctival goblet cells, and a significant reduction in the number of goblet cells was noted. Benzalkonium chloride-induced significant increase in the number of new blood vessels was mitigated significantly by the addition of cyclosporine. Conclusion: This study demonstrated the magnitude of conjunctival injury caused by chronic instillation of benzalkonium chloride. Although cyclosporine did not mitigate the effects on goblet cells, its addition minimized inflammatory angiogenesis induced by benzalkonium chloride.

RESUMO Objetivo: A instilação crônica de cloreto de benzal­cônio, um conservante, tem efeitos inflamatórios na superfície ocular. No entanto, a adição do agente anti-inflamatório ciclosporina a um protocolo terapêutico pode atenuar esses efeitos. Este estudo comparou os efeitos tóxicos de uma solução de cloreto de benzalcônio a 0,1% e o possível efeito protetor de ciclosporina a 0,05% quando aplicado topicamente à conjuntiva de coelho. Métodos: Quinze coelhos fêmeas brancos da raça Nova Zelândia, pareados por idade e peso, foram categorizados em três grupos e tratados por 30 dias consecutivos. Os grupos 1, 2 e 3 - receberam cloreto de benzalcônio 0,1% a cada 24h, ciclosporina a 0,005% a cada 6h e ambos os tratamentos, respectivamente. Em cada coelho, o olho esquerdo foi submetido a tratamento e o olho direito foi controle. Os coelhos foram submetidos à eutanásia após o experimento. Células caliciformes e vasos sanguíneos foram então enumerados em tecidos conjuntivais corados com ácido periódico-Schiff e hematoxilina-eosina, respectivamente. As diferenças entre os olhos tratados e não tratados e entre os grupos foram comparadas usando o teste t e análise de variância. Resultados: O tratamento com cloreto de benzalcônio, com e sem ciclosporina, reduziu significativamente (p£0,05) o número de células caliciformes nos olhos tratados em comparação com os olhos controle correspondentes. Alternativamente, a adição de ciclosporina ao cloreto de benzalcônio não impediu a perda de células caliciformes conjuntivais, e foi observada uma redução significativa no número de células caliciformes. O aumento significativo induzido pelo cloreto de benzalcônio no número de novos vasos sanguíneos foi significativamente mitigado pela adição da ciclosporina. Conclusão: Este estudo demonstrou a magnitude da lesão conjuntival resultante da instilação crônica de cloreto de benzalcônio. Embora a ciclosporina não tenha atenuado os efeitos nas células caliciformes, sua adição minimizou a angiogênese inflamatória induzida pelo cloreto de benzalcônio.

Effects of Preservative on the Meibomian Gland in Glaucoma Patients Treated with Prostaglandin Analogues / 전남의대학술지

This study compared the effect of preservative-containing (PC) and preservative-free (PF) prostaglandin analogue (PGA) formulations on the ocular surface, especially on the meibomian gland (MG) in patients with open-angle glaucoma (OAG). This is a retrospective study of treatment-naïve patients with OAG (n=80) and healthy controls (n=40). OAG patients were randomized into groups using either PC-PGA or PF-PGA for 12 months. All participants underwent ocular surface and MG examinations including their meibum score, meiboscore, and lid margin abnormality score (LAS). Eighty OAG patients were randomized into two groups (n=42 in PC, n=38 in PF). All PGA and control groups showed similar ocular surface and MG parameters at the baseline. Both PC- and PF-PGA groups showed increased meibum scores, meiboscores, and LASs at 12 months compared to the baseline (all p<0.05). At the 12-months visit, PC-PGA group showed severe OSDI, shorter TBUT, greater OSS, and worse MG parameters than those of the other two groups (all p<0.05). In addition, PF-PGA group showed worse meiboscores, meibum scores, and severe OSS scores than those of the control group (all p<0.05). Both PC and PF formulations can cause damage to the MG in patients using PGA. However, PC formulations induced more ocular discomfort, poorer ocular surface, and more severe MG loss compared to PF formulations. Therefore, it would be advisable to use PF formulations in patients with a preexisting or concomitant ocular surface disease or MGD.

The relationship between topical anti-glaucoma medications and the development of lacrimal drainage system obstruction / A relação entre medicamentos tópicos anti-glaucoma e o desenvolvimento de obstrução do sistema de drenagem lacrimal

ABSTRACT Purpose: To evaluate whether any topical anti-glaucoma medications increase the risk of lacrimal drainage system obstruction or whether the presence of preservatives alone is sufficient to generate obstruction. Methods: This nested case-control study compared a group of patients with lacrimal duct obstruction who received topical anti-glaucoma medications to a control group of patients without obstruction. Results: The medical records of 255 patients with glaucoma who consulted the Oculoplastic Section with complaints of watery eyes were reviewed. Among these patients, 59 exhibited lacrimal drainage obstruction. Ninety-four percent of patients with lacrimal drainage obstruction used beta-blockers, and 41% used prostaglandin analogs. A logistic regression model was used to adjust for age, sex, and the use of other medications. No significant differences were observed regarding the topical anti-glaucoma medications used between groups. Conclusion: No single topical anti-glaucoma medication demonstrated a stronger association with the development of lacrimal duct obstruction.

RESUMO Objetivo: Avaliar se algum medicamento tópico anti-glaucoma aumenta o risco de obstrução do sistema de drenagem lacrimal ou se a presença de conservantes é su fi cien te para gerar obstrução. Métodos: Este estudo de caso-controle aninhado comparou um grupo de pacientes com obstrução do ducto lacrimal que receberam medicações tópicas anti-glaucoma contra um grupo controle de pacientes sem obstrução. Resultados: Foram revistos os prontuários de 255 pacientes com glaucoma que consultaram a Seção de Oculoplástica com queixas de olhos lacrimejantes. Dentre esses pacientes, 59 apresentavam obstrução da via lacrimal de drenagem. Noventa e quatro por cento dos pacientes com obstrução usaram betabloqueadores e 41% usaram análogos de prostaglandinas. Um modelo de regressão logística foi utilizado para ajustar a idade, sexo e o uso de outros medicamentos. Não foram observadas diferenças significativas em relação às medicações tópicas anti-glaucoma usadas entre os grupos. Conclusão: Nenhum medicamento anti-glaucoma tópico único demonstrou uma associação mais forte com o desenvolvimento de obstrução do ducto lacrimal.

In vitro cytotoxicity of chemical preservatives on human fibroblast cells

Preservatives are widely used substances that are commonly added to various cosmetic and pharmaceutical products to prevent or inhibit microbial growth. In this study, we compared the in vitro cytotoxicity of different types of currently used preservatives, including methylparaben, imidazolidinyl urea (IMU), and sodium benzoate, using the human newborn fibroblast cell line CCD1072Sk. Of the tested preservatives, only IMU induced a reduction in cell viability, as shown using the MTT assay and propidium iodide staining (IMU>methylparaben>sodium benzoate). IMU was shown to promote homeostatic alterations potentially related to the initiation of programed cell death, such as decreased mitochondrial membrane potential and caspase-3 activation, in the treated cells. Methylparaben and sodium benzoate were shown to have a very low cytotoxic activity. Taken together, our results suggest that IMU induces programed cell death in human fibroblasts by a canonical intrinsic pathway via mitochondrial perturbation and subsequent release of proapoptotic factors

Effects of prostaglandin analogs on blood flow velocity and resistance in the ophthalmic artery of rabbits / Efeitos dos análogos da prostaglandina na velocidade do fluxo sanguíneo e resistência na artéria oftálmica de coelhos

ABSTRACT Purpose: The aim of this study was to investigate the effects of prostaglandin analogs on blood flow in the ophthalmic artery of clinically healthy rabbits. Methods: Fifty-five clinically healthy New Zealand white rabbits were divided into six groups, and the left eyes were treated for four weeks with the preservative benzalkonium chloride (BAK) only or a topical formulation of different prostaglandin analogs (bimatoprost BAK, tafluprost BAK-free, travoprost BAK, travoprost POLYQUAD, and latanoprost BAK). Color Doppler imaging was performed before and after the treatments. The mean values of the peak systolic velocity (PSV) and end diastolic velocity and the resistive index (RI) were calculated. Statistical analysis was performed to compare the differences pre- and post-treatment for each drug and post-treatment among the drugs. Results: The prostaglandin analogs did not affect PSV. Bimatoprost BAK, travoprost POLYQUAD, and latanoprost BAK did not change RI. Tafluprost BAK-free and travoprost BAK therapy resulted in similar reductions in RI. No significant differences pre- and post-treatment were found when BAK was administered alone. Conclusion: The prostaglandin analogs tafluprost BAK-free and travoprost BAK improved blood flow in the ophthalmic artery in healthy New Zealand white rabbits, which suggests that these drugs enhance the prevention of the progression the progression of glaucoma.

RESUMO Objetivo: O objetivo deste estudo foi investigar os efeitos dos análogos da prostaglandina (PGAs) no fluxo sanguíneo da artéria oftálmica em coelhos. Métodos: Cinquenta e cinco coelhos da raça Nova Zelândia clinicamente saudáveis foram divididos em seis grupos para tratamento com formulação tópica de diferentes APGs (bimatoprosta BAK, tafluprosta BAK-free, travoprosta BAK, travoprosta POLYQUAD e latanoprosta BAK) e formulações contendo apenas o conservante cloreto de benzalcônio (BAK). Foi realizada ultrassonografia com Doppler antes e após os tratamentos. Os valores do pico da velocidade sistólica (PSV) e da velocidade diastólica final foram obtidos e o índice de resistência (RI) foi então calculado. A análise estatística foi realizada para comparar as diferenças entre cada droga no pré e pós-tratamento, além das diferenças no pós-tratamento entre as drogas. Resultados: Estes colírios PGAs não afetaram o PSV. A bimatoprosta com o conservante BAK, travoprosta com o conservante POLYQUAD e latanoprosta com o conservante BAK não alteraram o RI. Já o tratamento com tafluprosta sem conservante (BAK-free) e travoprosta com o conservante BAK promoveram redução similar dos valores do RI. Não houve diferença significativa na comparação entre valores pré e pós-tratamento quando BAK foi administrado isoladamente. Conclusão: Os PGAs tafluprosta BAK-free e travoprosta BAK melhoraram o fluxo sanguíneo na artéria oftálmica em coelhos da raça Nova Zelândia sugerindo que estes medicamentos possam contribuir na prevenção da progressão do glaucoma.

In Vivo Effects of Preservative-free and Preserved Prostaglandin Analogs: Mouse Ocular Surface Study

PURPOSE: Chronic use of topical hypotensive agents induces several side effects caused by preservatives. The purpose of this study was to evaluate the effects of prostaglandin analogs with varying concentrations of benzalkonium chloride (BAC), preservative-free (PF), and alternative preservatives on mouse corneal tissue. METHODS: Thirty-five, 8- to 10-week-old female C57BL/6 mice (five mice for each group) were used for this study. To the control group, we applied normal saline, and to each drug-treated group we applied 0.02% BAC, bimatoprost 0.01% (with BAC 0.02%), latanoprost 0.005% (with BAC 0.02%), travoprost 0.004% (with 0.001% polyquad) or tafluprost 0.0015% with/without 0.001% BAC, once a day (9 p.m.) for 4 weeks. Corneal fluorescein staining was evaluated in all groups. After harvest, the corneal tissues were embedded in paraffin and then Hematoxylin-Eosin stain was performed for histopathological examination. Immunofluorescence staining was done against TNF-alpha, IL-6, HLA DR, pJNK, and pAkt. RESULTS: In corneal fluorescein staining, severe punctate epithelial keratitis was seen in the groups of 0.02% BAC, 0.02% BAC containing bimatoprost 0.01% and latanoprost 0.005%. The surface desquamation, irregular surface, loss of cell borders, anisocytosis and stromal shrinkage were observed in the groups of BAC-containing eye drops. Moreover, the groups treated with BAC-containing eye drops have high inflammatory markers, significantly decreased cell viability-related signal, pAkt, and higher apoptosis-inducing signal, pJNK, than the control group. On the other hand, travoprost 0.004% and PF tafluprost 0.0015% have less cellular morphologic changes, lower inflammation, and higher cellular viability than BAC-containing formulations. CONCLUSIONS: Corneal damage, increased inflammation and apoptosis and low cell viability were observed in BAC-containing groups. PF or alternatively preserved glaucoma medications seem to be a reasonable and viable alternative to those preserved with BAC.

Microbial spoilage, instability risk of antacid suspension in the presence of commonly used preservative system

Manifestation of microbial spoilage of any product by bacteria and to assess the effectiveness of the antimicrobial preservatives [parabens] used for the prevention and stability purpose. The aim of the present work is to study the effectiveness of preservatives used in the antacid suspensions and to analyze the effect of microbial growth on the quality of respective antacid suspensions. Samples of various antacid suspensions were randomly collected from local market and Government hospital pharmacies. Three different antacid formulations were prepared in the laboratory. All the formulations were preliminarily evaluated on the basis of organoleptic characteristics, pH, viscosity and assay. Efficacy of the preservative system in suspension formulation was determined by inoculating the samples in its final container, with specific strains of bacteria i.e. Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Staphylococcus aureus ATCC 6538, taking samples from the inoculated preparation at specified intervals of time i.e. 0 time, 07 days, 14 days and 28 days, growing it on nutrient agar medium and colony forming units [CPUs] were scored by plate count. At the same time the samples were also subjected to qualitative and quantitative testing. The decrease in CPU and alteration in assay, pH and viscosity was observed in all the formulations except formulation M2 and F3 that showed stability throughout the study period

Timerosal en las vacunas: ¿blanco, negro, o más bien todo lo contrario? / Thimerosal in vaccines: white, black, or quite the opposite?

El presente artículo tiene por objetivo analizar la controversia ocurrida en Chile, especialmente durante los últimos meses, en relación a un proyecto de ley que busca prohibir la fabricación, importación, comercialización o distribución de vacunas que contengan dentro de sus compuestos, en cualquier nivel de concentración, timerosal o compuestos organomercúricos. Sin constituir una síntesis formal de toda la investigación existente, se analiza la evidencia científica que los distintos actores han utilizado, las razones de la controversia y las anomalías en el proceso de toma de decisión sanitaria.

This article analyzes the recent controversy regarding the introduction of a bill to Chilean Congress that aims to ban thiomersal and/or any trace of organomercurial compounds from vaccines in the country. Rather than providing a formal overview of all available evidence, this analysis focuses on the reasons behind the controversy, the scientific evidence invoked by both sides in the debate, and the anomalies in the healthcare decision-making process.

J'accuse desde la bioética: análisis de la discusión sobre el timerosal en Chile / A bioethical j’accuse: analysis of the discussion around thiomersal in Chile

El Poder Legislativo chileno propone una ley que elimine el timerosal como preservante de las vacunas parenterales del Programa Nacional de Inmunizaciones, proyecto que el Poder Ejecutivo se ha propuesto vetar. El mundo científico informa mayoritariamente que la sospecha de neurotoxicidad atribuida al timerosal es infundada. Pese a ello, las autoridades médicas han oscilado entre sostener que la precaución sugiere apoyar la ley y en otros momentos han manifestando que es más precautorio mantener los programas de vacunación actualmente vigentes. Estas contradicciones y oposiciones ilustran que materias que conciernen a la ciudadanía, requieren una reflexión bioética acabada sobre las políticas públicas sanitarias. Han quedado claro las deficiencias de la deliberación política y la falta de participación social en decisiones que, dado el grado de incertidumbre involucrada en temas como inmunización, requieren no sólo la inclusión de la ciudadanía sino el respeto de la autonomía individual para aceptar o rechazar la inclusión en los programas de vacunación propuestos por las políticas sanitarias. La participación ciudadana en nuestro país se ve severamente limitada por la falta de instrumentos sociales como el plebiscito, el ombudsman y, especialmente, la desidia en crear la Comisión Nacional de Bioética exigida por la Ley 20.120 de 2006, una de cuyas funciones más importantes es mediar deliberativamente entre legos, expertos y políticos en la generación de políticas sanitarias legitimadas por la participación ciudadana.

Chilean legislators have voted to ban vaccines preserved with thiomersal, an initiative that the Executive has vetoed. Most scientific evidence has dismissed the alleged toxicity of this substance, in accordance with the formal and publicly expressed opinion of local experts, and yet, medical authorities have issued contradictory statements. Some have argued that the principle of precaution suggests eliminating thiomersal preserved vaccines; others have declared that current vaccines should be maintained to protect the population. From the perspective of bioethics, this polemic is another example of the shortcoming of the deliberation process leading to controversial laws in lieu of including citizens in the discussion of regulations that harbor uncertainties, and respect for individual autonomy to accept or reject public immunization programs. The Chilean legal system has been unwilling to implement participatory democratic procedures like plebiscites or institutions such as the ombudsman. In 2006 a law was enacted that creates a National Commission of Bioethics, but successive governments have failed to create such a commission, which is an efficient social instrument to conduct deliberation on bioethical issues that require a balanced participation of the public, experts, and politicians.

The prevalence of ocular surface complaints in Brazilian patients with glaucoma or ocular hypertension / Prevalência de sintomas da doença da superfície ocular em pacientes brasileiros com glaucoma ou hipertensão ocular

PURPOSE: To examine the prevalence of ocular surface complaints in Brazilian patients with glaucoma or ocular hypertension who used topical intraocular pressure (IOP)-lowering regimens. METHODS: In this multicenter, noninterventional, single-visit study, adults with glaucoma or ocular hypertension treated with an IOP-lowering regimen were administered the 12-item ocular surface disease index (OSDI) questionnaire. Each response was scored on a 5-point scale, with 0 indicating symptom present none of the time and 4 indicating symptom present all of the time. The average of the 12 item responses for each patient was transformed to a scale from 0 to 100, with higher scores representing worse disabilities. OSDI results then were categorized as absence of OSD (scores of 0-12), mild OSD (scores of 13-22), moderate OSD (scores of 23-32), or severe OSD (scores of 33100). RESULTS: The 173 enrolled patients had a mean age of 61.2 years, were women in 65.3% of cases, and had glaucoma in 89.0% of cases and ocular hypertension in 11.0% of cases. OSDI scores for 158 patients using 1 IOP-lowering therapy indicated no OSD in 37.3% of patients (59/158), mild OSD in 20.9% (33/158), moderate OSD in 17.1% (27/158), and severe OSD in 24.7% (39/158). For the 120 patients using 1 IOP-lowering medication and having a known duration of diagnosis of glaucoma or ocular hypertension, mean OSDI scores were numerically higher (worse) for the 39 patients with a diagnosis ≥6 years long (score 25 [± 20], indicating moderate OSD) than for the 81 patients with a diagnosis lasting <6 years (score 22 [± 20], indicating mild OSD); however, no significant differences in OSDI scores by duration of diagnosis were evident in means (P=0.49), distributions (P≥0.26), or correlation (P=0.77). CONCLUSIONS: A large proportion of Brazilian patients treated with 1 IOP-lowering therapy had some ocular surface complaints.

OBJETIVO: Avaliar a prevalência de sintomas decorrentes de doença de superfície ocular (DSO) em pacientes brasileiros com glaucoma ou hipertensão ocular que utilizam tratamento ocular tópico para redução da pressão intraocular (PIO). MÉTODO: Neste estudo multicêntrico, não intervencional de uma única visita, pacientes adultos com glaucoma ou hipertensão ocular em tratamento para redução da pressão intraocular (PIO) responderam aos 12 itens do questionário "índice de doença da superfície ocular" (OSDI). Cada resposta foi pontuada numa escala de 5 pontos, com 0 (zero) indicando a ausência de sintomas e 4 indicando sintomas presentes todo o tempo. A média de respostas dos 12 itens para cada paciente foi transformada numa escala de 0 a 100, com pontuações mais elevadas representando piores deficiências. Os resultados do OSDI foram categorizados como ausência de DSO (pontuação de 0-12), DSO leve (pontuação de 13-22), DSO moderada (pontuação de 23-32) ou DSO grave (pontuação de 33-100). RESULTADOS: Os 173 pacientes incluídos apresentavam idade média de 61,2 anos, 65,3% eram mulheres (65,3%), tinham glaucoma em 89,0% dos casos e hipertensão ocular em 11,0% dos casos. As pontuações do OSDI para os 158 pacientes utilizando uma medicação para redução da PIO indicaram "DSO ausente" em 37,3% dos pacientes (59/158), "DSO leve" em 20,9% (33/158), "DSO moderada" em 17,1% (27/158) e "DSO grave" em 24,7% (39/158). Para os 120 pacientes utilizando medicação redutora da PIO e com duração conhecida do diagnóstico de glaucoma ou hipertensão ocular, a pontuação média do OSDI foi numericamente superior (pior) para 39 pacientes com diagnóstico realizado há mais de 6 anos (pontuação 25 [± 20] indicando DSO moderado) do que para 81 pacientes com o diagnóstico realizado há menos de 6 anos (pontuação 22 [± 20] indicando DSO leve); no entanto, não houve diferença estatisticamente significativa na média da pontuação OSDI na duração do diagnóstico (P=0.49), distribuição (P≥0,26), ou correlação (P=0,77). CONCLUSÃO: Uma grande proporção de pacientes brasileiros tratados com uma medicação para redução da PIO apresenta sintomas decorrentes de doença da superfície ocular (DSO).