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1.
Article in Portuguese | LILACS | ID: biblio-1359467

ABSTRACT

RESUMO: Dermatite alérgica de contato é uma doença cutânea inflamatória, não infecciosa, cuja base do tratamento é a identificação e eliminação do agente causal. Cocoamidopropil betaína é um surfactante muito utilizado nos produtos de uso pessoal, notadamente de uso capilar. Essa substância não está presente na bateria padrão brasileira. Neomicina é um antibiótico usado em preparações tópicas. Objetivamos mostrar paciente que desenvolveu alergia no couro cabeludo e que fez erroneamente automedicação com produto que continha substância a qual era ainda mais sensível. O caso é de uma mulher, 36 anos, evoluindo há dois meses com eczema pruriginoso, em áreas de implantação capilar e nuca. Relatava progressiva piora. Diante da suspeita de dermatite de contato, foi realizado teste de contato, utilizando-se da bateria padrão Latino-Americana. Com 96 horas (D4) evidenciou-se positividade leve (+) para cocoamidopropil betaína e forte (++) para neomicina. O resultado positivo para a neomicina foi intrigante, uma vez que a observação do rótulo dos produtos de uso pessoal não a continha. Diante do resultado do teste, após ser questionada novamente, ela confirmou a omissão da automedicação diária com pomada de neomicina. Em conclusão, mostramos a alergia a produtos de uso capilar. Reforçamos a necessidade de se fazer um teste de contato com bateria padrão atualizada. Por fim, alertamos sobre o risco da automedicação. (AU)


ABSTRACT: Allergic contact dermatitis is an inflammatory, non-infectious skin disease. The treatment is based on the identification and elimination of the causal agent. Cocamidopropyl betaine is a surfactant widely used in products for personal use, especially capillary use. This substance is not present in the Brazilian baseline series. Neomycin is an antibiotic used in topical preparations. We aimed to show a patient who developed na allergy in the scalp and mistakenly self-medicated with a product that contained a substance to which it was even more sensitive. The case is of a woman, 36 years old, evolving for 2 months with pruritic eczema, in areas of capillary and nape implantation. She reported progressive worsening. When contact dermatitis was suspected, a contact test was performed using the Latin American baseline series. At 96 hours (D4) there was mild positivity (+) for cocamidopropyl betaine and strong (++) for neomycin. The positive result for neomycin was intriguing, since the observation of the label of products for personal use did not contain it. In view of the test result, after being questioned again, she confirmed the omission of daily self-medication with neomycin ointment. In conclusion, we showed the allergy to hair products. We reinforced the need for an updated baseline series patch test. Finally, we warned about the risk of self-medication. (AU)


Subject(s)
Humans , Female , Adult , Scalp , Self Medication , Skin Diseases, Infectious , Patch Tests , Neomycin/therapeutic use , Dermatitis, Allergic Contact/diagnosis , Dermatitis, Allergic Contact/therapy
2.
São Paulo; s.n; s.n; 2019. 82 p. graf, tab, ilus.
Thesis in Portuguese | LILACS | ID: biblio-1008499

ABSTRACT

Para efetivamente tratar uma infecção, é necessário que o antibiótico possua atividade antimicrobiana adequada e seja capaz de inibir o crescimento do microrganismo patogênico. O doseamento microbiológico é uma metodologia indicada para a análise do antimicrobiano de forma simples, quando comparado com outras metodologias. A Food and Drug Administration (FDA) tem encorajado uma abordagem proativa para introduzir inovações e benefícios associados ao processo de produção farmacêutica. A Qualidade por Design Analítico (AQbD) ajuda no desenvolvimento de métodos analíticos robustos e de baixo custo, que são aplicáveis durante todo ciclo de vida do produto. Os métodos microbiológicos tradicionais, de forma geral, apresentam baixa reprodutibilidade e alta incerteza. Desta forma, justifica-se o desenvolvimento de métodos microbiológicos alternativos para a análise de antimicrobianos empregando-se os conceitos de Qualidade por Design Analítico, com a finalidade de melhorar a reprodutibilidade e reduzir a incerteza final. O objetivo deste trabalho foi aplicar o conceito de Qualidade por Design Analítico (AQbD) no desenvolvimento de método colorimétrico para análise de sulfato de neomicina. O sulfato de neomicina é um antimicrobiano aminoglicosídeo amplamente empregado no tratamento de infecções cutâneas ou mucosas, tais como queimaduras, úlceras, e dermatites infecciosas. Métodos cromatográficos como a cromatografia líquida de alta eficiência em fase reversa, de pareamento iônico ou cromatografia iônica com derivatização (pré ou pós-coluna) são utilizados para a análise de aminoglicosídeos, inclusive sulfato de neomicina. Contudo, de acordo com as farmacopeias, o método microbiológico é o método analítico de escolha para a análise de sulfato de neomicina e outros aminoglicosídeos. A análise colorimétrica é um método amplamente utilizado para a detecção e quantificação de diferentes substâncias, incluindo o crescimento microbiano em estudos de eficácia terapêutica. Neste trabalho, propomos o uso de resazurina como marcador colorimétrico. O indicador sofre uma reação de oxido-redução na qual altera a coloração em resposta à redução química resultante do crescimento celular. O uso de microplacas para a análise colorimétrica é uma alternativa ao método realizado em tubos de ensaio. Uma alternativa ao uso de espectrofotômetros para a análise colorimétrica é o uso de aparelhos smartphones, pois são equipados com CPUs rápidas, câmeras de alta resolução e sensores de imagem. O processamento da imagem captada pela câmera do dispositivo é utilizado como um analisador colorimétrico. Portanto, a aplicação dos conceitos de Qualidade por Design Analítico (AQbD) possibilitou o desenvolvimento racional de método microbiológico colorimétrico para análise de sulfato de neomicina


o effectively treat an infection, the antibiotic must have adequate antimicrobial activity and be capable of inhibiting the growth of the pathogenic microorganism. The microbiological assay is an indicated methodology for the analysis of the antimicrobial in a simple way, when compared with other methodologies. The Food and Drug Administration (FDA) has encouraged a proactive approach to introducing innovations and benefits associated with the pharmaceutical production process. Analytical Design Quality (AQbD) assists in the development of robust, low cost analytical methods that are applicable throughout the product life cycle. Traditional microbiological methods, in general, have low reproducibility and high uncertainty. Thus, it is justified the development of alternative microbiological methods for the analysis of antimicrobials using the concepts of Quality by Analytical Design, in order to improve reproducibility and reduce final uncertainty. The objective of this work was to apply the concept of Quality by Analytical Design (AQbD) in the development of a colorimetric method for the analysis of neomycin sulfate. Neomycin Sulfate is an aminoglycoside antimicrobial widely used in the treatment of cutaneous or mucosal infections, such as burns, ulcers, and infectious dermatitis. Chromatographic methods such as reverse phase high performance liquid chromatography, ion-pairing or ion chromatography with derivatization (pre or post-column) are used for the analysis of aminoglycosides, including neomycin sulfate. However, according to pharmacopoeias, the microbiological method is the analytical method of choice for the analysis of neomycin sulphate and other aminoglycosides. Colorimetric analysis is a widely used method for the detection and quantification of different substances, including microbial growth in studies of therapeutic efficacy. In this work, we propose the use of resazurin as a colorimetric marker. The indicator undergoes an oxidation-reduction reaction in which it alters the coloration in response to the chemical reduction resulting from cell growth. The use of microplates for colorimetric analysis is an alternative to the method carried out in test tubes. An alternative to the use of spectrophotometers for colorimetric analysis is the use of smartphones because they are equipped with fast CPUs, high resolution cameras and image sensors. The image processing captured by the device's camera is used as a colorimetric analyzer. Therefore, the application of the concepts of Quality by Analytical Design (AQbD) allowed the rational development of a microbiological colorimetric method for analysis of neomycin sulfate


Subject(s)
Neomycin/classification , Colorimetry/instrumentation , Analytical Methods/analysis , Anti-Infective Agents/adverse effects , Anti-Bacterial Agents
3.
Braz. dent. j ; 29(6): 555-561, Nov.-Dec. 2018. tab, graf
Article in English | LILACS | ID: biblio-974188

ABSTRACT

Abstract Bleaching gel containing hydrogen peroxide (H2O2) cause damages in pulp tissue. This study investigated the action of a topical anti-inflammatory, the Otosporin®, in rats' bleached teeth with the null hypothesis of which the Otosporin® is no able to minimize the pulp inflammation that bleaching gel generates. The rat's molars were divided into groups: BLE: bleached (35% H2O2 concentration /single application of 30 min); BLE-O: bleached followed by Otosporin® (10 min); and control: placebo gel. In the second day after dental bleaching, the rats were killed, and the jaws were processed for hematoxylin-eosin and immunohistochemistry analysis for tumor necrosis factor alpha (TNF-α), interleukin (IL)-6 and IL-17. The data collected were subjected to Kruskal-Wallis and Dunn statistical tests with at a 5% level of significance (p<0.05). The BLE group had moderate to strong inflammation in the occlusal third of the coronary pulp, with necrotic areas; and BLE-O, mild inflammation (p<0.05). There was a significant difference in the occlusal and middle thirds of the coronary pulp between the BLE with BLE-O and control groups (p<0.05). There was no difference in the cervical third (p>0.05). The BLE group had a high immunoexpression of TNF-α than BLE-O and control groups (p<0.05), with moderate and mild immunoexpression, respectively. Regarding IL-6 and IL-17, the BLE group had higher immunoexpression than control (p<0.05); the BLE-O was similar to the control (p>0.05). The topical anti-inflammatory Otosporin® can reduce pulp inflammation after dental bleaching in the rat teeth.


Resumo O gel clareador à base de peróxido de hidrogênio (H2O2) causa danos ao tecido pulpar. Este estudo investigou a ação de um anti-inflamatório tópico, o Otosporin®, nos dentes de ratos clareados com a hipótese nula de que o Otosporin® não é capaz de minimizar a inflamação da polpa gerada pelo gel clareador. Os molares dos ratos foram divididos em grupos: ClA: clareado (H2O2 a 35% / aplicação única de 30 min); CLA-O: clareado seguido do Otosporin® (10 min); e controle: gel placebo. No segundo dia após a clareação dentária, os ratos foram mortos e suas maxilas foram processadas para análise de hematoxilina-eosina e imunohistoquímica para o fator de necrose tumoral alfa (TNF-a), interleucina (IL)-6 e IL-17. Os dados coletados foram submetidos aos testes estatísticos de Kruskal-Wallis e Dunn com um nível de significância de 5% (p<0,05). O grupo CLA apresentou inflamação moderada à severa no terço oclusal da polpa coronária, com áreas necróticas; e CLA-O, inflamação leve (p<0,05). Houve diferença significativa nos terços oclusal e médio da polpa coronária entre o grupo CLA com os grupos CLA-O e controle (p<0,05). Não houve diferença no terço cervical (p>0,05). O grupo CLA apresentou maior imunoexpressão para TNF-a comparado aos grupos CLA-O e controle (p<0,05), com imunoexpressão moderada e leve, respectivamente. Em relação a IL-6 e IL-17, o grupo CLA apresentou maior imunoexpressão comparado ao controle (p<0,05); o CLA-O foi semelhante ao controle (p>0,05). O anti-inflamatório tópico Otosporin® pode reduzir a inflamação pulpar após clareação em dentes de ratos.


Subject(s)
Animals , Rats , Polymyxin B/pharmacology , Pulpitis/chemically induced , Pulpitis/prevention & control , Tooth Bleaching/adverse effects , Hydrocortisone/pharmacology , Neomycin/pharmacology , Hydrocortisone/administration & dosage , Immunohistochemistry , Biomarkers/analysis , Administration, Topical , Interleukin-6/analysis , Tumor Necrosis Factor-alpha/analysis , Interleukin-17/analysis , Drug Combinations , Hydrogen Peroxide/adverse effects
4.
Med. Afr. noire (En ligne) ; 65(12): 571-580, 2018.
Article in French | AIM, AIM | ID: biblio-1266317

ABSTRACT

Contexte : La vaginite est un motif fréquent de consultation gynécologique. Dans les pays à ressources limitées, en l'absence de laboratoires d'analyses microbiologiques des sécrétions vaginales, le traitement est prescrit sur la base de l'évaluation clinique.Objectif général : Evaluer l'efficacité de notre pratique concernant la prise en charge des vaginites en situation de vie réelle, par la prescription de l'associationternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®).Méthodologie : Nous avons réalisé, dans trois structures sanitaires d'Abidjan, une étude prospective observationnelle sur cinq mois. Elle a inclus, de façon aléatoire, 233 patientes qui ont donné leur consentement écrit et signé et qui présentaient des signes cliniques évidents de vaginites. N'ont pas été incluses les patientes enceintes et allaitantes, celles qui présentaient des co-infections, des infections sexuellement transmissibles, le VIH, une hypersensibilité ou une idiosyncrasie à l'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®). Les patientes ont été divisées en deux groupes : le groupe de référence (n = 200) pour lequel une analyse microbiologique des sécrétions vaginales était effectuée 2 à 4 jours avant la mise sous traitement et le groupe contrôle (n = 33) pour qui le traitement était débuté d'emblée. Les critères d'évaluation étaient la présence des symptômes cliniques et leur cinétique d'évolution, le bilan microbiologique réalisé 10 à 14 jours après le début du traitement et la survenue d'effets indésirables liés à l'utilisation du médicament (notamment les picotements ou les irritations locales). Les tests statistiques utilisés pour la comparaison des effectifs étaient le khi-deux et le Fisher exact avec un seuil de signification de 5% (p < 0,05).Résultats et discussion : Avant l'instauration du traitement, les leucorrhées pathologiques (178/233) et le prurit vulvaire (157/233) étaient les principaux symptômes rencontrés dans les deux groupes. La prédominance des leucorrhées pathologiques était très significativement différente dans le groupe référence versus le groupe contrôle (p = 0,001).Lors de la visite de contrôle, il n'y avait pas de différence significative entre les deux groupes concernant la présence d'une récidive (p = 0,99). Ainsi l'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®) pourrait représenter une option thérapeutique intéressante chez les femmes présentant des signes cliniques évidents de vaginite, en l'absence d'analyse microbiologique préalable des sécrétions vaginales. L'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®) a démontré son efficacité thérapeutique en cas de vaginite à Candida albicans (VC), de Vaginose Bactérienne (VB), de vaginite à Trichomonas vaginalis (VT), et même en cas d'infection mixte (VM). En effet il a été observé une amélioration significative et rapide (3 à 4 jours maximum) des symptômes (p = 0,001) et un faible taux de récidive biologiquement prouvée dans les deux groupes (3,4%). Durant toute la durée du traitement, les patientes n'ont déclaré aucune réaction allergique liée à l'utilisation de l'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®) (picotements ou irritations locales) et 97,3% des patientes ont été globalement très satisfaites de l'utilisation de l'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®).Conclusion : Dans nos pays à ressources limitées, sous-médicalisés, l'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®) apparaît comme une option thérapeutique intéressante pour traiter les vaginites d'origine mycosique, parasitaire, bactériologique et mixte. Cette étude a montré que l'association ternidazole, néomycine sulfate, nystatine, prednisolone (Tergynan®) pouvait être administrée, en initiation de traitement des vaginites dès leur apparition sans besoin de procéder à des prélèvements préalables des sécrétions vaginales


Subject(s)
Africa South of the Sahara , Clinical Decision-Making , Neomycin , Nystatin , Pelvic Infection , Prednisolone
5.
Yonsei Medical Journal ; : 141-147, 2018.
Article in English | WPRIM | ID: wpr-742492

ABSTRACT

PURPOSE: microRNAs (miRNAs) are non-coding RNAs composed of 20 to 22 nucleotides that regulate development and differentiation in various organs by silencing specific RNAs and regulating gene expression. In the present study, we show that the microRNA (miR)-183 cluster is upregulated during hair cell regeneration and that its inhibition reduces hair cell regeneration following neomycin-induced ototoxicity in zebrafish. MATERIALS AND METHODS: miRNA expression patterns after neomycin exposure were analyzed using microarray chips. Quantitative polymerase chain reaction was performed to validate miR-183 cluster expression patterns following neomycin exposure (500 µM for 2 h). After injection of an antisense morpholino (MO) to miR-183 (MO-183) immediately after fertilization, hair cell regeneration after neomycin exposure in neuromast cells was evaluated by fluorescent staining (YO-PRO1). The MO-183 effect also was assessed in transgenic zebrafish larvae expressing green fluorescent protein (GFP) in inner ear hair cells. RESULTS: Microarray analysis clearly showed that the miR-183 cluster (miR-96, miR-182, and miR-183) was upregulated after neomycin treatment. We also confirmed upregulated expression of the miR-183 cluster during hair cell regeneration after neomycin-induced ototoxicity. miR-183 inhibition using MO-183 reduced hair cell regeneration in both wild-type and GFP transgenic zebrafish larvae. CONCLUSION: Our work demonstrates that the miR-183 cluster is essential for the regeneration of hair cells following ototoxic injury in zebrafish larvae. Therefore, regulation of the miR-183 cluster can be a novel target for stimulation of hair cell regeneration.


Subject(s)
Animals , Animals, Genetically Modified , Cell Count , Gene Expression Profiling , Gene Expression Regulation/drug effects , Gene Knockdown Techniques , Green Fluorescent Proteins/metabolism , Hair Cells, Auditory/drug effects , Hair Cells, Auditory/physiology , Larva/drug effects , Larva/genetics , MicroRNAs/genetics , MicroRNAs/metabolism , Morpholinos/pharmacology , Neomycin/toxicity , Regeneration/drug effects , Regeneration/genetics , Zebrafish/genetics
6.
Article in Korean | WPRIM | ID: wpr-719004

ABSTRACT

Allergic contact dermatitis is an inflammatory condition associated with periorbital erythema, edema, and pruritus. The periorbital skin is relatively thin compared with the skin over other facial areas; therefore, it is vulnerable to allergen penetration and may show a variety of cutaneous manifestations. Recently, vision enhancement surgery is a widely performed procedure, and the prevalence of senile cataract and glaucoma is increasing. The prevalence of periocular allergic contact dermatitis is increasing secondary to the growing use of topical ophthalmic medications. Several studies in Korea have reported periocular allergic contact dermatitis secondary to the use of topical ophthalmic medications including latanoprost (Latano®), fluorometholone (Tolon®), polymyxin B (Terramycin®), atropine sulfate (Atropine®), neomycin sulfate (Cambison®), and befunolol hydrochloride (Bentos®), among others. However, ofloxacin (Effexin®)-induced allergic contact dermatitis has not been reported in the domestic and/or foreign literature. We report a case of periocular allergic contact dermatitis secondary to the use of ofloxacin ophthalmic ointment.


Subject(s)
Atropine , Cataract , Dermatitis, Allergic Contact , Edema , Erythema , Fluorometholone , Glaucoma , Korea , Neomycin , Ofloxacin , Polymyxin B , Prevalence , Pruritus , Skin
7.
Laboratory Animal Research ; : 257-263, 2018.
Article in English | WPRIM | ID: wpr-718842

ABSTRACT

Trefoil factor 1 (TFF1, also known as pS2) is strongly expressed in the gastrointestinal mucosa and plays a critical role in the differentiation of gastric glands. Since approximately 50% of all human gastric cancers are associated with decreased TFF1 expression, it is considered a tumor suppressor gene. TFF1 deficiency in mice results in histological changes in the antral and pyloric gastric mucosa, with severe hyperplasia and dysplasia of epithelial cells, resulting in the development of antropyloric adenoma. Here, we generated TFF1-knockout (KO) mice, without a neomycin resistant (NeoR) cassette, using the clustered regularly interspaced short palindromic repeats/CRISPR-associated nuclease 9 (CRSIPR/Cas9) system. Though our TFF1-KO mice showed phenotypes very similar to the previous embryonic stem (ES)-cell-based KO mice, they differed from the previous reports in that a reduction in body weight was observed in males. These results demonstrate that these newly established TFF1-KO mice are useful tools for investigating genetic and environmental factors influencing gastric cancer, without the effects of artificial gene insertion. Furthermore, these findings suggest a novel hypothesis that TFF1 expression influences gender differences.


Subject(s)
Adenoma , Animals , Body Weight , Carcinogenesis , Epithelial Cells , Gastric Mucosa , Genes, Synthetic , Genes, Tumor Suppressor , Humans , Hyperplasia , Lotus , Male , Mice , Mucous Membrane , Neomycin , Phenotype , Stomach Neoplasms
8.
Laboratory Animal Research ; : 279-287, 2018.
Article in English | WPRIM | ID: wpr-718839

ABSTRACT

Placenta specific 8 (PLAC8, also known as ONZIN) is a multi-functional protein that is highly expressed in the intestine, lung, spleen, and innate immune cells, and is involved in various diseases, including cancers, obesity, and innate immune deficiency. Here, we generated a Plac8 knockout mouse using the CRISPR/Cas9 system. The Cas9 mRNA and two single guide RNAs targeting a region near the translation start codon at Plac8 exon 2 were microinjected into mouse zygotes. This successfully eliminated the conventional translation start site, as confirmed by Sanger sequencing and PCR genotyping analysis. Unlike the previous Plac8 deficient models displaying increased adipose tissue and body weights, our male Plac8 knockout mice showed rather lower body weight than sex-matched littermate controls, though the only difference between these two mouse models is genetic context. Differently from the previously constructed embryonic stem cell-derived Plac8 knockout mouse that contains a neomycin resistance cassette, this knockout mouse model is free from a negative selection marker or other external insertions, which will be useful in future studies aimed at elucidating the multi-functional and physiological roles of PLAC8 in various diseases, without interference from exogenous foreign DNA.


Subject(s)
Adipose Tissue , Animals , Body Weight , Codon, Initiator , DNA , Exons , Humans , Intestines , Lung , Male , Mice , Mice, Knockout , Neomycin , Obesity , Placenta , Polymerase Chain Reaction , RNA, Guide , RNA, Messenger , Spleen , Zygote
9.
Brasília; CONITEC; mar. 2017. g, tab.
Non-conventional in Portuguese | LILACS, BRISA | ID: biblio-906981

ABSTRACT

CONTEXTO: Otite externa aguda é uma inflamação que ocorre na orelha externa ­ pavilhão e canal auditivos. Essa condição clínica é caracterizada pelo acometimento da pele e do tecido subcutâneo, sendo a infecção bacteriana a principal causa. O paciente com essa doença tem inflamação no local, acompanhada de intensa dor e secreção. Além disso, experimenta dificuldades de audição, que deixam de existir com a cura da condição clínica. São alternativas terapêuticas para pacientes com otite externa aguda a assepsia (remoção de cerume e limpeza local), aplicação tópica de antibióticos, anti-inflamatórios esteroides e anestésicos, além da administração por via oral de analgésicos e antibióticos. Há no Brasil diversas apresentações farmacêuticas registradas para o tratamento da otite externa aguda. Contudo, nenhuma delas integra a Relação Nacional de Medicamentos Essenciais ­ RENAME. PERGUNTA: Qual alternativa terapêutica é mais eficaz/efetiva e segura para o tratamento de pacientes com otite externa aguda? EVIDÊNCIAS CIENTÍFICAS: Evidências clínicas: foi realizada revisão sistemática para sintetizar as evidências disponíveis sobre eficácia/efetividade e segurança de alternativas terapêuticas para o tratamento de pacientes com otite externa aguda. Foram incluídos dois estudos que avaliam alternativas terapêuticas disponíveis no Brasil. Um dos estudos aponta que a utilização de ciprofloxacino 2 mg/mL se mostrou mais eficaz em curar a doença em menos tempo que a associação entre polimixina B 10.000 UI, neomicina 3,5 mg/mL, hidrocortisona 10 mg/mL. O outro estudo concluiu que tanto ciprofloxacino 2 mg/mL associado a hidrocortisona 10 mg/mL quanto polimixina B 10.000 UI, neomicina 3,5 mg/mL, hidrocortisona 10 mg/mL são semelhantes em resolver o quadro de dor entre seis e sete dias. Para ampliar a análise, nova seleção de estudos foi feita incluindo a avaliação de medicamentos com equivalentes classes farmacêuticas no Brasil. Foram incluídos doze estudos. Foi notada maior eficácia da utilização de quinolona em relação à associação entre não quinolonas e anti-inflamatório esteroide em relação à cura em sete a dez dias de acompanhamento. Avaliação de custo-efetividade: foi realizada avaliação de custo-efetividade em virtude da diferença na eficácia entre quinolona e a associação entre não quinolonas e anti-inflamatório esteroide. Os preços considerados para as alternativas foram os Preços Fabrica definidos pela Câmara de Regulação do Mercado de Medicamentos ­ CMED. Foi construída árvore de decisão para avaliar o desfecho de cura clínica em sete a dez dias. O custo foi representado pelo valor monetário do medicamento e a efetividade pela cura clínica em sete a dez dias. A razão de custo-efetividade incremental de quinolona em relação à associação entre não quinolonas e anti-inflamatório esteroide foi de R$ 136,25. Esse é o valor necessário para que o tratamento com quinolona proporcione uma cura clínica a mais em relação à associação entre não quinolonas e anti-inflamatório esteroide. Avaliação de Impacto Orçamentário: Compreendendo o período entre os anos de 2017 e 2021, foram consideradas as projeções populacionais calculadas pelo IBGE, as taxas de atendimentos de pacientes com otite externa aguda e a cobertura da atenção básica pelo SUS no Brasil. Considerando a perspectiva de financiamento pelo Componente Básico da Assistência Farmacêutica, além do impacto orçamentário total, foram calculados o impacto orçamentário médio por município e por habitante. O impacto orçamentário total em cinco anos para a potencial incorporação de quinolona foi de R$ 87.362.082,52 e para a da associação entre não quinolonas e anti-inflamatório esteroide foi de R$ 16.373.657,88. Os respectivos valores médios por município foram de R$ 15.684,40 e R$ 2.939,62. O impacto orçamentário médio por habitante foi de R$ 0,4148 para quinolona e R$ 0,0778 para a associação entre não quinolonas e anti-inflamatório esteroide. DISCUSSÃO: São escassos os estudos sobre alternativas terapêuticas disponíveis no Brasil. A avaliação por classes farmacêuticas deve se dar com cautela, haja vista a pequena quantidade de estudos disponíveis e a heterogeneidade entre eles. Por meio da evidência disponível, pouco se sabe sobre os efeitos atribuídos a cada princípio ativo. Para a seleção de medicamentos antimicrobianos, pode ser importante avaliar, em vez de uma infecção isolada, um conjunto de infecções para verificar os potenciais benefícios e riscos de se optar por um determinado medicamento. RECOMENDAÇÃO DA CONITEC: A matéria será disponibilizada em Consulta Pública com recomendação preliminar desfavorável à incorporação de medicamentos tópicos para o tratamento de otite externa aguda. CONSULTA PÚBLICA: Foram recebidas três contribuições técnico-científicas e 2 contribuições de experiência ou opinião. Todas as contribuições técnico-científicas continham argumentação técnico-científica contra a recomendação inicial da Conitec. As contribuições de experiência ou opinião também foram contra a recomendação inicial da Conitec. No geral, houve evidências com potencial de alteração desta recomendação. DELIBERAÇÃO FINAL: Por recomendar a incorporação da associação entre sulfato de polimixina B 10.000 UI, sulfato de neomicina 3,5 mg/mL, fluocinolona acetonida 0,25 mg/mL e cloridrato de lidocaína 20 mg/mL, apresentada em frasco com 5 mL, para otite externa aguda. DECISÃO: Incorporar a associação de sulfato de polimixina B 10.000 UI, sulfato de neomicina 3,5 mg/mL, fluocinolona acetonida 0,25 mg/mL e cloridrato de lidocaína 20 mg/mL, apresentada em frasco com 5 mL, para otite externa aguda no âmbito do Sistema Único de Saúde ­SUS. Decisão dada pela Portaria SCTIE-MS nº 15 publicada no Diário Oficial da União (DOU) nº 58, de 24 de março de 2017, pág. 107.(AU)


Subject(s)
Humans , Fluocinolone Acetonide/therapeutic use , Lidocaine/therapeutic use , Neomycin/therapeutic use , Otitis Externa/drug therapy , Polymyxin B/therapeutic use , Brazil , Cost-Benefit Analysis , Drug Combinations , Technology Assessment, Biomedical , Unified Health System
10.
An. bras. dermatol ; 91(5): 604-610, Sept.-Oct. 2016. tab, graf
Article in English | LILACS | ID: biblio-827754

ABSTRACT

Abstract: Background: Topical antimicrobial drugs are indicated for limited superficial pyodermitis treatment, although they are largely used as self-prescribed medication for a variety of inflammatory dermatoses, including atopic dermatitis. Monitoring bacterial susceptibility to these drugs is difficult, given the paucity of laboratory standardization. Objective: To evaluate the prevalence of Staphylococcus aureus topical antimicrobial drug resistance in atopic dermatitis patients. Methods: We conducted a cross-sectional study of children and adults diagnosed with atopic dermatitis and S. aureus colonization. We used miscellaneous literature reported breakpoints to define S. aureus resistance to mupirocin, fusidic acid, gentamicin, neomycin and bacitracin. Results: A total of 91 patients were included and 100 S. aureus isolates were analyzed. All strains were methicillin-susceptible S. aureus. We found a low prevalence of mupirocin and fusidic acid resistance (1.1% and 5.9%, respectively), but high levels of neomycin and bacitracin resistance (42.6% and 100%, respectively). Fusidic acid resistance was associated with more severe atopic dermatitis, demonstrated by higher EASI scores (median 17.8 vs 5.7, p=.009). Our results also corroborate the literature on the absence of cross-resistance between the aminoglycosides neomycin and gentamicin. Conclusions: Our data, in a southern Brazilian sample of AD patients, revealed a low prevalence of mupirocin and fusidic acid resistance of S. aureus atopic eczema colonizer strains. However, for neomycin and bacitracin, which are commonly used topical antimicrobial drugs in Brazil, high levels of resistance were identified. Further restrictions on the use of these antimicrobials seem necessary to keep resistance as low as possible.


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Adult , Young Adult , Staphylococcus aureus/drug effects , Drug Resistance, Bacterial , Dermatitis, Atopic/microbiology , Anti-Bacterial Agents/pharmacology , Bacitracin/pharmacology , Gentamicins/pharmacology , Neomycin/pharmacology , Cross-Sectional Studies , Mupirocin/pharmacology , Disk Diffusion Antimicrobial Tests/methods , Fusidic Acid/pharmacology
11.
Braz. j. med. biol. res ; 49(4): e5064, 2016. tab, graf
Article in English | LILACS | ID: biblio-951670

ABSTRACT

In mammals, damage to sensory receptor cells (hair cells) of the inner ear results in permanent sensorineural hearing loss. Here, we investigated whether postnatal mouse inner ear progenitor/stem cells (mIESCs) are viable after transplantation into the basal turns of neomycin-injured guinea pig cochleas. We also examined the effects of mIESC transplantation on auditory functions. Eight adult female Cavia porcellus guinea pigs (250-350g) were deafened by intratympanic neomycin delivery. After 7 days, the animals were randomly divided in two groups. The study group (n=4) received transplantation of LacZ-positive mIESCs in culture medium into the scala tympani. The control group (n=4) received culture medium only. At 2 weeks after transplantation, functional analyses were performed by auditory brainstem response measurement, and the animals were sacrificed. The presence of mIESCs was evaluated by immunohistochemistry of sections of the cochlea from the study group. Non-parametric tests were used for statistical analysis of the data. Intratympanic neomycin delivery damaged hair cells and increased auditory thresholds prior to cell transplantation. There were no significant differences between auditory brainstem thresholds before and after transplantation in individual guinea pigs. Some mIESCs were observed in all scalae of the basal turns of the injured cochleas, and a proportion of these cells expressed the hair cell marker myosin VIIa. Some transplanted mIESCs engrafted in the cochlear basilar membrane. Our study demonstrates that transplanted cells survived and engrafted in the organ of Corti after cochleostomy.


Subject(s)
Animals , Female , Organ of Corti/surgery , Stem Cells , Stem Cell Transplantation/methods , Hair Cells, Auditory, Inner/transplantation , Hearing Loss, Sensorineural/surgery , Auditory Threshold , Immunohistochemistry , Protein Synthesis Inhibitors , Neomycin , Cell Survival , Cells, Cultured , Reproducibility of Results , Evoked Potentials, Auditory, Brain Stem , Treatment Outcome , Guinea Pigs , Mice, Inbred BALB C
12.
PAFMJ-Pakistan Armed Forces Medical Journal. 2016; 66 (2): 235-239
in English | IMEMR | ID: emr-179019

ABSTRACT

Objective: To compare the efficacy of topical Ciprofloxacin with Neomycin in the management of Chronic Supportive Otitis Media [CSOM]


Study Design: Randomized Clinical Trial [RCT]


Place and Duration of Study: Combined Military Hospital [CMH], Peshawar from Jan 2013 to Dec 2013


Patients and Methods: A total of 186 patients with the diagnosis of chronic suppurative otitis media were included in the study. Patients were randomly allotted to either group I that was treated by topical Ciprofloxacin eardrops [n = 93] or to group II, treated by topical Neomycin eardrops [n = 93]. Outcomes were measured by disappearance of discharge and congestion at follow-up examination. SPSS 16 was used for data analysis .Chi square test was used for analysis and p-values less than 0.05 were considered significant


Results: Topical Ciprofloxacin is more effective in earlier control of congestion and discharge of ear in CSOM; [p value = 0.001 and < 0.005 respectively] as compared to Neomycin


Conclusion: Topical Ciprofloxacin is a better drug for the treatment of CSOM as compared to topical Neomycin


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Ciprofloxacin , Neomycin , Drug Therapy, Combination , Treatment Outcome
13.
Bauru; s.n; 2016. 109 p. graf, tab.
Thesis in Portuguese | LILACS, BBO | ID: biblio-881174

ABSTRACT

O objetivo deste estudo foi avaliar o uso do cetorolaco de trometamina 10mg sublingual 30 minutos antes do procedimento de biopulpectomia em pacientes com pulpite irreversível com relação à dor antes do procedimento e nas 48 horas subsequentes, a quantidade de medicação consumida no pós-operatório e tempo esperado para sua utilização. Também foi avaliada a influência da anestesia intrapulpar, o uso da automedicação analgésica antes da procura pelo atendimento e diferença entre gêneros sobre os níveis de dor pré e pós-operatória. Propôs-se avaliar também a necessidade da presença do antibiótico na medicação intracanal, comparando o Otosporin® com hidrocortisona. Participaram da pesquisa 608 pacientes que procuraram o Setor de Urgência Odontológica da Faculdade de Odontologia de Bauru ou o Setor Odontológico do Pronto Socorro Central da Prefeitura Municipal de Bauru, sendo que 34 completaram de forma adequada o protocolo previsto. Foram divididos em 4 grupos que receberam cetorolaco ou placebo como medicação pré-operatória e Otosporin® ou hidrocortisona como medicação intracanal. Foram anotados os valores de intensidade de dor, em uma escala visual analógica, antes da medicação pré-operatória, antes do atendimento, após o atendimento, 1, 2, 4, 12, 24, 48 horas após e quando houve necessidade de medicação pós-operatória para alívio da dor. Também foi anotado se o paciente havia se automedicado e qual a droga utilizada, se houve necessidade de anestesia intrapulpar, a quantidade de medicação consumida pelo paciente no pós-operatório e o tempo esperado para seu consumo. Dos resultados observou-se que os pacientes que receberam cetorolaco como medicação pré-operatória tiveram uma redução significativa da dor em 30 minutos, quando comparado ao placebo. Foi observado que o tempo necessário para a ingestão de medicamentos pós-operatórios não demonstrou diferença significativa entre os grupos, assim como na quantidade de medicação ingerida. O tempo decorrido entre a primeira e a última dose de medicação pós-operatória também não demonstrou diferença estatística. Com relação a anestesia intrapulpar, 78% dos pacientes necessitaram desta técnica, mas devido ao pequeno tamanho da amostra obtida, não foi possível correlacionar o seu uso com a utilização da medicação pós-operatória. Para os pacientes que se automedicaram previamente, não houve diferença significativa em relação à dor inicial. Quando os gêneros foram comparados, não foi possível observar uma diferença estatística significante entre eles com relação aos parâmetros estudados. Também foram descritos no trabalho os motivos de não inclusão dos 574 pacientes que foram abordados durante a realização deste estudo. Com base nos resultados, conclui-se que o cetorolaco diminuiu expressivamente o nível de dor durante a espera pelo atendimento, porém com relação ao tempo esperado pelo paciente para tomar a primeira dose de medicação pós-operatória, a última dose, a quantidade de comprimidos e a frequência de ingestão não demonstrou a mesma diferença. Também não houve diferença no nível de dor inicial entre os pacientes que se automedicaram e os que não fizeram uso dessa prática. Devido ao pequeno número da amostra, não foi possível encontrar uma correlação entre o uso da técnica anestésica intrapulpar e medicação pós-operatória, sugerindo mais estudos futuros.(AU)


The aim of this study was to evaluate the use of ketorolac tromethamine (10mg sublingual taken 30 minutes before pulpectomy in patients with irreversible pulpitis) in pain reduction immediately before the procedure and the 48 subsequent hours, postoperative consumption of analgesic drugs and time for its use. The influence of intrapulpal anesthesia, the use of analgesic self-medication prior to the demand for care and gender difference on the levels of pre- and postoperative pain was also evaluated. It was also proposed assess the need for antibiotic presence in the intracanal medicament, comparing Otosporin® with hydrocortisone. A total of 608 patients who presented to Dental Urgency Sector from Dental School of Bauru (USP) or Emergency Dental Sector from Bauru City Hall were invited to participate, and 34 completed properly planned protocol. They were distributed in 4 groups that received either ketorolac or placebo as preoperative medication and Otosporin® or hydrocortisone as intracanal medication. The rates of pain intensity were recorded by means of a visual analogue scale before pretreatment medication, immediately before the appointment, 1, 2, 4, 12, 24, 48 hours after the appointment, and when there was taken post medication for postoperative pain relief. It was also recorded if the patient had self medicated and which the drug used and, if there was need intrapulpal anesthesia, amount of ketorolac and rescue medication (paracetamol 750mg) consumed by the patient postoperative time and the waitng time for consumption. The results showed that patients receiving Ketorolac as preoperative medication had a significant reduction of pain in 30 minutes compared to placebo. It was observed that the time required for the intake of postoperative drug showed no significant difference between groups, as well as the amount of medication intake. The time elapsed between the first and last dose of postoperative medication also showed no statistical difference. Concerning intrapulpal anesthesia, 78% of patients required for this technique, but because of the small sample size obtained it was impossible to correlate their use with the use of postoperative medication. For patients who practiced self medication previously, there was no significant difference with respect to initial pain. When genders were compared, it was not possible to observe a statistically significant difference between them regarding the parameters studied. Were also described in the study the reasons of non-inclusion of 574 patients that were addressed during this study. Based on the results, it is concluded that ketorolac significantly decreased the level of pain during the waiting time, but with respect to the time length for the patient to take the first dose of postoperative medication, the last dose, the number of tablets and taken frequency did not show the same difference. There was no difference in the initial level of pain among patients who practiced self medication and those who did not use this practice. Due to the small sample size, it was not possible to find a correlation between the use of the anesthetic technique intrapulpal and postoperative medication, suggesting more future studies.(AU)


Subject(s)
Humans , Male , Female , Anesthesia, Dental/methods , Anti-Bacterial Agents/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Hydrocortisone/therapeutic use , Ketorolac Tromethamine/therapeutic use , Pulpectomy/methods , Pulpitis/drug therapy , Root Canal Irrigants/therapeutic use , Toothache/drug therapy , Acute Pain/drug therapy , Drug Combinations , Neomycin/therapeutic use , Pain Measurement , Polymyxin B/therapeutic use , Preoperative Care , Time Factors , Treatment Outcome
14.
Article in English | WPRIM | ID: wpr-258810

ABSTRACT

Immunoassays greatly contribute to veterinary drug residue analysis. However, there are few reports on detecting neomycin residues by immunoassay. Here, a rapid and sensitive chemiluminescent enzyme immunoassay (CLIEA) was successfully developed for neomycin residue analysis. CLIEA demonstrated good cross-reactivity for neomycin, and the IC50 value was 2.4 ng/mL in buffer. The average recovery range was 88.5%-105.4% for spiked samples (10, 50, and 100 μg/kg), and the coefficient of variation was in the range of 7.5%-14.5%. The limit of detection of CLEIA was 9.4 μg/kg, and this method was compared with the liquid chromatography-tandem mass spectrometry method using naturally contaminated samples, producing a correlation coefficient of >0.95. We demonstrate a reliable CLIEA for the rapid screening of neomycin in milk.


Subject(s)
Animals , Anti-Bacterial Agents , Metabolism , Drug Residues , Metabolism , Food Contamination , Immunoenzyme Techniques , Limit of Detection , Luminescent Measurements , Milk , Chemistry , Neomycin , Metabolism
15.
Article in English | WPRIM | ID: wpr-148737

ABSTRACT

Infectious coryza (IC) is an infectious disease caused by Avibacterium (Av.) paragallinarum. IC is known to cause economic losses in the poultry industry via decreased egg production in layers. Between 2012 and 2013, Av. paragallinarum was isolated from seven chicken farms by Chungbuk National University. We identified Av. paragallinarum, the causative pathogen of IC by polymerase chain reaction (PCR) and serovar serotype A, by multiplex PCR. Antibiotic sensitivity tests indicated that a few field-isolated strains showed susceptibility to erythromycin, gentamicin, lincomycin, neomycin, oxytetracycline, spectinomycin, and tylosin. A serological survey was conducted to evaluate the number of flocks that were positive for Av. paragallinarum by utilizing a HI test to determine the existence of serovar A. Serological surveys revealed high positivity rates of 86.4% in 2009, 78.9% in 2010, 70.0% in 2011, and 69.6% in 2012. We also challenged specific pathogen-free chickens with isolated domestic strains, ADL121286 and ADL121500, according to the measured efficacy of the commercial IC vaccine, PoulShot Coryza. We confirmed the effectiveness of the vaccine based on relief of clinical signs and a decreased re-isolation rate of ADL121500 strain. Our results indicate IC is currently prevalent in Korea, and that the commercial vaccine is effective at protecting against field strains.


Subject(s)
Agriculture , Chickens , Communicable Diseases , Erythromycin , Gentamicins , Korea , Lincomycin , Multiplex Polymerase Chain Reaction , Neomycin , Ovum , Oxytetracycline , Polymerase Chain Reaction , Poultry , Serogroup , Spectinomycin , Tylosin
16.
Indian J Biochem Biophys ; 2015 Apr; 52 (2): 189-195
Article in English | IMSEAR | ID: sea-158219

ABSTRACT

The carboxylic groups of glutamic acid and aspartic acid residues of catalase (CAT) were chemically modified using the treatment of the enzyme with 1-ethyl-3-(3'-dimethylamino) carbodiimide hydrochloride (EDC) and neomycin. The effect of covalent attachment of neomycin on the enzymatic activity, conformational and aggregation properties of CAT was investigated. The modification of CAT with different concentrations of neomycin showed two different types of behavior, depending up on the concentration range of neomycin. In the concentration range from 0.0 to 5.2 mM, neomycin-modified CAT, compared to the native enzyme exhibited higher α-helix content, reduced surface hydrophobicity, little enhancement in CAT activity and a better protection against thermal aggregation, whereas at concentrations greater than 5.2 mM, the modified enzyme exhibited a significant decrease in CAT activity and an increase in random coil content which may result in disorder in the protein structure and increase in thermal aggregation. This modification is a rapid and simple approach to investigate the role of aspartate and glutamate residues in the structure, function and folding of CAT.


Subject(s)
Aminoglycosides/chemistry , Catalase/chemistry , Catalase/metabolism , Catalase/physiology , Neomycin/chemistry , Surface Properties/drug effects
17.
Braz. oral res. (Online) ; 29(1): 1-6, 2015. tab
Article in English | LILACS | ID: lil-777180

ABSTRACT

Guedes-Pinto paste is the filling material most employed in Brazil for endodontic treatment of deciduous teeth; however, the Rifocort® ointment has been removed. Thus, the aim of this study was to investigate the antimicrobial potential of filling pastes, by proposing three new pharmacological associations to replace Rifocort® ointment with drugs of already established antimicrobial power: Nebacetin® ointment, 2% Chlorhexidine Gluconate gel, and Maxitrol® ointment. A paste composed of Iodoform, Rifocort® ointment and Camphorated Paramonochlorophenol (CPC) was employed as the gold standard (G1). The other associations were: Iodoform, Nebacetin® ointment and CPC (G2); Iodoform, 2% Chlorhexidine Digluconate gel and CPC (G3); Iodoform, Maxitrol® ointment and CPC (G4). The associations were tested for Staphylococcus aureus (S. aureus), Streptococcus mutans (S. mutans), Streptococcus oralis (S. oralis), Enterococcus faecalis (E. faecalis), Escherichia coli (E. coli), and Bacillus subtilis (B. subtilis), using the methods of dilution on solid medium – orifice agar – and broth dilution. The results were tested using statistical analysis ANOVA and Kruskal-Wallis. They showed that all the pastes had a bacteriostatic effect on all the microorganisms, without any statistically significant difference, compared with G1. S. aureus was statistically significant (multiple comparison test of Tukey), insofar as G2 and G3 presented the worst and the best performance, respectively. All associations were bactericidal for E. coli, S. aureus, S. mutans and S. oralis. Only G3 and G4 were bactericidal for E. faecalis, whereas no product was bactericidal for B. subtilis. Thus, the tested pastes have antimicrobial potential and have proved acceptable for endodontic treatment of primary teeth.


Subject(s)
Anti-Bacterial Agents/pharmacology , Bacteria/drug effects , Root Canal Filling Materials/pharmacology , Tooth, Deciduous/drug effects , Analysis of Variance , Bacitracin/pharmacology , Bacteria/growth & development , Chlorhexidine/analogs & derivatives , Chlorhexidine/pharmacology , Drug Combinations , Fluprednisolone/pharmacology , Microbial Sensitivity Tests , Neomycin/pharmacology , Ointments , Polymyxin B/pharmacology , Prednisolone/analogs & derivatives , Prednisolone/pharmacology , Reproducibility of Results , Rifamycins/pharmacology , Statistics, Nonparametric , Time Factors
18.
Article in English | WPRIM | ID: wpr-34093

ABSTRACT

OBJECTIVES: In mammals, cochlear hair cell loss is irreversible and may result in a permanent sensorineural hearing loss. Secondary to this hair cell loss, a progressive loss of spiral ganglion neurons (SGNs) is presented. In this study, we have investigated the effects of neural-induced human mesenchymal stem cells (NI-hMSCs) from human bone marrow on sensory neuronal regeneration from neomycin treated deafened guinea pig cochleae. METHODS: HMSCs were isolated from the bone marrow which was obtained from the mastoid process during mastoidectomy for ear surgery. Following neural induction with basic fibroblast growth factor and forskolin, we studied the several neural marker and performed electrophysiological analysis. NI-hMSCs were transplanted into the neomycin treated deafened guinea pig cochlea. Engraftment of NI-hMSCs was evaluated immunohistologically at 8 weeks after transplantation. RESULTS: Following neural differentiation, hMSCs expressed high levels of neural markers, ionic channel markers, which are important in neural function, and tetrodotoxin-sensitive voltage-dependent sodium currents. After transplantation into the scala tympani of damaged cochlea, NI-hMSCs-injected animals exhibited a significant increase in the number of SGNs compared to Hanks balanced salt solution-injected animals. Transplanted NI-hMSCs were found within the perilymphatic space, the organ of Corti, along the cochlear nerve fibers, and in the spiral ganglion. Furthermore, the grafted NI-hMSCs migrated into the spiral ganglion where they expressed the neuron-specific marker, NeuN. CONCLUSION: The results show the potential of NI-hMSCs to give rise to replace the lost cochlear cells in hearing loss mammals.


Subject(s)
Animals , Bone Marrow , Cell Differentiation , Cochlea , Cochlear Nerve , Colforsin , Ear , Fibroblast Growth Factor 2 , Guinea Pigs , Hair , Hearing Loss , Hearing Loss, Sensorineural , Humans , Ion Channels , Mammals , Mastoid , Mesenchymal Stem Cells , Neomycin , Neurons , Organ of Corti , Regeneration , Scala Tympani , Sensory Receptor Cells , Sodium , Spiral Ganglion , Transplantation , Transplants
19.
Article in English | IMSEAR | ID: sea-157655

ABSTRACT

Lobate GM Neo, 15 mg is a triple drug combination of a steroid clobetasol with anti-fungal miconazole and antibacterial neomycin in treatment of Eczematous disorders associated with underlying Tinea or Yeast Infections. Aims and Objectives: The study was designed to evaluate the efficacy, safety and tolerability of a combinations of clobetasol, neomycin and miconazole (Group A) versus betamethasone, clotrimazole, neomycin (Group B) versus betamethasone, gentamicin, miconazole (Group C) in subjects with any type of eczematous disorder associated with underlying tinea or yeast infection. Materials and Methods: This was an open label, parallel group, randomized comparative study. The primary endpoint analyzed was improvement in clinical score from baseline at the end of day 7 and other primary endpoint like hyperpigmentation were analyzed by the visual analogue scale of 1 to 10 at the end of day 7. Results: Thirty-six subjects were randomized to three groups. The clinical score showed a significant reduction from baseline at the end of day 7 in all the groups, i.e. 82.9%, 81.3% and 85.6% in Group A, B and C respectively. However, the difference between the groups were not statistically significant. Mean hyper pigmentation score showed significant decrease of 82.9% in Group A, 81.6% in Group B and 92.2% in Group C from baseline at the end of day 7. Conclusion: The triple combination of antifungal, antibacterial and potent steroid was found to be efficacious, safe and tolerable in reducing signs and symptoms (scaling, inflammation, burning and itching) of eczematous disorder associated with underlying tinea/yeast infection.


Subject(s)
Adult , Antifungal Agents/administration & dosage , Betamethasone/administration & dosage , Clobetasol/administration & dosage , Clotrimazole/administration & dosage , Drug Combinations , Gentamicins/administration & dosage , Humans , Male , Miconazole/administration & dosage , Mycoses/drug therapy , Neomycin/administration & dosage , Tinea/drug therapy
20.
Article in English | IMSEAR | ID: sea-157645

ABSTRACT

Vaginitis is among the most common conditions for which women seek medical care, with vaginal discharge accounting for approximately 10 million office visits each year. Since there are no published studies till date that evaluated the Clinical Effectiveness and Safety of Topical Cream of Formula A [Ofloxacin (0.75 % w/w) + Ornidazole (2% w/w) + Terbinafine Hydrochloride (1% w/w) + Clobetasol Propionate (0.05% w/w)] compared to Formula B [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], Formula C [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], and Formula D [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], in mild to moderate vaginitis, hence we undertook this randomized controlled Post Marketing Multicentric trial. Materials and methods: Female subjects diagnosed with mild to moderate symptoms of Vaginitis were eligible and those fulfilling the subject selection criteria were randomized to receive either Formula A, Formula B, Formula C or Formula D for 14 days. The Primary efficacy measures were assessment of symptoms of Vaginitis i.e. vaginal pruritis, vaginal irritation, vaginal soreness or pain, dyspareunia, vaginal erosion and vaginal inflammation and Secondary efficacy measures were assessment of Physical characteristics of vaginal discharge, assessment of pH of vaginal discharge and Microbiological evaluation. Assessment of Safety was done by recording the occurrence of adverse drug reactions. Results: The clinical success rates were comparable and even far better in case of Formula A group (in vaginal pain, Dyspareunia and vaginal erosion it was 100 %, in case of vaginal inflammation it was 92.655 % while in case of vaginal irritation, it was 94.767 % and vaginal pruritus, it was 87.096 %). Adverse events were mild and self limiting while it was totally absent in case of Formula A group. Conclusion: Topical Cream of Formula A is safe and effective for the treatment of mild to moderate vaginitis.


Subject(s)
Adult , Beclomethasone/administration & dosage , Beclomethasone/analogs & derivatives , Clobetasol/administration & dosage , Clotrimazole/administration & dosage , Drug Combinations , Dyspareunia/drug therapy , Dyspareunia/microbiology , Female , Humans , Naphthalenes/administration & dosage , Naphthalenes/analogs & derivatives , Neomycin/analogs & derivatives , Neomycin/administration & dosage , Ofloxacin/administration & dosage , Ornidazole/administration & dosage , Vaginal Diseases/drug therapy , Vaginal Diseases/microbiology , Vaginitis/drug therapy , Vaginitis/microbiology
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