Administração de medicamentos por via intramuscular: caracterização dos vídeos brasileiros veiculados no YouTube® / Intramuscular drug administration: characterization of Brazilian videos on YouTube®

RESUMO Objetivo caracterizar os vídeos que contém a demonstração do procedimento de administração de medicamentos por via intramuscular em indivíduos adultos. Métodos estudo de corte transversal descritivo, foram selecionados 44 vídeos brasileiros disponíveis no YouTube® que abordavam o procedimento de administração de medicamentos por via intramuscular. Resultados a maioria dos vídeos selecionados é de origem pessoal (86,4%), tem como autor um técnico de Enfermagem (59,1%), adota a região dorsoglútea como local de injeção (54,5%), foi produzido em ambiente de saúde utilizando um paciente para a demonstração do procedimento (52,3%). Nenhum vídeo apresentou a completude do procedimento, sendo identificada grande frequência de erros em todas as etapas do procedimento. Observou-se uma diferença estatisticamente significante entre os testes de confiabilidade e popularidade dos vídeos (p=0,042). Conclusão os vídeos que abordam o procedimento de administração de medicamentos por via intramuscular disponíveis na plataforma YouTube® foram considerados atuais, de pouca relevância, elaborados por fontes não confiáveis, de baixa acurácia e frágil finalidade. Contribuições para a prática os vídeos disponíveis na plataforma YouTube® sobre a administração de medicamentos por via intramuscular não devem ser indicados como material educativo para a formação ou atualização profissional.

ABSTRACT Objective to characterize videos that contain a demonstration of the procedure for administering drugs intramuscularly to adults. Methods a descriptive cross-sectional study, 44 Brazilian videos available on YouTube® were selected which addressed the procedure of intramuscular drug administration. Results the majority of the videos selected are of personal origin (86.4%), were made by a Nursing technician (59.1%), used the dorsal gluteal region as the injection spot (54.5%), and were produced in a healthcare environment using a patient to demonstrate the procedure (52.3%). No video showed the completeness of the procedure, and a high frequency of errors was identified at all stages of the procedure. There was a statistically significant difference between the reliability and popularity tests of the videos (p=0.042). Conclusion the videos on intramuscular drug administration available on the YouTube® platform were considered to be up-to-date, of little relevance, produced by unreliable sources, of low accuracy, and with a weak purpose. Contributions to practice the videos available on the YouTube® platform on intramuscular drug administration should not be used as educational material for professional training or updating.

Transição de via de linezolida endovenosa para via oral: uma análise de custo-minimização / Switching from intravenous to oral linezolid therapy: a cost-minimization analysis

Objetivo: Comparar custos da terapia endovenosa exclusiva com linezolida com os custos da terapia iniciada por via endovenosa com transição para via oral após 72 horas, como estratégia de intervenção em programas de gestão de antimicrobianos. Métodos: Avaliação econômica de custo-minimização comparando custos diretos da terapia endovenosa exclusiva com linezolida com a terapia endovenosa seguida de transição para via oral em cenário simulado, sob a perspectiva do Sistema Único de Saúde (SUS), com árvore de decisão como modelo para tomada de decisão. Resultados: A alternativa englobando a transição de via mostrou-se a mais econômica em todos os cenários analisados. Para 28 dias de tratamento com linezolida, houve redução de 22% nos custos, considerando o paciente internado. Ao considerar alta após o sexto dia de tratamento, a redução de custos variou de 26%, com financiamento pelo SUS do restante do tratamento, a 84%, com financiamento do tratamento pós-alta pelo paciente. Conclusão: Conclui-se que a transição de via de linezolida é uma importante estratégia nos programas de gerenciamento de antimicrobianos, capaz de gerar economia significativa para a instituição. As avaliações econômicas de custo-minimização, nesse contexto, são uma importante ferramenta para demonstrar o aspecto econômico com potencial para sensibilizar gestores e tomadores de decisão.

Objective: To compare the direct costs of linezolid intravenous therapy with the costs of intravenous therapy switching to oral therapy after 72 hours as an intervention strategy in antimicrobial stewardship programs. Methods: Economic evaluation cost-minimization comparing direct costs of exclusive linezolid intravenous therapy with intravenous therapy for 72 hours and after switching to oral therapy in a simulated scenario, from the perspective of the National Health Service, with a decision tree as a decision modeling. Results: The alternative encompassing the therapy transition proved to be the most economical in all analyzed scenarios. For 28 days of treatment with linezolid, there was a 22% reduction in costs, considering the hospitalized patient. When considering discharge after the sixth day of treatment, the cost reduction ranged from 26%, with funding from the National Health Service for the rest of the treatment, to 84%, with funding for the post-discharge treatment by the patient. Conclusion: It was concluded that the linezolid therapy transition is an important strategy in antimicrobial management programs, capable of generating significant savings for the institution. In this context, economic cost-minimization assessments are an important tool to demonstrate the economic aspect with the potential to raise awareness among managers and decision-makers.

Evaluation of Mass Drug Administration to Eliminate Lymphatic Filariasis in Surguja and Surajpur District, Chhattisgarh

Background: Mass Drug Administration of a single dose of DEC was launched on June 5, 2004 by the Government of India. MDA coverage increased gradually from 72.42% in 2004 to 88.96% in 2014. However, compliance has remained relatively low in most of the endemic areas as in 9 endemic Districts in State of Chhattisgarh. In Chhattisgarh State, Lymphatic Filariasis affected 14,818 people in the year 2011 and 13921 in the year 2013 with demonstrated manifestation. Objectives: To assess the coverage and compliance along with factors affecting compliance regarding MDA implementation in Surguja and Surajpur District of Chhattisgarh. Methods: A cross-sectional descriptive study was conducted from July-September 2021 in two district of Chhattisgarh. The division of segments and selection of the households was done based on the WHO criteria of coverage evaluation survey field guide in which from 30 villages, 450 households were covered. Result: The overall coverage rate was 95.55% in Surguja and 89.16% in Surajpur District. The overall compliance was 89.3% with Coverage-Compliance gap of 4.12. The Effective Coverage Rate was 89.3% in 2243 eligible population of Surguja and Surajpur District. Coverage and Compliance was found more in females as compared to males but was found to be statistically not significant. Coverage and Compliance was found more in Surguja district as compared to Surajpur district. Conclusion: Training programme for drug distributors should emphasize more on how to address the fear of side effects among beneficiaries and other reasons of low compliance for the benefit of the MDA programme.

Coverage evaluation of Mass Drug Administration (MDA) for lymphatic filariasis in a district of Bundelkhand Region of Uttar Pradesh

Introduction: Lymphatic filariasis results in severe disability that leading to severe social and economic burden at each level from individual to family, and community. This study was carried out to assess the coverage and compliance of MDA. Methods: From 300 households (1837 individuals) in both rural & urban area were covered in coverage evaluation survey by systematic selection of subunits using probability proportionate to size (PPS). Each household was visited by WHO designated team and data were collected using predesigned questionnaire. Data was compiled on MS-excel spreadsheet, frequency and percentage were calculated. Results: The overall effective coverage for all drugs was low (19.1%). The coverage was low, compliance was higher in urban as compared to rural area. Females had better coverage and compliance than males. The primary reasons for drug not offered was nobody came to offer drug, drug not swallowed was not sick, drug swallowed was useful information from drug administrator (DA). Only one female reported adverse effect. Conclusion: Increase in coverage along with decrease in coverage-compliance gap is needed to achieve filariasis elimination that warrants intense IEC activities using different platforms, development of better drug delivery strategies and strengthening monitoring system.

In vitro transdermal drug permeation tests: a regulatory scenario evaluation

SUMMARY Introduction: The Transdermal Drug Delivery Systems (TDDS) could circumvent the inconveniences of oral administration, increasing treatment adhesion. Meanwhile, despite being highly widespread systems, there are discrepancies between the performance and quality control methodologies recommended by the leading regulatory agencies, which is an issue for the pharmaceutical industry. Aim: To identify and to compare the requirements for TDDS regulatory approval by important agencies, focusing on the in vitro release and drug permeation studies, which are crucial tests for the evaluation of safety, efficacy, and performance of these systems. Methods: The documents that regulate the scope of TDDS in FDA, EMA and Anvisa were analyze, as well as the contributions of OECD. In addition, an approaching regarding the pharmacopeial requirements was made regarding USA, Europe, and Brazil. Results and conclusion: Concerning the regulatory approval aspects, the FDA is reviewing its documents because the current guidance is not specific to transdermal systems. On the other hand, the EMA presents a unique guideline that includes specific requirements for TDDS. The USA and the European Pharmacopoeias have specific mentions to performance and quality control of TDDS, while the Brazilian Pharmacopoeia does not mention this dosage form. Recently, Anvisa published a guide, which helps Brazilian manufacturers concerning the tests required for the regulatory approval of a new TDDS. The launch of this standardized national statute associated with the use of a validated in vitro release and permeation tests represents a remarkable breakthrough regarding TDDS.

Introducción: los sistemas de administración de fármacos transdérmicos (TDDS) podrían sortear los inconvenientes de la administración por vía oral, aumentando la adherencia al tratamiento. Mientras tanto, a pesar de ser sistemas muy extendidos, existen discrepancias entre las metodologías de desempeño y control de calidad recomendadas por las principales agencias reguladoras, lo cual es un problema para la industria farmacéutica. Objetivo: identificar y comparar los requisitos para la aprobación regulatoria de TDDS por parte de las principales agencias reguladoras, enfocándose en los estudios de liberación in vitro y premiación de fármacos. Métodos: se analizaron los documentos que regulan el alcance de la TDDS en la FDA, EMA y Anvisa, así como los aportes de la OCDE. Además, se realizó un planteamiento sobre los requisitos de las farmacopeas de los Estados Unidos, Europa y Brasil. Resultados y conclusión: la FDA está revisando los aspectos de aprobación regulatoria porque la guía actual no es específica para los sistemas transdérmicos. Por otro lado, la EMA presenta una guía única que incluye requisitos específicos para TDDS. Las farmacopeas de los Estados Unidos e Europa tienen menciones específicas al rendimiento y control de calidad de TDDS, mientras que la Farmacopea brasileña no menciona esta forma de dosificación. Recientemente, Anvisa publicó una guía que ayuda a los fabricantes brasileños en cuanto a las pruebas requeridas para la aprobación regulatoria de un nuevo TDDS. El lanzamiento de este estatuto nacional estandarizado asociado con el uso de pruebas validadas de liberación y premiación in vitro representa un avance notable con respecto a TDDS.

Introdução: os sistemas de liberação transdérmica (SLT) são capazes de contornar as desvantagens da administração oral de medicamentos, aumentando a adesão ao tratamento. Entretanto, apesar de serem sistemas difundidos, existem discrepâncias entre as metodologias de desempenho e controle de qualidade recomendadas pelas agências regulatórias, dificultando o desenvolvimento destes pela indústria farmacêutica. Objetivo: identificar e comparar os requisitos para aprovação regulatória de SLT por importantes agências regulatórias, com foco nos estudos de liberação e permeação de fármacos in vitro, testes fundamentais para avaliação da segurança, eficácia e desempenho desses sistemas. Métodos: foram analisados os documentos que regulam o escopo dos SLT publicados pela FDA, EMA e Anvisa e as contribuições da OCDE. Além disso, foi realizada a abordagem sobre os requisitos farmacopeicos nos Estados Unidos, Europa e Brasil. Resultados e conclusão: FDA está revisando os aspectos de aprovação regulatória, pois os documentos atuais não são específicos para os SLT. Em contraponto, a EMA apresenta uma diretriz única que inclui requisitos específicos para estes sistemas. Em relação às farmacopeias, enquanto EUA e Europa apresentam recomendações específicas para desempenho e controle de qualidade dos SLT, a Farmacopeia brasileira não menciona esta forma farmacêutica. Recentemente, a Anvisa publicou um guia com os testes necessários para o registro destes sistemas. O lançamento de tal publicação, associado a ensaios devidamente validados representam um avanço notável no escopo regulatório dos SLT.

Efficacy of intratympanic injection versus intravenous drip of prednisolone acetate in the treatment of sudden hearing loss / 中国基层医药

Objective:To investigate the efficacy of intratympanic injection versus intravenous drip of prednisolone acetate in the treatment of sudden hearing loss. Methods:A total of 120 patients with sudden hearing loss who received treatment in the Department of Otolaryngology, Mingzhou Hospital between January 2017 and January 2020 were included in this study. They were divided into intratympanic injection group (intratympanic injection of prednisolone acetate, n = 60) and intravenous injection group (intravenous injection of prednisolone acetate, n = 60) according to route of drug administration. After 8 days of treatment, clinical efficacy was compared between the two groups. The hearing thresholds at 500 Hz and 1 000 Hz in both groups were detected using pure tone audiometry. The levels of procalcitonin and high-sensitivity C-reactive protein and adverse drug reactions were compared between the two groups. Results:After treatment, total response rate in the intratympanic injection group was significantly higher than that in the intravenous injection group (93.33% vs. 80.00%, χ2 = 4.61, P < 0.05). The hearing threshold at 500 Hz in the intratympanic injection group was significantly lower than that in the intravenous injection group [(38.69 ± 3.56) vs. (42.36 ± 4.36), t = 5.05, P < 0.001). The hearing threshold at 1 000 Hz in the intratympanic injection group was significantly lower than that in the intravenous injection group [(32.36 ± 3.36) vs. (40.15 ± 4.12), t = 11.35, P < 0.001). After treatment, procalcitonin level in the intratympanic injection group was significantly lower than that in the intravenous injection group [(0.65 ± 0.12) μg/L vs. (0.98 ± 0.15) μg/L, t = 13.30, P < 0.001)]. High-sensitivity C-reactive protein level in the intratympanic injection group was significantly lower than that in the intravenous injection group [(3.28 ± 0.36) mg/L vs. (5.26 ± 0.56) mg/L, t = 23.03, P < 0.001]. There was no significant difference in incidence of adverse reactions between intratympanic injection and intravenous injection groups (8.33% vs. 10.00%, χ2 = 0.10, P > 0.05). Conclusion:Compared with intravenous drip of prednisolone acetate, intratympanic injection of prednisolone acetate can improve the clinical symptoms of patients with sudden hearing loss and enhance clinical efficacy.

Advances in the study of peptide drugs in oral drug delivery system / 药学学报

Peptide drugs exhibit an irreplaceable role in clinics due to their high specificity, efficiency and low toxicity. At present, more than 80 peptide drugs have been approved for marketing with global sales exceeding $50 billion in 2019. However, with large molecular weights, high hydrophilicity and instability in digestive tract, oral peptide drugs encounter substantial physiological barriers leading to low oral bioavailability. Therefore, peptide drugs are mostly administered by parenteral routes. Although parenteral delivery of peptide drugs achieves high bioavailability, this is associated with inconvenience and discomfort, even causing severe side effects compared with the oral route possessing a high degree of patient compliance. Therefore, numerous studies concentrate on novel strategies to improve the oral bioavailability of peptide drugs. Some delivery technologies such as Eligen™ and Axcess™ have been successfully applied to the oral dosage form of therapeutic peptides and have accelerated relevant oral formulations for Food and Drug Administration (FDA) approval and clinical treatment. In this review, we focus on the oral peptide delivery, mainly summarizing the progress of recent strategies used to overcome oral barriers and the commercialization applications of related patents, which could facilitate the research and development (R&D) of clinical applications of oral delivery techniques for peptide drugs.

Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law / 中国药房

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

Updated key points of chronic hepatitis B virus infection: developing drugs for treatment issued by the U.S. food and drug administration(clinical part) / 临床肝胆病杂志

In November 2018, the U.S. food and drug administration (FDA) issued guidance for the development of drugs for chronic hepatitis B virus infection (draft for comments) (hereinafter referred to as draft for comments), and in April 2022, the FDA issued Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, which has been updated with some details based on the Draft for Comments. This guidance further emphasizes the importance of HBsAg clearance in clinical trials, and classifies chronic suppressive therapy into two categories, namely noninferiority (NI) (or superiority) test with nucleos(t)ide analogues as control and add-on superiority trial with nucleos(t)ide analogues as control, and as for the latter, HBV DNA is no longer recommended as a primary endpoint of the trial, which poses a huge challenge to the development of innovative drugs targeting HBV DNA. The new finite duration therapy should aim to eliminate HBsAg and reduce virologic relapse and the risk of liver disease progression during treatment cessation. Reduction in HBsAg from baseline is not recommended as a primary endpoint for phase Ⅲ clinical trials, since the correlation between such reduction and clinical response remains unclear. In addition, this guidance also specifies the duration of treatment cessation and treatment consolidation period and the criteria for withdrawal of nucleos(t)ide analogues.

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America / Autorización de la Administración de Alimentos y Medicamentos de Estados Unidos de declaraciones sobre exposición reducida respecto de IQOS: implicaciones para la regulación en América Latina / Autorização pela Administração de Alimentos e Fármacos dos Estados Unidos de alegações de exposição reduzida para os produtos IQOS: implicações para a regulamentação na América Latina

ABSTRACT Philip Morris International has used the July 7, 2020 United States Food and Drug Administration's (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US's unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International's global public relations campaign largely ignored the FDA's rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers - including tobacco users and Philip Morris International's customers - to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

RESUMEN Philip Morris International ha empleado el dictamen que la Administración de Alimentos y Medicamentos (FDA) de Estados Unidos emitió el 7 de julio del 2020 sobre IQOS como producto de tabaco de riesgo modificado —que la autorizó a usar ciertas declaraciones relativas a una exposición reducida al comercializar el producto— como estrategia corporativa para promover y normalizar sus productos de tabaco calentado en América Latina. Los dictámenes sobre productos de tabaco de riesgo modificado se fundamentan en el sistema regulatorio único de Estados Unidos, que no se replica ni debería ser replicado en ningún otro lugar del mundo. La campaña mundial de relaciones públicas de Philip Morris International omitió en gran medida que la FDA rechazó los argumentos de que IQOS implica un riesgo reducido y otros hallazgos clave de la FDA que son importantes para que los responsables de las políticas, los reguladores y los consumidores, incluidos los consumidores de tabaco y los clientes de Philip Morris International, comprendan los riesgos asociados con el producto. En América Latina en particular, Philip Morris International ha utilizado los medios de comunicación para difundir esta información engañosa. Esta compañía también ha utilizado el fallo de la FDA para presionar a los reguladores en América Latina con el objetivo de que flexibilicen las regulaciones sobre IQOS en la Región. A medida que las compañías tabacaleras introducen con celeridad nuevos productos de tabaco en países de ingresos bajos y medianos, los defensores de la salud pública y los Estados Parte del Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud (CMCT de la OMS) deben tomar medidas para evitar la difusión de declaraciones engañosas sobre los productos de tabaco calentado, como IQOS. Dado que los países latinoamericanos se encuentran en diferentes etapas en la regulación de los productos de tabaco calentado, los gobiernos deben cumplir con sus obligaciones estipuladas en el CMCT de la OMS y las recomendaciones de la Conferencia de las Partes mediante la prohibición total de la venta de productos de tabaco calentado o la aplicación estricta a los productos de tabaco calentado de todas las políticas pertinentes sobre la reducción de la demanda de tabaco basadas en el CMCT de la OMS (y asegurarse de abarcar tanto los cigarrillos calentados como los dispositivos de calentamiento).

RESUMO A Philip Morris International utilizou a decisão de 7 de julho de 2020 da Administração de Alimentos e Fármacos dos Estados Unidos (United States Food and Drug Administration, FDA), que caracterizou o IQOS como produto de tabaco com risco modificado e que permitiu o uso de determinadas alegações de exposição reduzida no marketing do produto, como estratégia corporativa para promover e normalizar seus produtos de tabaco aquecido na América Latina. As decisões relativas aos produtos de tabaco com risco modificado se baseiam no singular sistema regulatório dos EUA, que não é e não deve ser reproduzido em nenhum outro lugar do mundo. A campanha global de relações públicas da Philip Morris International ignorou em grande parte a rejeição da FDA às afirmações de risco reduzido do IQOS e outros achados fundamentais da FDA, que são informações importantes para formuladores de políticas, órgãos regulamentadores e consumidores - incluindo usuários de tabaco e clientes da Philip Morris International - entenderem os riscos associados ao produto. A Philip Morris International tem usado a mídia para veicular essa informação enganosa ao público, principalmente na América Latina. A empresa também usou a decisão da FDA para pressionar órgãos regulamentadores na América Latina a flexibilizarem a regulamentação do IQOS na região. Conforme as empresas de tabaco introduzem rapidamente novos produtos em países de baixa e média renda, os ativistas de saúde pública e as Partes da Convenção-Quadro para Controle do Tabaco (CQCT) da Organização Mundial da Saúde (OMS) devem tomar providências para prevenir a promoção de alegações enganosas sobre produtos de tabaco aquecido, incluindo o IQOS. Como os países da América Latina estão em diferentes estágios da regulamentação de produtos de tabaco aquecido, os governos devem cumprir suas obrigações com a CQCT da OMS e seguir as recomendações da Conferência das Partes, proibindo totalmente a venda de produtos de tabaco aquecido ou aplicando rigorosamente aos produtos de tabaco aquecido todas as políticas relevantes de redução da demanda por tabaco, com base na CQCT da OMS (certificando-se de abranger tanto os cigarros aquecidos quanto os dispositivos de aquecimento).

Aplicación Intralesional de Antimoniales en el Tratamiento de Leishmaniasis Cutánea

Resumen Objetivo: evaluar la eficacia clínica de la aplicación intralesional de 3 versus, 6 inyecciones de Glucantime®, durante una o dos semanas en pacientes con leishmaniasis cutánea. Métodos: estudio de tipo cuasi experimental. Se incluyó a 41 pacientes con leishmaniasis cutánea del área endémica tropical de Cochabamba, Bolivia. Los pacientes, fueron distribuidos aleatoriamente para recibir tratamiento intralesional con Glucantime®, en tres o seis aplicaciones. Todos ellos firmaron un consentimiento escrito de aceptación voluntaria de participar del estudio, que cuenta con el aval del comité de ética de la facultad de medicina UMSS. Resultados: la evaluación realizada a la eficacia clínica, del empleo de tres o seis aplicaciones intralesionales de Glucantime® no encontró diferencias estadísticamente significativas entre ambas. Así mismo, tampoco se encontró diferencias significativas en cuanto a la cicatrización completa alcanzada al primer mes post tratamiento por ambos esquemas de aplicación. Conclusiones: la cicatrización de las úlceras observada en este estudio, se consiguió independiente del esquema de tres o seis aplicaciones intralesionales de Glucantime® y estos resultados son comparables al tratamiento sistémico. Se considera que tres aplicaciones de Glucantime® intralesional es el límite mínimo como tratamiento para leishmaniasis cutánea con una sola úlcera cuyo tamaño sea menor a tres por tres centímetros.

Abstract Objective: to evaluate the clinical efficacy of intralesional application of 3 versus 6 injections of Glucantime® for one or two weeks in patients with cutaneous leishmaniasis. Methods: quasi-experimental study. 41 patients with cutaneous leishmaniasis were included from the tropical endemic area of Cochabamba, Bolivia. Participants were randomly assigned to receive intralesional treatment with Glucantime®, in three or six applications. All patients signed a written consent to voluntarily participate in the study, approved by the ethics committee of the UMSS medical school. Results: evaluation of the clinical effectiveness of three or six intralesional applications of Glucantime® found no statistically significant differences between the two. Likewise, no significance differences were found regarding complete healing achieved at one month post-treatment by both application schemes. Conclusions: ulcer healing observed in this study was achieved independent of the scheme of either three or six intralesional applications of Glucantime® and these results are comparable to systemic treatment. Three intralesional Glucantime® applications are considered to be the minimal treatment limit for cutaneous leishmaniasis with a single ulcer smaller than three by three centimeters.

Efecto sedativo de Dexmedetomidina intranasal versus sublingual más Remifentanil-Propofol mediante bombas de infusión

Objetivos: evaluar el efecto de dexmedetomidina sublingual frente a dexmedetomidina vía nasal más remifentanilo -propofol con bomba de infusión en procedimientos ginecológicos. Métodos: ensayo clínico no controlado, doble ciego, prospectivo. 68 pacientes con criterios de inclusión dividas en 3 grupos, grupo A [dexmedetomidina sublingual a 0.75 ug/kg], grupo B [dexmedetomidina vía nasal a 0,9 gg/kg] y grupo C [control] más adición de remifentanil y propofol por bombas de infusión. Análisis estadístico de variables cualitativas con chi cuadrado, variables cuantitativas de distribución libre se usó Kruskal-Wallis y distribución normal Anova. Nivel de confianza del 95 % y margen de error del 9 %. Resultados: edad con un rango de 30 a 32 años, la dosis de inicio y sostén tanto del remifentanilo y propofol se disminuyó hasta la mitad comparada con el grupo control, a predominio en el grupo A. Con poca variabilidad en los parámetros hemodinámicos sin repercusión clínica. Efectos adversos más frecuentes como depresión respiratoria en el grupo control, no se observó analgesia con el uso de dexmedetomidina. Y con menor tiempo de estancia en salas de recuperación en pacientes que se administró dexmedetomidina vía nasal. Conclusiones: la administración sublingual es superior con la nasal debido al menor requerimiento de propofol, menos cambios en la presión sanguínea media, sin efectos adversos que se puedan manejar, con mayor facilidad en su administración. Aunque la administración nasal produce un despertar más rápido y mejor control de la frecuencia cardiaca.

Objectives: to evaluate the effect of sublingual dexmedetomidine versus nasal dexmedetomidine plus remifentanil-propofol infusion pump in gynecological procedures. Methods: Uncontrolled, double-blind, prospective clinical trial. 68 patients with inclusion criteria were divided into 3 groups, group A [sublingual dexmedetomidine at 0.75 ug/kg], group B [nasal dexmedetomidine at 0.9 ug/kg] and group C [control] plus the addition of remifentanil and propofol by infusion pumps. Statistical analysis of qualitative variables with chi- square, quantitative variables with free distribution used Kruskal-Wallis and normal distribution Anova. Confidence level of 95% and margin of error of 9%. Results: age with a range of 30 to 32 years, the starting and maintenance dose of both remifentanil and propofol was halved compared to the control group, mainly in group A. With little variability in hemodynamic parameters without clinical repercussion. The most frequent adverse effects were respiratory depression in the control group, no analgesia was observed with the use of dexmedetomidine. And with a shorter stay in recovery rooms in patients who received nasal dexmedetomidine. Conclusions: sublingual administration is superior to nasal due to the lower requirement of propofol, less changes in mean blood pressure, with no adverse effects that can be managed, and with greater ease of administration. Although nasal administration produces a faster awakening and better control of heart rate.

Pain management & opioid dose reduction with topical sevoflurane instillations in intractable venous ulcers: a case report

Abstract Vascular ulcers (VU) constitute a major cause of pain and disability, and significantly compromise quality of life. VU have a natural tendency to become chronic and in many cases exhibit anunsatisfactoryresponse to many of the standard therapeutic options.The case of a 73 year-old Caucasian female with severe pain and poorly-controlled pain (Visual Analogic Scale-VAS- of 8-9) due to three lower leg long-standing VUs is reported and discussed herein. The patient was treated with topical instillations of undiluted sevoflurane as per institutional off-label protocol (starting doses of 1mL/cm2 twice a day, and up-titrated according to response to a maximum of 7 mL twice daily). The VAS score dropped to 0-1 shortly after initiation of therapy and remained stable throughout treatment up until the closure of the observations. Subsequently, opioid therapy was gradually tapered down and ultimately abandoned.Sevoflurane application resulted on adequate and sustained pain management of refractory VU, with no significant side effects. On account of its beneficial effectivity and safety profiles, topical sevoflurane emerges as an add-on alternative for the long-term management of VU, and potentially other painful conditions.

Meta analysis of the effect of pre-transfusion prophylactic medication on the incidence of adverse reactions to blood transfusion / 中国输血杂志

【Objective】 To systematically evaluate the correlation between pretransfusion prophylactic medication and the incidence of adverse reactions to blood transfusion(ARBT) by Meta analysis. 【Methods】 The relevant literature concerning the effect of pretransfusion prophylactic medication on the incidence of ARBT was searched via Pubmed, Embase, Cochrane Library, CNKI, WanFang Data, and VIP databases, with the date duration from database creation to May 9, 2021. The literature was independently screened by two researchers according to the inclusion and exclusion criteria, relevant data information was extracted, quality evaluation was performed, and Meta analysis was performed using RevMan 5.3 software. 【Results】 A total of 36 publications were finally included, involving 137 996 transfusion recipients, of which 62 581 were administered medication before transfusion while 75 415 not. And1742 patients experienced ARBT. Meta analysis results showed that the incidence of ARBT in the pre-transfusion medication group was not statistically different from that in the non-medication group {[RR=0. 88, 95% CI(0.76, 1.01), P>0.05]}, the incidence of febrile reactions was lower in the pre-transfusion group than in the control {[RR=0. 72, 95% CI(0.61, 0.86), P0.05] vs [RR=0. 24, 95% CI(0.03, 2.13), P>0.05]. Pre-transfusion use of dexamethasone, isoproterenol, and niclosamide had no preventive effect on ARBT, i. e. [RR=0. 91, 95% CI(0.79, 1.04), P>0.05] vs [RR=0. 83, 95% CI(0.68, 1.01), P>0.05] vs [RR=1.21, 95% CI(0.69, 2.10), P>0.05]. 【Conclusion】 The incidence of ARBT in the pre-transfusion prophylaxis group was not significantly different from that in the control without considering the patient's history of transfusion, history of ARBT, and use of leukocyte-deleted blood products. The incidence of febrile reactions in the pre-transfusion medication group was lower than that in the control, and further studies in larger randomized controlled trials of higher quality still need to be established due to the suboptimal quality of the included literature and study size. Strictly grasping the indications for blood transfusion, strengthening the monitoring and awareness of ARBT, and using life-saving drugs rationally remain the key clinical concerns.

Antimicrobianos en neonatología. Parte II: Recomendaciones para la dilución y administración de antimicrobianos utilizados en el recién nacido / Antimicrobials in neonatology. Part II: Recommendations for the dilution and administration of antimicrobials in the newborn

Resumen Los antimicrobianos corresponden al grupo de medicamentos más utilizados en Unidades de Cuidados Intensivos Neonatales; no obstante, su uso ha sido asociado a constantes errores de medicación en la práctica clínica. Paradojalmente, aún no existe consenso en torno a la administración adecuada de estos medicamentos y existen importantes brechas de conocimiento en torno a los procesos de dosificación, administración y manipulación de antimicrobianos en esta población. Con el fin de mejorar el uso de antimicrobianos, disminuir errores y optimizar los resultados clínicos en el recién nacido, la presente revisión tiene por objetivo entregar recomendaciones y servir de guía para la correcta preparación de aquellos antimicrobianos de mayor relevancia en neonatología.

Abstract Antimicrobials are among the most commonly prescribed classes of medications in Neonatal Intensive Care Units; however, its use has been constantly associated with a number of medication errors in clinical practice. In contrast to this situation, there is no common agreement when it comes to determining the right dosing, administration, or handling of antibiotics in this population. In order to help improve the use of antibiotics, decrease the rate of medication errors and optimize clinical results in the newborn, this review aims to provide recommendations to support and guide the correct preparation of some of the most relevant antibiotics used in neonatal wards.

Diseño de un programa educativo sobre interacciones entre alimentos y medicamentos en ancianos con enfermedades cardiovasculares

RESUMEN Introducción: Las interacciones entre alimentos y fármacos pueden ser provocadas por alteraciones en los mecanismos farmacocinéticos. La mayoría de los problemas ocurren durante la absorción del fármaco. Su resultado puede ser una variación en la biodisponibilidad, lo que puede tener repercusiones clínicas. Es importante que los profesionales sanitarios reciban educación continuada para optimizar el tratamiento. Objetivo: Identificar posibles interacciones entre fármacos y alimentos en pacientes con enfermedades cardiovasculares, y elaborar un programa educativo para aumentar el nivel de información. Método: Se realizó un estudio descriptivo sobre las características de la administración de fármacos y alimentos en el anciano, se analizaron las historias clínicas de 35 pacientes con enfermedades cardiovasculares de un Hogar de Ancianos; se realizó entrevista individual con pacientes y trabajadores de la salud. Se analizaron los fármacos y los alimentos que ingieren, así como el horario de administración de ambos, y se diseñó un programa educativo. Resultados: La enfermedad cardiovascular más frecuente fue la hipertensión arterial (77,2%), por lo que los fármacos más prescriptos son los antihipertensivos; y, en la mayoría de los casos, son administrados juntos con los alimentos (80,0%). Se diseñó un programa educativo a partir de las deficiencias encontradas, donde se conformó un plegable y se impartieron charlas educativas a los pacientes sobre aspectos generales de tema. Además, se impartió un curso de postgrado, para el personal de salud, sobre farmacocinética y los alimentos que la modifican, así como los horarios de administración. Conclusiones: Existe administración conjunta de fármacos y alimentos, el programa educativo diseñado estuvo basado en estos aspectos dirigido a pacientes y personal de salud.

ABSTRACT Introduction: Food-drug interactions may be caused by alterations in pharmacokinetic mechanisms. Most problems occur during drug absorption. The result may be a variation in bioavailability and could have clinical repercussions. Healthcare professionals should receive ongoing education to optimize treatment. Objective: To identify possible drug-food interactions in patients with cardiovascular diseases and develop an educational program to increase the level of information. Methods: We conducted a descriptive study on the characteristics of drug and food administration in the elderly. We analyzed the medical records of 35 patients with cardiovascular disease from a Nursing Home and conducted an individual interview with patients and healthcare workers. We also analyzed the drugs and food prescribed, as well as their respective administration schedules. Finally, an educational program was designed. Results: High blood pressure was the most frequent cardiovascular disease (77.2%), which is why antihypertensive drugs are the most frequently prescribed. In most cases, they are administered together with food (80.0%). Based on the deficiencies found, we began the design of an educational program. We created a poster and agreed to hold educational talks for the patients on general aspects of the subject. Moreover, we offered a postgraduate course for the healthcare staff on pharmacokinetics, foods that modify it, and administration schedules. Conclusions: We were able to ascertain the co-administration of drugs and food. Both patients and healthcare personnel received an educational program based on this aspect.

Quality by Design-driven investigation of the mechanical properties of mucoadhesive films for needleless anesthetics administration

Objectives: To systematically evaluate the effects of hydroxypropyl methyl cellulose (HPMC) type (E5LV, E15LV, and K100LV); plasticizer type (glycerol and mannitol), plasticizer loading (0.12 and 0.24% w/w); and loading of prilocaine and lidocaine hydrochlorides combined at 1:1 ratio (0 and 47 mg/cm2) in the mechanical properties of buccal films. Methods: A quality by design (QbD) approach based on a full factorial design (3 x 23) and complementarily multivariate statistical tools i.e., principal component analysis (PCA), response surface methodology (RSM), and correlation matrix were used in this pursuit. The thickness, elongation at break, tensile strength, force at break, and Young`s modulus of the anesthetic buccal films obtained by solvent casting were assessed. Results: The QbD, PCA and RSM altogether demonstrated that all studied formulation variables, mainly the drug loading, affect the mechanical properties of the films at different significance levels. The multivariate analysis yielded the modelling of elongation at break, tensile strength, and force at break, which significantly correlated with each other. The drugs exerted a synergic plasticizing effect on the films, and the use of HPMC K100 LV (with greater hydroxypropyl substitution degree and viscosity) and mannitol favored their elasticity and resistance. Furthermore, the majority of the films fulfilled the requirements for buccal administration due to their softness and mechanical resistance. Conclusion: Mannitol is suitable plasticizer for manufacturing HPMC anesthetic buccal films with improved mechanical properties. These results are a step forward in the rational development of formulations for the replacement of needles in dentistry

Esquema de manejo de COVID-19 en adultos / COVID-19 treatment guidelines in adults

RESUMEN Un nuevo coronavirus, denominado COVID-19, fue descubierto por el brote iniciado en China a finales de diciembre del año 2019. Los síntomas característicos son fiebre, tos seca, dificultad respiratoria y malestar general. Muchas investigaciones se están llevando a cabo ya que, si bien no es una enfermedad considerada mortal, tiene un índice de contagio muy alto. Sin embargo, junto a los cuidados hospitalarios y extrahospitalarios, existe un grupo de fármacos que se vienen utilizando para combatir esta enfermedad, tales como hidroxicloroquina, cloroquina, remdesivir, lopinavir/ritonavir, tocilizumab, interferón beta 1B, entre otros.

ABSTRACT A novel coronavirus disease called COVID-19 was discovered as a result of the outbreak that began in China at the end of December 2019. Common symptoms are fever, dry cough, shortness of breath and malaise. Several research are being conducted since the disease has high transmission rate even though it is not considered life-threatening. However, together with hospital and out-of-hospital care, there is a group of medications being used to fight this disease, such as hydroxychloroquine, chloroquine, remdesivir, lopinavir/ritonavir, tocilizumab, interferon beta-1b, among others.

Analysis and Suggestions on National Drug Quality Disclosure System / 中国药房

OBJECTIVE：To provide reference for further improving the national drug quality disclosure system. METHODS ： The national drug quality disclosure system was analyzed in respects of general information ，implementation procedure ， implementation situation and effects ，and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS：The national drug quality disclosure system had gone through the bulletin stage ，notice stage and announcement stage. At present ，it had become drug regulatory measure with timely release ，rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ，ie. informing the sampling enterprises of the fact that the drugs were unqualified，controlling the risk of unqualified drugs ，providing legal relief to the notified units ，preparing the contents of the national drug quality notice ，and releasing the national drug quality notice to the public. In recent years ，National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ，there are also some problems ，such as the non-conforming report is not delivered in time ，the tracing time for suspected counterfeit TCM pieces is too long ，and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ，review and punishment of provincial drug regulatory departments ；at the same time ，provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ，pay attention to relevant work and strengthen daily supervision.

Fatores associados à adesão ao tratamento medicamentoso em trabalhadores de universidade pública / Factors related to adherence to drug treatment in public university workers

RESUMO Objetivo analisar fatores associados à adesão medicamentosa entre trabalhadores de universidade pública que referiram uso de medicação contínua. Métodos estudo transversal, desenvolvido junto a 629 trabalhadores de instituição pública de ensino superior. Dados coletados mediante entrevistas com formulários adaptados do Ministério da Saúde brasileiro e analisados pelo teste qui-quadrado. Resultados verificou-se que 331 (52,6%) dos participantes utilizavam medicação contínua, destes, 175 (52,9%) apresentaram padrão de adesão parcialmente satisfatória e 156 (47,1%) totalmente satisfatória. Trabalhadores com problema crônico de coluna, depressão, fraqueza/cansaço, dispneia e dor no peito apresentaram significativamente menor adesão ao tratamento medicamentoso (p≤0,050). Características sociodemográficas e laborais, polifarmácia e tipo de medicamento não se mostraram associados à adesão medicamentosa (p>0,050). Conclusão observou-se adesão satisfatória entre os trabalhadores pesquisados em relação ao tratamento medicamentoso, estando a presença de alguns sintomas e as doenças crônicas específicas associados à adesão medicamentosa parcialmente satisfatória.

ABSTRACT Objective to analyze factors associated with medication adherence among public university workers who reported use of continuous medication. Methods cross-sectional study carried out with 629 workers from a public university. Data were collected through interviews using forms adapted from the Brazilian Ministry of Health and analyzed using the chi-square test. Results three hundred thirty-one (52.6%) participants were users of continuous medication, of these, 175 (52.9%) had a partially satisfactory adherence pattern and 156 (47.1%) a totally satisfactory pattern. Workers with chronic back problems, depression, weakness/tiredness, dyspnea, and chest pain had significantly less adherence to drug treatment (p≤0.050). Sociodemographic and labor characteristics, polypharmacy, and type of medication were not associated with medication adherence (p>0.050). Conclusion satisfactory drug adherence was observed among the participants in relation to drug treatment, and the presence of some symptoms and specific chronic diseases was associated with partially satisfactory drug adherence.