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1.
Rev. Paul. Pediatr. (Ed. Port., Online) ; 41: e2021167, 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1406947

ABSTRACT

ABSTRACT Objective: To analyze the profile of the compounded cardiovascular medicines prescribed in neonatology in Brazil. Data source: An integrative bibliographic review was carried out, including studies published in the last 20 years. The used descriptors were: Intensive Care Neonatal, Off-Label Use, Pharmaceutical Preparations, in the databases Virtual Health Library (VHL), PubMed, and Scientific Electronic Library Online (SciELO). Review articles and guidelines were excluded. The quality of the evidence was analyzed, and 10 articles were selected to integrate the study. Data synthesis: The profile of routine prescrption in the neonatal unit was evaluated. The main cardiovascular medications prescribed as compounding formulation were: Spironolactone, Captopril, Furosemide, Hydrochlorothiazide, Propranolol, Amiodarone, Nifedipine, Carvedilol, Digoxin, Enalapril, Epinephrine, and Hydralazine. The drugs were obtained from adaptations of dosage forms, through the transformation of capsules or tablets into liquid formulations, as a solution, suspension, or syrup, as well as in the form of solutions prepared from active pharmaceutical ingredients. The compounding of medications made drug therapy possible in neonatology, considering that such medications do not have registration of the oral liquid dosage form in the country, despite being part of the List of Essential Medicines for Children of the Word Health Organization. Conclusions: It was possible to analyze the profile of compounded cardiovascular medicines prescribed in neonatology in Brazil. The results showed the need for the development of medications suitable for the neonatal population, and the standardization of operational procedures for preparing extemporaneous formulations in neonatology to increase drug safety.


RESUMO Objetivo: Analisar o perfil dos medicamentos cardiovasculares manipulados prescritos em neonatologia no Brasil. Fontes de dados: Foi realizada uma revisão bibliográfica integrativa, incluindo estudos publicados nos últimos 20 anos. As palavras-chave utilizadas foram: intensive care neonatal, off-label use, pharmaceutical preparations, nos bancos de dados da Biblioteca Virtual em Saúde (BVS), PubMed e Biblioteca Eletrônica Científica Online (SciELO). Os artigos de revisão e diretrizes foram excluídos. A qualidade da evidência foi analisada, e foram selecionados 10 artigos para integrar o estudo. Síntese dos dados: Todos os estudos possibilitaram a avaliação do perfil de prescrição na rotina da unidade. Os principais fármacos cardiovasculares, prescritos em formulação extemporânea, foram espironolactona, captopril, furosemida, hidroclorotiazida, propranolol, amiodarona, nifedipina, carvedilol, digoxina, enalapril, epinefrina e hidralazina. Os medicamentos foram obtidos mediante adaptações de formas farmacêuticas, por meio da transformação de cápsulas ou comprimidos em formulações líquidas, como solução, suspensão ou xarope, assim como também na forma de soluções preparadas com base nos insumos farmacêuticos ativos. A manipulação de medicamentos tornou possível o tratamento medicamentoso em neonatologia, uma vez que tais medicamentos não possuem registro da forma farmacêutica líquida oral no país, apesar de integrarem a lista de medicamentos essenciais em pediatria da Organização Mundial da Saúde. Conclusões: Foi possível analisar o perfil dos medicamentos cardiovasculares manipulados prescritos na neonatologia no Brasil. Os resultados evidenciaram a necessidade do desenvolvimento de medicamentos adequados à população neonatal e à padronização dos procedimentos operacionais do preparo de formulações extemporâneas na neonatologia, para aumentar a segurança dos medicamentos.

2.
ABCS health sci ; 47: e022202, 06 abr. 2022. tab
Article in English | LILACS | ID: biblio-1363542

ABSTRACT

INTRODUCTION: Tigecycline is an antimicrobial agent, approved for the treatment of complicated skin and soft tissue infections, hospital-acquired and community-acquired pneumonia, intra-abdominal infections and anaerobic or atypical infections. OBJECTIVE: To describe the use of tigecycline in a teaching hospital and to compare data from patients who had their prescriptions audited by the hospital infection committee with those who did not have audited prescriptions. METHODS: Retrospective observational cohort study conducted at a teaching hospital from April 2012 to March 2014 including patients who received tigecycline. Demographic variables, comorbidities, microbiological findings, prescribed antibiotics and technical opinions issued by the Hospital Infection Control Service were collected. RESULTS: 71 patients were included, aged between 13 and 92 years, 63.4% were male and 56.3% were non-white. Tigecycline was the first antimicrobial choice in 19.7% (14/71) of the cases, while the use associated with other antibiotics was observed in 66.2% (45/71) of the prescriptions. mainly with meropenem (28.9%). Empirical use was performed in 69.0% of cases, after culture and the antibiogram in 31.0% and off label use in 81.7%. The microorganisms frequently identified by the culture tests were Enterococcus faecalis (17.6%), Pseudomonas aeruginosa (14.7%) and Klebsiella penumoniae (11.8%). CONCLUSION: The study demonstrated that empirical and off label use is common in clinical practice and few prescriptions were guided by the results of the culture and the antibiogram, demonstrating the need for prescribers to evaluate the benefits/ risks of using this antibiotic, risk of resistance, adverse effects and drug interactions, in addition to cost.


INTRODUÇÃO: A tigeciclina é agente antimicrobiano, aprovada para o tratamento de infecções complicadas na pele e tecidos moles, pneumonia hospitalar e adquirida na comunidade, infecções intra-abdominal e infecções anaeróbias ou atípicas. OBJETIVO: Descrever o uso da tigeciclina em hospital de ensino e comparar dados de pacientes que tiveram suas prescrições auditadas pela comissão de infecção hospitalar com os que não tiveram prescrições auditadas. MÉTODOS: Estudo de coorte retrospectivo observacional realizado em hospital de ensino de abril de 2012 a março de 2014 incluindo pacientes que receberam tigeciclina. Foram coletadas variáveis ​​demográficas, comorbidades, achados microbiológicos, antibióticos prescritos e pareceres técnicos emitidos pelo Serviço de Controle de Infecção Hospitalar. RESULTADOS: Foram incluídos 71 pacientes, com idade entre 13 e 92 anos, 63,4% eram do sexo masculino e 56,3% eram não brancos. A tigeciclina foi primeira escolha antimicrobiana em 19,7% (14/71) dos casos, enquanto o uso associado a outros antibióticos foi observado em 66,2% (45/71) das prescrições. principalmente com meropenem (28,9%). O uso empírico foi realizado em 69,0% dos casos, após cultura e o antibiograma em 31,0% e o uso off label em 81,7%. Os microrganismos frequentemente identificados pelos testes de cultura foram Enterococcus faecalis (17,6%), Pseudomonas aeruginosa (14,7%) e Klebsiella penumoniae (11,8%). CONCLUSÃO: O estudo demonstrou que o uso empírico e off label é comum na prática clínica e poucas prescrições foram orientadas pelos resultados da cultura e do antibiograma, demonstrando necessidade de prescritores avaliarem os benefícios/riscos do uso desse antibiótico, risco de resistência, efeitos adversos e interações medicamentosas, além do custo.


Subject(s)
Humans , Male , Female , Tigecycline , Hospitals, University , Cross Infection , Off-Label Use , Anti-Infective Agents
3.
Chinese Journal of Endemiology ; (12): 305-308, 2022.
Article in Chinese | WPRIM | ID: wpr-931541

ABSTRACT

Objective:To understand the sales characteristics and salt iodine content in urban and rural salt market of Guizhou Province.Methods:In accordance with the "Guizhou Province 2020 Iodine Deficiency Disorders Monitoring Field Technical Guidance Work Program", 14 counties (cities, districts) from 88 counties (cities, districts) of 9 cities (states) in Guizhou Province were selected in August 2020. Each county (city, district) selected the urban area and a representative township, and at least 2 supermarkets were selected from the urban area, and 5 supermarkets or retail stores from the townships as the investigation sites, to collect the label information of all commercially available salt within the scope of investigation. At the same time, salt samples were collected after excluding the same brand, variety, and specification, and salt iodine was detected by redox titration.Results:A total of 107 labels of commercially available salt were collected, involving 21 brands, of which Biyuan brand had the largest number (53 samples, 49.5%) and the widest sales range, involving 12 counties (cities, districts). Salt producing areas came from 13 provinces, and the salt produced in Sichuan Province was the most widely distributed in the surveyed area (36 samples), followed by Chongqing Municipality (17 samples) and Hubei Province (16 samples). There were 19 brands (75 samples) and 7 brands (32 samples) of salt sold in urban and rural areas, respectively, and the main brand was Biyuan, accounting for 38.7% (29/75) and 75.0% (24/32), respectively. There were 8 brands (27 samples) and 16 brands (80 samples) of salt sold in retail stores and supermarkets, respectively, and the main brand was Biyuan, accounting for 66.7% (18/27) and 43.8% (35/80), respectively. Among 107 salt samples, it was found that the labeled iodine content did not meet the Guizhou Province salt iodization implementation standard (21 - 39 mg/kg), and only 39 samples (36.4%) had electronic anti-counterfeiting traceability codes on their labels. After excluding the same brand, variety, and specification, the median salt iodine of the 51 salt samples was 23.6 mg/kg, ranging from 19.2 to 38.1 mg/kg, and 21 - 39 mg/kg accounted for 96.1% (49/51).Conclusions:There are many salt brands sold in urban and rural areas in Guizhou Province, and the electronic traceability platform needs to be improved. Salt iodine is mainly distributed in the low-value area of the standard range, which brings potential risks to the sustainable and effective prevention and control of iodine deficiency disorders.

4.
Article in Chinese | WPRIM | ID: wpr-930856

ABSTRACT

Off-label antibiotics use in pediatric intensive care unit is not rare.Off-label antibiotics use is due to indication, age, dosage, frequency, route and method of administration, course of treatment, etc.It is necessary and reasonable for off-label antibiotics use in clinical practice, but there are also some risks.Off-label antibiotics use in clinical practice should follow the corresponding principles and standardized management.Drug treatment decisions should always be made on the basis that the individual child would be ultimately benefit.

5.
Article in Chinese | WPRIM | ID: wpr-929592

ABSTRACT

ObjectiveTo evaluate the warning effect of different tobacco packaging on teenagers and provide an objective evidence for improving tobacco packaging in China. MethodsA multi-stage cluster sampling method was used to investigate students from two middle schools and two high schools in Huangpu District, Shanghai with a self-filled questionnaire survey, and a total of 1 238 valid questionnaires were collected. Epidata 3.1 was used to input data and SPSS 20.0 was used for data analysis. ResultsAbout 69% of the respondents supported printing pictures of diseases on tobacco packages in China, and 81.58% thought graphic warnings should cover more than 70% of the tobacco package. The effect of graphic health warning labels was better than that of text-only warning labels (P<0.05), and the effect of real photos was better than abstract pictures. In addition, labels with real graphic warnings had the highest scores in terms of preventing youth smoking and the degree of support, which was significantly different from abstract graphic warning labels and text-only warning labels (P<0.05). ConclusionCigarette packs with graphic health warnings have a stronger effect on teenagers than plain text health warnings. Teenagers support the use of graphic warnings. It is recommended to apply graphic health warnings with real photos of diseases on the cigarette packages to maximize the effect of the health warnings.

6.
S. Afr. j. clin. nutr. (Online) ; 35(3): 108-114, 2022. tables, figures
Article in English | AIM | ID: biblio-1398069

ABSTRACT

Objective: This study aimed to assess the objective understanding of five front-of-pack label formats, namely the Reference Intake, Multiple Traffic Light label, Nutri-Score, health endorsement logo and warning label, among consumers in Nelson Mandela Bay, South Africa. Design: This was a cross-sectional, exploratory study. Setting: Interviewer-administered surveys were conducted at 12 randomly selected food retail outlets in an urban setting.Subjects: A total of 359 adult participants were included in this study. Outcome measures: Objective understanding was measured by asking participants to rank food products according to their nutritional quality, using the displayed front-of-pack label. Results: The type of front-of-pack label significantly influenced ranking ability (p < 0.00001). All the evaluative front-of-pack labels significantly improved the participants' ability to identify healthier food products compared with the no-label control. The reductive Reference Intake, however, showed no significant impact on consumer understanding. Conclusion: Evaluative front-of-pack labels significantly improved the participants' ability to identify healthier food products, when compared with the Reference Intake and no-label control. Future research should test the objective understanding of culturally diverse groups in South Africa, particularly among rural populations.


Subject(s)
Humans , Organizational Objectives , Traffic , Disaster Warning , Comprehension , Recommended Dietary Allowances
7.
Braz. j. med. biol. res ; 55: e11877, 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1364548

ABSTRACT

Roflumilast, a highly selective oral phosphodiesterase IV inhibitor, exerts anti-inflammatory and anti-fibrotic effects. Oral roflumilast causes gastrointestinal side effects, especially vomiting, which could be reduced by administering roflumilast via off-label routes. Inhaled roflumilast reportedly improved inflammatory and histopathological changes in asthmatic mice. The current study investigated the effects of oral and rectal roflumilast on trinitrobenzenesulfonic acid (TNBS)-induced chronic colitis in rats, an experimental model resembling human Crohn's disease. Five groups of rats (n=8) were used: normal control, TNBS-induced colitis, and three TNBS-treated colitic groups, which received oral sulfasalazine (500 mg·kg-1·day-1), oral roflumilast (5 mg·kg-1·day-1), or rectal roflumilast (5 mg·kg-1·day-1) for 15 days after colitis induction. Then, the following were assessed: the colitis activity score, tumor necrosis factor (TNF)-α, interleukin (IL)-2, and IL-6 serum levels, colonic length, and myeloperoxidase, malonaldehyde, and glutathione levels. Histological examinations employed H&E, Masson trichrome, and PAS stains in addition to immunostaining for KI-67 and TNF-α. The TNBS-induced colitis rats showed significant increases in disease activity scores, serum TNF-α, IL-2, and IL-6 levels, and colonic myeloperoxidase and malonaldehyde content. They also showed significant decreases in colonic length and glutathione levels in addition to histopathological and immunohistochemical changes. All the treatments significantly improved all these changes. Sulfasalazine provided the greatest improvement, followed by oral roflumilast, and then rectal roflumilast. In conclusion, both oral and rectal roflumilast partially improved TNBS-induced chronic colitis, suggesting the potential of roflumilast as an additional treatment for Crohn's disease.

8.
Interface (Botucatu, Online) ; 26: e210619, 2022. tab, graf
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1385939

ABSTRACT

As percepções e o uso de metilfenidato entre universitários foram investigados em estudo descritivo realizado em duas etapas. A primeira, quantitativa, foi realizada por meio do preenchimento de um questionário semiestruturado on-line. Para a segunda etapa, qualitativa, foi realizado um grupo focal. Dos 337 participantes da primeira etapa, 14,5% relataram usar o metilfenidato. Entre os usuários, a prevalência de uso sem prescrição foi maior para o sexo masculino (65,3%), após ingresso na faculdade (57,1%), e 61,2% relataram eventos adversos. O principal motivo de uso foi o doping intelectual (65,3%). Já na etapa qualitativa, além de reforçar os achados anteriores, foram identificados tópicos temáticos como a pressão externa exercida por familiares, sociedade e a rotina universitária. Esses achados apontam para a necessidade de medidas de apoio e orientação aos universitários e de reformulação do processo ensino-aprendizagem.(AU)


This descriptive study investigated the use and perceptions of methylphenidate among university students. The study was conducted in two stages. In the first stage (quantitative), the students completed an online semi-structured questionnaire. The second stage (qualitative) consisted of focus group discussions. Of the 337 participants in the first stage, 14.5% reported using methylphenidate. The prevalence of methylphenidate use without a prescription was greater among men (65.3%) and after starting university (57.1%); 61.2% of the students reported adverse events. The main reason for using the drug was intellectual doping (65.3%). In the qualitative stage, which reinforced the findings of the quantitative stage, we identified themes such as external pressure from family, society and university routine. The findings underline the need to provide student support and advice and reformulate the teaching and learning process.(AU)


Se investigaron las percepciones y el uso del metilfenidato entre universitarios, en un estudio descriptivo realizado en dos etapas. La primera, cuantitativa, se realizó por medio del llenado de un cuestionario semiestructurado online. Para la segunda etapa, cualitativa, se realizó un grupo focal. De los 337 participantes de la primera etapa, el 14,5% relató que usaba metilfenidato. Entre los usuarios, la prevalencia de uso sin prescripción fue mayor para el sexo masculino (65,3%), después del ingreso en la facultad (57,1%) y el 61,2% relataron eventos adversos. El principal motivo de uso fue el dopping intelectual (65,3%). En la etapa cualitativa, además de reforzar los hallazgos anteriores, se identificaron tópicos temáticos tales como la presión externa ejercida por los familiares, la sociedad y la rutina universitaria. Esos hallazgos señalan la necesidad de medidas de apoyo y orientación a los universitarios y de reformulación del proceso enseñanza-aprendizaje.(AU)

9.
China Pharmacy ; (12): 1810-1813, 2022.
Article in Chinese | WPRIM | ID: wpr-936483

ABSTRACT

OBJECTIVE To explore wheth er there is a relationship between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes related to off-label drug use up to 2021 on pkulaw.cn ,documents were extracted to record objective factors ,subjective factors and judgment results ;whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association ;univariate analysis was adopted to test the relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly occurred in the eastern China (63.2%)and tertiary hospitals (64.9%),the main appraisal agency was the appraisal center or institute(61.4%),and the most common type of off-label drug use was overdose drug use (45.6%). Among the judgment results , 23 cases(40.4%)of off-label drug use had a causal relationship with medical damage ,most of the responsibility of doctors was secondary responsibility (28.1%),and the actual compensation amount of the most cases were less than 100,000 yuan(54.4%). There were 25 cases(43.9%)with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence (P= 0.040),and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case (P=0.741),causality determination (P=0.256),liability type (P=0.598)or appraisal agency (P≥0.260). CONCLUSIONS There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence ,indicating that there may be certain differences between judicial trials and medical science. The off-label drug use should be regulated by establishing a complete off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn

10.
Rev. colomb. cienc. pecu ; 34(2): 84-94, Apr.-June 2021. tab
Article in English | LILACS-Express | LILACS | ID: biblio-1394932

ABSTRACT

Abstract Background: The slow-growing chicken strains have particular nutritional and digestive needs, so they may digest pelleted feeds differently compared to commercial strains. Objective: To evaluate performance, digestibility, serum biochemical profile, digestive morphometry, carcass and cut yields of slow-growing broiler chickens fed pelleted feed with different concentrations of fine particles. Methods: A total of 180 slow-growing broiler chicks (Isa Label strain) aged one day were used. The animals were distributed in a completely randomized design with a 2 x 3 factorial scheme (Sex: male or female; Proportion of fine particles: 0, 50, or 100%), with six repetitions of five birds/cage. The birds received water and feed ad libitum during the 28-day experimental period. Results: The proportion of fine particles did not affect the metabolic, digestive or productive variables evaluated. Males showed better overall performance, while females produced better thigh and liver yields. Conclusion: The proportion of fine particles in pelleted feeds did not affect productive or metabolic parameters. Thus, improving pellet quality for slow-growing broilers during the initial rearing phase may not be justified.


Resumen Antecedentes: Los linajes de pollo de crecimiento lento presentan particularidades nutricionales y digestivas; por lo tanto, es posible que aprovechen los alimentos peletizados de manera diferente a los linajes comerciales. Objetivo: evaluar el desempeño, digestibilidad, perfil sérico bioquímico, morfometría digestiva, rendimiento de la carcasa y los cortes de pollos de engorde de crecimiento lento alimentados con raciones peletizadas con diferentes concentraciones de partículas finas. Métodos: Se utilizaron 180 pollitos machos y hembras, de crecimiento lento, de un día de edad, del linaje Isa Label. Los animales se distribuyeron en un diseño completamente aleatorizado y en un esquema factorial 2 x 3 (Sexo: macho y hembras; Proporción de partículas finas en la ración: 0, 50, y 100%) con seis repeticiones de cinco aves/jaula. Las aves recibieron agua y ración ad libitum durante el período de prueba de 28 días. Resultados: la proporción de partículas finas no afectó las variables metabólicas, digestibles y productivas evaluadas. Los machos presentaron mejor desempeño, mientras que las hembras tuvieron mayor rendimiento de muslos e hígado. Conclusión: la proporción de partículas finas en raciones peletizadas no afecta los parámetros productivos y metabólicos. Por lo tanto, probablemente no se justifica mejorar la calidad del pelet para pollos de crecimiento lento en la fase inicial de cría.


Resumo Antecedentes: linhagens de crescimento lento apresentam particularidades nutricionais e digestivas, portanto é possível que aproveitem os alimentos peletizados de maneira diferente das linhagens comerciais. Objetivo: avaliar o desempenho, digestibilidade dos alimentos, o perfil sérico bioquímico, a morfometria digestiva, rendimento de carcaça e cortes de frangos de corte com crescimento lento alimentados com rações peletizadas com diferentes concentrações de partículas finas. Métodos: Foram utilizados 180 pintos de corte, machos e fêmeas de crescimento lento, com um dia de idade, da linhagem Isa Label. Os animais foram distribuídos em delineamento inteiramente casualizado em esquema fatorial 2 x 3 (Sexo: macho e fêmeas; Proporção de partículas finas na ração: 0, 50, e 100%) com seis repetições de cinco aves/gaiola. As aves receberam água e ração ad libtum durante o período experimental de 28 dias. Resultados: a proporção de partículas finas não afetou as variáveis metabólicas, digestórias e produtivas avaliadas. Os machos apresentaram melhor desempenho, enquanto as fêmeas tiverem maior rendimento de coxas e fígado. Conclusão: a proporção de partículas finas nas rações peletizadas não afetaram os parâmetros produtivos e metabólicos e, portanto, não justifica-se melhorias na qualidade de peletes de rações para frangos de crescimento lento na fase inicial de criação.

11.
Rev. bras. ter. intensiva ; 33(2): 266-275, abr.-jun. 2021. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1289071

ABSTRACT

RESUMO Objetivo: Avaliar o uso de medicamentos off-label e sem licença em recém-nascidos prematuros hospitalizados em unidade de terapia intensiva neonatal. Métodos: Estudo de coorte não concorrente, incluindo prematuros admitidos em três unidades de terapia intensiva neonatais, nos anos de 2016 e 2017, acompanhados durante o período neonatal. O uso de medicamentos e o número foram registrados para todo o período e classificados segundo a Anatomical Therapeutic Chemical. Foram realizadas análises descritivas e bivariadas dos dados para avaliar associações entre o número de medicamentos utilizados (total, off-label e sem licença) e as variáveis explicativas de interesse. Resultados: Os 400 neonatos prematuros utilizaram 16.143 medicamentos, com 86 especialidades diferentes; 51,9% desses itens foram classificados como off-label e 23,5% como sem licença. Os mais prescritos foram gentamicina e ampicilina (17,5% e 15,5% dos off-label, respectivamente) e cafeína (75,5% dos não licenciados). O estudo demonstrou associações significativas do uso de medicamentos off-label com a menor idade gestacional, baixo peso ao nascer, menor escore de Apgar no quinto minuto, manobra de reanimação avançada em sala de parto e óbito. Com os medicamentos não licenciados, foram verificadas associações com a menor idade gestacional, baixo peso ao nascer e escore de Apgar no quinto minuto menor que 7. Conclusão: Os neonatos internados em unidades de terapia intensiva neonatais são muito expostos ao uso de medicamentos off-label e sem licença. Tornam-se necessários mais investimentos em estudos para alcançar maior segurança e qualidade da terapêutica medicamentosa empregada em neonatologia.


ABSTRACT Objective: To evaluate the use of off-label and unlicensed medications in preterm infants hospitalized in a neonatal intensive care unit. Methods: This nonconcurrent cohort study included preterm infants admitted to 3 neonatal intensive care units in 2016 and 2017 who were followed up during the neonatal period. The type and number of medications used were recorded for the entire period and classified based on the Anatomical Therapeutic Chemical. Descriptive and bivariate data analyses were performed to assess associations between the number of drugs used (total, off-label and unlicensed) and the explanatory variables of interest. Results: Four hundred preterm infants received 16,143 prescriptions for 86 different pharmaceuticals; 51.9% of these medications were classified as off-label and 23.5% as unlicensed. The most prescribed drugs were gentamicin and ampicillin (17.5% and 15.5% among off-label, respectively) and caffeine (75.5% among unlicensed). The results indicated significant associations between the use of off-label drugs and lower gestational age, low birth weight, lower 5-minute Apgar score, advanced resuscitation maneuver in the delivery room and death. The prescription of unlicensed drugs was associated with lower gestational age, low birth weight and 5-minute Apgar score below 7. Conclusion: Neonates admitted to neonatal intensive care units are highly exposed to off-label and unlicensed medications. Further studies are needed to achieve greater safety and quality of drug therapy used in neonatology.


Subject(s)
Humans , Infant, Newborn , Infant , Pharmaceutical Preparations , Intensive Care Units, Neonatal , Infant, Premature , Cohort Studies , Prescriptions , Off-Label Use
12.
Arq. gastroenterol ; 58(1): 32-38, Jan.-Mar. 2021. tab
Article in English | LILACS | ID: biblio-1248997

ABSTRACT

ABSTRACT BACKGROUND: Intravenous (IV) use of proton pump inhibitors (PPIs) is advised only in cases of suspected upper gastrointestinal bleeding (UGIB) or impossibility of receiving oral medication, although there has been a persistent practice of their inappropriate use in health institutions. OBJECTIVE: The purpose of our study was to measure the inappropriate use of IV PPIs in a high complexity hospital in Brazil and to estimate its costs. METHODS: Retrospective study of 333 patients who received IV omeprazole between July and December of 2018 in a high complexity hospital in Brazil. RESULTS: IV omeprazole was found to be appropriately prescribed in only 23.4% patient reports. This medication was administered mainly in cases of suspected UGIB (19.1%) and stress ulcer prophylaxis in patients with high risk of UGIB unable to receive medication orally (18.7%). It was observed a statistically significant association between adequate prescription and stress ulcer prophylaxis in patients with high risk of UGIB unable to receive medication orally; patient nil per os with valid indication for PPIs usage; prescription by intensive care unit doctors; prescription by emergency room doctors; intensive care unit admission; evolution to death; sepsis; and traumatic brain injury (P<0.05). On the other hand, inadequate prescription had a statistically significant association with surgical ward prescription and non-evolution to death (P<0.05). The estimated cost of the vials prescribed inadequately was US$1696. CONCLUSION: There was a high number of inappropriate IV omeprazole prescriptions in the studied hospital, entailing greater costs to the institution and unnecessary risks.


RESUMO CONTEXTO: Atualmente, o uso intravenoso (IV) dos inibidores de bomba de prótons (IBPs) é indicado em poucas situações, como em casos de hemorragia digestiva alta ou impossibilidade de recebê-los via oral. Há diversos estudos mostrando o uso excessivo desse fármaco, na forma intravenosa, desnecessariamente e acarretando altos custos aos hospitais. OBJETIVO: Avaliar as indicações, posologias, duração do tratamento e custos das prescrições de omeprazol intravenoso. MÉTODOS: Estudo retrospectivo de 333 pacientes que receberam omeprazol intravenoso entre julho a dezembro de 2018 em um hospital de alta complexidade no Brasil. RESULTADOS: A prescrição de omeprazol intravenoso foi considerada totalmente adequada em apenas 23,4% das prescrições analisadas. O medicamento foi administrado principalmente em casos de suspeita de hemorragia digestiva alta (HDA) (19,1%) e profilaxia de úlcera de estresse em paciente com alto risco de HDA impossibilitado de receber via oral (18,7%). Foi observada associação estatisticamente significativa entre prescrição adequada e profilaxia de úlcera de estresse em paciente com alto risco de HDA impossibilitado de receber medicamento via oral; paciente em nil per os com indicação válida de IBPs; prescrição por médico da UTI; prescrição por médico do pronto atendimento; admissão na UTI; evolução a óbito; sepse; e traumatismo cranioencefálico (P<0,05). Já a prescrição inadequada teve associação estatisticamente significativa com prescrição por setor cirúrgico e a não evolução a óbito (P<0,05). O custo estimado do total de ampolas prescritas inadequadamente foi de US$1696,00. CONCLUSÃO: Houve um elevado número de prescrições de omeprazol intravenoso inadequadas no hospital estudado, acarretando um custo elevado para a instituição.


Subject(s)
Humans , Omeprazole , Proton Pump Inhibitors , Brazil , Retrospective Studies , Hospitals
13.
Article in Chinese | WPRIM | ID: wpr-934515

ABSTRACT

Off-label drug use is a global problem in clinical practice. The management status, attitude and medical insurance coverage of off-label drug use are different in various countries. By analyzing the management and reimbursement policy of off-label drug use in other countries, the authors suggested that China should speed up the institutional arrangements of off-label drug use and establish relevant management systems, and strengthen the supervision of off-label drug use, so as to guarantee the rights of patients to the best treatment.

14.
Article in English, Portuguese | LILACS | ID: biblio-1155473

ABSTRACT

ABSTRACT Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). Results: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. Conclusions: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths.


RESUMO Objetivo: Analisar o uso de medicamentos off-label (OL), segundo a agência reguladora nacional, em unidade de terapia intensiva neonatal de uma maternidade de alto risco em Aracaju. Métodos: Foi realizado um estudo transversal, utilizando amostra de conveniência de recém-nascidos (RN) da Unidade Intensiva, que fizeram uso de ventilação mecânica. Consideramos OL o medicamento que não era liberado para uso em RN nos bulários eletrônicos da Agência Nacional de Vigilância Sanitária (ANVISA) e da U.S. Food and Drug Administration (FDA). Resultados: A amostra consistiu de 158 neonatos, sendo 58,3% do sexo masculino, 87,7% prematuros e 70,2% com baixo ou muito baixo peso. De acordo com a ANVISA, das 1.167 prescrições analisadas, 440 foram OL, com 98,1% dos RN expostos a pelo menos um desses medicamentos. Já para a FDA, 484 prescrições foram OL, com 75,8% dos neonatos expostos a pelo menos um deles. As medicações OL mais prescritas foram os anti-infecciosos. Neonatos que apresentaram insuficiência respiratória e pneumonia fizeram mais uso deles e não houve relação entre o seu uso e o número de óbitos. Conclusões: Quase todos os RN internados, principalmente os prematuros, foram expostos a pelo menos um medicamento OL, de acordo com a agência reguladora nacional e internacional, durante a internação. Entretanto, isso não teve relação com a frequência de complicações nem de óbitos neonatais.


Subject(s)
Humans , Male , Female , Infant, Newborn , Practice Patterns, Physicians'/statistics & numerical data , Intensive Care Units, Neonatal/statistics & numerical data , Off-Label Use/statistics & numerical data , Respiration, Artificial , Brazil/epidemiology , Infant, Premature , Cross-Sectional Studies , Infant, Very Low Birth Weight
15.
Chinese Journal of Radiology ; (12): 1191-1196, 2021.
Article in Chinese | WPRIM | ID: wpr-910284

ABSTRACT

Objective:To construct a multi-label learning MRI model for assisting diagnosis of sports injury in knee.Methods:A total of 1 391 knee MRI cases from 1 343 young adults with sports injury in Affiliated Jinling Hospital Nanjing University School of Medicine were retrospectively enrolled. The image cases were randomly divided into training set ( n=973), validation set ( n=139) and test set ( n=279) with ratio of 7∶1∶2. The knee injuries were divided into six categories: meniscus injury, tendon injury, ligament injury, osteochondral injury, synovial bursa disorder and soft tissue injury. Using PyTorch V1.1.0 algorithm package, the Yolo model of deep learning was used to construct the MRI knee joint sports injury detection model. The model was validated on the test set, and the sensitivity, specificity and mean average precision of lesion detection were evaluated. Results:Among the 279 patients in test set, the mean average precision of meniscus injury, tendon injury, ligament injury, osteochondral injury, synovial bursa disorder and soft tissue injury were 83.1%, 89.0%, 88.0%, 85.8%, 85.5% and 83.2%, respectively, and the overall mean average precision was 85.8%. The model was most effective in detecting tendon injury. The sensitivity and specificity of the model for tendon injury were 91.2% and 87.1% respectively.Conclusions:The multi-label MRI knee joint exercise-related injury detection model based on deep learning can effectively assist in detecting the exercise-related injury of knee joint in each tissue structure, and is expected to improve the efficiency of diagnosis and treatment in orthopedics.

16.
Article in Chinese | WPRIM | ID: wpr-908546

ABSTRACT

Objective:To characterize proteomic profile in aqueous humor of patients with high myopia using quantitative proteomic analysis.Methods:Sixty-eight age-related cataract patients were divided into high myopic cataract group and simple cataract group according to that they had high myopia or not, with 34 patients (34 eyes) in each group.Aqueous humor samples (100 μl/patient) were collected from each patient using a 1 ml tuberculin syringe during cataract surgery at Tianjin Medical University Eye Hospital from January 2019 to August 2019.Sixteen samples from each group were selected for protein quantification and comparison by BCA method.The differentially expressed proteins between the two groups were analyzed using label-free liquid chromatography tandem mass spectrometry.The function and signal transduction pathways of differentially expressed proteins were further analyzed by Gene Ontology enrichment and Kyoto Encyclopedia of Genes and Genomes.Eighteen aqueous humor samples from each group were selected to verify the results of mass spectrometry by enzyme-linked immunosorbent assay (ELISA). This study protocol adhered to the Declaration of Helsinki.The use of human samples was approved by an Ethics Committee of Tianjin Medical University Eye Hospital (No.2020KY[L]-40). Written informed consent was obtained from each patient prior to surgery.Results:The mean protein mass concentration of aqueous humor sample in the high myopic cataract group was (1 134.91±104.78) ng/L, which was significantly higher than that in the simple cataract group (706.71±85.43) ng/L, showing statistically significant difference ( t=11.977, P<0.01). A total of 463 proteins were identified and 86 proteins were found to be differentially expressed, including 49 up-regulated proteins and 37 down-regulated proteins in the two groups.These differentially expressed proteins were mainly protein-binding activity modulator, extracellular matrix protein, carrier protein, intercellular signal molecule, protein modifying enzyme and so on, accounting for 32.70%, 14.50%, 9.10%, 9.10% and 7.30%, respectively.Bioinformatics analysis showed that 86 differentially expressed proteins were mainly related to biological processes such as complement activation and regulation, acute inflammatory response, and extracellular matrix tissue remodeling.Among them, 21 differentially expressed proteins were enriched in the complement and coagulation cascades pathways, 15 in the extracellular matrix-receptor interaction pathway, and 8 in the PI3K-Akt signaling pathway.ELISA results showed that the expression trends of three randomly selected differentially expressed proteins of the two groups were consistent with the results of label-free quantitative proteomic analysis. Conclusions:There are significant changes in proteomic profiles of aqueous humor between the high myopia cataract patients and simple cataract patients.High myopia is closely associated with inflammation and immune interactions, and remodeling of extracellular matrix.

17.
Article in Chinese | WPRIM | ID: wpr-907740

ABSTRACT

Objective:To investigate the safety and efficacy of moxifloxacin in children with severe Mycoplasma pneumoniae pneumonia (SMPP).Methods:The patients with SMPP in the Pediatric Intensive Care Unit of Beijing Children's Hospital between January 2017 and April 2020 were retrospectively analyzed. Clinical data were collected to assess therapeutic efficacy, analyze drug safety and summarize positive rate of macrolide-resistant Mycoplasma pneumoniae genes mutation.Results:Thirty-nine children diagnosed SMPP treated with moxifloxacin were included. The positive rate of macrolide-resistant Mycoplasma pneumoniaegenes mutation was 95.2%. In the 39 patients, 6 (15.4 %) were cured, 29 (74.4 %) were effective, 2 (5.1 %) were no response, 2 (5.1 %) were discharged automatically during treatment with moxifloxacin, and the overall response rate was 89.8 %. The situations of consciousness, skin, joint, heart rhythm and gastrointestinal function were carefully observed; Blood routine test, liver and kidney function were closely monitored. There were no adverse drug reactions in the period of medication. No children were discontinued due to adverse reactions.Conclusions:Moxifloxacin can improve efficacy and prognosis for pediatric patients with SMPP. There are no drug adverse reactions during treatment with moxifloxacin, indicating that short-term medication is safe. The application of quinolones in pediatric patients is off-label drug use, and clinical pharmacists should assist clinicians in reducing medical risks.

18.
Article in Chinese | WPRIM | ID: wpr-906189

ABSTRACT

Objective:To explore the potential targets and related mechanism involved in the paclitaxel resistance to ovarian cancer. Method:Ovarian cancer A2780 cells and A2780 paclitaxel-resistant cells (A2780/T) were treated by 2, 4, 8, 16, 32, 64, 128, 256 μmol·L<sup>-1</sup> paclitaxel (PTX) for 24 h or 48 h respectively <italic>in vitro</italic>. The proliferation rate of A2780 cells and A2780/T cells treated with paclitaxel was determined by methyl thiazolyl tetrazolium (MTT) colorimetric method assay. A2780 and A2780/T cells were analyzed by LC-MS/MS Label-Free quantitative proteomics to identify and screen differentially expressed proteins in the two groups of cells. Gene ontology (GO) annotation and Kyoto encyclopedia of genes and genomes (KEGG) pathway analysis were used to determine the potential biomarkers of paclitaxel resistance in ovarian cancer. Conventionally cultured A2780 cells were used as a control group, and A2780/T cells were treated with 0, 1, 4 μmol·L<sup>-1</sup> PTX. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot methods were used to detect and verify the mRNA and protein expression levels of potential target transforming growth factor-<italic>β</italic>-activated kinase 1 binding protein 1 (TAB1) and its downstream related molecules transforming growth factor-<italic>β</italic>-activated kinase (TAK1) and p38. Result:After PTX treatment for 24 h and 48 h, the cell viability of A2780 and A2780/T cells decreased. The inhibitory rate of PTX on A2780 cells was significantly higher than that of A2780/T cells. In A2780 cells, the IC<sub>50</sub> of PTX treatment for 48 h was 0.002 μmol·L<sup>-1</sup>, while in A2780/T cells, the IC<sub>50 </sub>of PTX was greater than the maximum concentration of 128 μmol·L<sup>-1</sup>, indicating that A2780/T cells were resistant to PTX compared with A2780 cells. 441 differentially expressed proteins and 421 special differentially expressed proteins between A2780/T and A2780 cells were screened by label-free quantitative proteomic analysis. GO function enrichment analysis showed that the binding proteins accounted for the majority (80%) among the differentially expressed proteins. According to the results of KEGG pathway analysis and expression site analysis, TAB1 might be a potential biomarker in paclitaxel-resistant ovarian cancer. Compared with A2780 cells, mRNA and protein expression levels of TAB1 in A2780/T cells were significantly reduced (<italic>P</italic><0.01). mRNA expression of TAK1 and p38 that interacted with TAB1 were also significantly reduced (<italic>P</italic><0.05, <italic>P</italic><0.01), while there was no significant change in protein expression. Conclusion:TAB1 may be a potential biomarker of paclitaxel resistance to ovarian cancer , and its mechanism may be related to the TAB1/TAK1/p38 MAPK pathway.

19.
Article in Chinese | WPRIM | ID: wpr-904764

ABSTRACT

Objective To analyze the current situation of off-label drug use for tic disorder in a tertiary maternity and child hospital, so as to promote clinical safe and rational drug use. Methods Through the hospital information system, the pediatric outpatient prescriptions diagnosed with tic disorder from July 2019 to August 2020 were selected, and the prescriptions of off-label use was evaluated according to the 2020 off-label drug management regulations. Results A total 1251 pediatric prescriptions diagnosed with tic disorder were collected. The incidence of off-label drug use was 29.58%. The main types of off-label were over-indications and over-age. The main varieties of off-label drug use were risperidone tablets (47.84%) and aripiprazole tablets (43.74%). Conclusion The off-label use of drug for tic disorder in pediatric outpatient department of our hospital is relatively common,and it is necessary to standardize the management of off-label drug use to ensure rational drug use.

20.
Article in Chinese | WPRIM | ID: wpr-887999

ABSTRACT

Nano-LC-MS/MS was used to analyze trypsin digested deer-horn gelatin( DCG) and deer-hide gelatin( DHG) samples.The glycopeptides in DCG and DHG were quantified by Label-free quantitative( LFQ) peptidomics,on the basis of which the glycopeptides with significant difference in DCG and DHG were determined. As a result,5 736 peptides were identified from DCG samples,including 213 galactosyl-hydroxylysine containing peptides( Gal-Hyl-peptides) and 102 glucosyl-galactosyl-hydroxylysine containing peptides( Glc-Gal-Hyl-peptides),while 6 836 peptides were identified from DHG samples,among which there were 250 Gal-Hyl-peptides and 98 Glc-Gal-Hyl-peptides. With over 3-fold peak area difference and highly significant intergroup difference( P < 0. 01) as the screening criteria,444 differential peptides were determined in DCG and DHG,including 16 Gal-Hyl-peptides and 5 Glc-Gal-Hyl-peptides. Then XIC peak shapes,standard deviation of peak area,and fold change were applied for further screening and 5 glycopeptides with significant differences in DCG and DHG were confirmed,which could serve as potential biomarkers for distinguishing DCG and DHG. The present study provided ideas and strategies for the in-depth investigation on the discrimination of DCG and DHG and is of good theoretical significance and application value for the further research on chemical constituents and quality control of gelatin derived Chinese medicinals.


Subject(s)
Animals , Chromatography, Liquid , Deer , Gelatin , Glycopeptides , Tandem Mass Spectrometry
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