Comparación de antibióticoterapia en la apendicitis complicada en pediatría / Comparison of antibiotic therapy in complicated appendicitis in pediatrics

INTRODUCCIÓN. La apendicitis aguda es una patología pediátrica quirúrgica que en su fase complicada requiere uso de antibióticos en el postoperatorio; encontrar la mejor opción como experiencia local, fue necesario. OBJETIVO. Comparar un esquema de antibioticoterapia triple vs un doble respecto a variables: demográficas, clínicas y de costos en pacientes pediátricos con apendicitis complicada. MATERIALES y MÉTODOS. Estudio analítico transversal. Población de 133 pacientes y una muestra de 93, operados por apendicitis complicada; 58 recibieron ampicilina + metronidazol + gentamicina y 35 ceftriaxona + metronidazol. Se comparó las variables: estadía hospitalaria, complicaciones y costo monetario de cada esquema. Se realizó en la Unidad de Cirugía Pediátrica del Hospital de Especialidades Carlos Andrade Marín, en el periodo enero de 2017 a octubre de 2018. Los datos fueron analizados con R-Studio 1.8.366 para Windows. RESULTADOS. No hubo diferencia estadística con respecto a: estadía hospitalaria (p=0,261); complicaciones como infección del sitio quirúrgico (p=0,196), re-intervención quirúrgica (p=0,653) y costo (p=0,059). CONCLUSIÓN. Se comparó el esquema de antibioticoterapia triple vs un doble, utilizados en apendicitis complicada en pediatría. No se encontró diferencias estadísticamente significativas en este reporte preliminar, con la diferencia de que con el esquema doble la frecuencia de administración fue menor y se evitó la exposición a los efectos colaterales de los aminoglicósidos.

INTRODUCTION. Acute appendicitis is a pediatric surgical pathology that in its complicated phase requires the use of antibiotics during the postoperative period; finding the best option as local experience was a must. OBJECTIVE. Compare a triple vs a double antibiotic therapy scheme respect demographic, clinical and cost variables in pediatric patients whit complicated apendicitis. MATERIALS AND METHODS. Cross-sectional analytical study. Population of 133 patients and sample of 93, with complicated appendicitis; 58 received ampicillin + metronidazole + gentamicin and 35 ceftriaxone + metronidazole. The following variables were compared; hospital stay, complications and monetary cost of each scheme. It was performed in the Pediatric Surgery Unit of the Hospital of Specialties Carlos Andrade Marin, during january 2017, through october 2018. The data were analyzed with R-Studio 1.8.366 for Windows. RESULTS. There was no statistical difference regarding hospital stay (p=0.261); complications such as surgical site infection (p=0.196), re-surgical intervention (p=0.653); nor cost (p=0.059). CONCLUSION. Triple vs. Double antibiotic therapy scheme used in complicated appendicitis in pediatrics was compared. No statistically significant differences were found in this preliminary report, how ever with the double scheme the frequency of administration was lower and exposure to side effects of aminoglycosides was avoided.

Chitosan Nanoparticles As Drug Delivery System For Cephalexin And Its Antimicrobial Activity Against Multiidrug Resistent Bacteria

Objective: The evolution of antimicrobial resistance is a universal obstacle that necessities the innovation of more effective and safe antimicrobial alternatives with synergistic properties. The purpose of this study was to investigate the possible improvement of cephalexin antimicrobial treatments by loading into chitosan-based nanoparticles, then evaluate their antibacterial and antibiofilm activities as well as determination of its cytotoxicity. Methods: Chitosan nanoparticles (CSNPs) were prepared by ionic gelation method. Parameters were studied to optimize the particle size of CSNPs including pH, stirring rate, homogenization and ultra-sonication time. Size was measured by transmission electron microscope (TEM) and Zeta sizer, morphology seen by scanning electron microscope (SEM). Entrapment efficiency, drug loading and drug content were calculated. Stability of both plain and loaded chitosan Nano-carriers, Drug release and Kinetics also compatibilities were studied. Antimicrobial activity of CSNPs and cephalexin loaded CSNPs were evaluated against 4 Gram-positive and 4 Gram-negative standard and clinical isolates by microdilution method, also assessment of antibiofilm activity of both formulas was investigated against two biofilm producers clinical isolates by tube assay in addition to determination of their cytotoxicity by MTT(3-(4, 5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay. Results: Chitosan nanoparticles and its loaded antibiotics proved compatible combination with small Zeta size, suitable Zeta potential, maximum EE% and drug-loading capacity, sustained controlled release properties followed diffusion kinetic model and six month stability studies. Cephalexin loaded CSNPs showed better antimicrobial activity than plain CSNPs. Synergistic effects were found against S. aureus (ATCC 25923), B. subtilis (ATCC 9372), S. epidermidis, E. faecalis, P. aeruginosa (ATCC 29853) in addition to two carbapenem resistant isolates k. pneumoniae and E. coli. Also cephalexin loaded CSNPs exhibited antibiofilm activity against E. faecalis clinical isolate. Even though, cephalexin loaded CSNPs exhibited significant antibacterial activity, it showed less toxicity against mammalian cells, it had IC50 equal to 231.893 and did not exhibit any cytotoxicity against the WI-38 fibroblast cells at concentration 23.4 µg/ml. Conclusion: Cephalexin loaded CSNPs possessed good stability and sustained release effect in addition to its antimicrobial, antibiofilm activities and reduced cytotoxicity.

Ronda clínica y epidemiológica: club de revistas / Clinical and epidemiological round: journal club

RESUMEN En esta edición de la Ronda Clínica y Epidemiológica presentamos cuatro artículos que desde la práctica clínica consideramos de especial interés. Wan-Chuan, et al., contribuyen con una revisión sistemática y meta-análisis a la discusión de las metas ideales de presión arterial en pacientes hipertensos, esta vez desde una perspectiva diferente: impacto de metas intensivas de presión arterial en pacientes no diabéticos con enfermedad renal crónica. Adicionalmente, Valent, et al., realizan un ensayo clínico aleatorizado para estudiar el efecto de la profilaxis antibiótica postoperatoria en el riesgo de infección de sitio operatorio en gestantes obesas llevadas a cesárea. Por otro lado, Miro, et al., siguen una cohorte de pacientes con falla cardíaca aguda para probar la posibilidad de predecir la mortalidad usando información que puede obtenerse desde el ingreso a urgencias. Para finalizar, Andersson, et al., traen una propuesta prometedora para mejorar el enfoque diagnóstico de pacientes con sospecha de apendicitis y el impacto en el uso de recursos en esta población.

SUMMARY In this edition of the clinical and epidemiological round, we present four articles that we consider relevant from a clinical point of view. Wan-Chuan, et al., contribute with a systematic review and meta-analysis to the discussion of the ideal blood pressure goals, this time from a different perspective: impact of intensive blood pressure goals in non-diabetic patients with chronic kidney disease. In addition, Valent et al., performed a randomized clinical trial to study the effect of the post-operatory prophylaxis in the risk of infection of the surgical site in obese pregnant women underwent a cesarean section. On the other hand, Miro et al. followed a cohort of patients with acute heart failure to prove the possibility to predict mortality using information which can be taken in the emergency room. To conclude, Andersson et al., bring a promising proposal to improve the diagnostic approach in patients in which an appendicitis is suspected, as well as its impact in the use of the resources.

Asymptomatic Bacteriuriain Pregnant Women: Screening Bya Simple Method and Treatment with Single Dose Antimicrobial Therapy

The term asymptomatic bacteriuria in pregnancy indicates persistent actively multiplying bacteria within the urinary tract without showing any symptom in pregnancy. A total of 500 pregnant women were screened for the incidence of asymptomatic bacteriuria by comparing the reliability of urine dip stick evaluation for nitrites and leukocyte esterase activity with that of urine culture in diagnosing asymptomaticbacteriuria. The efficacy of single dose antimicrobial therapy (2 g of Cephalexin or 3 g of Amoxycillin) was evaluated for eradicating asymptomatic bacteriuria. The incidence was found to be 9.2% among the 500 cases in the study group. The dip stick screening could detect the bacteriuric patients correctly in 89.1% of cases. Single dose therapy cured 76.1% of asymptomatic bacteriuria patients. Amoxycillin was found to be more effective when compared to Cephalexin as a single dose antimicrobial therapy.

Dissolution efficiency and bioequivalence study using urine data from healthy volunteers: a comparison between two tablet formulations of cephalexin / Eficiência de dissolução e estudo de bioequivalência utilizando dados de urina de voluntários saudáveis: uma comparação entre duas formulações de comprimidos de cefalexina

The aim of the present study was to assess the bioequivalence of two cephalexin tablet formulations available in the Brazilian market (product A as reference formulation and product B as test formulation). Dissolution efficiency (DE%) was calculated for both formulations to evaluate their in vitrobiopharmaceutical features. The oral bioequivalence study was performed in twenty-four healthy volunteers in a crossover design. Single oral dose (tablet containing 500 mg of cephalexin) of each product was administered with two weeks of washout period. Urinary concentrations of cephalexin were measured by high-performance liquid chromatography (HPLC) method and pharmacokinetics parameters were estimated by urinary excretion data. The bioequivalence was determined by the following parameters: the cumulative amount of cephalexin excreted in the urine, the total amount of cephalexin excreted in the urine and the maximum urinary excretion rate of cephalexin. DE values of immediate-release cephalexin tablets (500 mg) were 68.69±4.18% for product A and 71.03±6.63% for product B. Regarding the dissolution test of the two brands (A and B) analysed, both were in compliance with the official pharmacopeial specifications, since the dissolution of both formulations was superior to 80% of the amount declared in the label after 45 minutes of test (A=92.09%±1.84; B=92.84%±1.08). The results obtained indicated that the products A and B are pharmaceutical equivalents. Confidence intervals for the pharmacokinetic parameters were in compliance with the international standards, indicating that products A and B can be considered bioequivalents and, therefore, interchangeable...

O objetivo do presente estudo foi avaliar a bioequivalência de duas formulações de cefalexina disponíveis no mercado brasileiro (produto A como formulação referência e produto B como formulação teste). A eficiência de dissolução (DE%) foi calculada para ambas as formulações para avaliar suas características biofarmacêuticas. O estudo de bioequivalência oral foi realizado em vinte e quatro voluntários sadios utilizando um desenho cruzado. Uma dose oral única (comprimido contendo 500 mg de cefalexina) de cada produto foi administrada com um período de washout de duas semanas. Concentrações urinárias de cefalexina foram mensuradas por método de cromatografia líquida de alta eficiência (CLAE) e os parâmetros farmacocinéticos foram estimados por dados de excreção urinária. A bioequivalência foi determinada pelos seguintes parâmetros: quantidade acumulada da cefalexina excretada na urina, quantidade total da cefalexina excretada na urina e a taxa de excreção máxima da cefalexina. Os valores de DE dos comprimidos de liberação imediata de cefalexina (500 mg) foram 68,69±4,18% para o produto A e de 71,03±6,63% para o produto B. Com relação ao teste de dissolução das duas marcas analisadas (A e B), ambas apresentaram-se de acordo com as especificações farmacopéicas, uma vez que a dissolução de ambas formulações foi superior a 80% da quantidade declarada após 45 minutos de teste (A=92,09%±1,84; B=92,84% ±1,08). Os resultados obtidos indicaram que os produtos A e B são equivalentes farmacêuticos. Os intervalos de confiança para os parâmetros farmacocinéticos estavam de acordo com os padrões internacionais, demonstrando que os produtos A e B podem ser considerados bioequivalentes e, portanto, intercambiáveis...

Dissolution Determination of Cephalexin from Different Preparations by Optical Fiber in-Situ Process Anal-ysis / 中国药师

Objective:To develop a UV optical fiber in situ process monitoring method for the dissolution behavior of five cepha-lexin solid dosage forms and compare the drug dissolution behavior of different cephalexin preparations. Methods: The dissolution of five different cephalexin preparations was on-line monitored according to the dissolution method for cephalexin tablets in Chinese Phar-macopeia (2010 edition) combined with a six channel optical fiber chemical sensor in situ dissolution monitor. Results:The dissolu-tion curves could show the drug release characteristics of different cephalexin preparations, and the five different preparations exhibited various drug release features. Conclusion:An in-situ, real time, on-line and process analysis of dissolution can be obtained by optical fiber dissolution test system automatically. The release characteristics of different preparations can be presented through dissolution curves directly, which can provide reference for the overall assessment of drug internal quality and clinical medication.

Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula / Study of dissolution profile of the pioneer brand name, generic and similar brand name pharmaceutical products containing cephalexin in the form of capsules

Com o avanço da tecnologia e das pesquisas envolvendo liberação de fármacos, modernização de testes e maior ênfase da previsibilidade de efeitos terapêuticos por meio dos testes in vitro, os testes de dissolução e os estudos de perfis de dissolução têm ganhado cada vez mais importância. Apesar de terem sido introduzidos inicialmente como uma forma de caracterizar o perfil de liberação de fármacos pouco solúveis, atualmente os testes de dissolução fazem parte das monografias de quase todas as formas farmacêuticas sólidas orais. Este trabalho teve como objetivo estudar o perfil de dissolução (porcentagem de fármaco dissolvido versus tempo) dos medicamentos de referência, genérico e similar contendo cefalexina 500 mg na forma farmacêutica de cápsulas. Foram analisadas três especialidades farmacêuticas (referência, genérico e similar), os quais foram submetidos ao teste de dissolução e perfil de dissolução in vitro. Os resultados obtidos no teste de dissolução permitem concluir que as amostras encontraram-se de acordo com as especificações e o perfil de dissolução deste medicamento, nesta forma farmacêutica, é considerado de dissolução rápida (85% de fármaco dissolvido em 15 minutos). Portanto, existe uma grande semelhança entre as curvas obtidas, o que sugere que se trata de equivalentes farmacêuticos.

With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.

A Comparison of Dissolution Rates of Domestic Cephalexin Tablets / 中国药房

The dissolution rates of the cephalexin tablets made by five t actories in China were determined with rotating basket method. The dissolution constants Ki were calculated using single exponential method. The analysis of variance was carried out for Ki. The results showed that constants Ki of products from different factories were significantly different (p