Trend analysis of hemagglutinin and ovalbumin content for influenza virus split vaccines in 2021 / 中国生物制品学杂志

@#Objective To analyze the trend of the hemagglutinin(HA) and ovalbumin contents in the lot release of influenza virus split vaccines in 2021,and evaluate the quality and quality control level of the vaccines.Methods The HA and ovalbumin content data of influenza virus split vaccines from two domestic enterprises in 2021 were collected and collated. The mean value and standard deviation were calculated according to the first 40 batches of data of the enterprise in the year,and the warning limit and action limit were established. The trend analysis of the above indexes was carried out to evaluate the stability and consistency of the product quality of the enterprise. Statistical data comparison and consistency analysis were made between the test results of the batch inspected by the lot release institution and the results of the enterprise.Results Through the retrospective data analysis of quadrivalent influenza virus split vaccines from two vaccine enterprises A and B,it was found that the content of H1N1 subtype HA and ovalbumin in the two enterprises and the content of Bv HA in the B enterprise had out of trend(OOT)situations,while the trend of other items was stable. The results of paired student's t test or Wilcoxon signed-rank test of the samples inspected by the lot release institution showed that except Bv subtype HA(t = 1. 094 and 0. 742 respectively)and ovalbumin(w =-64 and 36 respectively)contents showed no statistically significant difference(P > 0. 05),the HA contents of H1N1(t = 3. 862,w = 232),H3N2(t = 8. 225 and3. 473 respectively)and By(t = 5. 616 and 4. 934 respectively)of the two enterprises had significant differences(P <0. 05). The results of enterprises were generally higher than the lot release institution. Bland-Altman test analysis found that the consistency between the test data of enterprise A's HA content and the data of the lot release institution was better than that of enterprise B.Conclusion The stability and consistency of data trends of active ingredients and main impurity ingredients of quadrivalent influenza virus split vaccine batches in 2021 were generally good. The trend analysis can identify potential problems in vaccine production,and enterprises should carefully implement trend analysis and effectively monitor the product quality of vaccines.

Research progress of sustained-release drug delivery system for uveitis / 国际眼科杂志(Guoji Yanke Zazhi)

Uveitis, a complex ocular disorder with numerous etiologies, can result from infection, autoimmune, and various physicochemical and mechanical injury factors. The treatment of this disease is difficult, and failure to receive timely and effective treatment can often lead to blindness. With the deepening of people's understanding of uveitis and its related mechanisms, various new sustained-release drug delivery systems for uveitis have been studied. However, due to the existence of various anatomical and physiological barriers in the eye, there are multiple obstacles to the sustained release treatment of uveitis. In this paper, the main research results in this field in recent years are reviewed, and the innovations and limitations of various new sustained-release drug delivery systems are discussed in order to provide new ideas for the sustained-release drug delivery treatment of uveitis in the future. These new sustained-release drug delivery systems will help to completely change the traditional treatment mode of uveitis with side effects and poor compliance in the future, bringing longer targeted sustained release and less toxic reactions.

Prevalência e fatores associados ao uso de cigarro eletrônico por estudantes universitários / Prevalence and factors associated with electronic cigarette use by university students / Prevalencia y factores asociados al uso de cigarrillos electrónicos por estudiantes universitarios

Este estudo objetivou estimar a prevalência do uso do cigarro eletrônico e a associação com fatores preditores. Trata-se de um estudo transversal, analítico, com amostra probabilística de universitários matriculados em um Centro Universitário de Montes Claros, Minas Gerais, Brasil no segundo semestre de 2022. A variável dependente referiu-se ao uso do cigarro eletrônico. As variáveis independentes referiram a fatores sociodemográficas, laborais e comportamentais. A associação entre as variáveis investigadas e a prevalência do uso do CE foi verificada pela análise bivariada e a regressão de Poisson. Foram entrevistados 730 universitários, com a média de idade de anos 22,56 (±6,25). Destes, 21,8 % faziam o uso cigarro eletrônico e após a análise multivariada manteve-se associado ao desfecho não ter companheiro (RP= 3,31; IC95% 1,04-10,48), morar com amigos/sozinho (RP=1,53; IC95% 1,07-2,18), ter histórico de usuários de cigarro eletrônico na residência (RP= 1,76; IC95%: 1,17- 1,89), consumir bebida alcoólica (RP= 3,07; IC95%: 1,72-5,49) e não praticar atividade física (RP= 3,37; IC95% 2,35-4,83). Conhecer sobre o cigarro eletrônico foi fator protetor (RP= 0,31 IC95% 0,20-0,46). Registrou-se elevada prevalência do uso do cigarro eletrônico, e manteve associados a fatores sociodemográficos e comportamentais. Esses achados chamam a atenção para a necessidade de novas medidas regulatórias, a fim de reduzir o uso desse dispositivo.

This study aimed to estimate the prevalence of e-cigarette use and the association with predictors. This is a cross-sectional, analytical study with a probabilistic sample of university students enrolled in a University Center of Montes Claros, Minas Gerais, Brazil in the second half of 2022. The dependent variable referred to the use of electronic cigarettes. The independent variables referred to sociodemographic, labor and behavioral factors. The association between the variables investigated and the prevalence of EC use was verified by bivariate analysis and Poisson regression. A total of 730 university students were interviewed, with a mean age of 22.56 (±6.25). Of these, 21.8% used electronic cigarettes and after multivariate analysis, it remained associated with the outcome of not having a partner (PR= 3.31; CI95% 1.04-10.48), living with friends/alone (PR=1.53; CI95% 1.07-2.18), having a history of e-cigarette users in the residence (PR= 1.76; CI95%: 1.17- 1.89), alcohol consumption (PR= 3.07; CI95%: 1.72-5.49) and not practicing physical activity (PR= 3.37; IC95% 2.35-4.83). Knowing about electronic cigarettes was a protective factor (PR= 0.31 CI95% 0.20-0.46). There was a high prevalence of e-cigarette use, and it was associated with sociodemographic and behavioral factors. These findings draw attention to the need for new regulatory measures in order to reduce the use of this device.

Este estudio tuvo como objetivo estimar la prevalencia del uso de cigarrillos electrónicos y la asociación con predictores. Se trata de un estudio analítico transversal con una muestra probabilística de estudiantes universitarios matriculados en un Centro Universitario de Montes Claros, Minas Gerais, Brasil, en el segundo semestre de 2022. La variable dependiente se refería al uso de cigarrillos electrónicos. Las variables independientes se refirieron a factores sociodemográficos, laborales y conductuales. La asociación entre las variables investigadas y la prevalencia de uso de CE fue verificada por análisis bivariado y regresión de Poisson. Fueron entrevistados 730 estudiantes universitarios, con una edad promedio de 22,56 (±6,25). De estos, 21,8% utilizaron cigarrillos electrónicos y después del análisis multivariado, se mantuvo asociado con el resultado de no tener pareja (RP= 3,31; IC95% 1,04-10,48), vivir con amigos/solo (RP=1,53; IC95% 1,07-2,18), con antecedentes de usuarios de cigarrillos electrónicos en la residencia (RP= 1,76; IC95%: 1,17- 1,89), consumo de alcohol (RP= 3,07; IC95%: 1,72-5,49) y no practicar actividad física (RP= 3,37; IC95% 2,35-4,83). El conocimiento de los cigarrillos electrónicos fue un factor protector (RP= 0,31 IC95% 0,20-0,46). Hubo una alta prevalencia de uso de cigarrillos electrónicos, y se asoció con factores sociodemográficos y de comportamiento. Estos hallazgos llaman la atención sobre la necesidad de nuevas medidas regulatorias para reducir el uso de este dispositivo.

Recent Advances in the development of Modified Release Tablets by amalgamating both Solubility Enhancement and Polymer Matrix Sintering Technologies.

Background: The fact that about 90 % of newly discovered API’s or new molecular entity(NME) have little or no aqueous solubility, causes a significant protest to the initialization of development and their scale up of dosage form in the Pharma Industry. Aqueous solubility of API’s has critical role in drug dissolution or availability of drug at the site of action or bioavailability, when a dosage form is administered orally.Objective: The object of this study is to formulate a modified release tablet dosage form of a poorly aqueous soluble drug, which not only have higher aqueous solubility or bioavailability but also have sustained release characteristics with high mechanical strength &their commercial viability. Numerous techniques are available for the solubility enhancement but all individual techniques have its own limitations for commercialization.Method: Aqueous solubility of drugs is improved by the known Solubility enhancement techniques like Micronization &Solid dispersions. After successful solubility enhancement, sustained release or modified release tablets of poorly aqueous soluble drug can be easily formulated into a suitable shape or size by using a known Polymer Matrix Sintering Technology with commercial feasibility. Micronization of poorly water-soluble drugs can be performed by Air Jet Mill or Ball Mill. Whereas Solid dispersion technique involves, molecular dispersion of poorly soluble drug in a suitable inert carrier, to form an amorphous and highly soluble compounds. Sintering Technology is defined as the bonding of adjacent particle surfaces in a mass of powder, or in compact, by the application of heat. Conventional sintering technique involves the heating of compact at a temperature below the melting point of the solid constituents in a controlled environment under atmospheric pressure.Results: Enhanced solubility of poorly soluble API’s by these proposed techniques is due to either conversion of crystalline compound in to amorphous form or reduction of particle size to its molecular level by the application of Micronization or solid dispersion techniques. The developed modified release tablets will show a sustained release characteristic due to Sintering aspect and provides enhanced solubility of BCS class II or IV drugs.Conclusion: Novel modified release tablets have been designed through consolidation of Solubility enhancement and Polymer Matrix Sintering technologies. Simultaneous exploitation of well-known and established approaches- Micronization (optimum particle size reduction) or solid dispersion, optional surfactant and Polymer Matrix Sintering Technique in the recent concept, produces significant enhancement of solubility of poorly water soluble API’s without compromising the content uniformity of dosage form and also provide a modified or sustained release characteristics with high mechanical strength. The release profile of drug can be easily tailored by using combination of both techniques where challenges of low solubility are prominent.

Autopercepção dos benefícios da mobilização miofascial em praticantes de exercício físico: um estudo transversal / Self-perception of the benefits of myofascial mobilization in physical exercise practitioners: a cross-sectional study

A mobilização miofascial vem sendo utilizada com frequência no meio esportivo como forma de melhorar as restrições da fáscia que surgem com as atividades físicas. Objetivo: Analisar e comparar os benefícios da mobilização miofascial para praticantes adultos de exercício físico regular, verificando os métodos e técnicas utilizados, assim comparando a maior eficácia segundo a percepção dos praticantes. Métodos: Trata-se de um estudo transversal onde foi aplicado um questionário online a 160 pessoas de ambos os sexos, com o intuito de analisar informações de técnicas aplicadas e sua eficácia. Os dados foram analisados por meio da estatística descritiva. Resultados: Os resultados demonstraram que a satisfação e benefícios foram predominantes, e o uso da técnica manual foi a de maior escolha entre os praticantes, ressaltando que a maioria foi aplicada por fisioterapeutas. Conclusões: Quem utiliza a técnica, independente da forma executada, os resultados são considerados satisfatórios e trazem bem-estar e benefícios à saúde dos praticantes de exercício físico

Myofascial mobilization has been frequently used in sports as a way to improve fascia restrictions that arise with physical activities. Objective: To analyze and compare the benefits of myofascial mobilization for adult practitioners of regular physical exercise, verifying the methods and techniques used, thus comparing the greater effectiveness according to the practitioners' perception. Methods: This is a cross-sectional study where an online questionnaire was applied to 160 people of both sexes, with the aim of analyzing information on applied techniques and their effectiveness. Data were analyzed using descriptive statistics. Results: The results showed that satisfaction and benefits were predominant, and the use of the manual technique was the most preferred among practitioners, emphasizing that most were applied by physiotherapists. Conclusion: Those who use the technique, regardless of the way it is performed, the results are considered satisfactory and bring well-being and benefits to the health of practitioners of physical exercise.

Analysis of pH, calcium ion release, and energy dispersive spectroscopy of a bioceramic root canal dressing

Abstract This study compared the pH and calcium ion release of calcium silicate- (Bio-C Temp) and calcium hydroxide-based (Ultracal XS) medications. Intracanal remnants of both medications were also evaluated using SEM-EDS after the removal protocol. Thirty-five bovine teeth were prepared. Fifteen were filled with Bio-C Temp and 15 with Ultracal XS. Five remained without intracanal medication (control group). Five samples from each experimental time (i.e.. 24, 72, and 168 hours) were used to measure pH and calcium ions release using a digital pH meter and microplate reader, respectively. Afterward, the peaks of the chemical elements composing both medications were analyzed in SEM-EDS. One-way ANOVA and Tukey's post hoc test analyzed the pH and calcium ion release data. Student's t-test compared the medications in each experimental time. SEM-EDS described the percentage of chemical elements in the samples. Bio-C Temp and Ultracal XS showed a significant pH increase from 24 to 168 hours (p<0.05). Ultracal XS showed a higher pH value at 24 hours than Bio-C Temp (p<0.05) but were similar at 72 and 168h (p > 0.05). Calcium ion release did not depend on the experimental period (p > 0.05). Bio-C Temp showed lower calcium ions release than Ultracal XS at 24 hours (p<0.05). SEM-EDS analyses showed the remains of both medications, but the concentration of Si, Al, and W ions was present only in the calcium silicate-based medication. Bio-C Temp presented alkaline pH and a satisfactory calcium ion release over the time. The remaining of both medications were present after the protocols for paste removal.

Resumo Este estudo comparou o pH e a liberação de íons cálcio de medicações intracanais a à base de silicato de cálcio (Bio-C Temp) e à base de hidróxido de cálcio (Ultracal XS). Remanescentes de ambas as medicações também foram avaliados usando microscopia eletrônica de varredura e espectroscopia de dispersão de energia após o protocolo de remoção. Trinta e cinco dentes bovinos foram preparados. Quinze dentes foram preenchidos com Bio-C Temp e 15 com Ultracal XS. Cinco permaneceram sem medicação intracanal (grupo controle). Cinco amostras de cada tempo experimental (ou seja, 24, 72 e 168 horas) foram usadas para medir o pH e a liberação de íons de cálcio usando um medidor de pH digital e um leitor de microplacas, respectivamente. Em seguida, os picos dos elementos químicos que compõem os dois medicamentos foram analisados ​​em microscopia eletrônica de varredura e por espectroscopia de dispersão de energia. Os testes One-way ANOVA e post hoc de Tukey analisaram os dados de pH e liberação de íons cálcio. O teste t de Student comparou as medicações em cada tempo experimental. A microscopia eletrônica de varredura e a espectroscopia de dispersão de energia descreveu a porcentagem de elementos químicos nas amostras. O Bio-C Temp e o Ultracal XS mostraram um aumento significativo de pH de 24 a 168 horas (p<0,05). O Ultracal XS apresentou um valor de pH mais alto em 24 horas do que o Bio-C Temp (p<0,05), mas foi semelhante em 72 e 168h (p > 0,05). A liberação de íons cálcio não dependeu do período experimental (p> 0,05). O Bio-C Temp apresentou menor liberação de íons de cálcio do que Ultracal XS em 24 horas (p<0,05). As análises de microscopia eletrônica de varredura e espectroscopia de dispersão de energia mostraram remanescentes de ambas as medicações, mas a concentração de íons Si, Al e W estavam presentes apenas na medicação à base de silicato de cálcio. O Bio-C Temp apresentou pH alcalino e maior liberação de íons cálcio. Remanescentes de ambas as medicações estiveram presentes após os protocolos de remoção da pasta.

COVID-19 in the nervous system: physiopathology and neurological manifestations / Covid-19 no sistema nervoso: fisiopatologia e manifestações neurológicas

Abstract Background Coronavirus disease 2019 (COVID-19) is a viral infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although respiratory manifestations have received greater visibility during the pandemic caused by this virus, numerous neurological complaints related to coronavirus 2 infection have been documented in several countries. These records suggest that this pathogen presents neurotropism, and it can cause different neurological conditions of varying intensity. Objective To investigate the ability of coronavirus 2 to invade the central nervous system (CNS) and its neurological clinical outcomes. Methods The present study consists in a comprehensive literature review of the records available in the PubMed, SciELO, and Google Scholar databases. The descriptors COVID-19, brain and physiopathology, associated with the Boolean operator AND, were used in the search. Regarding the inclusion and exclusion criteria, we selected the papers published since 2020 with the highest number of citations. Results We selected 41 articles, most of them in English. The main clinical manifestation associated with COVID-19 patients was headache, but cases of anosmia, hyposmia, Guillain-Barré syndrome, and encephalopathies were also described with considerable frequency. Conclusion Coronavirus-2 presents neurotropism, and it can reach the CNS by hematogenous dissemination and by direct infection of the nerve endings. It causes brain injuries through several mechanisms, such as cytokine storm, microglial activation, and an increase in thrombotic factors.

Resumo Antecedentes A doença do coronavírus 2019 (coronavirus disease 2019, Covid-19, em inglês) é uma infecção viral provocada pelo coronavírus 2 da síndrome respiratória aguda grave (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, em inglês). Embora as manifestações respiratórias tenham recebido maior visibilidade ao longo da pandemia provocada por esse vírus, inúmeras queixas neurológicas relacionadas à infecção pelo coronavírus 2 foram documentadas em diversos países. Tais registros sugerem que esse patógeno apresenta neurotropismo, e é capaz de provocar quadros neurológicos diversos e de intensidade variáveis. Objetivo Investigar a capacidade de invasão do sistema nervoso central (SNC) pelo coronavírus 2 e seus principais desfechos clínicos neurológicos. Métodos O presente estudo consiste em uma ampla revisão de literatura a partir dos registros das bases de dados PubMed, SciELO e Google Acadêmico. Nesse contexto, os descritores COVID-19, cérebro e fisiopatologia, associados com o operador booleano AND, foram utilizados na busca. Quanto aos critérios de inclusão e exclusão, selecionou-se os trabalhos publicados a partir de 2020 com o maior número de citações. Resultados Foram selecionados 41 artigos, a maioria na língua inglesa. A principal manifestação clínica associada a pacientes acometidos pela COVID-19 foi a cefaleia, mas casos de anosmia, hiposmia, síndrome de Guillain-Barré e encefalopatias também foram descritos com frequência considerável. Conclusão O coronavírus 2 apresenta neurotropismo, e é capaz de alcançar o SNC por disseminação hematogênica e por infecção direta das terminações nervosas. Ele provoca injúria cerebral por meio de variados mecanismos, como tempestade de citocinas, ativação da micróglia e aumento dos fatores trombóticos.

Ghost ileostomy release down: our initial experience

Background: Many publications describe the advantages of the creation of ghost ileostomy (GI) to prevent the need for formal covering ileostomy in more than 80% of carcinoma rectum patients. However, none of the papers describes exactly how to ultimately remove the GI in these 80% of patients in whom it doesn't need formal maturation. Aim: To describe and evaluate the ghost ileostomy release down (GIRD) technique in terms of feasibility, complications, hospital stay, procedure time etc. in patients with low anterior resection/ultra-low anterior resection (LAR/uLAR) with GI for carcinoma rectum. Method: The present was a prospective cohort study of patients with restorative colorectal resections with GI for carcinoma rectum, Postoperatively the patients were studied with respect to ease and feasibility of the release down of GI and its complications. The data was collected, analyzed and inference drawn. Results: A total of 26 patients needed the GIRD and were included in the final statistical analysis of the study. The procedure was done between 7th to 16th postoperative days (POD) and was successful in all patients without the need of any additional surgical procedure. None of the patients required any local anesthetic injection or any extra analgesics. The average time taken for procedure was 5-minutes and none of the patients had any significant difficulty in GI release. There were no immediate postprocedure complications. Conclusion: The GIRD technique is a simple, safe, and quick procedure done around the 10th POD that can easily be performed by the bedside of patient without the need of any anesthesia or additional analgesics. (AU)

Formulation and evaluation of Buccal mucoadhesive tablets of diclofenac sodium using 23 factorial designs

Buccal tablets

Diclofenac sodium

Drug release

Mucoadhesion

Mucoadhesive tablets

Release kinetics

An elevated HScore is associated with poor clinical outcomes in COVID-19 / Un HScore elevado se asocia a mal pronóstico en pacientes con COVID-19

BACKGROUND: Patients with Coronavirus Disease 2019 (COVID-19) frequently experience a hyperinflammatory syndrome leading to unfavorable outcomes. This condition resembles Secondary Hemophagocytic Lymphohistiocytosis (sHLH) described in neoplastic, rheumatic and other infectious diseases. A scoring system (HScore) that evaluates underlying immunosuppression, temperature, organomegaly, cytopenias, ferritin, triglycerides, fibrinogen and AST was validated for sHLH, and recently proposed to evaluate hyperinflammation in COVID-19. AIM: To assess the presence of sHLH among patients with COVID-19 admitted for hospitalization and to evaluate Hscore as a prognostic tool for poor outcomes. MATERIAL AND METHODS: One hundred forty-three patients aged 21-100 years (64% males) admitted because of COVID-19 were enrolled in a prospective study. HScore was calculated within 72 hours admission. The incidence of sHLH during hospitalization was evaluated. Additionally, the relationship between a HScore ≥ 130 points and either the requirement of mechanical ventilation or 60-days mortality was explored. RESULTS: The median HScore was 96 (33-169). A SHLH was diagnosed in one patient (incidence 0.7%), whose HScore was 169. After adjusting for age, sex, comorbidities and obesity, HScore ≥ 130 was independently associated with the composite clinical outcome (Hazard rartio 2.13, p = 0.022). CONCLUSIONS: sHLH is not frequent among COVID-19 patients. HScore can be useful to predict the risk for poor outcomes.

ANTECEDENTES: Los pacientes con Enfermedad por Coronavirus 2019 (COVID-19), experimentan frecuentemente un síndrome hiperinflamatorio que lleva a resultados desfavorables. Esta situación se asemeja al Síndrome Hemofagocítico Secundario (sHLH) descrito en enfermedades neoplásicas, reumatológicas y por otros agentes infecciosos. Un sistema simple de puntaje (HScore) que evalúa inmunosupresión, temperatura organomegalia, citopenias, ferritina, triglicéridos, fibrinógeno y AST ha sido validado para el diagnóstico de sHLH y ha sido propuesto recientemente para evaluar la hiperinflamación en COVID-19. OBJETIVO: Medir la frecuencia de sHLH entre pacientes con COVID-19 hospitalizados, y evaluar a HScore como una herramienta pronóstica. MATERIAL Y MÉTODOS: Ciento cuarenta y tres pacientes de 21 a 100 años (64% hombres) fueron ingresados en este estudio de cohorte prospectivo, unicéntrico. Se calculó HScore dentro de las primeras 72 horas desde el ingreso, y se midió la incidencia de sHLH durante la hospitalización. Adicionalmente, se evaluó la relación entre HScore ≥ 130 puntos y un desenlace compuesto de ventilación mecánica o muerte a los 60 días. RESULTADOS: La mediana de HScore fue 96 (33-169) puntos. Un paciente fue diagnosticado con sHLH (incidencia 0,7%). Luego de ajustar por edad, sexo, comorbilidades y obesidad, un HScore ≥ 130 se asoció de manera independiente con el desenlace compuesto. CONCLUSIONES: El sHLH no es frecuente en los pacientes con COVID-19. El uso de HScore puede ser útil para predecir el riesgo de desenlaces clínicos desfavorables.

Evaluation of tenotomy in the hip subluxation treatment of children with zika syndrome / Avaliação da tenotomia no tratamento da subluxação do quadril de crianças com zika

ABSTRACT Objectives: Evaluate the efficacy and effects of releasing the muscles of subluxated hips of patients with SCZ. Methods: This is a retrospective study with 29 patients with subluxation of the hip, corresponding to 55 hips operated in a public hospital in Recife, Brazil. Preoperative femoral head migration (PM) percentages were evaluated and compared with 6- and 12-month postoperative results. Results: Twenty-nine patients were eligible, representing 55 hips evaluated. 19 were female (65.5%), with a mean age of 31.45 months (ranging from 23 to 42 years). 19 patients were GMFCS level V (65.5%), 34.5% were level IV, and 20 of the 29 patients (69%) had no complications. The PM had an absolute reduction of 11.6% (GMFCS IV) and 13.31% (GMFCS V) in the first six months. After 12 months, there was a regression of MP of 7.14% (GMFCS V) and 11.25% (GMFCS IV) compared to preoperative values, with no significant statistical difference among MP values presented between 6 and 12 months after surgery. Conclusions: The surgery was effective in PM regression during the analyzed period and presented a low complication rate. Level of Evidence III; Comparative retrospective study.

RESUMO Objetivos: Avaliar a eficácia e os efeitos da liberação das musculaturas de quadris subluxados de pacientes com SCZ. Métodos: Trata-se de um estudo do tipo retrospectivo com 29 pacientes CZS com subluxação do quadril, correspondendo a 55 quadris operados em um hospital público de Recife, Brasil. Foram avaliados os percentuais migratórios da cabeça femoral (PM) no pré-operatório e comparados com os resultados pós-operatórios de 6 e 12 meses. Resultados: Foram elegíveis 29 pacientes, representando 55 quadris avaliados. 19 eram do sexo feminino (65,5%), com média de idade de 31,45 meses (variando de 23 a 42 anos). 19 pacientes eram GMFCS nível V (65,5%), 34,5% eram nível IV e 20 dos 29 pacientes (69%) não apresentaram complicações. O PM teve redução absoluta de 11,6% (GMFCS IV) e de 13,31% (GMFCS V), nos primeiros seis meses. Após 12 meses, houve regressão do PM de 7,14% (GMFCS V) e de 11,25% (GMFCS IV) em relação aos valores pré-operatórios, sem diferença estatística entre os valores do PM apresentados entre 6 e 12 meses da cirurgia. Conclusões: A cirurgia foi eficaz em regredir o PM no período analisado e apresentou uma baixa taxa de complicações. Nível de Evidência III; Estudo retrospectivo comparativo.

Development of metformin HCl granules using brown flaxseed mucilage as a retardant polymer: effects of polymer and drug ratio

Abstract Flaxseed (Linum usitatissimum L.) is the seed of a multipurpose plant of pharmaceutical interest, as its mucilage can be used as a natural matrix to develop extended-release dosage forms and potentially replace synthetic polymers. In this study, a 3² factorial design with two replicates of the central point was applied to optimize the development of extended-release granules of metformin HCl. The total fiber content of the mucilage as well as the friability and dissolution of the formulations were evaluated. The lyophilized mucilage presented a high total fiber content (42.63%), which suggests a high efficiency extraction process. Higher concentrations of the mucilage and metformin HCl yielded less friable granules. In addition, lower concentrations of metformin HCl and higher concentrations of the mucilage resulted in slower drug release during the dissolution assays. The release kinetics for most formulations were better represented by the Hixson-Crowell model, while formulations containing a higher concentration of the mucilage were represented by the Korsmeyer-Peppas model. Nonetheless, five formulations showed a longer release than the reference HPMC formulation. More desirable results were obtained with a higher concentration of the mucilage (13-18%) and a lower concentration of metformin (40%).

Electro-responsive drug delivery system for epilepsy therapy / 中国药理学与毒理学杂志

OBJECTIVE Temporal lobe epilepsy is a common neurological disease caused by abnormal syn-chronized discharge in the brain and it is mainly treated through long-term use of anti-epileptic drugs(AEDs).This project is supposed to provide an electro-responsive and brain-targeted drug delivery system(DDS)for on-demand drug release,which could promptly block the transmis-sion of epileptic discharges.METHODS The DDS was fab-ricated by co-polymerization of dopamine and pyrrole,together with conjugation of brain-targeted peptide.A number of characterization including electron microscopy,thermogravimetric analysis,dynamic light scattering and other methods were conducted to evaluate the physio-chemical properties of the nanomaterials.In vitro study based on a home-made electric device and high perfor-mance liquid chromatography was performed to record drug release profiles.Three epileptic models including acute,continuous and spontaneous models were estab-lished for the evaluation of therapeutic efficacy.RESULTS Our polymeric DDS has a nanoscale size(ca.80 nm)and could load AEDs such as phenytoin(drug loading capacity 20.4%).The hybrid nanomaterials can improve the brain delivery efficiency through a combination of receptor-mediated transcytosis and near-infrared-enabled brain transport.In vitro study proved that the DDS could release phenytoin in the electric field in a sensitive(50 μA),quick(30 s)and sustained(>3 times)manner.In vivo study demonstrated excellent anti-epileptic effects in a lower dose(20%).Biosafety study further verified that our strategy has limited damage.CONCLUSION For on-demand seizure control,we have developed a nano-engineered DDS with the capability of electro-responsive drug release and brain-targeted accumula-tion.The DDS could increase the AEDs accumulation at epileptic region and release the AEDs in response to the epileptic discharges.Such strategy could timely inhib-it the epileptic seizure.Our work provides a promising approach to"smart"therapy of epilepsy and sheds light on development of pharmacotherapy of other brain disorders.

Progress in controlled ocular anti-VEGF drug release delivery system / 中华实验眼科杂志

Neovascularization is the hallmark of many fundus diseases, including diabetic retinopathy, retinal vein occlusion and neovascular age-related macular degeneration.More and more evidence suggests that vascular endothelial growth factor (VEGF) plays a critical role in neovascularization.Anti-VEGF drugs are the first-line treatment for neovascular fundus diseases and have achieved significant results.However, there are drawbacks such as short drug half-lives and the need for long-term administration to maintain effective concentrations, which increases the economic burden and medical risk for patients and reduces compliance.Therefore, finding a new method for intraocular drug delivery is of great clinical importance.Based on the principle that diabetes patients use insulin pumps to gradually release drugs, the ocular anti-VEGF drug delivery system can continuously release anti-VEGF drugs over a period of time, significantly reducing the injection frequency and improving patient compliance.At present, the research on ocular anti-VEGF drug delivery systems is still immature, and various systems are in different stages of clinical trials.According to different design principles, they can be divided into three categories with their characteristics, micropump (extraocular storage delivery systems), biodegradable implants, and non-biodegradable implants.This article summarized and analyzed the controlled ocular anti-VEGF drug release delivery systems currently in clinical trials.

Latent tuberculosis infection and screening method among close contacts in schools in Xuhui District，Shanghai from 2020 to 2022 / 上海预防医学

ObjectiveTo investigate the latent tuberculosis infection （LTBI） of close contacts in schools of Xuhui District， and to explore the tuberculin skin test （TST）- interferon-γ release assay （IGRA） two-step method in order to discover the screening strategy of tuberculosis in Xuhui District. MethodsClose contacts of tuberculosis in schools of Xuhui District from 2020 to 2022 were selected as research subjects. Screening was conducted using symptom questionnaire， TST， chest X-rays， IGRA， and the information including the etiological results and grade of the index cases， as well as gender， age， and relationship with the index cases of the research subjects were collected. ResultsTotally 615 close contacts of 32 tuberculosis cases occurred in the schools were finally included. Of the 609 close contacts who completed tuberculosis infection screening and underwent TST testing， 153 TST（+） individuals underwent IGRA testing. The final LTBI rate was 4.6%， and the pulmonary tuberculosis detection rate was 163 per 100 000. The relationship with the index cases was an influencing factor for LTBI. The IGRA positivity rate was higher among close contacts with TST ≥15 mm than among those with 10 mm≤ TST <15 mm （χ2=14.41， P<0.05）. ConclusionThe latent tuberculosis infection among close contacts of school tuberculosis cases in Xuhui District remains serious. TST-IGRA two-step method can assist in the accurate diagnosis of LTBI and pulmonary tuberculosis cases.

Advances in Hormone Replacement Therapy for Adult Adrenal Insufficiency / 罕见病研究

Adrenal insufficiency is a disease characterized by insufficient secretion of adrenocortical hormones, usually treated with glucocorticoid replacement therapy. The routine drugs have two forms-short-acting and long-acting. The shorter one should be taken 2-3 times a day resulting hormone level of patients fluctuating greatly within a day. Although long-acting drugs reduce the frequency of administration, it is easy to lead to excessive replacement, resulting in adverse effects on metabolism. New alternative treatments for adult patients have emerged, including modified-release hydrocortisone and hydrocortisone subcutaneous infusion pumps. In this review, we briefly introduce these new therapies, emphasizing the pharmacodynamics and pharmacokinetics of the replacement, the effects on metabolism and drug safety, aiming at contributing to the future clinical practice.

In vivo pharmacokinetics and in vitro-in vivo correlation of silymarin phospholipid complex microporous osmotic pump controlled-release tablets in beagle dogs / 药学实践杂志

Objective To evaluate the release characteristics in vitro, pharmacokinetics in rabbits and in vivo-in vitro correlation of silymarin phospholipid complex microporous osmotic pump controlled release tablets（SM-PC MPOP）. Methods The release characteristics of SM-PC MPOP in vitro were detected by HPLC in the artificial gastric fluid. Six beagle dogs were subjected to double cycle cross control, which were given SM-PC MPOP and Legalon（30 mg/kg）. The concentration of silybin in plasma was determined by HPLC and the data were processed by software. Results The cumulative release rate of SM-PC MPOP in vitro was over 85% in 12 h. The pharmacokinetics in beagle dogs showed that SM-PC MPOP and legalon conformed to double compartment first-order absorption model and the pharmacokinetic parameters were obtained: tmax:（3.2±0.4）and（0.9±0.1）h, Cmax:（0.298 6±0.068 9）and（0.629 9±0.076 5）μg/ml, AUC0→24:（2.996 8±0.583 3）and（2.268 9±0.432 8）h·μg /ml. The relative bioavailability of SM-PC MPOP was（162.21 ± 30.82）%. Conclusion SM-PC MPOP could release slowly, which could increase the relative bioavailability significantly. The correlation between the absorption in vivo and release in vitro was fine（r = 0.839 0）.

In vitro release of paclitaxel derivative liposome by paddle membrane binding assay / 中国药科大学学报

@#The in vitro release is an important index to evaluate the quality of liposome formulation.Currently, there is no evaluation method for the in vitro release of liposome in pharmacopoeia of various countries, which leads to the lack of unified standard and safety guarantee for the quality evaluation of liposome formulation.Taking the self-made paclitaxel derivative liposomes as an example, the paddle membrane binding method established by optimizing external release conditions was used to simulate the complete release of paclitaxel derivative drugs in 12 hours under physiological conditions.The results showed that using 0.5% SDS-HEPES as the release medium and a dialysis bag with a molecular weight cutoff of 1 000 kD to release the liposome solution met the requirements and had discrimination ability, providing a reference for the development of drug-loaded liposomes release methods in vitro.

Efficacy and safety of domestic Paliperidone extended-release tablets in the treatment of stable schizophrenia / 中国药房

OBJECTIVE To investigate the efficacy and safety of domestic Paliperidone extended-release tablets as a substitute for original Paliperidone extended-release tablets in the treatment of stable schizophrenia. METHODS A total of 65 patients with schizophrenia， who were treated with single original Paliperidone extended-release release tablets for 2 months or more in the outpatient or inpatient department of Shandong Daizhuang Hospital from June 2021 to June 2022， were collected and randomly divided into the domestic group （33 cases） and the original group （32 cases）. The domestic group was treated with the same dose of domestic Paliperidone extended-release tablets instead for 2 months， and the original group continued to use the previous dose of the original drug for 2 months. Positive and negative syndrome scale （PANSS） and treatment emergent symptom scale （TESS） were used to evaluate the two groups at the time of enrollment and the end of 1 week， 1 month and 2 months after enrollment. The incidence of ADR was calculated at the end of 2 months after enrollment. The fasting blood glucose， blood lipid indicators （triglyceride， total cholesterol， low-density lipoprotein， high-density lipoprotein， very-low-density lipoprotein）， serum prolactin levels， and paliperidone blood concentration were determined after the intravenous blood sample was collected. The ratio of paliperidone blood concentration to dose （C/D value） was calculated， and an electrocardiogram was performed. RESULTS There were 31 and 30 patients in the domestic group and the original group who completed the trial， respectively. There were no statistical significances in PANSS score， TESS score or C/D value at the time of enrollment and the end of 1 week， 1 month and 2 months after enrollment； there were no statistical significances in the levels of fasting blood glucose， blood lipid or serum prolactin at the time of enrollment and at the end of 2 months after enrollment （P＞0.05）. PANSS scores of both groups significantly decreased at the end of 1 month and 2 months after enrollment （P＜0.01）. The incidences of ADR were 25.81% in the domestic group and 30.00% in the original group， without significant difference （P＞0.05）， and there were no significant abnormalities in the electrocardiograms of the two groups. CONCLUSIONS Domestic Paliperidone extended-release tablets can directly replace the original tablets in the treatment of stable schizophrenia， and their clinical efficacy and safety are comparable.

Bioorthogonal click-to-release reaction for regulating iodo-BODIPY PDT probe / 药学学报

In this study, we synthesized six tetrazine-dipyrromethene boron difluoride (BODIPY) probes and achieved a remarkable up to 14-fold increase in singlet oxygen yield via tetrazine bioorthogonal click-to-release reactions. We systematically investigated the photodynamic activity of these probes, revealing crucial structure-activity relationships. Additionally, we evaluated the stability and release kinetics of these probes and identified P5 and P6 as ideal candidates for photodynamic therapy in live cells. This innovative strategy opens new avenues for fine-tuning the photodynamic properties of BODIPY dyes, thereby expanding their utility in cancer therapy.