Ethnobotanical knowledge on non-conventional food plants and medicinal plants in Extractivist Reserve in the Brazilian Amazon / Conocimiento etnobotánico sobre plantas alimenticias no convencionales y plantas medicinales en una Reserva Extractivista en la Amazonía Brasileña

Information on the knowledge and ways of using food and medicinal plants by traditional populations, family farmers and Brazilian native population in the Amazon is essential to guarantee the food sovereignty of these groups. This study was conducted using semi-structured interviews applied to local respondents. A total of 269 species of both non-conventional food plants and medicinal plants were identified, distributed in 83 botanical families and 198 genera. The Arecaceae and Lamiaceae families had the highest species richness (11 and 7, respectively). The Shannon-Wiener (H') and Pielou (J') diversity indices were considered high (5.02 and 0.9, respectively) when compared to other ethnobotanical works. In the environment in which these families are found, these species become the only food and medicinal resources available.

La información sobre los saberes y formas de uso de las plantas alimenticias y medicinales por parte de las poblaciones tradicionales, agricultores familiares e indígenas brasileños en la Amazonía es fundamental para garantizar la soberanía alimentaria de estos grupos. Este estudio se realizó utilizando entrevistas semiestructuradas aplicadas a encuestados locales. Se identificaron un total de 269 especies tanto de plantas alimenticiasno convencionales como de plantas medicinales, distribuidas en 83 familias botánicas y 198 géneros. Las familias Arecaceae y Lamiaceae tuvieron la mayor riqueza de especies (11 y 7, respectivamente). Los índices de diversidad de Shannon-Wiener (H') y Pielou (J') fueron considerados altos (5,02 y 0,9, respectivamente) en comparación con otros trabajos etnobotánicos. En el ambiente en que se encuentran estas familias, estas especies se convierten en los únicos recursos alimenticios y medicinales disponibles.

Cultura de segurança em unidades de terapia intensiva na perspectiva da equipe multiprofissional: Estudo multicêntrico / Cultura de seguridad en unidades de terapia intensiva en la perspectiva del equipo multiprofesional: Estudio multicéntrico / Safety Culture in intensive care units from multiprofessional team perspective: A multicenter study

Resumo Introdução: A Cultura de Segurança do Paciente é considerada um importante componente estrutural dos serviços, que favorece a implantação de práticas seguras e a diminuição da ocorrência de eventos adversos. Objetivo: Identificar os fatores associados à cultura de segurança do paciente nas unidades de terapia intensiva adulto em hospitais de grande porte da região Sudeste do Brasil. Método: Estudo transversal do tipo survey e multicêntrico. Participaram 168 profissionais de saúde de quatro unidades (A, B, C e D) de terapia intensiva adulto. Foi utilizado o questionário "Hospital Survey on Patient Safety Culture". Considerou-se como variável dependente o nível de cultura de segurança do paciente e variáveis independentes aspectos sociodemográficos e laborais. Foram usadas estatísticas descritivas e para a análise dos fatores associados foi elaborado um modelo de regressão logística múltipla. Resultados: Identificou-se associação entre tipo de hospital com onze dimensões da cultura de segurança, quanto à função a categoria profissional médico, técnico de enfermagem e enfermeiro foram relacionadas com três dimensões; o gênero com duas dimensões e tempo de atuação no setor com uma dimensão. Conclusão: Evidenciou-se que o tipo de hospital, categoria profissional, tempo de atuação no setor e gênero foram associados às dimensões de cultura de segurança do paciente.

Resumen Introducción: La cultura de seguridad del paciente se considera un componente estructural importante de los servicios, que favorece la aplicación de prácticas seguras y la reducción de la aparición de acontecimientos adversos. Objetivo: Identificar los factores asociados a la cultura de seguridad del paciente en unidades de terapia intensiva adulto en hospitales de la región Sudeste del Brasil. Metodología: Estudio transversal de tipo encuesta y multicéntrico. Participaron 168 profesionales de salud de cuatro unidades (A, B, C y D) de terapia intensiva adulto. Se utilizó el cuestionario "Hospital Survey on Patient Safety Culture". Se consideró como variable dependiente el nivel de cultura de seguridad del paciente y variables independientes los aspectos sociodemográficos y laborales. Fueron usadas estadísticas descriptivas y, para analizar los factores asociados, fue elaborado un modelo de regresión logística múltiple. Resultados: Se identificó asociación entre tipo de hospital con once dimensiones de cultura de seguridad del paciente. En relación a la función, personal médico, técnicos de enfermería y personal de enfermería fueron asociados con tres dimensiones, el género con dos dimensiones y tiempo de actuación con una dimensión en el modelo de regresión. Conclusión: Se evidenció que el tipo de hospital, función, tiempo de actuación en el sector y género fueron asociados a las dimensiones de la cultura de seguridad del paciente.

Abstract Introduction: Patient safety culture is considered an important structural component of the services, which promotes the implementation of safe practices and the reduction of adverse events. Objective: To identify the factors associated with patient safety culture in adult intensive care units in large hospitals in Belo Horizonte. Method: Cross-sectional survey and multicenter study. A total of 168 health professionals from four units (A, B, C and D) of adult intensive care participated. The questionnaire "Hospital Survey on Patient Safety Culture" was used. The patient's level of safety culture was considered as a dependent variable, and sociodemographic and labor aspects were the independent variables. Descriptive statistics were used and a multiple logistic regression model was developed to analyze the associated factors. Results: An association was identified between the type of hospital and eleven dimensions of the safety culture. In terms of function, the doctors, nursing technicians, and nurse were related to three dimensions; gender with two dimensions, and time working in the sector with one dimension. Conclusion: It was evidenced that the type of hospital, function, time working in the sector, and gender were associated with the dimensions of patient safety culture.

Aplicabilidade das tecnologias na assistência de enfermagem com foco na segurança do paciente / The technology applicability in the aid of nursing focusing on the patient's safety / Aplicabilidad de tecnologias en la asistencia de enfermeria con enfoque en la seguridad del paciente

Objetivo: Conhecer a percepção dos enfermeiros em ambiente hospitalar sobre a implementação das tecnologias na assistência de enfermagem com foco na segurança do paciente. Métodos: Estudo descritivo, qualitativo, realizado com oito enfermeiros, responsáveis pelo gerenciamento de riscos em hospitais. Utilizou-se a técnica Snowball para eleger os participantes e a plataforma Skype para as entrevistas, realizadas no período de março a abril de 2021. Resultados: Apontou-se a utilização da tecnologia por meio do prontuário eletrônico, com a inserção de programa como o Tasy, o qual avançou para comunicação em rede, com vistas a facilitar checagens, auditorias, indicadores, gerenciamento e análise dos eventos. Desvelou-se também para a utilização do código de barras na identificação do paciente e no controle de dispensação e recebimento de medicamentos. No entanto, foram apresentadas limitações na implementação como dificuldade no manuseio das ferramentas digitais por profissionais antigos, caracterizada como resistência. Conclusão: A aplicabilidade das tecnologias na práxis da enfermagem contribui para a segurança do paciente face a favorecer o controle de eventos e o gerenciamento de riscos. Remete para a importância de capacitação e treinamentos dos profissionais para desenvolvimento de habilidades na utilização das ferramentas digitais. (AU)

Objective: Getting to know the perceptions from nurses on hospital environment about the technology implantation in the aid of patient's safety focused nursing. Methods: Descriptive, qualitative study made with eight nurses, responsible for risk management in hospitals. The Snowball technique was used to select the participants and the Skype platform used in the interviews, from March to April 2021. Results: The technology use was detected on the patient's electronic records through the Tasy program, which advanced to a net communication to facilitate checking, audits, pointers, management and event analysis. It was also detected by the use of bar codes in the identification of patients and control of medication dispensation and receiving. However, some limitations were found in the technology implementation, like elderly people having trouble using the digital tools, which is characterized by resistance. Conclusion: The technology applicability in the nursing practice contributes to the patient's safety to favor event control and risk management. It points to the importance of staff training and qualification to promote the ability of using digital tools. (AU)

Objetivo: Conocer las percepciones de las enfermeras del entorno hospitalario sobre la implementación de tecnologias enfocado en la seguridad del paciente. Métodos: Fue realizado un estudio descripctivo, cualitativo, con ocho enfermeras responsables de la gestión de riesgos en los hospitales. Se utilizó la tecnica snowball para elegir a los participantes y la plataforma skype para las entrevistas realizadas de marzo a abril de 2021. Resultados: Con el desarrollo de la tecnologia a través de historias clínicas eletrónicas, la inserción de un programa como Tasy, que avanzó a la comunicación em red, con el objetivo de facilitar verificaciones como auditorias, gestión y análisis en cualquier eventualidad. Tambien se dio a conocer para el uso de códigos de barras en la identificación de pacientes y en el control de la dispensación y recepción de medicamentos. Sin embargo, se presentaron limitaciones en la implementación, como la dificultad en el manejo de herramientas digitales por parte de algunos profesionales. Conclusión: La aplicabilidad de tecnologias en la enfermeria contribuye a la seguridad del paciente favoreciendo en el control de riesgos. Se refiere a la importancia de la calificación y formación de los profesionales, para desarrollar habilidades en el uso de herramientas digitales. (AU)

Gerenciamento do protocolo de prevenção de lesão por pressão: construção de painel de bordo informatizado / Management of the pressure injury prevention protocol: construction of a computerized dashboard / Gestión del protocolo de prevención de lesiones por presión: construcción de panel informatizado

Objetivo: Relatar a construção e implantação de painel de bordo, desenvolvido por enfermeiros e profissionais da tecnologia da informação, para gerenciamento do Protocolo de Prevenção de Lesão por Pressão. Métodos: Trata-se de um relato de experiência sobre a construção e implantação de painel de bordo informatizado para gerenciamento de protocolo em um hospital privado universitário, localizado no interior do estado de São Paulo. Resultados: A construção do painel de bordo foi dividida nas seguintes etapas: revisão e atualização do protocolo, construção do modelo eletrônico e implementação. A divulgação foi realizada pela Comissão de Prevenção de Lesão por Pressão. Conclusão: O painel de bordo possibilitou a visualização rápida e em tempo real dos riscos dos pacientes, intervenções propostas e efetividade das medidas de prevenção, além de promover a integração e empoderamento dos profissionais na gestão do cuidado. (AU)

Objective: To report the construction and implementation of a dashboard, developed by nurses and information technology professionals, to manage the Pressure Injury Prevention Protocol. Methods: This is an experience report on the construction and implementation of a computerized dashboard for protocol management in a private university hospital, located in the interior of the state of São Paulo. Results: The construction of the dashboard was divided into the following steps: review and update of the protocol, construction of the electronic model and implementation. The Pressure Injury Prevention Commission disclosed the tool. Conclusion: The dashboard enabled the quick and real-time visualization of patient risks, proposed interventions and effectiveness of prevention measures, in addition to promoting the integration and empowerment of professionals in the management of care. (AU)

Objetivo: Informar la construcción e implementación de un panel, desarrollado por enfermeras y profesionales de tecnologías de la información, para gestionar el Protocolo de Prevención de Lesiones por Presión. Métodos: Se trata de un informe de experiencia sobre la construcción e implementación de un panel computarizado para la gestión del protocolo en un hospital universitario privado, en el interior del estado de São Paulo. Resultados: La construcción del panel se dividió en los siguientes pasos: revisión y actualización del protocolo, construcción del modelo electrónico e implementación. La divulgación fue realizada por la Comisión de Prevención de Lesiones por Presión. Conclusión: El panel permitió la visualización rápida y en tiempo real de los riesgos del paciente, las intervenciones propuestas y la efectividad de las medidas de prevención, además de promover la integración y el empoderamiento de los profesionales en la gestión del cuidado. (AU)

Eventos adversos em crianças submetidas a cirurgias orofaciais / Adverse events in children submitted to orofacial surgery / Eventos adversos en niños sometidos a cirugía orofacial

Objetivo: Identificar os eventos adversos no pós-operatório imediato de queiloplastia e/ou palatoplastia em crianças e comparar os eventos identificados aos notificados ao Núcleo de Segurança do Paciente. Métodos: Estudo descritivo, retrospectivo e quantitativo, realizado em um hospital público e terciário brasileiro. Os dados foram coletados por meio da descrição nos registros de enfermagem e comparados aos notificados ao Núcleo de Segurança do Paciente, referente a junho e dezembro de 2019. Os resultados foram submetidos a análise estatística descritiva. Resultados: A amostra constou de 203 crianças, das quais 51% (n=103) apresentaram evento adverso. Foram identificados 176 eventos adversos, de 8 tipos, com prevalência da laringite pós-extubação (n=50; 28%), edema de língua (n=34; 19%) e lesão de comissura labial (n=25; 14%). Destes, apenas 5% (n=9) foram notificados ao Núcleo de Segurança do Paciente. Conclusão: Os eventos adversos prevalentes se relacionaram a cavidade oral e tecidos adjacentes, e a subnotificação foi expressiva. (AU)

Objective: To identify adverse events in the immediate postoperative period of cheiloplasty and/or palatoplasty in children and compare the identified events to those notified to the Patient Safety Center. Methods: Descriptive, retrospective and quantitative study, carried out in a Brazilian public and tertiary hospital. Data were collected through descriptions in nursing records and compared to those notified to the Patient Safety Center, referring to June and December 2019. The results were subjected to descriptive statistical analysis. Results: The sample consisted of 203 children, of which 51% (n=103) had an adverse event. A total of 176 adverse events of 8 types were identified, with prevalence of post-extubation laryngitis (n=50; 28%), tongue edema (n=34; 19%) and labral commissure lesion (n=25; 14%). Of these, only 5% (n=9) were notified to the Patient Safety Center. Conclusion: The prevalent adverse events were related to the oral cavity and adjacent tissues, and underreporting was significant. (AU)

Objetivo: Identificar eventos adversos en el postoperatorio inmediato de queiloplastia y/o palatoplastia en niños y comparar los eventos identificados con los notificados al Centro de Seguridad del Paciente. Métodos: Estudio descriptivo, retrospectivo y cuantitativo, realizado en un hospital público y terciario brasileño. Los datos se recolectaron mediante descripciones en registros de enfermería y se compararon con los notificados al Centro de Seguridad del Paciente, referidos a junio y diciembre de 2019. Los resultados fueron sometidos a análisis estadístico descriptivo. Resultados: La muestra estuvo conformada por 203 niños, de los cuales el 51% (n = 103) tuvo un evento adverso. Se identificaron un total de 176 eventos adversos de 8 tipos, con prevalencia de laringitis posextubación (n=50; 28%), edema de lengua (n=34; 19%) y lesión de la comisura del labrum (n=25; 14%). De estos, solo el 5% (n=9) fueron notificados al Centro de Seguridad del Paciente. Conclusion: Los eventos adversos prevalentes se relacionaron con la cavidad bucal y los tejidos adyacentes y el subregistro fue significativo. (AU)

Cuidados de enfermagem no banho de aspersão em instituição de longa permanência: revisão integrativa / Nursing care in the spray bath in a long-term care institution: integrative review

Identificar os cuidados de enfermagem necessários para o banho de aspersão seguro para idosos no quotidiano de uma instituição de longa permanência. Método: Revisão Integrativa da literatura, recorte entre 2001 e 2022. Os dados dos estudos incluídos resultaram em uma síntese descritiva, fundamentada na Teoria das Necessidades Humanas Básicas. Resultados: Obteve-se 13 estudos sobre cuidados no banho com e sem auxílio, envolvendo o equilíbrio psicobiológico, psicossocial e psicoespiritual, remoção de barreiras ambientais, adaptação domiciliar, maneiras de abordagem, musicoterapia e cuidados com a integridade da pele, oportunizando segurança e qualidade nas ações prestadas. Conclusões: Os cuidados precisam estar integrados às necessidades humanas básicas, respeitando as peculiaridades do processo de envelhecimento e as fragilidades dos idosos mais vulneráveis. A qualificação dos profissionais de enfermagem/cuidadores formais visa a padronização da execução do procedimento e a redução de ocorrência de desvios de procedimento.(AU)

To identify the nursing care necessary for safe spray baths for elderly people in daily life in a long-term care institution. Method: Integrative literature review, cut between 2001 and 2022. Data from the included studies resulted in a descriptive synthesis, based on the Theory of Basic Human Needs. Results: 13 studies were obtained on bath care with and without assistance, involving psychobiological, psychosocial and psychospiritual balance, removal of environmental barriers, home adaptation, approaches, music therapy and care for the integrity of the skin, providing safety and quality in the actions provided. Conclusions: Care needs to be integrated with basic human needs, respecting the peculiarities of the aging process and the weaknesses of the most vulnerable elderly people. The qualification of nursing professionals/formal caregivers aims to standardize the execution of the procedure and reduce the occurrence of procedural deviations.(AU)

Identificar los cuidados de enfermería necesarios para baños de aspersión seguros para personas mayores en la vida diaria en una institución de cuidados a largo plazo. Método: Revisión integrativa de la literatura, cortada entre 2001 y 2022. Los datos de los estudios incluidos resultaron en una síntesis descriptiva, basada en la Teoría de las Necesidades Humanas Básicas. Resultados: Se obtuvieron 13 estudios sobre cuidados del baño con y sin asistencia, involucrando equilibrio psicobiológico, psicosocial y psicoespiritual, remoción de barreras ambientales, adaptación domiciliaria, abordajes, musicoterapia y cuidado de la integridad de la piel, brindando seguridad y calidad en las acciones. proporcionó. Conclusiones: Los cuidados deben integrarse con las necesidades humanas básicas, respetando las peculiaridades del proceso de envejecimiento y las debilidades de las personas mayores más vulnerables. La calificación de los profesionales de enfermería/cuidadores formales tiene como objetivo estandarizar la ejecución del procedimiento y reducir la ocurrencia de desviaciones procesales.(AU)

Aplicativos de apoio à educação sobre a segurança do paciente hospitalizado: uma prospecção tecnológica / Educational apps to support patient safety in hospitals: a technology perspective

OBJETIVO: Investigar os aplicativos móveis que foram desenvolvidos com a finalidade de orientar os profissionais, os pacientes e seus acompanhantes quanto às ações de segurança do paciente no contexto de hospitalização. MÉTODO: Prospecção tecnológica realizada nas lojas virtuais App Store e Google Play e na ferramenta de busca da Google, cujo critério de inclusão foi aplicativos voltados para segurança do paciente no contexto hospitalar sem limitação de recorte temporal. RESULTADOS: Foram incluídos e analisados no estudo 25 aplicativos. A maioria dos aplicativos eram móveis, desenvolvido em inglês, com ênfase para os profissionais de saúde. Ademais, tiveram como limitação, fragilidades relacionadas ao design e características lúdicas. CONCLUSÃO: O estudo pode contribuir para desenvolvimento de novos aplicativos para educação sobre a segurança do paciente, promovendo o aumento do engajamento nas ações de prevenção de erros.

OBJECTIVE: To examine mobile applications developed to guide healthcare professionals, patients, and their caregivers regarding patient safety interventions in the context of hospitalization. METHODS: A technological prospection was conducted in the virtual stores App Store and Google Play and through the Google search tool. Inclusion criteria included applications focused on patient safety in the context of hospitalization without temporal limitations. RESULTS: 25 applications were included in the study and analyzed. The Most applications were mobile, developed in English, and focused on healthcare professionals. In addition, they had limitations and weaknesses related to design and playful features. CONCLUSIONS: The study may contribute to developing of new patient safety education applications that promote increased engagement in error prevention interventions.

Progressão da Lesão Miocárdica após Ablação por Radiofrequência em Crianças em Idade Escolar / Myocardial Injury Progression after Radiofrequency Ablation in School-Age Children

Resumo Fundamento As últimas décadas têm assistido ao rápido desenvolvimento do tratamento invasivo de arritmias por procedimentos de ablação por cateter. Apesar da sua segurança e eficácia bem estabelecida em adultos, até o momento, há poucos dados nos cenários pediátricos. Uma das principais preocupações é a possível expansão da cicatriz do procedimento de ablação nessa população e suas consequências ao longo dos anos. Objetivos Este estudo teve como objetivo analisar o risco da progressão da lesão miocárdica após ablação por cateter de radiofrequência em pacientes pediátricos. Métodos Este é um estudo retrospectivo de 20 pacientes pediátricos com tratamento prévio de arritmia supraventricular com ablação, submetidos à ressonância magnética cardíaca e angiografia coronária para avaliação de fibrose miocárdica e da integridade das artérias coronárias durante o acompanhamento. Resultados A idade mediana no procedimento de ablação foi 15,1 anos (Q1 12,9, Q3 16,6) e 21 anos (Q1 20, Q3 23) quando a ressonância magnética cardíaca foi realizada. Quatorze dos pacientes eram mulheres. Taquicardia por reentrada nodal e síndrome de Wolf-Parkinson-White foram os principais diagnósticos (19 pacientes), com um paciente com taquicardia atrial. Três pacientes apresentaram fibrose miocárdica ventricular, mas com um volume inferior a 0,6 cm 3 . Nenhum deles desenvolveu disfunção ventricular e nenhum paciente apresentou lesões coronarianos na angiografia. Conclusão A ablação por cateter de radiofrequência não mostrou aumentar o risco de progressão de lesão miocárdica ou de lesões na artéria coronária.

Abstract Background The past decades have seen the rapid development of the invasive treatment of arrhythmias by catheter ablation procedures. Despite its safety and efficacy being well-established in adults, to date there has been little data in pediatric scenarios. One of the main concerns is the possible expansion of the ablation procedure scar in this population and its consequences over the years. Objectives This study aimed to analyze the risk of myocardial injury progression after radiofrequency catheter ablation in pediatric patients. Methods This is a retrospective study of 20 pediatric patients with previous ablation for treatment of supraventricular arrhythmia that underwent cardiac magnetic resonance and coronary angiography for evaluation of myocardial fibrosis and the integrity of the coronary arteries during follow-up. Results The median age at ablation procedure was 15.1 years (Q1 12.9, Q3 16.6) and 21 years (Q1 20, Q3 23) when the cardiac magnetic resonance was performed. Fourteen of them were women. Nodal reentry tachycardia and Wolf-Parkinson-White Syndrome were the main diagnosis (19 patients), with one patient with atrial tachycardia. Three patients had ventricular myocardial fibrosis, but with a volume < 0.6 cm 3 . None of them developed ventricular dysfunction and no patient had coronary lesions on angiography. Conclusion Radiofrequency catheter ablation did not show to increase the risk of myocardial injury progression or coronary artery lesions.

Aplicativos móveis sobre segurança do paciente idoso no ambiente cirúrgico: uma prospecção tecnológica / Mobile applications on the safety of elderly patients in the surgical environment: a technological prospecting

OBJETIVO: Descrever os aplicativos voltados para a segurança do paciente idoso cirúrgico nos períodos pré e pós-operatório. MÉTODO: Prospecção tecnológica com abordagem qualitativa realizada nas lojas virtuais Apple Store, Google Play e aplicativo web. Como estratégia de busca utilizou-se os termos: 'autocuidado idoso', 'pré-operatório', 'pós-operatório', 'segurança do paciente', 'segurança do paciente idoso'. RESULTADOS: Foram identificados 12 aplicativos na loja virtual Apple Store, 17 na Google Play e um web app, os quais estavam voltados a gamificação de profissionais da saúde e da população; aplicativos educacionais aos profissionais de saúde e usuários do sistema de saúde; aplicativos relacionados como ferramenta de trabalho para os profissionais de saúde; aplicativos como ferramenta de autocuidado para usuários do sistema de saúde; e, aplicativos voltados para pós-operatório de usuários do sistema de saúde. CONCLUSÃO: Não foram encontradas tecnologias voltadas para o autocuidado e segurança do paciente idoso nos períodos pré e pós-operatório

OBJECTIVE: To describe applications focused on the safety of elderly surgical patients in the pre- and postoperative periods. METHOD: Technology prospecting with a qualitative approach in the Apple Store, Google Play virtual stores, and web application. As a search strategy, the following terms were used: 'elderly self-care', 'preoperative', 'postoperative', 'patient safety', 'elderly patient safety'. RESULTS: 12 applications were identified in the Apple Store, 17 in Google Play, and a web app, which focused on the gamification of health and population professionals; educational applications to health professionals and health system users; related applications as a work tool for health professionals; applications as a self-care tool for health system users; and, post-operative applications for health system users. CONCLUSION: Technologies aimed at self-care and the safety of elderly patients were not found in the pre- and postoperative periods.

No Incidence of Liver Cancer Was Observed in A Retrospective Study of Patients with Aristolochic Acid Nephropathy / 中国结合医学杂志

OBJECTIVE@#To assess the risk of aristolochic acid (AA)-associated cancer in patients with AA nephropathy (AAN).@*METHODS@#A retrospective study was conducted on patients diagnosed with AAN at Peking University First Hospital from January 1997 to December 2014. Long-term surveillance and follow-up data were analyzed to investigate the influence of different factors on the prevalence of cancer. The primary endpoint was the incidence of liver cancer, and the secondary endpoint was the incidence of urinary cancer during 1 year after taking AA-containing medication to 2014.@*RESULTS@#A total of 337 patients diagnosed with AAN were included in this study. From the initiation of taking AA to the termination of follow-up, 39 patients were diagnosed with cancer. No cases of liver cancer were observed throughout the entire follow-up period, with urinary cancer being the predominant type (34/39, 87.17%). Logistic regression analysis showed that age, follow-up period, and diabetes were potential risk factors, however, the dosage of the drug was not significantly associated with urinary cancer.@*CONCLUSIONS@#No cases of liver cancer were observed at the end of follow-up. However, a high prevalence of urinary cancer was observed in AAN patients. Establishing a direct causality between AA and HCC is challenging.

Curative Effect Observation of Burosumab for Children and Adults with X-Linked Hypophosphatemicrickets / 罕见病研究

We studied the patients diagnosed with X-linked hypophosphatemicrickets(XLH) and treated with burosumab in Peking Union Medical College Hospital from January 2021 to December 2022. In addition, we described the clinical characteristics of the patients, the changes of clinical indexes before and after burosumab treatment, and the adverse drug reactions during treatment. We also evaluated the efficacy and safety of burosumab for XLH. The results showed that three children XLH patients and one adult XLH patients received burosumab treatment. After treatment, the serum phosphorus level of all patients increased; the serum phosphorus of 3 children patients increased above the lower limit of the reference value range; the serum alkaline phosphatase(ALP) of all patients was lower than that of before treatment; the serum ALP of one adult patient was close to the normal range after 2.5 years of treatment. One child patient showed small crystals in kidney through ultrasound 48 weeks after treatment; one child and one adult showed increased serum parathyroid hormone(PTH)level before treatment and serum PTH continued increasing after treatment. Finally, it may be concluded that burosumab increased serum phosphorus levels in XLH patients, kept the level relatively stable, and reduced serum ALP levels. No serious adverse reactions occurred during treatment, in order to provide reference for the use of burosumab in patients with XLH.

Efficacy and safety of tyrosine kinase inhibitors in the treatment of HER2-positive breast cancer：a meta-analysis / 中国药房

OBJECTIVE To evaluate the efficacy and safety of tyrosine kinase inhibitors （TKI） in the treatment of HER2- positive breast cancer in order to provide evidence-based evidence for clinical medication. METHODS Retrieved from CNKI， Wanfang database， VIP， PubMed， Cochrane Library， Embase and Web of Science， randomized controlled trial （RCT） about TKI （trial group） versus drugs excluding TKI （control group） in the treatment of HER2-positive breast cancer were collected from the establishment of the database to April 2023. Meta-analysis and sensitivity analysis were performed by using RevMan 5.4.1 and Stata 17 software. RESULTS Total of 24 RCT studies were included， involving 15 538 HER2-positive breast cancer patients. The meta- analysis results showed that compared with the control group， the progression-free survival （PFS） [HR＝0.91， 95%CI （0.80， 1.02）， P＝0.12]， overall survival （OS） [HR＝0.95， 95%CI （0.89， 1.01）， P＝0.11]， objective response rate （ORR） [OR＝1.21， 95%CI （0.86， 1.69）， P＝0.27]， and pathological complete response rate （pCR） [OR＝1.44， 95%CI （0.91， 2.27）， P＝0.12] had no statistically significant difference in the trial group； among the 3/4 grade ADRs， the trial group had a higher incidence of anemia [OR＝1.77， 95%CI （1.16，2.70）， P＝0.008]， rash [OR＝11.26， 95%CI （7.32，17.31）， P＜0.000 01]， paronychia [OR＝8.67， 95%CI（1.62，46.53）， P＝0.01]， diarrhea [OR＝10.17， 95%CI（5.03，20.58）， P＜0.000 01]， oral mucositis inflammation [OR＝ 9.34， 95%CI （3.13， 27.83）， P＜0.000 1]， elevated aspartate aminotransferase [OR＝2.09， 95%CI （1.13，3.84）， P＝0.02]， and hypokalemia [OR＝2.37， 95%CI （1.31，4.30）， P＝0.005] than that of the control group. Subgroup analysis results showed that compared with the placebo group， TKI could improve OS and ORR （P＜0.05）， while compared with trastuzumab， TKI had no advantage in PFS， OS， ORR， and pCR， and TKI combined with trastuzumab could significantly improve PFS， OS， ORR， and pCR compared with the trastuzumab group （P＜ 0.05）. Sensitivity analysis suggested that the results were relatively robust and the risk of publication bias was low. CONCLUSIONS Compared with trastuzumab， TKI has no advantages in PFS， OS， ORR and pCR in the treatment of HER2- positive breast cancer， but TKI combined with trastuzumab can significantly improve PFS， OS， ORR and pCR； TKI can increase the risk of grade 3/4 anemia， rash， paronychia， diarrhea， oral mucositis， elevated aspartate aminotransferase， and hypokalemia.

Meta-analysis of efficacy and safety of sedative therapy with midazolam and dexmedetomidine/propofol in critically ill patients undergoing mechanical ventilation / 中国药房

OBJECTIVE To systematically evaluate the efficacy and safety of midazolam and dexmedetomidine/propofol for the sedation of critically ill patients undergoing mechanical ventilation， and to provide evidence-based reference for clinical treatment. METHODS Retrieved from PubMed， Embase， Web of Science， Cochrane Library， Clinical trials. gov， China Journal Full Text Database， Chinese Science and Technology Journal Database， Wanfang database and China Biomedical Literature Database， the data on the efficacy and safety of midazolam and dexmetomidine/propofol for the sedation of critically ill patients undergoing mechanical ventilation were collected from the establishment of the database to March 31， 2023. After extracting data from clinical studies that met the inclusion criteria， the meta-analysis was conducted by using the RevMan 5.3 statistical software. RESULTS A total of 31 literature were included， with a total of 2 765 patients. Results of meta-analysis showed that the mechanical ventilation time [MD＝14.13， 95%CI （13.75， 14.52）， P＜0.000 01] and the length of hospitalization in the intensive care unit [MD＝0.92， 95%CI （0.54， 1.30）， P＜0.000 01] of patients in the midazolam group was longer than dexmedetomidine/ propofol group. The incidence of bradycardia in midazolam group was lower dexmedetomidine/propofol group [OR＝0.60， 95%CI （0.41， 0.90）， P＝0.01]， but there was no statistically significant difference in the incidence of hypotension between the two groups [OR＝0.69， 95%CI （0.47， 1.01）， P＝0.06]. The incidence of delirium [OR＝3.88， 95%CI （2.74， 5.49）， P＜0.000 01]， ventilator- associated pneumonia [OR＝2.32， 95%CI （1.19， 4.51）， P＝0.01]， and respiratory depression [OR＝5.70， 95%CI （3.09， 10.52）， P＜0.000 01] in midazolam group were higher than dexmedetomidine/propofol group. CONCLUSIONS Compared with dexmedetomidine/propofol， midazolam increases patients’ mechanical ventilation time and the length of hospitalization in the intensive care unit in terms of efficacy， and increases the risk of delirium and pulmonary complications in terms of safety， but has a smaller cardiovascular impact.

Meta-analysis of the efficacy and safety of Saccharomyces boulardii versus Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea / 中国药房

OBJECTIVE To compare the efficacy and safety of Saccharomyces boulardii and Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CBM， Wanfang data， CNKI and VIP， randomized controlled trials （RCTs） about S. boulardii （S. boulardii group） versus Bifidobacterium triple liver bacteria （Bifidobacterium group） were collected. After screening the literature， extracting data and evaluating the quality， meta-analysis was performed by using RevMan 5.3 software. RESULTS A total of 9 RCTs were included， involving 898 patients. Results of meta-analysis showed there was no statistical significance in total response rate [OR＝1.69， 95%CI （0.93， 3.09）， P＝0.09]， duration of diarrhea [MD＝－1.39， 95%CI （－3.35， 0.57）， P＝0.16]， the time of abdominal pain disappearance [MD＝0.09， 95%CI（－0.87， 1.05），P＝0.86] or the incidence of adverse reactions [OR＝0.65， 95%CI （0.05， 8.03）， P＝0.74]. The number of stools in S. boulardii group was significantly less than Bifidobacterium group [MD＝－0.91， 95%CI （－1.80， －0.02）， P＝0.04]. The results of subgroup analysis showed that the duration of diarrhea in children with antibiotic-associated diarrhea in S. boulardii group was significantly shorter than Bifidobacterium group （P＜0.05）. CONCLUSIONS The efficacy and safety of S. boulardii are similar to those of Bifidobacterium in the treatment of diarrhea， but S. boulardii is better than Bifidobacterium in terms of stool number， the duration of diarrhea in children with antibiotic-associated diarrhea.

Meta-analysis of efficacy and safety of aspirin versus other anticoagulants in the prevention of thromboembolism after orthopedic surgery / 中国药房

OBJECTIVE To evaluate the clinical efficacy and safety of aspirin versus other anticoagulants in the prevention of thromboembolism after orthopedic surgery. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CNKI， Wanfang data and VIP， randomized controlled trials （RCTs） and cohort studies about aspirin （trial group） versus other anticoagulants （control group） were collected during the inception and June 1st， 2023. After literature screening， data extraction and quality evaluation， the meta-analysis was conducted by using RevMan 5.4 software. RESULTS A total of 22 studies were included， involving 9 RCTs and 13 cohort studies. RCT results showed that the incidences of deep vein thrombosis （DVT） [RR＝1.81， 95%CI（1.36， 2.40）， P＜0.000 1] and postoperative pulmonary embolism （PE） [RR＝1.55， 95%CI（1.01， 2.40）， P＝0.05] in trial group were significantly higher than control group. There was no statistically significant difference in the incidences of postoperative massive bleeding， postoperative surgical site infection， all-cause death， or any bleeding after surgery between 2 groups. In the cohort study， the incidence of any bleeding in trial group was significantly lower than control group [RR＝0.71，95%CI （0.64， 0.79）， P＜0.000 1]， while the differences in other indicators were not statistically significant （P＞0.05）. The results of subgroup analysis based on different anticoagulants showed that in RCT， the incidences of DVT and PE after surgery in patients using low-molecular-weight heparin （LMWH） were significantly lower than using aspirin （P＜0.05）； in the cohort study， the incidences of DVT and PE after surgery were significantly lower in patients using direct oral anticoagulants （DOAC） than using aspirin （P＜0.05）. There was no statistically significant difference in the incidence of major bleeding between patients using aspirin and using DOAC and LWMH （P＞0.05） in both RCT and cohort study. CONCLUSIONS Aspirin is equally safe as other anticoagulants for the prevention of thromboembolism after orthopedic surgery， but its efficacy may not be as good as other anticoagulants. After orthopedic surgery， other anticoagulants should be preferred to prevent venous thromboembolism， and aspirin should be carefully considered.

Kinase modulators approved by FDA in 2022 / 药学学报

The FDA approved a total of 37 new drugs in 2022, including 22 new molecular entities and 15 new biological products. This is the year with the lowest number of new drugs approved by the FDA since 2017. Among these approved drugs, 21 new drugs belong to the "first-in-class" category, accounting for 56% of the total approved drugs, which is the highest ratio in the past 10 years. Among the drugs approved in 2022, there are 5 small molecule kinase modulators, including the tyrosine kinase 2 (TYK2) allosteric inhibitor deucravacitinib, the first oral pyruvate kinase (PK) activator mitapivat, the Janus kinase 1 (JAK1) selective inhibitor abcrocitinib, the JAK2 selective inhibitor pacritinib and the broad-spectrum fibroblast growth factor receptor (FGFR) inhibitor futibatinib. This review briefly describes the discovery background, research and development process, synthesis routes and clinical efficacy and safety of small molecule kinase modulators approved by the FDA in 2022, hoping to provide ideas and methods for further research on kinase modulators.

Safety Evaluation of Tianzhi Granules in Treating Mild-to-moderate Vascular Dementia / 中国实验方剂学杂志

ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized， double-blind， double-simulated， positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions， laboratory indicators， vital signs， and electrocardiogram （ECG） results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial， and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules， donepezil， and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial， and the symptoms were mild and recovered. Laboratory tests （blood routine， urine routine， liver function， kidney function， and coagulation） and vital signs were compared before treatment （baseline） and after treatment of 12 and 24 weeks， respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial， there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort， with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules， and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.

Clinical Effect of Runzaoling Combined with Iguratimod on Primary Sjögren's Syndrome / 中国实验方剂学杂志

ObjectiveTo investigate the clinical efficacy and safety of iguratimod combined with the Chinese medicine Runzaoling in the treatment of primary Sjögren's syndrome （pSS）. MethodSeventy-two patients treated in the Department of Rheumatology and Immunology of the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine（TCM） from January 2021 to June 2022 who met the Western medical diagnosis of pSS and had the TCM syndrome of Yin deficiency and heat toxin syndrome were randomly assigned into an observation group and a control group， with 36 patients in each group. The observation group was treated with iguratimod combined with Runzaoling， and the control group was treated with iguratimod. The treatment in both groups lasted for 12 weeks. The clinical symptoms， EULAR Sjogren's syndrome patient reported index （ESSPRI）， EULAR Sjögren's syndrome disease activity index （ESSDAI）， erythrocyte sedimentation Rate （ESR）， C-reactive protein （CRP）， immunoglobulin （IgG）， Schirmer score， and saliva flow of the two groups were determined before and after treatment. Furthermore， the incidence of adverse reactions was compared between the two groups. ResultThe total response rate in the observation group was 75.0% （27 patients with response and 9 patients with no response）， which was higher than that （61.11%， 22 patients with response and 14 patients without response） in the control group （P<0.05）. After treatment， the ESSPRI， ESSDAI， and TCM syndrome scores in both groups decreased and the decreases were more obvious in the observation group than in the control group （P<0.05）. The treatment in both groups recovered the ESR， CRP， IgG， Schirmer score， and saliva flow （P<0.05）. Moreover， the observation outperformed the control group in terms of the ESR， CRP， IgG， and saliva flow （P<0.05） and had no significant difference in the Schirmer score compared with the control group. During the treatment period， 2 patients in the observation group had nausea， and 1 patient had an abnormal liver function， which were relieved after symptomatic treatment and did not affect the treatment. In the control group， 1 patient withdrew from the study due to rashes and showed no special discomfort in the follow-up 4 weeks， and 1 patient had nausea， which was relieved after symptomatic treatment. ConclusionIguratimod combined with Runzaoling has good clinical efficacy and safety in the treatment of pSS.

Construction of Evidence Body for Revision of Safety Information on Package Inserts of Chinese Patent Medicines in Post-marketing： Taking Xiaoke'an Capsules as an Example / 中国实验方剂学杂志

ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.