FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

A commitment to marginalized children in the European Union: The hope and challenges of the EU Child Guarantee

While children in general are usually seen as a societal priority, many children are disadvantaged by marginalization, with adverse effects on health and development. Following feasibility studies, the European Commission has now adopted a formal Child Guarantee of service access. This paper links the Feasibility Studies to other reports on the need to address marginalized and institutionalized children. The problems in identifying and quantifying such children are outlined, as are the challenges of planning for these groups of children and the difficulty of finding universal definitions and data. This European Union initiative is timely, given that around a quarter of European children are marginalized, while the effects of Covid-19 will add to this marginalization.     

Development and validation of a novel scoring system to predict severe intraventricular hemorrhage in very low birth weight infants

ObjectiveWe sought to develop and validate a novel scoring system for the prediction of severe intraventricular hemorrhage (SIVH) in very low birth weight infants (VLBWI).MethodsThis retrospective cohort multicenter study included 615 VLBWI born between 24 and 32 weeks gestational age (GA). Multivariable logistic regression analyses were used to determine which factors evaluated within the first 5 days of life were associated with SIVH and the weights of these variables. The accuracy of the predictive scoring system was prospectively tested in the same units.ResultsThe final SIVH scoring system included the following variables: antenatal steroid therapy, GA, birth weight (BW), 1-min Apgar score, mechanical ventilation and hypotension. The SIVH scores used to divide the subjects into three tiers (low-risk (<5), moderate-risk (5–8) and high-risk (>8)) were developed based on these variables. Of infants with a score below 5, 1.2% (4/339) developed SIVH. Of those with a score above 8, 42.5% (17/40) developed SIVH. The scores were successfully verified in 99 VLBWI.ConclusionsThese findings suggest that among infants with a score >8, the incidence of SIVH is significantly higher. This scoring system can be used to predict the incidence of SIVH during the first 5 days after birth and may contribute to the early intervention in and prevention of SIVH.     

中药特殊煎法的探讨与思考(三):包煎

"包煎"是中药汤剂特殊煎法的一大特色,而一些人对需包煎的中药、包煎的原因以及如何包煎缺乏基本的认识或存在一定的误解,从而出现因中药煎煮不当导致的临床疗效不佳或副作用等一系列问题。结合古今文献,尝试剖析中药包煎的原因及注意事项,并对如何包煎提出探索性的思考,为中药包煎提供科学依据以促进临床合理用药。     

医科达数字化电子直线加速器控制软件IPV基本原理与应用解读

目的 介绍医科达数字化医用电子直线加速器控制软件里子项目和项目成分值(IPV)的工作原理,并具体说明控制软件通过三类子项目及其项目分项实时监测、控制子系统的运行状态。方法 首先介绍医科达数字化医用电子直线加速器的控制系统组成,然后介绍控制软件里子项目和项目分项的定义和分类,以及各类子项目的基本原理,最后通过分析高功率移相器的运动控制具体说明控制软件的子项目在实时监测、控制子系统运行状态的应用。结果 通过分析原理和举例详细、具体说明了控制软件IPV的工作原理及其应用,使用户尤其是维修人员能掌握相应理论知识,在日常使用和维修时能通过软件快速准确地查找运行参数,并根据相关子系统的控制原理分析问题和解决故障。结论 用户尤其是维修人员掌握这些子项目及其项目分项的工作原理,就能在日常使用或维修、校准时,快速准确地通过控制软件查看、校准运行参数,解决设备故障,并避免错误操作引起事故。     

嗜肺军团菌致病性与效应蛋白的研究进展

嗜肺军团菌是一种可以引起军团菌肺炎和庞蒂亚克热的兼性胞内病原菌，主要侵染阿米巴原虫和人类巨噬细胞。该菌在宿主胞内能依靠Dot/Icm IVB型分泌系统产生的效应蛋白成功逃避溶酶体的降解。本文主要对嗜肺军团菌的致病物质、胞内存活与增殖机制及其效应蛋白的生物学功能进行综述，详细介绍嗜肺军团菌的毒力因子与致病机制，为军团病防治的研究提供新思路，也为其他胞内病原菌所致感染性疾病的研究提供重要的借鉴意义。