医学科技期刊中语言文字的规范性应用

阐述了医学科技期刊语言的特殊性,剖析医学科技期刊编审工作中常出现的问题,以引起编辑人员和医务工作者的关注。     

新药临床试验中医学伦理学问题的探讨

目的通过对新药临床试验中存在的医学伦理学问题的探讨,阐明在新药临床试验研究过程中,如何解决好试验阶段相关的医学伦理学问题。方法以相关的法律、法规、原则、规范以及社会伦理、道德为依据,探讨新药临床试验中的医学伦理学问题。结果临床受试者是一群生理甚至于心理均处于非正常状态的病人,因此在新药临床试验研究过程中,不但涉及到大量的技术问题,更重要的是存在相关的医学伦理学问题。结论在新药临床试验研究过程中,试验者必须执行和遵守相关的法律法规,解决好试验阶段相关的医学伦理学问题。     

Pharmacy students' knowledge, attitudes, and evaluation of direct-to-consumer advertising

Objectives

To assess pharmacy students'' knowledge, attitudes, and evaluation of direct-to-consumer advertising (DTCA).

Methods

A cross sectional, self-administered, 106-item survey instrument was used to assess first, second, and third professional year pharmacy students'' knowledge about DTCA regulations, attitudes toward DTCA, and evaluation of DTC advertisements with different brief summary formats (professional labeling and patient labeling) and in different media sources (print and television).

Results

One hundred twenty (51.3%) of the 234 students enrolled participated in the study. The mean percentage knowledge score was 48.7% ± 12.5%. Based on the mean scores per item, pharmacy students had an overall negative attitude toward DTC advertisements. Students had an overall negative attitude toward television and print advertisements using the professional labeling format but an overall positive attitude toward the print advertisement using the patient labeling format.

Conclusions

Lectures discussing DTC advertising should be included in the pharmacy curriculum.     

完善法规和要求保障公众用药安全——《药品不良反应报告和监测管理办法》解读

1 我国<药品不良反应报告和监测管理办法>出台的背景 近百年来,尤其近30年,大量药品不断上市,在人类防病、治病、保障健康过程中发挥了重要作用,同时人们也逐渐认识其不良反应给人类带来的危害.药品犹如一把双刃剑,既有其有利的一面,又有其有害的一面,即在达到治疗作用的同时,也会发生不良反应,对人体造成危害.     

医学研究中受试者权益保护的伦理审查

本研究回顾了医学科研伦理中受试者保护规范的发展历程，介绍了医学伦理审查的基本目的、原则、要素和程序，指出独立的伦理审查对于保护受试者利益的积极意义，并就我国如何推进医学伦理审查工作提出几点建议。     

关于完善我国禁毒法律、法规的思考

自 17世纪鸦片传入我国以来 ,毒品就给中华民族造成了深重灾难 ,新中国成立后 ,党和人民政府很快就在全国范围内禁绝了毒害。然而进入 2 0世纪80年代后期 ,吸毒、贩毒现象死灰复燃 ,并且有愈演愈烈之势。截止 2 0 0 2年 ,全国吸食在册登记人数10 0万[1] ,严重危害了社会安定 ,给国家、社会和家庭带来了巨大灾难。 1990年 12月 2 8日第七届全国人民代表大会常务委员会第 17次会议通过了《全国人大常委会关于禁毒的决定》 ,随后 ,陆续颁布了有关禁毒法律法规 ,在禁毒方面起到了重要的作用。然而 ,现在国内外的毒情发生了巨大的变化 ,我们至今…     

Adolescent gambling: Temperament,sense of coherence and exposure to advertising

This study examines the relationships between gambling behaviour and temperament, sense of coherence (SOC) and exposure to advertising among adolescents, and the interactions between these three independent variables in relation to problem gambling (PG). One thousand and sixty-nine Israeli adolescents (males = 539, females = 530), aged 16–19, were sampled from 19 high schools. The following instruments were used: a gambling behaviour scale; a PG scale; an advertising exposure scale; Buss and Plomin's emotionality, activity and sociability (EAS) questionnaire measuring temperament; and a short version of Antonovsky's SOC scale. The findings indicated a relationship between recall of exposure to advertising and gambling behaviour and PG among adolescents. No correlations were found between SOC and gambling behaviour and PG, and no correlation was found between temperament and gambling behaviour. However, the effect of temperament on PG was significant for girls only. In addition, no interaction was found between the three independent variables relating to PG. The findings of this study underline the social role of advertisements in the process of developing gambling behaviour among adolescents and its effect on problem gambling.     

Associations Between Thematic Content and Industry Self-Regulation Code Violations in Beer Advertising Broadcast During the U.S. NCAA Basketball Tournament

Background: Beer marketing in the United States is controlled through self-regulation, whereby the beer industry has created a marketing code and enforces its use. We performed a thematic content analysis on beer ads broadcast during a U.S. college athletic event and determined which themes are associated with violations of a self-regulated alcohol marketing code. Methods: 289 beer ads broadcast during the U.S. NCAA Men's and Women's 1999–2008 basketball tournaments were assessed for the presence of 23 thematic content areas. Associations between themes and violations of the U.S. Beer Institute's Marketing and Advertising Code were determined using generalized linear models. Results: Humor (61.3%), taste (61.0%), masculinity (49.2%), and enjoyment (36.5%) were the most prevalent content areas. Nine content areas (i.e., conformity, ethnicity, sensation seeking, sociability, romance, special occasions, text responsibility messages, tradition, and individuality) were positively associated with code violations (p < 0.001–0.042). There were significantly more content areas positively associated with code violations than content areas negatively associated with code violations (p < 0.001). Conclusions: Several thematic content areas were positively associated with code violations. The results can inform existing efforts to revise self-regulated alcohol marketing codes to ensure better protection of vulnerable populations. The use of several themes is concerning in relation to adolescent alcohol use and health disparities.     

医疗机构药品短缺原因分析与防范

目的分析医疗机构药品短缺原因,采取相应的防范措施,保障药品供应。方法对2012年药品出库单进行回顾性分析,追溯短缺药品采购计划时间、供应商交货时间,并结合供应商无法供货的情况说明,利用Excel对短缺药品信息进行分类、统计,总结医疗机构药品短缺的外因与内因。结果 2012年调剂部门请领计划共46 862条,短缺药品1 423条,药品短缺率为3.0%,外因导致的药品短缺共计643次,占45.2%;内因导致的药品短缺780次,占54.8%。在导致药品短缺的外因中,价格倒挂占40.7%,居药品短缺外因之首,低价小品种及普药占外因导致的药品短缺的71.2%;药品短缺的内因中,控制库存占45.0%,排首位。结论如果药品定价合理,完善招标政策及药品供应链,加强短缺药品的预警与管理,可减少药品短缺状况。     

Recent developments in drug and alcohol medical education in Australia

Drug and alcohol training in Australian medical schools is about to undergo a transformation with the appointment of drug and alcohol co-ordinators to all medical schools. These federally-funded positions will ensure the development and implementation of integrated drug and alcohol medical curricula at the undergraduate level.     

中国药业:竞争特点、市场状况与发展思考

目的 :研究中国药业的市场竞争状况和发展战略。方法 :运用产业经济理论分析方法。结果与结论 :药业竞争表现为产品差别竞争、相对垄断竞争和规模优势竞争等特点。我国药业发展迅速 ,但产业集中度不高 ,赢利能力与规模效应较低 ,产品研究开发与技术创新能力较弱 ,处于分散的、低水平的竞争状态。我国在建立新型药业管理体制的过程中 ,需要建立有效的产业政策传导机制 ,实施多元取向的竞争发展战略 ,支持优势医药企业的快速成长 ,推动药业的集约化发展     

Evolution of drug regulations and regulatory innovation for anticancer drugs in China

Over the past two decades, China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals, keeping in line with the rapidly growing scientific innovation in drug research and development (R&D). In this study, we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998. More particularly, we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021, as a powerful illustration of how the revolution has changed the drug R&D landscape. Innovative drug development in China has boomed, benefiting in particular from pro-innovation policies as well as expedited program designations by the authority. We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021, with the emergence of drugs with novel mechanisms of action, including immune checkpoint inhibitors and cell therapy products. Drug lag has also been dramatically shortened by more than 70% for imported drugs in years 2016–2020 compared to years 2006–2010. Furthermore, we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China. This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.     

医学专业基础课教学中加强职业道德教育的探索

医学生的职业道德素质直接影响医生的职业道德水平。为探讨在专业基础课程中加强对医学生的职业道德的培养的方法,本院教师在生理学及病理生理学教学中,采取结合相关专业知识组织医学生讨论医学伦理学原则,用医界德材兼备的楷模鼓励医学生树立钻研医学难题的志向,加强医学生职业道德自我评估等措施,促进了医学生职业道德和专业技能的平衡发展。     

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.