Challenges of ethical research in resource-poor settings.

The disparity in resources between economically developed and developing countries presents ethical concerns when commercial sponsors of studies and investigators propose to conduct them with subjects in developing countries. Vulnerable people may be recruited into studies of little health benefit to themselves or their communities and, under undue inducements, may accept disproportionate risks. Reproductive health studies may present women with undue risks. Guidelines have been developed to protect exploitable populations in resource-poor settings, although guarding their right to make informed and voluntary choices poses special challenges. Guidelines pay special attention to pregnant women as research subjects, and may approve and even require their enrollment in studies of products not known to be harmful. Placebo-controlled studies are addressed in contexts where no recognized treatments are routinely accessible. The structure and functions of research ethics review committees present difficult challenges, but they may be mitigated by enlightened international collaboration.     

灵芝多糖肽中单糖的组成

为充分发挥任选课对完善学生知识结构、促进学生个性发展的作用，我们通过对830名同学选课情况调查，在详细了解学生选择任选课内容分布、选课目的、希望增设的任选课和影响选课因素基础上，对加强任选课建设和管理提出了建议：转变观念，明确学习任选课的目的；增加任选课设置；建立指导学生选课制度。     

高等中医药院校学科交叉的实践与深化建设

通过收集、研究具有代表性的北京、上海、南京、广州四所中医药大学承担国家自然科学基金项目、三级实验室、硕士研究生招生、重点学科、研究机构、所办学术刊物等资料，分析中医院校目前开展学科交叉实践的阶段和现状。认为学科交叉建设、学科交叉显学科已初步形成。     

Recruitment and coaching of healthy elderly subjects for invasive cardiovascular research with right-sided catheterisation

BACKGROUND AND AIMS: Heart failure is primarily a disorder of the elderly. To investigate a non-invasive method to diagnose heart failure in the elderly, right-sided catheterisation was needed in healthy elderly subjects. We studied the feasibility of recruitment of healthy elderly subjects for this invasive investigation and aimed to identify the factors important for recruitment and for successful participation. METHODS: Healthy subjects, aged >/=65 years, were invited by advertisement in a local newspaper to participate in an invasive study, preceded by extensive medical examination. An experienced research nurse provided coaching and care on an individual basis. Motivation to participate, satisfaction and the expected and perceived burden were assessed with a questionnaire before and after catheterisation. RESULTS: From 180 subjects responding, 53 were invited for screening of whom 38 were included. Cardiovascular examination was the most important reason for participation. The questionnaire showed considerable satisfaction about the information and care given and about participating in the study in general. CONCLUSIONS: Recruitment of healthy elderly subjects for an invasive cardiovascular study is feasible. Individual coaching contributed to the satisfaction experienced. The appointment of an experienced research nurse appears important for successful recruitment and participation of healthy elderly subjects in an invasive cardiovascular study.     

生药学研究生培养应注意的几个研究方向

生药学是各学科知识的综合应用基础学科,以生药资源为研究对象,研究其品质评价、本草学、引种驯化、标准化栽培与养殖、采收加工、贮藏、寻找新药源及从分子水平研究其遗传育种的学科.目的是培养具有高级的生药学理论知识和技能、在医药领域从事研究和高级技术工作的专门人才.本文主要从生药学研究生培养中应注意的几个研究方向提出一些认识,为生药学研究生人才培养提供有益参考.     

Ⅰ期临床试验过程中受试者的管理体会

目的:促进Ⅰ期临床试验过程中受试者的规范化管理。方法:总结我院Ⅰ期临床试验过程中受试者的管理体会,探讨有效的管理模式。结果与结论:通过设立专人管理受试者,在知情同意环节坚持完全告知等原则,选择依从性好的受试者,与其建立相互尊重、理解及合作的关系,为其营造舒适的受试环境等规范受试者的管理,从而提高受试者的依从性,提升临床试验的质量。     

注重审查项目的辨证论治内容——中医药研究伦理审查特点研究（二）

在中医药研究伦理审查中,审查项目的辨证论治内容是检验项目是否符合中医规律和理论,其目的不是检验项目的科学性,而是为了保护受试者的安全.在这其中,要坚持伦理审查与科学审查的统一,更要注重中医药本身发展研究的特点和规律,不能简单的套用审查西医西药的方法.在审查辨证论治内容的实践操作层面,应当注意：对辨证论治内容的审查,要纳入中医药研究伦理审查标准操作规程.在保护患病受试者安全的审查上,要坚持证候标准,要审查既往临床应用证候与研究中患病受试者证候是否一致.对辨证论治的审查,要重视理法方药的内在逻辑关系,要充分发挥熟悉项目研究内容的中医药专家的作用.在强调审查辨证论治内容的同时,要注重审查项目的其他内容,形成伦理审查的合力,防止片面性.     

Effects of alcohol on polysomnographically recorded sleep in healthy subjects

BACKGROUND: After studying the sleep of alcohol-dependent patients at the beginning and over the course of abstinence in earlier studies, our interest in the current study focused on the direct effect of 2 doses of alcohol [0.03 and 0.1% blood alcohol level (BAL)] on healthy sleep. This is the first polysomnographic study testing the impact of 2 doses of alcohol ingestion (thus reflecting "normal" social drinking and alcohol abuse) in a single-blind randomized design in healthy volunteers. The study evaluated a short-term acute drinking period for 3 and 2 days of withdrawal from alcohol not only for polysomnographic variables but also for subjective estimates of sleep quality. METHODS: In a crossover design with a 1-week interval, healthy subjects received alcohol to raise their blood alcohol to either 0.03 or 0.1% BAL at bedtime for 3 consecutive nights after an alcohol-free baseline night. Objective (polysomnography) and subjective sleep (questionnaires) was recorded each night. During the following 2 days, alcohol was discontinued with simultaneous measurements of sleep to gauge withdrawal effects. RESULTS: At a dose of alcohol leading to BAL of 0.03%, no clear effects could be detected. Following an evening BAL of 0.1%, a hypnotic-like effect (shortened sleep latency, reduced number of wake periods, decreased stage 1 sleep) occurred primarily during the first half of the night with signs of rebound effects being already present during the second half of the night (increased stage 1 sleep). At this dose, alcohol significantly increased slow-wave sleep (SWS) in the first half of the night and reduced REM density in the beginning of the night. After discontinuation of the higher alcohol dose, REM sleep amount increased. No significant withdrawal or rebound effects could be observed for parameters of sleep continuity during the 2 nights after discontinuation from alcohol at a BAL of 0.1%. CONCLUSIONS: Owing to the small sample size, the results of this study need to be interpreted with caution. Short-term moderate alcohol consumption (BAL 0.03%) did not significantly alter objective or subjective parameters of sleep. Higher doses of alcohol resulting in a BAL level of 0.10% immediately before going to bed mainly influenced sleep in the first half of the night, resembling the effects of a short-acting hypnotic drug, including a suppression of phasic aspects of REM sleep (REM density). Interestingly, analysis of the latter part of these nights indicated the immediate presence of withdrawal effects (increased light sleep). No statistically significant effects on sleep parameters were observable during the 2 nights of withdrawal from alcohol at the higher BAL. Interpreted carefully, our data indicate that negative effects on sleep occur already with short-term use of alcohol at doses of BAL of 0.10%, despite hypnotic-like effects during the first hours of sleep, especially during the latter part of the night.     

论药物临床试验受试者的权益保护

药物临床试验在国内日渐频繁,但受试者权益保护却没有得到应有的重视。介绍了受试者在药物临床试验中享有的生命健康权、知情同意权、隐私权、医疗救治及补偿权,以及应落实的相关保障措施等,并分析了受试者权益保护中的种种不足。