从北京艾滋病药物试验案谈弱势受试人群的特殊保护

北京艾滋病药物试验案,揭示出药物临床试验中弱势受试人群权利保护特殊问题。弱势人群是指不具备自我保护能力的人,包括儿童、孕妇、精神病人、囚犯、绝症患者、文盲等等。临床试验伦理审查中,应重点关注他们特殊的知情能力、自我保护能力、个体健康特质。     

解码老人心——看老年顾客消费特征

在对老年顾客的调查中，我们看到，他们是大部分药店的主力消费人群。但作为经营者，你对这一主力人群的购药消费心理和行为模式是否有足够的认识呢？对于该提供给这些弱势顾客怎样的商品和服务又是否曾经有过探索和尝试？     

儿科人群临床试验中对受试者疼痛管理的伦理考虑

作为“临床试验中对受试者疼痛管理的伦理考虑”系列标准之一，主要论述《儿科人群临床试验中对受试者疼痛管理的伦理考虑》的起草背景、制定依据和适用范围，以及儿科人群临床试验中受试者疼痛等负担的来源和识别、在儿科人群临床试验方案设计和临床试验执行过程时使受试者疼痛最小化的措施，以期从伦理角度对儿科人群临床试验中受试者疼痛管理提出指导意见。其适用于伦理审查中对于儿科人群临床试验中受试者疼痛管理的伦理考虑，以及研究者制定临床试验方案和试验流程对儿科人群疼痛管理的关注。对临床试验中儿科人群疼痛予以更多关注，是保护儿科受试者权益的措施之一，有助于保障儿科临床试验顺利开展。     

从民法角度探讨临床试验弱势群体保护

弱势群体保护是医院伦理委员会医学伦理审查关注的重要环节，从民法的民事行为能力角度分析知情同意能力，包括未成年人、精神神经疾病等限制(无)民事行为能力、意思表示不真实的特殊群体知情同意能力诸多情形，尝试以“同龄的正常人群”为参照对象判断弱势群体，提出弱势群体保护其目的是补足弱势群体自身及监护能力缺陷使其达到正常同龄人的标准，缺乏阅读能力受试者见证人制度对弱势群体保护措施存在缺陷，应该提供全程录音。提出完善《药物临床试验质量管理规范》弱势受试者的定义建议，可以简化为：无(或限制)民事行为能力受试者且监护能力较弱(或无),以及自身或外在因素导致自愿参加临床试验的意思表示可能不真实的受试者。     

出生缺陷高危人群调查

目的对出生缺陷高危人群进行调查,了解出生缺陷高危人群的构成,提出对高危人群优生指导意见。方法对计划怀孕农村妇女609例进行问卷调查,依据家族史、遗传史、既往生育史等确定高危人群。结果有自然流产史（孕20周内）、死胎死产史者占45.0%;夫妇双方或家系成员患有某些遗传性疾病或先天性畸形者占18.9%;长期接触高危环境者占16.6%;年龄〉35岁占14.9%;曾生育遗传病患儿、不明原因智力低下或先天缺陷儿者占4.6%。结论出生缺陷高危人群是出生缺陷高发风险人群。建立高危人群数据库,对其孕前分类实行宣传指导、咨询培训和实验室筛查以及孕期实施重点监控,是有效预防出生缺陷发生的重要措施。     

医疗机构改革与国有医院托管模式

1现代医院管理理念 1．1政府对社会公共产品责任的理念 政府应切实承担起提供社会预防保健服务的职责，包括传染病控制、食品安全等；通过财政转移支付等多种手段，保护老年人、妇女儿童、残疾人等弱势人群的卫生医疗．     

Lancet：2030年全球卒中负担或增一倍

根据《柳叶刀》和《柳叶刀全球健康》杂志公布的最新研究称,全世界的卒中负担不断增加,尤其是在中青年人群和中低收入国家尤甚。     

宫内使用nelfinavr与基础人群致新生儿缺陷发生率没有显著差别

美国研究人员报道，子宫内使用nelfinavir(Ⅰ)致新生儿缺陷的发生率与基础人群的发生率没有显著差别。为了检查(Ⅰ)的致畸性，他们使用了来自国际抗逆转录病毒妊娠注册处的数据，包括944名在妊娠期间使用过(Ⅰ)的妇女的妊娠结局信息。     

茶碱不影响哮喘患儿学习成绩

以前曾有人报告哮喘患儿服用茶碱可能影响他们的智力和学习成绩。但是最近美国衣阿华州医学院的儿科研究人员报告,合理使用茶碱并不会影响哮喘患儿的学习成绩。他们说:“如果患儿没有持续的剧烈头痛或恶心,则服用茶碱并不会影响他们的学习成绩或智力。”     

他汀类药物与肺炎：全人群重叠病例对照研究

应用全人群、回顾性、重叠病例对照研究方法对他汀类药物的使用是否对因肺炎而就诊、住院和死亡有影响进行研究。研究包括134262人（年龄≥30岁），其中55118例服用他汀类药物和（或）氯贝特，29144例高血脂患者没有服用降血脂药物，50000人无高血脂也没有服用降血脂药物。     

手术室护理中的法律法规在护理实践中的合理运用

手术室护理中存在和潜在的法律问题包括:手术室查对的法律问题;手术中患者物理损伤的法律问题;手术标本管理的法律问题;术中医务人员语言的法律问题;手术护理记录中的法律问题;术中静脉输血的法律问题等。手术室护士要充分了解自己工作中存在和潜在的法律问题,做到学法、懂法,在医疗行为中守法,强化法制观念,用法律规范自己的语言和行为;严格执行术中的各项规章制度和技术操作规程,减少差错事故和护患纠纷的发生,确保手术患者的安全。同时手术室护理人员应认识到遵章守法也是一种自我保护,在维护手术患者权益的同时,也是用法律保护自己的合法权益。     

The ethics of drug research in children

The obligation of society to improve the welfare of its members requires the conduct of paediatric drug trials. Nevertheless, research activities must satisfy obligations to individual participants. The obligation to protect the welfare of children requires that nontherapeutic research procedures generally involve no more than minimal risk. It also requires that randomisation occurs only when the relative merits of therapeutic procedures remain unsettled among the relevant community of experts. The duty to respect the developing autonomy of children requires that they be included in decision-making about research participation in a manner consistent with the level of their decision-making capacity. However, when children lack mature decision-making capacities, the duty of parents to protect their welfare may properly constrain their choices. Justice requires that the benefits and burdens of research be distributed in a manner that assures equal opportunity for all children. Vulnerable children should receive special protection against the burdens of nontherapeutic research procedures. The benefits of participating in clinical trials should be available to all children with serious illnesses for which current treatment is unsatisfactory. Justice also requires that initiatives be undertaken to rectify current shortcomings in the scope of paediatric drug research. Striking an appropriate balance between obligations to conduct research and to protect the interests of participants is essential to the moral integrity of paediatric drug research.     

Stakeholders in recovery: demands, expectations, and research opportunities

A broad array of agencies, institutions, and individuals interact with community-based substance abuse treatment programs, providing resources or services and asserting demands and expectations in return. These relationships shape the environment in which treatment and community-based research take place, and themselves raise issues worthy of research attention. This article enumerates the stakeholders in one well-established program and describes the scope of the program's efforts to accommodate these stakeholders, along with some of the complications and difficulties programs confront in their attempts to satisfy stakeholders, especially when their demands are unrealistic or their interests conflict. The article concludes by identifying research areas that could facilitate these relationships, enhancing their benefits for patients.     

Genetic testing of children for adult-onset diseases: is testing in the child's best interests?

Questions related to testing children for adult-onset genetic diseases include many variables that generate different answers among different families. These issues include the biological nature of specific genes, concern about what benefits or harms may accrue from testing children, possible psychosocial sequelae, and ethical and legal concerns about personal autonomy. The shift in the physician-patient relationship from professional beneficence to patient autonomy has established the patient, or parents, as the primary decision-makers in questions about treatment or testing options. The role of parents as decision-makers for their own minor children has been reinforced by four seminal holdings of the United States Supreme Court. Assertions about protecting the future autonomy of children are invalid because minor children are not autonomous. Their parents, on the other hand, have a right--and perhaps even a duty--to exercise their own vested autonomy in making decisions that they believe are in the best interests of their own families. Geneticists are urged to provide clear and complete counseling to parents who seek testing for their children, and then defer to the parents as the primary decision-makers for their own minor children.     

青年教师要走在以科研促教学的前列

科研在教学中具有重要的作用,它可以把学生引领到科学技术的最前沿;可以培养学生的探索精神,提高学生的创新能力;可以使教学实现认识上的飞跃,理论上的突破。科研与教学相结合,以科研促教学,应是高校教学发展的一个重要方向。青年教师具有扎实的学科基础并对学科前沿发展趋势有相当程度的了解,能够成功申请到各类科研项目,应当充分发挥自己的优势,走在以科研促教学的前列,以所获资助的科研工作为切入点,与学生分享自己对学科发展的独特见解,进行良性互动,丰富课堂教学内容,提升教学效果。     

Treatment of HIV infection in pregnant women: antiretroviral management options

Increasing rates of HIV infection in women worldwide, especially among those of childbearing age, reinforce the importance of understanding the management of HIV in pregnancy. Over the past decade, significant advances have been made in the prevention of vertical HIV transmission, including the use of single and combination antiretroviral therapy, elective caesarean section as the preferred mode of delivery and the elimination of breast feeding. Multiple clinical trials assessing antiretroviral therapy in pregnancy have been carried out worldwide. The first pivotal clinical trial, the AIDS Clinical Trials Group (ACTG) 076 study, was conducted in 1994 using a three-part zidovudine regimen. Despite the success of this regimen at decreasing rates of vertical transmission, it is not affordable in many developing countries. Consequently, many international clinical trials have concentrated on short-course antiretroviral regimens including zidovudine alone, zidovudine and lamivudine, and nevirapine alone. In the developed world, the management of nonpregnant HIV-infected individuals has also undergone significant advances and has implications for the management of HIV in pregnancy. A number of countries have participated in the development of guidelines for the management of HIV in pregnancy, which recommend that HIV-infected pregnant women should be offered combination antiretroviral therapy based on viral load and CD4+ cell count cut-offs used for individuals who are not pregnant, preferably with the inclusion of zidovudine. However, to maximise the benefits to their offspring, therapy is recommended at lower viral load thresholds than for nonpregnant adults. For antiretroviral-naive women, therapy is deferred until the second trimester because of the potential and uncertain risk of teratogenesis and the low risk of transmission during this period. Research has also found that maternal factors including viral load, immune status, chorioamnionitis, prematurely ruptured membranes and, to a lesser extent, intravenous drug use and smoking are associated with increased vertical transmission. These represent potentially modifiable risk factors that should be addressed before and throughout pregnancy. Despite the benefits of antiretroviral therapy to reduce HIV vertical transmission, its use can be complicated by known and unknown risks of toxicity to the mother, fetus or both as well as carrying the risk of developing drug-resistant virus. The latter can potentially compromise future treatment options for both the mother and child. Other important challenges include the use of antiretroviral drugs during pregnancy when the mother does not meet criteria for them for her own health, and balancing the relative risks and benefits of elective caesarean section at various degrees of viral load suppression. Clinicians managing HIV in pregnancy need to keep up to date with all the literature to provide optimal care, including counselling to allow mothers to balance the risks and benefits while deciding on treatment for both themselves and their children.     

Heroin users' views and experiences of physical activity, sport and exercise

BackgroundAlthough there is limited research on heroin users’ participation in physical activity, sport and exercise, public health literature asserts that being physically active is good for individuals. Critics, however, caution that the benefits of sport and exercise are overstated and sport may itself reinforce or create inequalities.MethodsIn-depth interviews were conducted with 40 current or ex-heroin users, of whom 37 were re-interviewed three months later. Data from all 77 interviews were analysed to explore individuals’ self-reported participation in physical activity, sport and exercise; their desire to participate; and any barriers to participation experienced.FindingsParticipants were very interested in sport and exercise and engaged in a wide variety of active pastimes. Although they did little structured sport or exercise during periods of heavy heroin use, they still often walked or cycled. Enjoyment was a key feature of being physically active in treatment and in early recovery. Additionally, individuals reported diverse health and social gains and felt that sport and exercise helped them to reduce their heroin use. These benefits notwithstanding, there were personal, social and structural barriers to being active and so individuals were generally keen to take advantage of any sport or exercise opportunities offered to them by services.ConclusionsBy focusing on the meanings that heroin users themselves attribute to being active, our analyses reveal that members of this population derive great pleasure from all manner of physical pastimes. A small but growing literature on embodied sporting practices helps us to interpret this. We conclude that there is an important role for physical activity, sport and exercise within policy and practice responses to heroin use, but with a need to be creative and flexible regarding the kinds of activities promoted.     

The generalisability of pharmacoeconomic studies

Authors of pharmacoeconomic analyses understandably want their findings to apply as broadly as possible. Also, decision-makers may have to interpret the results of analyses conducted in healthcare settings other than their own. The validity of transferring or generalising results from one setting to another raises important issues for health-economic evaluation. Pharmacoeconomic analyses attempt to model the costs and benefits of alternative treatments in normal clinical practice. Usually, no single clinical study directly provides all the required information, and a variety of data sources is generally included in each analysis. Different data sources present different problems in terms of their relevance to decision-makers. At one extreme, an analysis based purely on trial outcomes and resource use may be precise, but not reflect normal practice; at the other extreme, an analysis using practice data may appear relevant, but be exposed to biases and confounding. Reviews of published studies suggest that general standards have been inadequate in the past. Reapplying such analyses in different localities may simply replicate inadequate findings. The 'perfect' should not become the enemy of the merely 'good'. Models can be helpful in decision-making, provided that they accurately communicate uncertainties in modelling and data. Even so, there will be limits to the generalisability of pharmacoeconomic models, since the required analysis differs between jurisdictions, and because of variations in normal clinical practice. The transferability of research findings re-opens the issue of credibility in pharmacoeconomics. Methodological standardisation, reporting standards and researcher independence are recognised as important factors for enhancing credibility. Where possible, pharmacoeconomic analyses should reflect the findings of systematic reviews of health outcomes to avoid the risk of biased selection of the evidence. In addition, the application of findings to individual healthcare settings must be considered, since cost effectiveness may vary markedly by setting and perspective.     

Breast tumours: a review of adjuvant chemotherapy trials

Updated randomized trials using adjuvant chemotherapy for breast cancer have generally shown significantly improved disease-free survival in young women. Nevertheless, this improvement does not appear to be lasting in locally advanced disease. The effects on overall survival remain controversial and have been observed in only five trials. Except for three trials, results in postmenopausal women have also been disappointing. The best regimen of adjuvant chemotherapy and, more importantly, its timing are still not well defined, although early or perioperative treatments seem to have a fair chance of success.