临床随机对照试验的外部真实性及其评价的探讨

一、临床试验及其真实性 临床随机对照试验(RCT)严格遵循随机、对照、盲法等三大设计原则,并在试验过程中有效控制了潜在的混杂与偏倚,从而保证试验结果的真实可靠.现已成为验证临床药物或某项干预措施是否安全有效的重要研究手段.     

临床随机对照试验的外部真实性及其评价的探讨

一、临床试验及其真实性 临床随机对照试验(RCT)严格遵循随机、对照、盲法等三大设计原则,并在试验过程中有效控制了潜在的混杂与偏倚,从而保证试验结果的真实可靠.现已成为验证临床药物或某项干预措施是否安全有效的重要研究手段.     

实施药物临床试验质量全过程控制的探讨

药物临床试验质量管理贯穿临床试验的全过程,应充分发挥研究者、机构办公室、申办方、伦理委员会等各方面的质控作用,确保临床试验遵循《药物临床试验质量管理规范》执行,有效保证临床试验过程的规范性和质量的可控性,切实保护受试者的安全和权益.     

基于GCP的药物临床试验质量管理探讨

遵循《药物临床试验质量管理规范》开展药物临床评价是根本原则.本文对我国药物临床试验机构、合同研究组织及政府监管部门的临床研究质量与管理现状进行了分析,旨在探索有效的质量管理模式,为研究者及管理者提供参考.     

022 抗氧化营养素用于癌症治疗的研究进展

一些学者提出科学地服用抗氧化营养素能有效改善抗癌治疗的效果,减轻放、化疗的副作用.已有大量的细胞培养试验和动物试验支持这一观点,部分临床试验也观察到复合抗氧化营养素在抗癌治疗中的积极效果.但复合抗氧化营养素的成分、剂量和用药时间还有待进一步研究,也亟需一些严格的临床随机双盲试验来进一步评价抗氧化营养素在癌症治疗中的效果.     

疗效比较研究的方法学应用及其实施过程

疗效比较研究(CER)可有效比较诊疗措施的临床效果,为医疗决策提供证据.其设计除采用大规模临床随机对照试验、整群随机对照试验、类试验、数学模型外,以电子病历为基础的观察性研究备受重视.对研究课题的证据生成、综合、传播及应用的每一环节上,采用CER均需相应的统计学方法进行统计分析和质量控制.     

微型高峰流速仪对哮喘类似冠心病胸闷的鉴别

目的探讨临床对哮喘类似冠心病胸闷症状鉴别诊断的有效方法,减少误诊的发生.方法对以类似冠心病胸闷为主要症状首诊的26例患者,用微型高峰流速仪支气管舒张试验,根据测定的呼气峰值流量(PEF)筛选出支气管舒张试验阳性的胸闷患者.可疑阳性患者再用肺功能测定仪进行支气管舒张试验.结果PEF改善率大于15%的支气管舒张试验阳性类似冠心病胸闷的患者16例,占61.54%,达支气管哮喘诊断标准;另外10例胸闷患者的PEF改善率均大于6%.结论采用微型高峰流速仪做支气管舒张试验测定PEF,是临床对哮喘类似冠心病胸闷鉴别诊断的无创、安全、方便、价廉、有效的筛选方法.     

神经根型颈椎病的诊断与治疗

为明确诊断及有效治疗神经根型颈椎病,主要诊断依据为典型的临床症状、体征及影像学检查;根性痛是神经根型颈椎病最重要的临床表现;常用的检查方法酶溶解术spurling试验、Jackson试验、上肢伸展试验、脊神经牵拉试验.治疗方法主要有非手术治疗和手术治疗;非手术治疗包括颈椎牵引疗法、理疗、硬膜外前侧间隙胶原等.手术治疗包括颈椎前路手术、颈椎侧方手术、颈椎后路手术.     

4种不同结核分枝杆菌检测方法对结核病的诊断价值比较

目的 利用基因芯片法、金标法检测结核抗体、抗酸染色涂片法及结核菌素试验等方法进行结核分枝杆菌的检测诊断比较,以评价不同方法在结核病诊断中的临床应用价值.方法 用基因芯片法、金标法检测结核抗体、抗酸染色涂片法及结核菌素试验对172例临床病例或临床标本进行同步检测;比较各方法的检出率、灵敏度及特异度的指标.结果 基因芯片法、金标法、抗酸染色法及结核菌素试验检测结核分枝杆菌的阳性率分别为36.0%、50.6%、11.6%和75.6%;4种方法的灵敏度分别为81.6%、73.7%、26.3%和88.2%;特异度分别为100.0%、67.7%、100.0%和34.4%.结论 基因芯片法与金标法、抗酸染色法及结核菌素试验比较,具有简便、快速、敏感性高和特异性强等优点,是临床结核病快速诊断的有效检测方法.     

心脏再同步化疗法治疗心力衰竭的15例临床分析

目的 观察心脏再同步化疗法治疗心力衰竭的临床疗效.方法 对15例行心脏再同步化治疗的心衰患者的临床资料进行总结分析.结果 患者术后3个月的心功能分级、QRS、LVEF、LVEDD及6 min步行试验均显著优于术前.结论心脏再同步化治疗能明显改善患者的心功能,确为治疗心力衰竭的有效新途径.     

Calcium intake in the elderly: validation of a dietary questionnaire

Epidemiological studies of calcium and osteoporosis have been hampered by the lack of a suitable tool for assessing calcium intake. This report describes a new frequency and amount questionnaire for measuring present and past calcium intake in the elderly. The validity of the questionnaire was tested against two commonly used standards of dietary assessment, five-day duplicate diets and seven-day weighed dietary inventories. The resulting correlation coefficients were, respectively, r = 0.76 and r = 0.69, while that for repeatability was r = 0.84. Furthermore, the questionnaire categorized subjects into thirds of the distribution of intake with almost no gross misclassification. It is suggested that the present findings may be extended to the majority of normal, healthy elderly subjects, implying wide application for the questionnaire in the assessment of calcium intake in the elderly.     

Self-reported health problems among Swedish miners one year after unemployment

Unemployment is considered to be a public health concern sincedeterioration in the health of the unemployed is often anticipated.However, for some groups, such as miners, unemployment mightimprove health due to a cessation of potentially harmful occupationalexposures. This study evaluates the health of 79 miners in oneSwedish iron-ore mine, and 226 age-matched controls from thegeneral population, during one year after the closure of themine. The participants received a questionnaire regarding medicalhistory and subjective symptoms at the beginning of the studyperiod, and after one year. Statistically significant negativeeffects on self-reported health attributable to unemploymentwere not found, although neuropsychiatric symptoms were morecommon among the unemployed miners. The miners reported a statisticallysignificant improvement in grip force (p=0.031). They had asignificantly higher prevalence of symptoms associated withmining related exposures when compared with the population controls;pain in the upper extremities [relative risk (RR)=2.27, 95%confidence interval (Cl)=1.44–3.59), back pain (RR=1.84;Cl=1.237–2.75), vasospastic disease of the fingers (RR=2.05;Cl=1.18–3.57) and obstructive respiratory symptoms (attacksof dyspnea and wheezing: RR=3.67; Cl=1.167–11.6).     

Excès de cas humains et animaux de tularémie en France au cours de l’hiver 2007–2008 : émergence ou phénomène isolé ?

Context

Tularemia is a zoonosis affecting humans and hares in France. We describe the results of surveillance in both species, in 2007 and 2008.

Methods

Human tularemia cases are mandatorily notifiable in France since 2003. In hares, surveillance relies on volunteer hunter associations in all districts of the country. Data from mandatory reports and volunteer surveillance in 2007/2008 were analyzed and compared with previous results.

Results

In 2007/2008, 144 cases were reported in humans and 117 cases in hares. This was a 100% increase compared to previous years. Human cases differed from those of previous years only by the frequency of contact with breeding animals. Human cases without any documented risk exposure were also more frequent.

Conclusion

An increase of tularemia cases occurred in 2007/2008 in both species. Complementary studies are needed to identify the species reservoir in France to understand the causes of this peak of cases.     

Occupational health hazards in mining: an overview

This review article outlines the physical, chemical, biological, ergonomic and psychosocial occupational health hazards of mining and associated metallurgical processes. Mining remains an important industrial sector in many parts of the world and although substantial progress has been made in the control of occupational health hazards, there remains room for further risk reduction. This applies particularly to traumatic injury hazards, ergonomic hazards and noise. Vigilance is also required to ensure exposures to coal dust and crystalline silica remain effectively controlled.     

Manufacture and use of nanomaterials: current status in the UK and global trends

This paper provides an overview of the production and use of nanomaterials (NMs), particularly in the UK. Currently, relatively few companies in the UK are identifiable as NM manufacturers, the main emphasis being the bulk markets in metals and metal oxides, and some niche markets such as carbon nanotubes and quantum dots. NM manufacturing in the UK does not reflect the global emphasis on fullerenes, nanotubes and fibres. Some assumptions have been made about the types of NM that are likely to be imported into the UK, which currently include fullerenes, modified fullerenes and other carbon-based NMs including nanotubes. Many university departments, spin-offs and private companies have developed processes for the manufacture of NMs but may only be producing small quantities for research and development (R&D) purposes. However, some have the potential to scale up to produce large quantities. The nanotechnology industry in the UK has strong R&D backup from universities and related institutions. This review has covered R&D trends at such institutions, and appropriate information has been added to a searchable database. While several companies are including NMs in their products, only a few (e.g. manufacturers of paints, coatings, cosmetics, catalysts, polymer composites) are using nanoparticles (NPs) in any significant quantities. However, this situation is likely to change rapidly. There is a need to collect more information about exposure to NPs in both manufacturing and user scenarios. As the market grows, and as manufacturers switch from the micro- to the nanoscale, the potential for exposure will increase. More research is required to quantify any risks to workers and consumers.     

深圳公立医院管理体制改革制度设计

深圳公立医院管理体制改革实行政事分开、管办分开,在理事会架构下按法定机构模式组建市医管中心,落实公立医院运营管理自主权.作者从当前公立医院管理体制的弊端入手,介绍了深圳市进行公立医院管理体制改革的基本思路及改革方案设计的主要举措,深入剖析了的改革方案的特点,并对改革效果进行了预测.     

Effects of nitrogen dioxide on red blood cells of rats: Changes in components of red cell membranes during in vivo exposure to NO2

Red cell membranes, prepared from red blood cells of rats exposed to 4, 10, or 20 ppm nitrogen dioxide (NO₂) for 1 to 10 days, were examined for evidence of changes in membrane components. Appreciable changes were not found in contents of phospholipid and cholesterol during exposure to 10 ppm NO₂. By contrast, protein content altered with the time of exposure. Moreover, changes in protein composition were observed by employing sodium dodecyl sulfate — polyacrylamide gel electrophoresis. Twenty-four-hour exposure to NO₂ at the concentration above 10 ppm resulted in a marked increase in the percentage of lysophosphatidylethanolamine (LysoPE) to the total phospholipids. The prolonged exposure to 10 ppm NO₂ gave rise to a further increase in LysoPE, whereas the percentage of phosphatidylethanolamine (PE) showed a gradual decrease. A 1-day exposure to 4.0 ppm NO₂ also caused an increase in sialic acid content and decreases in those of PE and hexose. In addition to contents of these components the percentage of LysoPE increased 5 days after exposure and the elevated values were maintained up to the end of exposure period. These results demonstrate that red blood cells in circulation exhibit different membrane properties in terms of lipid and carbohydrate composition during 10 days of exposure to 4.0 ppm NO₂.     

Investigating clusters in the workplace and beyond

Clusters of disease are common and occur in the workplace and in the general community. They often arouse considerable concern among the population. Investigations have sometimes lead to exciting new knowledge, but in general the investigation of clusters is difficult and often unrewarding, especially for community clusters. In the workplace, investigations are more likely to find associations and even new causes, but still many clusters remain enigmatic. Despite this, there are many reasons for investigating clusters, including allaying community concern and identifying uncontrolled exposures. A structure for investigating clusters in the workplace is suggested.