成年人连续三批次流感裂解疫苗接种的安全性、免疫原性观察

目的 评价流感裂解疫苗安尔来福TM的安全性和免疫原性,考核疫苗生产工艺的稳定性.方法 采用随机双盲设对照的临床试验设计,试验疫苗为连续三个批次的安尔来福TM,以进口疫苗为对照.受试者为566名18～60岁健康成年人,按照4个年龄层随机分配到4个试验组,疫苗含甲1型、甲3型和乙型流感病毒抗原各15 μg.免疫程序为1针,接种后进行30 min即时反应观察以及24、48、72 h的随访观察,免疫前及免疫后第21天采血,将成对血清设盲后进行血凝抑制(HI)抗体检测.结果 受试者以轻度不良反应为主,各试验组发热反应发生率为1.4%～2.8%,组间差异无统计学意义.4个组3个型别HI抗体阳转率均≥80.3%,GMT增长倍数≥11.1,抗体保护率≥93.4%.三个批次安尔来福TM3个型别的HI抗体阳转率、GMT增长倍数及血清抗体保护率均超过欧盟及美国FDA标准.结论 连续三批次安尔来福TM具有良好的免疫原性和安全性,疫苗生产工艺稳定.     

流行性感冒裂解疫苗安尔来福在成人和老年人中应用的安全性观察

目的 评价流行性感冒(简称流感)感裂解疫苗安尔来福的安全性.方法 在十堰市东风集团进行开放式临床观察,受试者为97名18～60岁成人和101名≥61岁老年人,其中28例有慢性病史,全部受试者健康状态稳定.在受试者签署知情同意书后接种0.5 ml/支流感裂解疫苗安尔来福,接种后观察7 d,直至不良反应消失.结果 共发生不良反应17例,不良反应发生率为8.6%,其中成人组和老年组不良反应发生率分别为13.4%(13/97)和4.0%(4/101),差异有统计学意义(x2=5.620,P=0.018).局部不良反应发生率为5.5%(11/198),主要为接种部位疼痛;全身不良反应发生率为3.5%(7/198),以发热最多.有慢性病史受试者未观察到不良反应.结论 本次观察未见由疫苗引起新的不良反应,亦未见严重不良事件及罕见不良反应,流感裂解疫苗安全性良好.     

季节性流感裂解疫苗安尔来福®up>®的安全性、免疫原性及与H7N9禽流感病毒的交叉免疫研究

目的 评价季节性流感裂解疫苗（安尔来福^®）的免疫原性及安全性,分析与H7N9禽流感病毒的交叉免疫反应。方法 采用临床研究开放式设计,选择6～35月龄婴幼儿（免疫接种方式：2针,0、28 d）、18～60岁成年人及>60岁老年人（1针）接种安尔来福^®。所有接种者免疫后均接受安全性观察,并采集成年人和老年人免疫前后21 d的血清标本,利用血凝抑制试验（HI）检测疫苗3种（甲型流感2种和乙型流感1种）病毒株以及H7N9禽流感病毒抗体。采用欧盟流感疫苗临床研究标准（欧盟标准）评价疫苗免疫效果。结果 共202（婴幼儿65、成年人69及老年人68）人完成接种和安全性观察。不良反应发生率为12.4%（25/202）,以全身不良反应为主,未见严重不良反应。有124（成年人64、老年人60）人采集到免疫前后配对血清。接种疫苗后21 d,成年组3个型别HI抗体阳转率为78.1%～90.6%,抗体保护率为92.2%～100.0%,GMT增长7.9～41.0倍;老年组HI抗体阳转率为66.7%～83.3%,抗体保护率为86.7%～100.0%,GMT增长5.7～20.4倍。均达到欧盟标准。而接种疫苗后,成年组和老年组抗H7N9抗体阳性率和阳转率仍保持为零,GMT增长仅1.2～1.4倍。结论 季节性灭活流感裂解疫苗的安全性和免疫原性良好,但对H7N9禽流感病毒无交叉免疫反应。     

国产无硫柳汞三价流感病毒裂解疫苗上市后免疫原性和安全性观察

目的评价一种无硫柳汞的国产三价流感病毒裂解疫苗(TIV)上市后免疫原性和安全性。方法采用单中心、无对照设计在湖北省某乡镇招募≥6月龄健康受试者,接种本研究TIV,检测受试者免疫前和全程免疫后21-28d血清H1N1、H3N2、B型流感病毒血凝抑制(HI)抗体,观察接种后7d内不良反应。结果 591名受试者TIV免疫后H1N1、H3N2、B型流感病毒HI抗体阳转率分别为73.3%、86.3%、65.8%,抗体几何平均滴度(GMT)分别比免疫前增长10.9倍、20.2倍、8.0倍,抗体保护率分别为97.5%、100%、96.6%。720名受试者接种疫苗后总不良反应发生率为4.4%,其中局部反应、全身反应分别为0.8%、3.6%,未发现严重不良反应。结论本研究TIV应用于≥6月龄人群的免疫原性和安全性良好。     

流行性感冒裂解疫苗与亚单位疫苗的血清学效果观察

为了观察流行性感冒 (流感 )亚单位疫苗和裂解疫苗的安全性和血清学效果 ,选择 2 39名 2 2～ 6 6岁 (平均 37岁 )健康人群 ,分两组于 2 0 0 3年 9月接种流感疫苗。第 1组接种流感亚单位疫苗 ,第 2组接种流感裂解疫苗 ,应用血凝抑制试验 (HI)检测流感抗体 ,同时进行临床反应观察。结果显示 :接种两组疫苗的发热弱、中反应发生率分别为 6 19%、5 5 5 % ,接种两组疫苗后 3个型别抗体阳转 (含HI抗体≥ 4倍增长 )率平均分别为 94 %～ 96 %、93%～94 %、90 %～ 92 %。抗体保护水平 (≥ 1∶4 0 )亚单位与裂解疫苗均达到 10 0 %。接种两组疫苗前后 3个型别抗体几何平均滴度增长倍数为 :流感亚单位疫苗增长 4～ 6倍 ,流感裂解疫苗增长 4～ 7倍。两组疫苗不良反应发生率与血清学效果差异均无显著的统计学意义。表明观察的两种流感疫苗均具有良好的安全性和血清学效果。     

流行性感冒裂解疫苗安尔来福在婴幼儿及儿童中应用的安全性观察

目的 进一步考察流感裂解疫苗安尔来福在6个月至3岁内婴幼儿及3～11岁儿童中应用的安全性,发现新药临床试验中可能未发现的不良反应.方法 本试验采用开放式临床试验设计,受试者为6个月至3岁以内婴幼儿和3～11岁儿童各100名,婴幼儿组使用剂量为0.25 ml/支,免疫程序为0、28 d.儿童组使用剂量为0.5 ml/支,免疫程序为1针.接种后进行30 min即时反应观察,以及进行24、48、72 h随访观察,接种后第7天如受试者未主动报告任何不良事件,将结束随访观察.结果 接种疫苗后总体不良反应发生率为6.0%(12/200),其中局部不良反应发生率为1.0%(2/200),全身不良反应发生率为5.5%(10/200),幼儿组和儿童组不良反应发生率分别为8.0%(8/100)和4.0%(4/100),均为轻度和中度反应,未见严重不良反应发生.结论 流感裂解疫苗安尔来福在6个月至3岁以内婴幼儿及3～11岁儿童中应用安全性良好.     

流行性感冒病毒裂解疫苗安尔来福^TM2007～2008年度安全性调查

目的考察流行性感冒（流感）病毒裂解疫苗安尔来福^TM在人群中应用的安全性。方法在14个设区的市,选择婴幼儿、儿童、少年、成人、老年人,按照程序接种流感病毒裂解疫苗,然后进行7d安全性观察,评价不良反应发生情况。结果观察对象2794人,年龄范围为6月龄～90岁。接种疫苗后总不良反应发生率为6.6%,以轻度反应最多,未见严重不良反应及新的、罕见的不良反应。局部反应发生率为2.1%,其中接种部位疼痛发生率为1.7%。全身反应发生率为5.0%,其中发热率为3.8%。结论流感病毒裂解疫苗安尔来福^TM安全性良好。     

国产流行性感冒病毒裂解疫苗的安全性和免疫原性研究

2000年11月～2001年4月在江西省九江市,对我国按日本工艺制备的三价流行性感冒(流感)病毒裂解疫苗的安全性和免疫原性进行了系统研究,并以进口的同类疫苗(防感灵)和安慰剂作对照,用血凝抑制试验(HI)检测疫苗抗体.结果显示国产疫苗和进口疫苗分别接种487人和245人,其发热反应率分别为2.26%和2.04%;皮疹发生率分别为0.21%和0.41%,两组的差异无显著的统计学意义.各组均未见局部反应及其它副反应.另两组分别有333人和190人采血做HI试验,其HI抗体总阳性率分别为81.1%～94.9%和78.4%～93.2%,两种流感疫苗的差异无显著的统计学意义.按欧盟标准分别对两种疫苗各型别间抗体保护率(≥1∶40)进行统计,均达到或超过该标准.表明国产流感病毒裂解疫苗反应轻微,安全性好,免疫原性亦好,可以推广使用.     

国产流行性感冒病毒裂解疫苗的安全性和免疫原性研究

目的观察国产流行性感冒(流感)病毒裂解疫苗的安全性和免疫原性。方法2003年6~11月,在广西柳城县,对北京科兴生物制品有限公司的三价流行性感冒(流感)病毒裂解疫苗进行安全性和免疫原性研究,并以进口的同类疫苗(凡尔灵)作对照,用血凝抑制试验(HI)检测疫苗抗体。结果国产疫苗和进口疫苗分别接种1094人和240人,各组均未见严重局部反应及其它严重副反应,其发热反应率分别为3 33%和6 25%,各有1例发生局部红肿,两组的差异无显著的统计学意义。两种疫苗组于免后分别对571人和163人采血做HI试验,流感病毒H1N1、H3N2、B(亚)型的HI抗体总阳转率分别为84.2%、50.0%、60.1%和84.0%、57.7%、58.3%,两种流感疫苗的HI抗体总阳转率差异无显著的统计学意义。结论国产流感病毒裂解疫苗反应轻微,安全性好,抗体应答与进口的同类疫苗相似,可以推广使用。     

一种澳大利亚流行性感冒裂解疫苗临床反应及血清学效果观察

[目的]评价澳大利亚CSL公司研制的流行性感冒裂解疫苗(试验疫苗)在不同人群的临床安全性与免疫效果,为论证其我国推广应用的可行性提供依据.[方法]2007年5～7月,在崇左市江州区对试验疫苗进行人群观察,并与对照组接种英国史克生物制品有限公司生产的流行性感冒裂解疫苗(对照疫苗)比较.[结果]试验组(460人)和对照组(230人),接种后试验组出现局部反应的占4.13%,包括1例重度反应;全身反应发生率为8.04%(19人为发热).对照组只有3.48%出现轻度局部反应,5.22%出现发热反应.接种后流感病毒H1N1、H3N2、B(亚)型HI抗体阳转率,试验疫苗组分别为88.09%、78.16%、82.13%,对照疫苗组分别为91.30%、82.13%、76.81%;H1N1、H3N2、B(亚)型抗体达到保护水平者所占比例,试验疫苗组分别为99.26%、97.29%、92.31%,对照疫苗组分别为96.62%、99.03%、88.41%,其中H1N1亚型试验组高于对照组(P＜0.05).[结论]进口流感裂解疫苗具有较好的安全性和免疫原性.     

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.     

The human drama of genetics: 'hard' and 'soft' media representations of inherited breast cancer

This paper examines media coverage of 'breast cancer genetics', and explores its implications for public understanding. We present a content analysis of coverage in British newspapers and look at a variety of popular forms, including women's magazines, television soap opera and radio drama. Genetic/inherited risk receives a great deal of coverage across a wide range of media formats and outlets. Much of this attention has focused on individuals from 'high risk families' and dilemmas around prophylactic mastectomies. Through examining media coverage, combined with interviews with media personnel and their sources, we show why this story proved so attractive to the media and highlight the different production values which influence coverage. Finally, we introduce preliminary findings from focus group discussions to demonstrate how such 'human interest' framing has engaged audience attention and influenced public understandings. The paper concludes by highlighting the implications for analysing, predicting, and engaging with, media representations of science.     

Worker education in the primary prevention of occupational dermatoses

This paper reports the evaluation of a skin care education programmeconducted on a fine chemicals manufacturing site where over1,000 employees are located. Approximately 60% are involvedin chemical manufacture. Over a 12 month period production staffreceived training in prevention of occupational dermatoses linkedto a site-wide poster initiative. The incidence of new casesof occupational dermatoses fell from 0.055 (70 cases in 1,277employees) to 0.021 (27 cases in 1,277 employees) before andafter the intervention respectively (p<0.0001). After otherfactors such as chemicals handled, observer bias and changesin reporting related to socioeconomic climate were taken intoaccount it is concluded that this study demonstrates the importanceof worker education as a tool for primary prevention of disease.Training materials such as video and poster presentations maybe effectively used in the chemical manufacturing industry asan adjunct to prevention and control of exposure to substanceshazardous to the skin. Such methods may also be used in otherindustries where there are significant risks of dermatoses.     

Regional Variation in Travel-related Illness acquired in Africa,March 1997–May 2011

To understand geographic variation in travel-related illness acquired in distinct African regions, we used the GeoSentinel Surveillance Network database to analyze records for 16,893 ill travelers returning from Africa over a 14-year period. Travelers to northern Africa most commonly reported gastrointestinal illnesses and dog bites. Febrile illnesses were more common in travelers returning from sub-Saharan countries. Eleven travelers died, 9 of malaria; these deaths occurred mainly among male business travelers to sub-Saharan Africa. The profile of illness varied substantially by region: malaria predominated in travelers returning from Central and Western Africa; schistosomiasis, strongyloidiasis, and dengue from Eastern and Western Africa; and loaisis from Central Africa. There were few reports of vaccine-preventable infections, HIV infection, and tuberculosis. Geographic profiling of illness acquired during travel to Africa guides targeted pretravel advice, expedites diagnosis in ill returning travelers, and may influence destination choices in tourism.     

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.     

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.     

The design of hazard risk assessment matrices for ranking occupational health risks and their application in mining and minerals processing

Two hazard risk assessment matrices for the ranking of occupational health risks are described. The qualitative matrix uses qualitative measures of probability and consequence to determine risk assessment codes for hazard-disease combinations. A walk-through survey of an underground metalliferous mine and concentrator is used to demonstrate how the qualitative matrix can be applied to determine priorities for the control of occupational health hazards. The semi-quantitative matrix uses attributable risk as a quantitative measure of probability and uses qualitative measures of consequence. A practical application of this matrix is the determination of occupational health priorities using existing epidemiological studies. Calculated attributable risks from epidemiological studies of hazard-disease combinations in mining and minerals processing are used as examples. These historic response data do not reflect the risks associated with current exposures. A method using current exposure data, known exposure-response relationships and the semi-quantitative matrix is proposed for more accurate and current risk rankings.