无细胞百白破联合疫苗安全性和免疫原性研究

[目的]评价长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗的安全性和免疫原性。[方法]在江苏省连云港市赣榆县选择3~5月龄、未接种过百白破联合疫苗、无百日咳白喉破伤风疾病史的足月健康儿童进行临床研究,采用随机、双盲、同类疫苗平行对照设计,将观察对象按3︰2的比例随机分别接受观察疫苗和对照疫苗的接种。在观察期内对接种对象进行安全性观察,接种前后采集血清样本,进行免疫原性的观察。[结果]受试者全身中度发热反应发生率为1.62%（15/924）,没有出现全身严重及以上反应。未出现中度以上局部反应。免疫原性结果表明：受试者破伤风抗毒素阳转率为100.00%;白喉抗毒素阳转率为98.05%;抗百日咳毒素抗体阳转率为87.99%,抗丝状血凝素抗体阳转率为93.18%。[结论]该疫苗接种后具有低反应性和较好的免疫原性。     

无细胞百白破联合疫苗的安全性及免疫原性研究

目的 评价玉溪沃森生物技术有限公司研制的吸附无细胞百白破联合疫苗(DTaP)的安全性和免疫原性.方法 在广西苍梧县选择600名3～5月龄,未接种过DTaP、无百日咳白喉破伤风病史的健康儿童进行临床研究,采用随机、盲法以及同类疫苗平行对照方法,将观察对象按2:1比例随机分别接种试验疫苗和对照疫苗(武汉所产DTaP),在观察期内对接种对象进行安全性观察,采集接种前后血清标本,采用ELISA法测定白喉和破伤风的抗体水平和免疫前后血清中抗PT和FHA抗体效价.结果 两疫莳组均未见严重局部和全身反应,局部反应率(1.02%)及全身反应率(21.38%)与对照组(分别为0.84%,18.15%)比较无统计学差异.免疫后抗白喉抗体(D)、抗破伤风抗体(T)、抗百日咳毒素抗体(PT)、抗丝状血凝素抗体(FHA)阳转率分别为100%、100%、97.32%和93.45%,与对照组(分别为95.78%、100.0%、88.55%和86.67%)比较D、PT、FHA抗体阳转率有统计学差异.免疫后D、T、PT、FHA抗体GMT水平分别为0.498、3.610、46.780和38.320,与对照组(0.381、2.160、33.380、32.840)比较有显著差异.结论 国产新的DTaP反应轻微,安全性好,抗体应答与同类上市疫苗相似,可以推广使用.     

吸附无细胞百白破联合疫苗的安全性和免疫原性研究

目的评价某公司研制的吸附无细胞百白破联合疫苗(DTaP)的安全性和免疫原性。方法选择1 200名3~5月龄知情同意、无百白破疫苗接种史、无百日咳白喉破伤风病史、无百白破疫苗接种禁忌症的健康婴幼儿,按1∶1比例随机接种3针次试验疫苗和对照疫苗,每针次间隔1个月。在观察期内对受试者进行安全性观察,采集免前和全程免疫后第28d血清样本,进行免疫原性观察。结果免疫后试验组抗百日咳毒素(PT)、丝状血凝素(FHA)、白喉类毒素(DT)、破伤风类毒素(TT)抗体阳转率均99%,与对照组相比,差异均无统计学意义(P值均0.05),试验组非劣效于对照组。4种抗体几何平均浓度(GMC)试验组均高于对照组(P值均0.01);抗体几何平均增长倍数(GMFI)除PT抗体外,其他3种抗体水平试验组均高于对照组(P值均0.05)。两组全身和局部不良反应均以1级和2级为主,3级不良反应发生率均2%,仅疲倦乏力、肿、疼痛等发生率试验组(2.17%~6.17%)高于对照组(0.67%~3.50%)(P值均0.05)。结论该公司研制的吸附无细胞百白破联合疫苗与同类上市疫苗相比,免疫原性较好,不良反应轻微,安全性可以耐受,可进一步进行多联疫苗探索和研究。     

一种无细胞百白破联合疫苗的免疫学效果评价

目的：评价长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗（观察疫苗）应用于3～5月龄儿童的免疫原性。方法：在江苏省赣榆县选择3～5月龄未接种过百白破联合疫苗的健康儿童进行现场试验,采用随机、双盲、同类疫苗平行对照设计,将观察对象按3;2的比例随机接受观察疫苗和对照疫苗（武汉生物制品研究所生产）的基础免疫全程接种。在接种前后采集血清样本,采用抗PT-ELISA、抗FHA—ELISA方法分别检测抗百日咳毒素抗体和抗丝状血凝素抗体,采用ELISA方法分别检测抗白喉和破伤风抗体。结果：受试者观察疫苗破伤风、白喉抗毒素阳转率分别为100．00％、98．05％;抗百日咳毒素抗体、抗丝状血凝素抗体阳转率分别为87．99％、93．18％。4种抗体阳转率与对照疫苗差异无显著性（P〉0．05）。观察疫苗免后四种抗体GMT水平分别为4．3985、0．8825、36．0000、43．5000,显著高于免疫前（P〈0．01）。结论：长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗接种后具有良好的免疫原性。     

中国不同区域婴儿抗百日咳白喉破伤风母体抗体水平的调查

目的调查中国不同区域婴儿抗百日咳、白喉、破伤风母体抗体水平。方法在10年内分别在中国6个不同区域,对3月龄左右未接种过百白破联合疫苗(DPT)的健康婴儿体内抗百日咳、白喉、破伤风抗体水平进行了8次调查。分别检测了抗百日咳凝集原(Aggs)抗体1 602人,抗百日咳毒素(PT)和抗丝状血凝素(FHA)抗体790余人,白喉、破伤风抗体1 196人。结果未接种过DPT健康婴儿体内的抗百日咳Aggs抗体和抗PT、FHA抗体都分别<1∶320和<20EU/ml的保护水平;抗白喉、抗破伤风抗体水平都<0.01HAU/ml的保护水平,而且在婴儿群体中这种低抗体水平不随时间、不依城市或农村、发达地区或不发达地区而变化。结论DPT的初免月龄建议提前至2月龄,推广使用无细胞DPT,在低龄婴儿达到有效预防百日咳、白喉、破伤风的目的。     

候选无细胞百白破-Sabin株灭活脊髓灰质炎联合疫苗免疫小鼠的效果研究

目的观察候选无细胞百白破-Sabin株灭活脊髓灰质炎联合疫苗(DTaP-sIPV)在小鼠中的免疫原性,为疫苗临床前研究提供依据。方法将候选疫苗分别稀释成5倍、10倍、20倍三组,以相应稀释的无细胞百白破-灭活脊髓灰质炎-b型流感嗜血杆菌联合疫苗(DTaP-IPV/Hib)、无细胞百白破联合疫苗(DTaP)为对照组,每组按0、4、8周3剂免疫程序免疫NIH小鼠(10只/组),检测各组小鼠每剂免疫后28d的血清百白破组分抗体水平。结果候选疫苗三个组完成3剂次免疫后PT抗体的几何平均浓度(GMC)(IU/mL)分别为2 157.29、2 142.51、2 135.17;FHA抗体GMC分别为10 098.30、10 068.33、9 143.30;PRN抗体GMC分别为1 683.86、1 130.29、193.00;DT抗体几何平均滴度(GMT)(1∶)分别为23.48、22.44、22.44;TT抗体GMT分别为22.31、21.24、21.34。候选疫苗三个组PT、FHA、DT、TT抗体水平均高于两种疫苗对照组或者与其无显著性差异,但PRN抗体水平低于DTaP对照组。结论候选疫苗免疫小鼠具有良好的免疫原性。     

吸附无细胞百日咳-白喉-破伤风联合疫苗的安全性及免疫原性研究

目的评价北京天坛生物制品股份有限公司生产市售的吸附无细胞百日咳一白喉一破伤风联合疫苗（Absorbed Diphtheria,Tetanusand Acellular Pertussis Combined Vaccine;DTaP）,在儿童中应用的安全性和免疫原性。方法在浙江省4个县（市、区）,选择3235名3～5月龄的初次免疫儿童和3198名18～23月龄加强免疫儿童,按照免疫程序接种此次观察的DTaP,进行接种后安全性观察。采用间接血凝试验（Indirect Hemagglutination Test,IHA）测定白喉、破伤风抗体（Antibodyto Diphtheria,Anti—D;Antibody to Tetanus,Anti—T）,采用酶联免疫吸附试验（Enzyme．1inked Immunosorbent Assay,ELISA）检测抗百日咳毒素抗体（Antibody to Pertussis Toxin,Anti—PT）、抗丝状血凝素抗体（Antibodyto Filamentous Hemagglutinin,Anti—FHA）,计算抗体阳转率。结果此次DTaP基础免疫共观察9560剂次,加强免疫3198剂次。基础免疫和加强免疫的不良反应发生率分别为6．31％和14．57％,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。基础免疫3剂后,Anti-D、Anti—T阳转率均达100％,Anti-FHA和Anti-PT阳转率分别为46．02％和95．58％;加强免疫后Anti—D、Anti-T阳性率100％,Anti-FHA和Anti-PT阳性率分别为80．53％和90．27％。结论此次观察的DTaP有良好的安全性;基础免疫和加强免疫后,Anti-D、Anti—T阳转率和Anti—PT阳转率均达到较高水平,但Anti—F-HA阳转率不高。     

吸附全细胞百白破乙肝四联疫苗效果观察

目的 考察武汉生物制品研究所研制的全细胞百日咳、白喉、破伤风、乙肝联合疫苗的安全性和免疫原性，探讨联合疫苗的免疫程序。方法 进行2期临床观察。将研究对象随机分为3组，第1组按照2、4、6月龄接种吸附百白破乙肝(CHO)联合疫苗；第2组按照3、4、5月龄接种吸附百白破乙肝(CHO)联合疫苗；第3组按照3、4、5月龄接种吸附百白破联合疫苗。2期研究也随机分为3组，第1组按照2、4、6月龄接种“百白破乙肝联合疫苗”；第2组按照2、4、6月龄左侧上臂接种乙肝对照疫苗，右侧上臂接种百白破三联对照疫苗。结果 一期安全性试验观察对象91名，其中接种四联疫苗的两组各有1名体温有较弱升高，分别占接种例数的3．3％。二期共接种365例，完成全程免疫共319例。其中四联疫苗2，4，6月龄接种组有4例出现副反应，发生率为3．1％；按2，4，6月龄左臂接种乙肝疫苗、右臂接种白百破三联疫苗组有5例发生副反应，发生率4．2％；第3组0、1、6月龄接种乙肝对照疫苗，3、4、5月龄接种百白破三联对照疫苗。共有14例发生副反应。发生率为12．2％。1、2期临床观察均未发现严重副反应。接种四联疫苗后，接种对象血清白喉、破伤风、乙肝抗体阳转率均达100％，百日咳抗体阳转率大于85％，免疫前后抗体水平具有显性差异。结论 吸附全细胞百白破乙肝四联疫苗具有较好的安全性和有效性，可用于免疫接种；采用2、4、6月龄接种程序可有效诱导产生百日咳、白喉、破伤风、乙肝的保护性抗体反应．     

国产麻疹-腮腺炎-风疹联合疫苗与麻疹疫苗的免疫效果评价

目的研究探讨国产麻疹-腮腺炎-风疹联合疫苗(MMR)和麻疹疫苗的免疫效果差异性,为下一步更好使用联合疫苗提供依据。方法选择8月龄儿童随机分为两组,分别接种MMR疫苗和麻疹疫苗,于免前免后采血,用酶联免疫吸附法(ELISA)定量检测接种者相应的IgG抗体水平。结果观察对象接种MMR疫苗前后麻疹IgG抗体GMT分别为1.536、27.763,抗体阳转率85.71%;另一组观察对象接种麻疹疫苗前后麻疹IgG抗体GMT为1.205、30.867,抗体阳转率82.14%,两组相比差异无统计学意义。观察对象接种MMR疫苗后风疹IgG抗体和腮腺炎IgG抗体的阳转率都在80%以上。结论国产MMR疫苗具有良好的免疫原性。     

江苏省2018年健康人群百日咳毒素和丝状血凝素IgG抗体水平调查

目的了解江苏省2018年健康人群百日咳毒素(Pertussis toxin,PT)和丝状血凝素(Filamentous hemagglutinin,FHA)IgG抗体水平。方法采用分层抽样在江苏省两个市选择7个年龄组健康人群,采用间接酶联免疫吸附试验检测血清PT IgG抗体(IgG antibody against PT,Anti-PT IgG)和FHA IgG抗体(IgG antibody against FHA,Anti-FHA IgG),分析抗体阳性(抗体浓度≥20IU/mL)率和几何平均浓度(Geometricmeanconcentration,GMC)。结果共纳入受试者752名,Anti-PT IgG、Anti-FHA IgG阳性率分别为14.76%、28.72%,GMC分别为12.37IU/mL、17.13IU/mL。各年龄组Anti-PT IgG阳性率在8.62%(3-5岁)-23.15%(10-14岁)之间(χ^2=15.59,P<0.05),Anti-FHAIgG阳性率在10.38%(0-1.4岁)-53.27%(10-14岁)之间(χ^2=57.50,P<0.05)。在<3岁儿童中,无细胞百白破联合疫苗0-2剂次、3剂次、4剂次免疫儿童Anti-PT IgG阳性率分别为6.67%、10.75%、13.25%(χ^2=1.30,P>0.05),Anti-FHA IgG阳性率分别为6.67%、17.39%、30.12%(χ^2=6.74,P<0.05)。结论江苏省2018年健康人群Anti-PTIgG和Anti-FHAIgG水平较低;建议对特定人群进行百日咳组分疫苗选择性免疫或补充免疫。     

Die sogenannte Vinylchlorid-Krankheit—eine berufsbedingte Systemsklerose?

Zusammenfassung Es wurden 13 Arbeiter untersucht, die zwischen 1 3/4 und 18 Jahren in einem PVC-herstellenden Betrieb beschäftigt waren. 8 von ihnen wiesen sklerodermieartige Hautveränderungen (Abb. 2) auf, die histologisch charakterisiert sind durch Verbreiterung und Homogenisierung der kollagenen Faserbündel (Abb. 3 u. 4) sowie Fragmentation und Rarefizierung der elastischen Fasern (Abb. 5). Bei 7 Patienten bestanden trommelschlegelartige Auftreibungen einzelner Fingerendphalangen (Abb. 1). 11 Patienten zeigten Durchblutungsstörungen der Extremitäten (4 von diesen ein Raynaud-Syndrom) und 6 Patienten Acroosteolysen einzelner Fingerendphalangen (Abb. 6, Tabellen 1–3).Darüber hinaus bestand bei allen Patienten eine Thrombocytopenie, bei 12 Patienten eine Splenomegalie, bei 11 Patienten eine Einschränkung der Leberfunktion (erhöhte BSP-Retention). An der Leber ließ sich histologisch bei den 5 laparoskopierten Patienten eine deutliche Fibrosierung der Portalfelder nachweisen. Bei 4 Patienten bestanden Oesophagusvaricen (Tabellen 4 u. 5). 8 Patienten zeigten eine Partialinsuffizienz mit Hinweisen für vorwiegend restriktive Veränderungen.Die hier beschriebenen Veränderungen gehen weit über das bisher bekannte Acroosteolysesyndrom hinaus. Es wird der dringende Verdacht geäußert, daß langfristige Vinylchlorid-Exposition dieses komplexe Krankheitsbild verursacht. Daher wird für diese systemische Krankheit die Bezeichnung Vinylchlorid-Krankheit vorgeschlagen.Wir danken Frau E. Voigtländer für die Herstellung der klinischen und histologischen Abbildungen.     

Empathic processes: perception by medical students of patients'' anxiety and depression

Perceptions by medical students of patients' affective states were investigated, and the effect of the students' own emotions on such perceptions. One hundred and one fourth-year medical students rated the levels of anxiety and depression of three women patients presented on videotape, rated their own levels of anxiety and depression and completed a questionnaire on aspects of the rating process. Students had widely different and often inappropriate perceptions of patients' levels of anxiety and depression. Students who consistently overrated anxiety or depression in patients, compared to those who consistently underrated, were themselves significantly more anxious or depressed. These data suggest a need in medical education for systematic teaching of empathic skills and for recognition of potential bias in clinical decision-making arising from the clinician's own emotional state.     

The reported incidence of work-related ill-health in Scotland (2002-2003)

BACKGROUND: Although incidence data for work-related ill-health in the UK are available, more detailed information for smaller geographical areas has hitherto been unpublished. AIMS: To estimate the incidence of work-related ill-health reported by clinical specialists in Scotland, 2002-2003. METHODS: THOR (The Health and Occupation Reporting network) is a UK wide reporting scheme for work-related ill-health. In 2002-2003, 241 out of 2162 physicians in THOR were based in Scotland. We have summarized the reported cases and calculated incidence rates for categories of ill-health by age, gender and industry. The UK Labour Force Survey (2002) was used to provide denominator data, with comparisons made between rates for Scotland and the rest of the UK. RESULTS: In 2002-2003, 4043 estimated cases were reported from Scotland. Mental ill-health was most frequently reported (41%); followed by musculoskeletal disorders (31%), skin disorders (16%), respiratory disease (10%), hearing disorders (2%) and infection (1%). The reported average annual incidence rate per 100,000 employees for all work-related ill-health in Scotland was 86.0. The highest reported rate for mental ill-health was found for employees in public administration and defence (76.7 per 100,000), and health and social work (72.3 per 100,000). The construction industry had the highest reported rate of musculoskeletal disorders (41.6 per 100,000), while hairdressers appeared at most risk of developing occupational contact dermatitis (rate=86.4 per 100,000). CONCLUSIONS: Despite its limitations, THOR has indicated types of work-related ill-health and related industries for targeted disease prevention in Scotland.     

Function of the protein RPE65 in the visual cycle

A protein called RPE65 performs a key role in the trans-cis isomerization of retinol in the retinal pigment epithelium of the eye. The palmitoylation of RPE65 serves to switch off the visual cycle in darkness and to switch it on in the light.     

Acute symptoms following work with pesticides

BACKGROUND: Serious accidental poisoning by pesticides is rare in the UK, but more minor pesticide-related illness may be under-reported. Anecdotally, use of sheep dip has been linked with flu-like symptoms. AIM: To explore the frequency, nature and determinants of acute symptoms following work with pesticides. METHODS: A postal survey of men in three rural areas of England and Wales provided data on occupational use of five categories of pesticide, occurrence of 12 specified symptoms within 48 h of using pesticides and tendency to somatize. Risk factors for pesticide-related symptoms were assessed by modified Cox regression. RESULTS: Of 10 765 responders (response rate = 31%), 4108 had at some time used pesticides occupationally, including 935 (23%) who reported symptoms following such work on at least one occasion. In two areas, acute symptoms were most frequent following use of sheep dip (29 and 32% of users), but in the third area the rate was significantly lower (13% of users). The relative frequency of symptoms was similar for all five categories of pesticide, and flu-like symptoms did not cluster unusually among users of sheep dip. Risk of pesticide-related symptoms increased with somatizing tendency (prevalence ratio for highest versus lowest category 2.4, 95% confidence interval 2.0-3.0) and was higher in men who had used pesticides most often or handled concentrate. CONCLUSION: Acute symptoms are common following work with pesticides, but in many cases the illness may arise through psychological rather than toxic mechanisms.     

The Life Events Inventory: re-scaling based on an occupational sample.

The objective of this study was to compare the validity of the original weightings used by the Life Events Inventory (LEI) with those obtained from a contemporary occupational sample. Fifty male and 62 female manufacturing employees (age range 16-55 years) assigned scores to each item on a slightly modified version of the LEI scale. The current sample consistently assigned higher weights to events/items than did the original sample, but there was high agreement in terms of item ranking. Some distinct age and gender differences in scoring were apparent, and are discussed further. It was concluded that when separate weightings are employed for age and gender groups, the LEI remains a useful tool for quantifying background levels of stress in both workplace stress audits and epidemiological studies where statistical control for non-occupational sources of stress is required.     

Maxillofacial injuries related to work accidents: a new concept of a hospital-based full electronic occupational trauma surveillance system

The objective of this study was to investigate the occurrence of occupational maxillofacial injuries using a newly installed relational database. Twenty-six injuries were identified out of 28,624 patients admitted to the emergency unit during a 12 month period. Falls from height or being struck by moving objects were common causes of these injuries. Two-thirds of those identified were construction workers. This paper demonstrates the power of modern databases to identify specific occurrences that may provide the basis for prevention in the future.     

Rôles physiologiques des endocannabinoïdes dans le contrôle de l’homéostasie énergétique

Endocannabinoids are endogenous lipids which modulate the release of neurotransmitters and activate different signaling pathways, through the binding to cannabinoïd receptors, CB1 and CB2. Endocannabinoids are involved in the control of a variety of behavioural and neuroendocrine functions, including feeding behaviour. In the central nervous system, they essentially modulate the expression of orexigen or anorexigen neuropeptides thus resulting in the stimulation of food intake. Their peripheral targets are mainly the liver and the white adipose tissue where they stimulate lipogenesis, through the modulation of several enzymes and proteins expressions. Cannabinoïd receptor agonists are nowadays prescribed to improve appetite of people suffering from cancer or AIDS. In the same way, CB1 antagonist, such as Rimonabant, could provide efficient treatment of obesity.     

Stress in police officers: a study of the origins,prevalence and severity of stress-related symptoms within a county police force

BACKGROUND: High levels of stress-related illness are causing concern across industry. Against a background of impending legislative moves to try to improve this situation, there is a need to identify key work-related stressors. Police work tends to be regarded as inherently stressful because of the personal risk of exposure to confrontation and violence and the day-to-day involvement in a variety of traumatic incidents. As a result, high levels of stress-related symptoms might be expected in this population. OBJECTIVE: To examine the sources of stress-related symptoms within police officers and measure the prevalence of significant associated mental ill-health. METHOD: A cross-sectional questionnaire survey of a population of 1206 police officers was performed to assess levels of strain associated with a series of potential home and work related stressors. Participants were then split into low and high scoring groups on the basis of a General Health Questionnaire (GHQ) threshold score in order to identify those stressors most associated with mental ill-health effects. RESULTS: Occupational stressors ranking most highly within the population were not specific to policing, but to organizational issues such as the demands of work impinging upon home life, lack of consultation and communication, lack of control over workload, inadequate support and excess workload in general. The high scoring group constituted 41% of the population and differed significantly from those with low scores in perception of all stressors, ranking both personal and occupational stressors more highly, and from personality constraints appeared significantly more 'stress-prone'. A significant association between gender and mental ill-health was found, with females more likely to score more highly on the GHQ than males. CONCLUSION: This study confirms previous findings of organizational culture and workload as the key issues in officer stress. Given that the degree of symptomatology appears to be worsening, management action is required. Further research is indicated within the police population into a possible increased susceptibility in female officers.