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Biomedical subjects

M Nübling

Publications and source records attributed to M Nübling.

At least 19 recordsLinked to original sources
PubMed2007

[Need for and use of a university clinic mental health liaison service].

BACKGROUND: Little is known about the complex decision-making process involving recognition of psychosocial stress, its diagnosis, and psychotherapeutic intervention within the framework of a psychosomatic consulting and liaison service. PATIENTS AND METHODS: Psychosocial stress was recorded using a psychometric questionnaire for 392 patients on admission to hospital, the estimated need of psychotherapeutic treatment, and the application of a psychosomatic liaison service. RESULTS: Of the examined patients, 44% presented with at least one mental disorder requiring treatment according to ICD-10 criteria. According to the expert opinions, a need for psychotherapeutic treatment was present in 41%, while 54% were themselves motivated for at least one of the psychotherapeutic treatments offered. Psychotherapy was actually received by 35% of the patients. While mental disorders and emotional distress were significant predictors of the need for treatment as rated by experts, they played no genuine role in determining indication or whether a patient accepts the use of psychotherapy CONCLUSION: Psychotherapeutic interventions in the liaison service are not always effective or related to the indication.

Adolescent↗
PubMed2005

[Regulatory aspects of clinical trials with emphasis on biologicals].

Clinical trials play a central role in clinical development for achieving marketing authorization for a drug. Carefully planned and carried out clinical trials allow for valid conclusions on the efficacy and/or safety of a drug. In order to do so, various requirements have to be fulfilled: clinical studies are to be planned and conducted in accordance with Good Clinical Practice, scientifically sound methods have to be applied, the patients' safety has to be ensured, trial objectives and results have to be clinically relevant, quality and transparency of all steps from planning to reporting a clinical study have to be ensured. For biologicals, special attention has to be paid to specific aspects, such as their mode of action or possible impact on the environment. Various guidelines reflecting regulatory aspects are available to support drug development. In addition, specific questions on drug development might be discussed directly between study sponsors and regulatory agencies. Due to the changes imposed by the 12th law amending the German Drug Law (Arzneimittelgesetz), the relevant German authorities will be more involved in the planning and conduct of clinical trials.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

A description of the standardized measurement procedures and recommended threshold limit values for biological hazards in Germany.

On the basis of EU directives 89/391/EEC (to encourage improvements in the safety and health of workers at work) and 2000/54/EC (on the protection of workers from risks related to exposure to biological agents at work), biological hazards at work have to be assessed and preventive measures have to be introduced in all member states of the EU. In Germany, national legislation (Biological Agents Ordinance - BioStoffV and Technical Rules on Biological Agents, TRBA) and recommendations of workers' compensation boards define standardized methods for the assessment of airborne mold, bacteria, and endotoxins. This article describes policies and practices in Germany for measurement of airborne bioaerosols and for interpretation of measurements relative to the standards. As an example, methods and results of measurements in agriculture are shown. The standardized measurement procedures proved suitable for use in livestock buildings. The results of the exploratory measurements in different livestock buildings confirmed the often high concentrations of airborne biological hazards in agriculture that are reported in the literature.

Agricultural Workers' Diseases↗
PubMed2004

Effect of a diphtheria booster vaccination in adults with a documented history of an incomplete primary series vaccination.

BACKGROUND: An incomplete series of diphtheria vaccination is frequently found in the vaccination documents of adult patients. This paper investigates the effect of a booster vaccination in adults with an incomplete series of primary vaccination. MATERIALS AND METHODS: The effect of one diphtheria booster vaccination in adults with a documented history of only two childhood vaccinations has been investigated in 21 adults. Before the vaccination and 4 to 8 weeks thereafter, blood samples were taken and analyzed with an in vitro neutralization assay. RESULTS: None of the participants had prevaccinal full protective diphtheria antitoxin levels (AT) > or = 0.1 IU/ml and four (19%) had limited serological protection (AT 0.01 to 0.1 IU/ml). After the vaccination, 14 individuals (67%) had protective LeveLs and six (29%) had limited protective levels. The risk for post-booster non-protection (AT < 0.1 IU/ml) was 7.7 times higher in comparison with a group of 170 adults with a history of at least one booster vaccination. CONCLUSION: A specific immunologic memory exists in adults with a history of only two previous diphtheria vaccinations. However, our results also indicate the need for a second booster vaccination in this group if long-term protection is to be achieved.

Adult↗
PubMed2002

Occupational risk for hepatitis A and hepatitis E among health care professionals?

BACKGROUND: Since transmission routes of hepatitis E virus (HEV) and hepatitis A virus (HAV) are believed to be similar, comparable risk factors and a correlation between the two seroprevalence rates may be assumed. MATERIALS AND METHODS: Anti-HAV and anti-HEV serology was assessed in 511 German subjects from nursing, pediatric nursing and administration groups, none of whom had been vaccinated against HAV. At the same time a standardized questionnaire on occupational and individual parameters was completed. RESULTS: Overall seroprevalence for anti-HEV was 3.9%, for anti-HAV 28%. Multivariate analysis revealed that anti-HEV seroprevalence was significantLy higher in persons working in emergency admission or in surgery, while persons working in children's psychiatry were more likely to be anti-HAV positive. Comparing the two serological resulLts, no contingency difference was found (chi2 = 0.42 (df = 1), p > 0.05). CONCLUSION: Specific departments of health care show higher prevalence of anti-HAV or anti-HEV. In the case of HEV further studies in the exposed working field are needed. Since no connection between the two serological results was found, transmission mechanisms might be (partly) different.

Adult↗
PubMed2000

Calibration of HCV working reagents for NAT assays against the HCV international standard. The Collaborative Study Group.

BACKGROUND AND OBJECTIVES: Five HCV RNA reference reagents, the Paul Ehrlich Institut (PEI) reference 75, the National Institute for Biological Standards and Control (NIBSC) reagent 96/586, the Central Laboratory of the Netherlands Red Cross Blood Transfusion Service (CLB) Pelispy HCV RNA run control S2001, the Istituto Superiore di Sanità (ISS) reagent 0498 and the CBER panel member No. 1, were calibrated against the WHO International Standard, 96/790. MATERIALS AND METHODS: The reference materials were calibrated in a collaborative study organised by NIBSC. Nineteen laboratories, using a range of qualitative and quantitative assays returned results. RESULTS: The concentrations of the reagents were: 25,000 IU/ml for the PEI material, 710 IU/ml for the NIBSC material 96/586, 1,000 IU/ml for the CLB material, 1,700 IU/ml for the ISS material 0498 and 250 IU/ml for the CBER panel member No. 1. CONCLUSIONS: The calibration of these five reference reagents for HCV RNA nucleic acid amplification technology (NAT) assays enables them to be used for standardisation and validation of assays. Such calibrants are essential for meeting the requirements of the European Medicinal Evaluation Agency (EMEA) for the testing of plasma pools and donations for HCV RNA for the release of blood products and the PEI requirements for the release testing of erythrocyte and thrombocyte concentrates.

Calibration↗
PubMed1998

[Occupational spinal diseases in employees of nursing services--epidemiological and legal insurance aspects (III). 3: Intervertebral disk-induced diseases of the lumbar spine in health care employees--expert assessment and prevention].

Due to spine-loading activities nursing professionals have a relatively high incidence/prevalence of low back pain. As lumbar disc disorders can be regarded as occupational diseases (since January 1993, occupational disease BK 2108, normally more than 10 years of exposition, lumbar disc disorders with pain and reduced motility) international literature is reviewed. Own results of different prevalence-, case-control- and incidence studies (relative risk for lumbago sciatica/odds ratio for disc prolaps appr. 3-6 depending on age and occupational age) are presented. Finally the question of compensation and prevention of disc disorders is discussed.

Disability Evaluation↗
PubMed1998

Factors influencing immunity against diphtheria in adults.

In about 50% of all adult Germans, serological immunity to diphtheria is lacking even though a vaccination history exists in most cases. In this study, the factors contributing to diphtheria immunity, up to 43 years after the last diphtheria vaccination, were analysed. Serum samples were taken from 287 adults whose complete vaccination history was available, and who had received a standard primary vaccination. The sera were tested by tissue culture neutralization assay for diphtheria antitoxin levels. The time lapse since the last diphtheria vaccination proved to be the most important factor influencing the protection rate. Secondly, the factor last vaccination within the first 3 years of life and, finally, female gender were found to correlate significantly with a low protection rate. No direct effect could be established for age, number of previous vaccinations, occupational contact with patients or travel within any endemic region during the last 10 years. Since diphtheritic infection can occur among previously vaccinated persons, the immunity gap observed among adults should be closed by regular diphtheria boosters. Special attention should be paid to the three groups mentioned. Further investigation is required to determine whether or not a single booster vaccination is sufficient to provide long-term protection for those in the risk groups indicated above.

Adolescent↗
PubMed1998

[Tick-borne encephalitis transmitted by raw milk--what is the significance of this route of infection? Studies in the epidemic region of South-West Germany].

Despite the observation of TBE cases after consumption of raw milk from cows or goats, so far the proof of the alimentary route of human infection has not been possible. In the regions of southwestern Germany, where TBE is known to be endemic, milk-borne TBE infections have not yet been observed. To assess the significance of raw milk consumption for viral transmission, a cross-sectional study (114 forestry workers, 177 individuals exposed during their leisure-time activities, 170 non-exposed individuals) and a case-control study (50 TBE patients, 150 controls) were carried out. The results of the study show that both the time spent in the endemic region and also the professional exposure to ticks do influence TBE seroprevalence, whereas the consumption of raw milk (milk directly from the farmer) is no major risk factor for TBE infection or disease. Among leisure-time activities, only hunting has an effect comparable to the one of the professional exposure to ticks. Besides epidemiological data obtained in humans, serological investigations of cows were performed. Here it is shown that milk-producing animals are involved in the natural transmission of TBE virus. Since former studies had shown that TBE-viremic animals excrete the virus with the milk--although over a short period and in low concentrations--the occurrence of milk-borne TBE infections cannot be excluded in the endemic regions of south-western Germany. However, from the epidemiological point of view, their significance may be neglected. Vaccination has proven the most reliable means of TBE prevention, irrespective of the route of infection.

Animals↗
PubMed1997

[Occupational diseases of the spine in health care professions-- epidemiologic and insurance aspects (I). 1. Review of internationally publicized studies].

Due to spine-loading activities nursing professionals have a relatively high incidence/prevalence of low back pain. As lumbar disc disorders can be regarded as occupational diseases (since January 1993, occupational disease BK 2108, normally more than 10 years of exposition, lumbar disc disorders with pain and reduced motility) international literature is reviewed. Own results of different prevalence-, case-control- and incidence studies (relative risk for lumbago sciatica/odds ratio for disc prolaps appr. 3-6 depending on age and occupational age) are presented. Finally the question of compensation and prevention of disc disorders is discussed.

Female↗
PubMed1997

[Diphtheria booster immunization for adults].

BACKGROUND AND OBJECTIVE: Nearly 50% of adults in Germany have no measurable antibody protection against diphtheria, even though most of them will have been vaccinated against it in their childhood. We investigated how vaccination should be performed in this situation to provide lasting protection. MATERIAL AND METHODS: 100 adults (53 men, 47 women; mean age 27.7 [19-54] years) whose last diphtheria vaccination had been at least 10 years previously, were injected up to three times with customary commercial monovalent diphtheria vaccine for adults (5 IU toxoid/0.5 ml), at intervals of 4-8 weeks. Each time, before and 4-8 weeks after the latest injection, the antitoxin level was determined by cell-culture neutralization test. RESULTS: Before the vaccination 30 of the 100 subjects had protection against diphtheria (antitoxin level > 0.1 IU/ml), 24 had "basic immunity" (0.01 to < 0.1 IU/ml), and 46 no measurable protection (< 0.01 IU/ml). After the first booster the protection threshold had not been reached in seven of the 100, all of them women. The main determinant for the pre- and post-vaccination antitoxin level was the interval since the last vaccination. In addition, women had significantly lower pre- and postvaccination levels than men. But after the second and third booster the antitoxin level of the seven women had risen to above the protection threshold, while the geometric mean of the whole collective had fallen, despite further boosters. It was 0.015 IU/ml before vaccination, 1.156 IU/ml after the first booster, 0.924 IU/ml after the second, and 0.952 after the third. CONCLUSION: Those adults who were last vaccinated against diphtheria more than 20 years ago should have two booster shots, more than 8 weeks apart, so that the highest possible and most lasting antitoxin level can be achieved. Women in particular should have at least two booster shots, as their antitoxin response tends to be less than that of men.

Adult↗
PubMed1997

[Non- and low-response after preventive hepatitis B vaccination].

20 years after the introduction of the hepatitis-B vaccine the question still remains unsolved as to how the 2 to 5 per cent of the vaccinees who, after basic immunisation, respond with no anti-HBs levels (0-10 IU/l nonresponder, NR) or low levels (11-99 IU/l low-responder, LR) should be boostered to acquire sufficient and long-lasting protective anti-HBs levels. In a retrospective analysis of booster results we found in 75 NR and LR that the probability for long-lasting protection is very low for NR, but better for LR (60%). In a second part of this publication, the efficacy of intradermal and intramuscular hepatitis-B boosters was examined by retrospective analysis of booster results among 26 NR and LR. A slight advantage of the intradermal application was found concerning post-booster anti-HBs increase and the maximal HBs values reached. Long-lasting protective anti-HBs values could not be established for either way of application. Finally, a survey of the literature summing up true results of intradermal hepatitis-B basic immunisations with reduced doses (mostly 2 micrograms), shows that whereas the seroconversion rates achieved by this method are almost compatible with those after regular basic vaccination, the GMT values were far lower than those after regular basic vaccination. Prospective and randomised studies are needed to show which kind of booster is most efficient for nonresponders and low-responders.

Adult↗
PubMed1997

[Spinal diseases in the nursing profession--a cross-sectional study].

A cross-sectional study on the profession-specific prevalence rates of back pain symptoms was conducted including N = 3332 nurses as the exposed group and N = 1720 office clerks as a control group. Only participants who had never changed from an exposed to an unexposed profession or vice versa, were included for the results presented here. Severity of symptoms was assessed, dividing into low back pain on the one hand, and lumbago-sciatica/sciatica on the other; frequency of pain episodes was measured using lifetime- and point-prevalence, in all these four combinations of severity and frequency the prevalence rates among nurses were clearly and significantly higher. Multivariate analyses revealed that profession is the most important risk factor among many others that were tested. Estimation of the prevalence rate for the heaviest symptom, the point-prevalence of lumbago-sciatica/sciatica, showed that about 4 out of 5 cases among nursing staff can be attributed to their profession. On the background of this high attributable risk the acceptance rate for LBP diseases of suspected occupational origin among nursing staff by statutory occupational health insurance bodies appears much too low.

Adult↗
PubMed1996

Prevalence of hepatitis C virus in plasma pools and the effectiveness of cold ethanol fractionation.

Screening blood donations for antibodies against hepatitis C virus (HCV) greatly reduces the risk of transmitting HCV by transfusions. However, despite such screening programs, plasma pools still contain a high percentage of HCV ribonucleic acid as determined by polymerase chain reaction. This result would not be alarming if the procedures for producing blood products included steps to inactivate or remove HCV. Although this appeared to be the case for all blood products, such as coagulation factors and most immunoglobulins, which are subjected to an inactivation step, the effectiveness of the cold ethanol fractionation process still needed to be determined. In validation experiments using bovine viral diarrhea virus as a model virus for HCV, we demonstrated that the Cohn-Oncley cold ethanol fractionation process neither inactivated nor removed this virus sufficiently. Our observations may help to explain how HCV was transmitted to a number of recipients of intravenous immunoglobulin.

Chemical Fractionation↗