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PubMedDate not supplied

Increase in urinary excretion of 6beta-hydroxycortisol in common marmosets as a marker of hepatic CYP3A induction.

The ratio of urinary 6beta-hydroxycortisol (6beta-OHF) to free cortisol (F), i.e., the 6beta-OHF/F ratio, has been reported to be a specific marker for human CYP3A induction by in vivo studies of human subjects. In the development of drugs, it is quite beneficial to predict human CYP3A induction in preclinical safety studies using urine samples from experimental animals. We examined the 6beta-OHF/F ratio in urine of common marmosets administered with rifampicin, a potent inducer of CYP3A, to evaluate the usefulness of common marmosets for the prediction of CYP3A induction. Rifampicin was orally administered to three groups of four male common marmosets at doses of 0, 10, and 20 mg/kg per day for 4 days. Amounts of 6beta-OHF and F in urine samples were determined by means of high-performance liquid chromatography (HPLC) during the experimental period. One day after the 4th dosing, animals were killed, and P450 contents and P450-catalyzed. 7-alkoxycoumarin O-dealkylase (ACD) activities in the liver were measured. Western blot analysis of liver microsomes was also performed using anti-rat P450 (CYP1A1, 2B1/2, 3A, and 4A) antibodies. The results indicated elevations in the 6beta-OHF/F ratios that were dependent on both the dosing period and dose levels adopted. The ratios on day 4 reached 4.7- and 5.3-fold the pre-administration values in the 10 and 20 mg/kg per day groups, respectively. P450 contents and ACD activities were also elevated in all of the groups. Western blot analysis showed specific increases in the protein which cross-reacts with anti-rat CYP3A antibody in all of the groups. Furthermore, the 6beta-OHF/F ratio was well correlated with the CYP3A contents in liver (r = 0.906). These results indicated that increase in urinary excretion of 6beta-OHF is a specific marker of the induction of hepatic CYP3A in common marmosets just as in humans. Consequently, the present study suggested that human CYP3A induction elicited by chemical agents can be predicted in common marmosets by measuring the urinary excretion of 6beta-OHF.

7-Alkoxycoumarin O-Dealkylase↗
PubMedDate not supplied

Pregnancy outcome after treatment with the ergot derivative, cabergoline.

The goal of this article is to assess the reproductive safety of cabergoline, a new ergot derivative proposed in hyperprolactinemic disorders. Investigated in different animal species, the drug showed no teratogenic or embryotoxic effects on rabbits. Considering the dose envisaged for humans, large safety margins exist. Our sample consists of 226 pregnancies occuring in 205 women. Follow-up is available for 204. There were 24 miscarriages and three abortions induced because of major malformations (one Down syndrome in a 42-year-old woman, one limb-body wall complex, one hydrocephalus). Two of the 148 single liveborn infants had significant malformations: one megaureter, one scaphocephaly. This series shows no increase in miscarriage rate, a distribution of birthweights and sex ratio within the expected range, and no increased rate of congenital malformations. Follow-up of babies, limited to 107 cases, thus far indicates normal physical and mental development.

Abnormalities, Drug-Induced↗
PubMedDate not supplied

Prevalence of intimate partner violence and health implications for women using emergency departments and primary care clinics.

OBJECTIVES: To determine prevalence of intimate partner violence (IPV) among women accessing health care, factors that influence rates of abuse, barriers to disclosure, and associated health problems and perceptions of safety. METHODS: A convenience sample of women seeking health care completed 1268 anonymous surveys (75 in Spanish) while at 1 of 24 urban, suburban, or rural emergency departments or primary care clinics. RESULTS: Of women in this study, 50-57% had experienced physical and/or emotional abuse and 26% reported sexual abuse in their lifetime. In the past year, 28% reported emotional abuse, 12% physical abuse, 6% severe physical abuse, and 4% sexual abuse. Logistic regression models found that younger, less-educated, less-affluent women presenting to urban emergency departments reported the highest rates of physical abuse. Although 83% welcomed abuse screening, only 25% ever had been asked and 86% would disclose abuse if asked directly, respectfully, and confidentially. Abused women reported significantly lower health status ratings than nonabused women (p < 0.001). Emotional abuse was as strongly associated with health problems as physical abuse. The majority (70-93%) of women with headaches, stomach problems, chronic pain, vaginal bleeding, substance abuse, depression, and suicidal thoughts had experienced lifetime physical/emotional abuse. CONCLUSIONS: Women experience many forms of abuse and present to a wide range of health care settings. The striking prevalence of IPV and associated emotional/physical health problems challenges providers to routinely assess for abuse in ways that minimize barriers to disclosure and enhance the development of an effective plan of care based on a patient's abuse experience.

Adult↗
PubMed2000

Direct on-filter assay of subtilisin-type proteolytic enzymes for rapid analysis of analyte captured from the workplace atmosphere.

A simple assay for some proteolytic enzymes has been developed which can be performed directly on the surface of a cellulose nitrate filter used to capture the analyte during workplace monitoring for health and safety purposes. Following air sampling the analysis is performed on the filter which is retained within the air sampler. This involves two steps: first, a 15 min incubation in which the captured enzyme is dissolved and then digests an alkaline-phosphatase-labelled antibody immobilised as a small dot on the surface of the filter; and second, is a 10 min incubation with substrate solution, which follows an in situ wash under a vacuum. During the incubation colour develops on the spot at the location of the immobilised enzyme antibody conjugate. The intensity of the spot can be assessed visually within the sampler to ascertain the presence or absence of captured enzyme, or alternatively quantitative results can be obtained using an optical scanner. The limit of detection is 5 ng per filter for subtilisin (20 ng for visual discrimination between this standard and the zero). The assay is stable to the effects of ambient air sampling at 31 min(-1) for 18 h.

Air Pollution, Indoor↗
PubMed1997

Increase in haemoglobin concentrations in growth hormone deficient adults during human recombinant growth hormone replacement therapy.

OBJECTIVE: Recombinant human growth hormone is being used increasingly in the treatment of GH deficiency in adults. In addition to erythropoietin, insulin-like growth factor-I (IGF-I) has been demonstrated to stimulate hematopoiesis in animals, especially rodents. We have determined the effect of growth hormone (GH) administration on haematopoiesis. PATIENTS AND DESIGN: Seventeen patients (10 males and 7 females; mean age 47 +/- 2 years; range 30-59) with biochemically proven adult-onset GH deficiency (GHD) were treated with human recombinant growth hormone (rhGH) as replacement therapy for more than 96 weeks in a dosage of 12.5 micrograms/kg/day (initial dosage during the first 4 weeks 6.25 micrograms/kg/day). The diagnosis of GHD had been confirmed using a standard arginine-infusion test (0.5 g/kg body weight). Blood samples were collected for safety and efficacy parameters before and during the GH treatment period. MEASUREMENTS: Routine methods were used for the haematological and biochemical measurements. IGF-I concentrations were measured, using a commercial RIA kit. RESULTS: From week 36 and onwards, we observed a significant increase in individual haemoglobin (Hb) concentrations, especially in the male patients. Mean Hb in the male patients before treatment amounted to 9.1 +/- 0.2 mmol/l (range 8.1-10.5) and increased by 0.93 +/- 0.2 mmol/l (P < 0.05) after 120 weeks of rhGH replacement therapy. The mean Hb concentration in female patients before treatment was 8.1 +/- 0.1 mmol/l and an increase of 0.32 +/- 0.1 mmol/l (P < 0.05) was observed after 120 weeks. For all 17 patients the mean increase in Hb after 120 weeks was 0.73 +/- 0.2 mmol/l (P < 0.05). IGF-I concentrations also increased during therapy from 86 +/- 9 pg/l to 253 +/- 26 pg/l within 24 weeks (P < 0.05). No significant changes in leucocyte or platelet counts were found. CONCLUSIONS: Long-term replacement therapy with rhGH in patients with adult-onset GHD induces a significant increase in Hb concentrations, while serum leucocyte and platelet counts do not change.

Adult↗
PubMed2004

Distribution of diarrhetic shellfish poisoning toxins in consignments of blue mussel.

Data describing the distribution of diarrhetic shellfish poisoning toxins in 13 consignments of Danish-produced blue mussels are reported. The content of diarrhetic shellfish poisoning toxins was measured by a liquid chromatography coupled with tandem mass spectrometry detection method, and mean levels in the 13 consignments varied from 58 to 243 microg kg(-1). The distributions of diarrhetic shellfish poisoning toxins in the consignments were relatively homogeneous as the relative standard deviation of the content varied from 7 to 19%. The results are discussed in relation to food safety, the uncertainty of sampling and analysis, and the newly introduced European Union maximum levels of marine biotoxins in seafood products.

Animals↗
PubMed2006

Study of the tools available in biological dosimetry to estimate the dose in cases of accidental complex overexposure to ionizing radiation: the Lilo accident.

PURPOSE: To compare the efficiency of different cytogenetic tools in estimating the doses received by four people involved in the Lilo accident and to monitor the dose estimate over 4.5 years. MATERIALS AND METHODS: Several young Georgian frontier guards handled at least one of the 12 Caesium sources found in a former Russian military camp. Overexposure lasted from July 1996 to May 1997. The Institute for Radiological Protection and Nuclear Safety (IRSN) obtained blood samples taken at several intervals post-exposure from the four most highly-exposed people. Dose estimation was performed using dicentric and translocation scoring. RESULTS: The first dose estimations performed by dicentric scoring gave whole-body doses ranging from 0.4 to 1.3 Gy. Overexposure was complex and several mathematical models were used to take this complexity into account. This could provide information concerning the circumstances of overexposure. Concerning follow-up, the yield of dicentrics decreased by about 50% in the first 4 months following the end of overexposure whereas translocations were stable over the period of analysis. CONCLUSION: It has been useful to compare cytogenetic results with clinical results. The results presented here reveal good stability of translocations. However the first dose estimation was not attempted until 6 months after the last exposure.

Chromosome Aberrations↗
PubMed2002

Safety attitudes and their relationship to safety training and generalised self-efficacy.

This paper studies safety attitudes, their relationship with safety training behaviour, and generalised self-efficacy. From a sociotechnical perspective, training programs might be used as a mechanism for enhancing attitudes, especially to improve safety and occupational health. Also, self-efficacy allows to enhance training effectiveness. The aim of this paper is to validate a safety attitude scale and to examine its relationship to safety training behaviour and self-efficacy in organisational settings. With data from 140 employees, results show a conceptually meaningful 3-factor solution. Hierarchical multiple regression analysis shows a main effect of safety training behaviour and levels of self-efficacy on safety attitude. Study limitations and its implications on safety training design are also discussed.

Accidents, Occupational↗
PubMed1996

Worker exposure to endotoxin, phenolic compounds, and formaldehyde in a fiberglass insulation manufacturing plant.

Worker exposures in a fiberglass wool insulation manufacturing plant were studied. The plant used a continuous process and operated at full production during a six-week study. Area samples were used to characterize spatial variability of contaminant levels. Repeated personal samples were used to characterize the distribution and to explore within- and between-worker variability of exposures. The greatest potential for exposure to each of the contaminants was restricted to specific areas of the plant. Area geometric mean concentrations were 1 to 390 ng/m3 for endotoxin and 22 to 414 micrograms/m3 for formaldehyde. There was considerable within-area variation of endotoxin (geometric standard deviation [GSD] 2.6 to 5.5) and formaldehyde (GSD 2.0 to 4.5). Concentrations of phenolic compounds were correlated with endotoxin and were influenced by a relatively high limit of detection. The ranges of personal GM exposures across homogeneous groupings were smaller than the range for the corresponding areas (endotoxin 5.8 to 36.4 ng/m3; formaldehyde 18.1 to 67.4 micrograms/m3). Variability in personal exposure was high. Individual GSDs ranged up to 10, with the mean individual GSD of 3.4 for endotoxin, and up to 12 with mean 3.7 for formaldehyde. Suggested thresholds for acute respiratory effects of endotoxin exposure were frequently exceeded (46% of 8-hr personal samples > 10 ng/m3, 7% > 100 ng/m3). No personal samples exceeded the Occupational Safety and Health Administration permissible exposure level or the American Conference of Government Industrial Hygienists' threshold limit value for formaldehyde; however, 34% were greater than 60 micrograms/m3 and 11% were greater than 120 micrograms/m3. Thus, exposures fell in a range where important exposure-response relationship could be examined.

Air Pollutants, Occupational↗
PubMed2005

Quantitative chemiluminescent immunoassay for NF-kappaB-DNA binding activity.

Nuclear factor-kappaB (NF-kappaB) is a ubiquitous redox-sensitive transcription factor involved in the pro-inflammatory response to several factors, including cytokines and oxidative stress. Upon activation, NF-kappaB translocates into the nucleus and binds to specific nucleotide sequences. The cellular responses to inflammatory and stress signals have been implicated in disease conditions, such as atherosclerosis, cancer, diabetes, and Alzheimer's disease. The conventional method for detection of NF-kappaB -DNA binding activity is the electrophoretic mobility shift assay (EMSA), which is time-consuming and non-quantitative. Here, we report (a) development of a rapid, sensitive and quantitative chemiluminescent immunoassay (QCI) for analysis of NF-kappaB DNA-binding activity, and (b) validation of the QCI with the EMSA using nuclear and cytosolic extracts from cultured prostate cancer cells (PC3), rat liver homogenates and human lymphocytes. The QCI for analysis of NF-kappaB DNA binding activity has advantages over the EMSA: (1) Higher speed: 3-5h post sample preparation, (2) Greater sensitivity: 10pg NF-kappaB/well, (3) Quantitative: linear range: 10-1000pg NF-kappaB; r2 = 0.999 (4) High throughput adaptability: 96-well plate format can analyze up to 40 samples in duplicate, (5) SAFETY: No radioactive isotopes, (6) Simplicity, and (7) Capability of measurement of both activated (free) NF-KB which is translocated into the nucleus and total (bound + unbound) NF-kappaB present in the cytosol/cell.

Animals↗
PubMed1999

Elevated prolactin in pediatric patients on typical and atypical antipsychotics.

As part of systematic treatment trials of haloperidol, clozapine, and olanzapine with a total of 35 children and adolescents with early onset psychosis, prolactin was measured at baseline and week 6 of treatment. The National Institute of Mental Health patients--13 females, 22 males (mean age, 14.1+/-2.3 years; range, 9.1-19 years) with childhood onset schizophrenia (n = 32), or Psychotic Disorder not otherwise specified (NOS) (n = 3) with onset of psychosis before age 13--were recruited for open or double-blind trials of haloperidol, clozapine, or olanzapine. Baseline serum prolactin was measured after a 3-week washout period and after 6 weeks of treatment. Mean prolactin concentration after 6 weeks of treatment was significantly elevated on all three drugs; however, on clozapine, mean prolactin remained within the normal range. Prolactin was increased above the upper limit of normal for 100% of 10 patients on haloperidol, 70% of 10 patients on olanzapine, and 0% of 15 patients on clozapine (chi2 analyses: H > C, p = 0.004; O > C, p = 0.001). Given the potential endocrine and possible cardiac correlates of hyperprolactinemia, these more robust prolactin elevations in pediatric patients after short-term exposure to olanzapine than those reported for adults justify longer observation intervals with bigger samples to establish treatment safety of atypical antipsychotics in adolescents.

Adolescent↗
PubMed2004

Increasing the safety-promoting behaviors of abused women.

OVERVIEW: Despite an epidemic of intimate-partner violence against women, and general agreement that women should be screened for it, few assessment and intervention protocols have been evaluated in controlled studies. To test a telephone intervention intended to increase the "safety-promoting behavior" of abused women, 75 women received six telephone calls over a period of eight weeks in which safety-promoting behaviors were discussed. A control group of 75 women received usual care. Women in both groups received follow-up calls to assess safety-promoting behaviors at three, six, 12, and 18 months after intake. Analysis showed that the women in the intervention group practiced significantly (P < 0.01) more safety-promoting behaviors than women in the control group at each assessment. On average, women in the intervention group practiced almost two more safety-promoting behaviors than they had at time of intake and nearly two more than women in the control group; the additional behaviors were practiced for 18 months. This nursing intervention requires only 54 minutes to complete (six nine-minute telephone calls) and can be integrated into any health care setting. Because less than one hour of professional nursing time is involved, the cost of the intervention is minimal. Future research should determine whether the adoption of safety-promoting behaviors by abused women averts trauma and its subsequent health care costs.

Adult↗
PubMed1999

Effect of heating human sera at a temperature necessary to deactivate human immunodeficiency virus on measurement of free phenytoin, free valproic acid, and free carbamazepine concentrations.

Minimizing the risk for infection to laboratory staff from a contaminated blood sample is a major safety goal in the clinical laboratory. One dangerous pathogen, the human immunodeficiency virus (HIV), can be deactivated by heating sera at 56 degrees C for 30 minutes. The authors previously reported that if serum was subjected to those conditions, the concentrations of the nine most commonly monitored drugs were not altered, whereas phenytoin and carbamazepine concentrations were reduced slightly. Monitoring free phenytoin, free valproic acid, and free carbamazepine concentrations is strongly recommended for patients with uremia, liver disease, and hypoalbuminemia. Because drug protein binding can be affected by temperature, the authors investigated the effect on free drug concentrations of sera heated to levels necessary for deactivation of the HIV virus. They measured total and free drug concentrations in serum pools prepared from patients receiving phenytoin, valproic acid, and carbamazepine. Serum pools were heated at 56 degrees C for 30 minutes and then brought to room temperature. The total and free drug concentrations were measured immediately after heating and then at 20- and 45-minute intervals. The concentrations of free phenytoin and free valproic acid were significantly higher after heat treatment. However, after equilibration of sera at room temperature for 20 minutes, the free concentrations of phenytoin were comparable to preheating values, although total phenytoin concentrations (Serum Separator Tubes) were reduced slightly. In contrast, free valproic acid concentrations did not return to the original levels even after 45 minutes. Free carbamazepine concentrations did not change even immediately after heating. However, total carbamazepine concentrations were reduced slightly when sera were heated in serum separator tubes (SST Tubes).

Anticonvulsants↗
PubMed2005

Evaluating the patient safety indicators: how well do they perform on Veterans Health Administration data?

BACKGROUND: The Patient Safety Indicators (PSIs), an administrative data-based tool developed by the Agency for Healthcare Research and Quality, are increasingly being used to screen for potential in-hospital patient safety problems. Although the Veterans Health Administration (VA) is a national leader in patient safety, accurate information on the epidemiology of patient safety events in the VA is still unavailable. OBJECTIVES: Our objectives were to: (1) apply the AHRQ PSI software to VA administrative data to identify potential instances of compromised patient safety; (2) determine occurrence rates of PSI events in the VA; and (3) examine the construct validity of the PSIs. METHODS: We examined differences between observed and risk-adjusted PSI rates in the VA, compared VA and non-VA PSI rates, and investigated the construct validity of the PSIs by examining correlations of the PSIs with other outcomes of VA hospitalizations. RESULTS: We identified 11,411 PSI events in the VA nationwide in FY'01. Observed PSI rates per 1000 discharges ranged from 0.007 for "transfusion reaction" to 155.5 for "failure to rescue." There were significant, although small, differences between VA and non-VA risk-adjusted PSI rates. Hospitalizations with PSI events had longer lengths of stay, higher mortality, and higher costs than those without PSI events. CONCLUSIONS: Our results suggest that the PSIs may be useful as a patient safety screening tool in the VA. Our PSI rates were consistent with the national incidence of low rates; however, differences between VA and non-VA rates suggest that inadequate case-mix adjustment may be contributing to these findings.

Aged↗
PubMed2005

Potential errors and their prevention in operating room teamwork as experienced by Finnish, British and American nurses.

This study describes how the potential sources of errors and error prevention in operating room (OR) teams are experienced by Finnish, American and British nurses. The data were collected by interviews and analysed using a qualitative content analysis. Results consisted of categories demanding teamwork practice, shared responsibility in teams and organized teamwork. The demanding practice category included fear of errors, turnover in teams, overtime work and emotional distress as potential factors leading to errors in OR teamwork. Shared responsibility emphasized how the familiar teams, safety control and formal documentation of errors prevented errors. At the organizational level, the prevention of errors required scheduling of work, good management, competency and a reasonable physical environment. In order to improve safety in OR teams, recognition should be given to the balance of error-making and learning from them. More effective ways in reporting incidents should be adopted and overall reporting systems should be developed in Finnish OR teams.

Adult↗
PubMed1998

Older people's lives in the inner city: hazardous or rewarding?

An exploratory, qualitative study was used to investigate the social health needs of older residents of a low-income inner-Sydney area characterised by multiple social and environmental hazards. The research was conducted to inform the development by the South Eastern Sydney Area Health Promotion Unit of a strategy to promote the health, wellbeing and independence of older people. As part of a needs assessment process, the investigation focused on specific subgroups of the population believed to be highly disadvantaged and neglected. In-depth interviews were conducted with 40 residents aged 60 to 86 years who were recruited through community centres, service providers and neighbours. The interviews were supplemented by observational field notes. We describe key dimensions of the physical and social environment, the many hazards it presented to vulnerable elderly residents and the practices they adopted in meeting their everyday needs in relation to shopping, meals, mobility outside the home and social participation. The description is from the perspectives of residents themselves. Key factors discussed include the neighbourhood, housing, activities of daily living, safety and security, and social participation. We explore the implications of our findings for the development of effective public health practice. The environmental hazards, such as pedestrian safety and traffic management, affect the whole population and require interventions at government level. Others, such as inadequate hygiene and food storage facilities in rented premises, also require an approach at the level of public policy and environmental change, but need to be carefully targetted and implemented.

Aged↗
PubMed2001

Comparison of a classical phagocytosis assay and a flow cytometry assay for assessment of the phagocytic capacity of sera from adults vaccinated with a pneumococcal conjugate vaccine.

Antibody- and complement-mediated phagocytosis is the main defense mechanism against Streptococcus pneumoniae. A standardized, easy to perform phagocytosis assay for pneumococci would be a great asset for the evaluation of the potential efficacy of (experimental) pneumococcal vaccines. Such an assay could replace the laborious phagocytosis assay of viable pneumococci (classical killing assay). Therefore, a newly developed phagocytosis assay based on flow cytometry (flow assay) was compared with the conventional killing assay and enzyme-linked immunosorbent assay (ELISA), using sera obtained from adults pre- and postvaccination with either a bivalent conjugate, a tetravalent conjugate, or the 23-valent polysaccharide vaccine. Highly significant correlations were observed between flow assay phagocytosis titers, killing assay phagocytosis titers, and ELISA antibody titers for serotype 6B and 23F as well. For serotype 19F, strong correlations were only observed between killing assay and ELISA titers. A potential drawback of the flow assay might be the low sensitivity compared with that of the killing assay. The choice of what assay to use, however, will depend on the objectives of the assay. When speed, easy performance, sample throughput, improved worker safety, absence of influence of antibiotics, and absence of false positives are the major criteria, the flow assay is the method of choice. When higher sensitivity is the major requirement, the classical killing assay should be used.

Adult↗
PubMed1996

Transtracheal aspiration using rigid bronchoscopy and a rigid needle for investigating mediastinal masses.

BACKGROUND: Use of the flexible needle via the fibreoptic bronchoscope to aspirate mediastinal nodes or masses has largely superseded the use of the rigid needle via the rigid bronchoscope. However, the yield at fibreoptic bronchoscopy is relatively low, although this improves with the use of a wider gauge needle. In this study the sensitivity and the safety of rigid needle sampling of the mediastinum in the diagnosis of lung cancer is evaluated. METHODS: Transtracheal needle aspiration (TTNA) was performed with the rigid bronchoscope and a rigid aspiration needle under general anaesthesia using a previous computed tomographic (CT) scan as a guide to the sample site. A cytopathologist immediately examined the specimens for adequacy and preliminary diagnosis, thus determining the number of aspirations. RESULTS: Twenty four patients were evaluated. The diagnostic sensitivity of TTNA was 88%. This led to a management decision in 21 patients. There were no false positives and no complications. CONCLUSIONS: TTNA using the rigid bronchoscope with CT scanning and a cytopathologist present is a sensitive and safe way of diagnosing lung cancer in patients with a mediastinal mass or enlarged mediastinal nodes.

Adult↗