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PubMed2004

Multiple myeloma: clinical review and diagnostic imaging.

Multiple myeloma (MM) is a malignant clonal neoplasm of plasma cells of B-lymphocyte origin that commonly results in overproduction of large amounts of monoclonal immunoglobulins. Important advances in the therapeutic management of this disease in the past decade have resulted in higher rates of durable complete remission, prolonged event-free survival, and improved overall survival. Clearer understanding of the effects of abnormal plasma cells on bone has led to therapeutic approaches that help prevent vertebral body fractures. Current imaging technologies and, in particular, survey marrow studies with magnetic resonance (MR) imaging have improved detection of the extent and location of disease in MM patients. In newly diagnosed cases, MR surveys of the axial skeleton accurately demonstrate the extent of disease-diffuse or focal involvement-and the presence of associated compression fractures and cord compression. After treatment, MR images show the effects of treatment and the presence of residual disease. Multiple sites of focal bone lesions detected on MR studies allow a more appropriate choice of biopsy site than the usual random iliac marrow biopsy. Use of MR to determine biopsy sites and computed tomographic guidance for biopsy performance have increased the safety and accuracy of sampling. These biopsies have resulted in increased identification of cytogenetic abnormalities, particularly the presence of chromosome 13 deletion, which is a grave prognostic indicator in MM.

B-Lymphocytes↗
PubMed1999

Effect of meal timing not critical for the pharmacokinetics of tegaserod (HTF 919).

This study assessed the pharmacokinetic profiles of administering tegaserod (HTF 919) at different time intervals with respect to a meal. It was a randomized, open-label, two-phase, five-period crossover study. In the first phase, 18 healthy subjects received a single 12 mg oral dose of tegaserod administered either 30 or 15 minutes prior to the start of the 600-calorie, fat-rich breakfast. In the second phase, subjects received a single 12 mg oral dose of tegaserod 1 minute before, 2.5 hours after the start of meal, or with a continued 4-hour postdose fast. Safety assessment and plasma samples for the determination of drug concentration were obtained for 24 hours postdose. Noncompartmental analysis results indicated that the AUC of tegaserod was reduced by almost half under fed conditions compared to the fasted condition. Exploratory analyses were implemented to further investigate the absorption characteristics of tegaserod under different fed conditions. A numerical deconvolution approach was used to obtain the tegaserod oral absorption versus time profiles under both fasted and fed conditions. The tegaserod oral absorption versus time profiles were then fitted by NONMEM to a model containing two absorption phases. Based on the absorption analyses, we found that the reduction in the bioavailability of tegaserod under fed conditions was primarily due to a decrease in the extent of absorption and less so to a decrease in the absorption rate(s). Therefore, although the timing of administration of food does not appear to significantly alter the pharmacokinetics of tegaserod, the administration of food reduces the AUC by approximately 50%.

Adult↗
PubMed1986

Age-related variations in renal structure and function in Sprague-Dawley rats.

Data from 500 male and 500 female Sprague-Dawley rats used as controls in studies performed at Huntingdon Research Centre to assess the safety of drugs were sampled at 17, 30, 56, 82, or 108 weeks of age. Plasma urea nitrogen levels remained constant, except in aged males. Aging caused increased proteinuria and decreased urinary concentrating ability, in addition to increased size, weight, and degree of cortical scarring of kidneys. Chronic progressive nephropathy, first seen histopathologically at 30 weeks of age, accounted for these changes and ultimately affected 81% of male and 44% of female rats. One-fifth of two-year-old male rats had diffuse parenchymal damage and a small number also had secondary hyperparathyroidism. Other notable changes included basophilic (often colloid-filled) cortical tubules, mononuclear cell infiltrations, parenchymal and pelvic mineralization, urothelial hyperplasia, and pyelonephritis. Miscellaneous low incidence findings included one lipomatous tumour and generalized lymphosarcoma.

Aging↗
PubMed2006

Hepatic yersiniosis in a cougar (Felis concolor).

A cougar (Felis concolor) was diagnosed with hepatic yersiniosis by bacterial culture and histopathology. The animal had a 2-week history of anorexia and jaundice before its death. Grossly, the liver exhibited caseo-necrotic foci. Histopathologically, there was necrotizing and suppurative hepatitis, with large numbers of intralesional gram-negative coccobacilli. Additional hepatic lesions included central vein thrombosis, lymphoplasmacytic portal hepatitis, and capsulitis. Yersinia pseudotuberculosis coccobacilli were isolated in pure culture from the hepatic lesions. Because the hepatic lesions in this animal resemble those of other zoonotic diseases, such as plague and tularemia, veterinarians and laboratory personnel who handle samples should take adequate safety precautions. This report is the first to describe the pathology associated with hepatic yersiniosis in a cougar.

Animals↗
PubMed2004

Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: a study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856].

BACKGROUND: Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. METHODS: 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. DISCUSSION: A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

Acupuncture Therapy↗
PubMed2002

Clarion 1.2 standard electrode array with partial space-filling positioner: radiological and histological evaluation in human temporal bones.

The purpose of this study was to evaluate whether use of a positioner for situating the Clarion 1.29 standard electrode array in close proximity to the modiolus, causes damage to fine intra-cochlear structures, and to provide a comparison with results obtained for insertions of the array performed without a positioner. The study was performed in seven freshly frozen human temporal bones. Electrode location and intra-cochlear trauma was analysed using cross-sectional imaging and histological analysis. Insertion of the Clarion array did not reveal major trauma. The devices inserted with the positioner showed a consistently closer location of the electron array towards the modiolus, however, insertion resulted in significant displacement of both the electrode array and the positioner resulting in severe destruction of the basilar membrane and osseous spiral lamina along the length of the basal and middle turns. The devices inserted with the positioner resulted in major trauma to the basilar membrane and osseous spiral lamina. Therefore, systematic safety studies in larger samples of human temporal bones should be performed and the results carefully evaluated before implantation can be recommended unreservedly.

Basilar Membrane↗
PubMed1995

Drinking and driving in Spain.

OBJECTIVE: The purpose of this study was to analyze the patterns of alcohol consumption among Spanish drivers and to evaluate possible repercussions on road safety policies. METHOD: A sample of 12,000 drivers aged over 16 were randomly selected from the National Register of Spanish Drivers. The questionnaires, with items on sociodemographic data and on patterns of driving and alcohol consumption, were mailed to selected drivers in the fall of 1993. The study was based on the 1,500 (1,016 from men, 484 from women) properly completed questionnaires received. RESULTS: Among those surveyed, 62.9% were regular drinkers, who had a mean daily alcohol intake of 46.9 grams/day; of these regular drinkers 26.8% drank at a dangerous level. Those who drove regularly were more likely to drink and had a higher alcohol intake. The majority of drinkers recognized that they drove after drinking, 14.3% even acknowledged that last year on some occasions they drove "in a drunken state." Those who drink show high figures of involvement in road accidents. CONCLUSIONS: The study indicates widespread consumption of alcohol by Spanish drivers and the need to develop and improve driving and drinking policies in Spain.

Accidents, Traffic↗
PubMed2006

Success in the prevention of infant walker-related injuries: an analysis of national data, 1990-2001.

OBJECTIVE: Here we describe the epidemiologic characteristics and secular trends of infant walker-related injuries among children who are younger than 15 months in the United States. METHODS: A retrospective analysis was conducted of data from the National Electronic Injury Surveillance System of the US Consumer Product Safety Commission, 1990-2001. Sample weights that were provided by the National Electronic Injury Surveillance System were used in all analyses to adjust for the inverse probability of case selection and make national projections regarding infant walker-related injuries. RESULTS: An estimated 197200 infant walker-related injuries occurred among children who were younger than 15 months and treated in US emergency departments from 1990 through 2001. Five percent of these children required admission to the hospital. The number of infant walker-related injuries remained relatively constant from 1990 through 1994, averaging 23,000 cases per year. After the introduction in 1994 of stationary activity centers as an alternative to mobile infant walkers and the implementation of the revised American Society for Testing and Materials F977 voluntary infant walker standard in 1997, there was a marked decrease in the number of infant walker-related injuries. Overall, there was a 76% decrease in the number of injuries from 1990 to 2001 from 20,900 injuries in 1990 to 5100 in 2001. Soft tissue injuries and lacerations represented 63% of the injuries. Trauma to the head region occurred in 91% of cases. Skull fractures were the most common (62%) type of fracture. Falls down stairs was the mechanism of injury in 74% of cases. CONCLUSIONS: The adoption of passive injury-prevention strategies, such as use of stationary activity centers as alternatives to mobile infant walkers and redesign of infant walkers to prevent falls down stairs, were associated with a marked decrease in the number of infant walker-related injuries.

Accident Prevention↗
PubMed2002

First human trial of FTY720, a novel immunomodulator, in stable renal transplant patients.

FTY720 is a novel immunomodulator to be developed for use in organ transplantation. The primary objective of this study was to measure safety, single-dose pharmacokinetics, and pharmacodynamics in stable renal transplant patients-the first human use of FTY720. This study used a randomized, double-blind, placebo-controlled design that explored single oral doses of FTY720 from 0.25 to 3.5 mg in 20 stable renal transplant patients on a cyclosporine-based regimen. Safety assessments and blood samples were taken predose and at multiple time points during a 96-h period postdose. Standard pharmacokinetic parameters were derived from the FTY720 whole blood concentrations, measured by HPLC/MS/MS. FTY720 was well tolerated, with no serious adverse events. Transient, asymptomatic bradycardia occurred after administration in 10 of 24 doses of FTY720. Pharmacokinetics are characterized by a prolonged absorption phase; the terminal elimination phase started 36 h after the administration, with elimination half-life (t(1/2)) ranging from 89 to 157 h independent of dose. Maximum plasma concentration and AUC were proportional to dose with low intersubject variability, the apparent volume of distribution (V(d)/F) ranged from 1116 to 1737 L. FTY pharmacodynamics were characterized by a reversible transient lymphopenia within 6 h, the nadir being 42% of baseline. The lymphocyte count returned to baseline within 72 h in all dosing cohorts except the highest. Single oral doses of FTY720 ranging from 0.25 to 3.5 mg were well tolerated and caused a reversible selective lymphopenia. Transient, but asymptomatic bradycardia was the most common adverse event. The long t(1/2) suggests less frequent dosing intervals. The size of V(d)/F is in excess of blood volume, consistent with widespread tissue distribution

Adult↗
PubMed1991

Brain stem glioma: the role of a biopsy.

A retrospective review of the clinical and histopathological features of 31 patients with brain stem gliomas treated between 1965 and 1990 at Kyushu University Hospital was performed to determine the role of biopsy on these lesions. These 16 male and 15 female patients ranged in age from 3 to 50 years at diagnosis (average: 18.1 years). The primary site of the tumour was the pons in 20 patients, followed by the medulla oblongata and midbrain, and the final histological diagnoses of the lesions based on either the biopsy or autopsy materials were grade I astrocytomas in five patients, grade II in nine, grade III in 10, grade IV in five, and ependymoma in two patients. No consistent correlation could be obtained between the CT findings and histological diagnoses. Open surgical posterior fossa exploration was performed on 17 patients (diagnostic biopsy: 10; volume reduction by tumour removal with or without cyst evacuation: 7) and stereotaxic biopsy on three patients, without any mortality related to these procedures. In our biopsy series, half of the patients with grade II astrocytoma died within 12 months after diagnosis, whereas three out of four patients with grade I astrocytoma survived more than 10 years after diagnosis. Because of the relative safety of the tissue sampling technique, and the importance of an accurate diagnosis in order to select appropriate treatment modalities, histological verification of the lesion should be considered for all patients harbouring a brain stem mass lesion.

Adolescent↗
PubMed1991

Parasitologic and clinical human response to immunoglobulin administration in falciparum malaria.

The protective effect of African IgG antibodies against Plasmodium falciparum malaria was investigated by passive transfer in Thai patients. Sera from 333 African adults were collected in the Cote d'Ivoire and subjected to extensive screening. One hundred fifty-three samples were discarded for safety reasons, and IgG was extracted from those remaining under conditions allowing their use by the intravenous (iv) route. Eight Thai patients with P. falciparum parasitemia were treated by iv inoculation of the IgG: six with a 100 mg/kg dose given over three days, one with a single 20 mg/kg dose, and one with a single 200 mg/kg dose. To ensure a safety margin of at least 48 hours, subjects were chosen among patients having a recrudescent parasitemia following quinine treatment failure at the RI level. At that stage, symptoms were mild or absent and parasitemia was low but increasing (range 4, 200-9,000/microliters). The IgG pool exerted a profound, stage-specific, but non-sterilizing effect on each of the strains tested, and proved to be safe. Asexual parasitemia decreased by a mean 728-fold (range 46-1,086), while gametocytes were unaffected. Clearance of parasites and symptoms was as fast or faster than with drugs, and was consistent in the eight patients treated, suggesting that target antigens were equally expressed in geographically remote isolates. In peripheral blood smears, no mature forms were seen at any time during the followup, which does not support the hypothesis that reversal of cytoadherence occurred. After the disappearance of the transferred antibodies, recrudescent parasites from three patients were found to be susceptible to the same extent (mean decrease of 1,310-fold) to the same IgG preparation, indicating that selection of parasites able to escape the effect of antibodies had not occurred. No adverse side-effects were detected during the followup, which lasted one year.

Adult↗
PubMed2002

[Clinical value of antenatal diagnosis of intrauterine active human cytomegalovirus infection with reverse transcription polymerase chain reaction].

OBJECTIVE: To study the clinical value of antenatal diagnosis of intrauterine active human cytomegalovirus (HCMV) infection with reverse transcription polymerase chain reaction (RT-PCR). METHODS: The active HCMV infection of pregnant women was diagnosed with enzyme-linked immunosorbent assay (ELISA), serum Nest-PCR (N-PCR) and RT-PCR. The methods of antenatal diagnosis include villus sampling, amniocentesis and cordocentesis under ultrasound guidance. RT-PCR and N-PCR was used to screen fetal active infection. RESULTS: The infection rate of chorionic villi and cord blood whose mother was in active infection is 53.3% (16/30) and 47.8% (33/69) respectively, whereas that whose mother just had infectious history is 8.3% (4/48), 9.7% (6/62) respectively, the differences are statistically significant respectively (P < 0.001). The active infection rate of chorionic villi and cord blood in maternal active infection group is 30.0% (9/30) and 29.0% (20/69) respectively, whereas that with infectious history is 4.2% (2/48) and 4.8% (3/62), the differences are statistically significant respectively (P < 0.001). In the active intrauterine infection, the incidence of abortion and premature delivery was 41.2% (14/34), significantly higher than that of the latent infection 8.0% (2/25, P < 0.01). CONCLUSIONS: Antenatal diagnosis of intrauterine active HCMV infection with RT-PCR and the means of sampling described are of safety and reliability. It has a great clinical value in management of the fetus whose mother had been in active HCMV infection.

Cytomegalovirus Infections↗
PubMed1992

Effects of countercurrent scalding and postscald spray on the bacteriologic profile of raw chicken carcasses.

In June and September 1988, the USDA Food Safety and Inspection Service sampled raw chicken carcasses at a federally inspected slaughter establishment in Puerto Rico to determine the effects of changing the scalding equipment on bacterial contents of raw poultry products. The scalding equipment was changed to a countercurrent configuration, with a postscald hot-water rinse cabinet that sprayed carcasses as they exited the scalder. Analysis of 250 carcass-rinse samples collected at preevisceration, prechill, and postchill sites over 7 days indicated that carcasses had mean aerobe plate counts of log(10)3.73 before evisceration, 3.18 before chilling, and 2.87 after chilling; Enterobacteriaceae counts of log(10)2.70 before evisceration, 2.25 before chilling, and 1.56 after chilling; and Escherichia coli counts of log(10)2.09 before evisceration, 1.61 before chilling, and 0.89 after chilling. Salmonellae were found on 24% of the carcasses before evisceration, on 28% before chilling, and on 49% after chilling. Although bacterial count reductions were significant at all 3 sites, the proportion of carcasses contaminated with salmonellae in this study was higher at the postchill than prechill site (49 vs 28%). This no doubt was caused by cross-contamination in the chiller. These percentages indicated that although simple scalder changes contributed substantially to the improvement of the bacterial quality of chicken carcasses, additional interventions in the chilling process (such as chlorination of chill water) are important to control cross-contamination and to preserve the positive effects obtained by the scalder changes.

Abattoirs↗
PubMedDate not supplied

Managing suicide risk in late life: access to firearms as a public health risk.

OBJECTIVE: The authors assessed the prevalence of gun availability for elderly patients to determine whether gun availability is related to the presence of suicidal or depressive symptoms. METHODS: This is a cross-sectional epidemiologic survey of firearm availability and safety practices. A random sample of older adults with a scheduled primary-care clinic appointment was selected and screened with the General Health Questionnaire and questions about suicidality and alcohol use. Participants were also asked about the availability of firearms in their home and about safe gun practices. RESULTS: Of 1,023 patients screened, 285 (27.9%) reported having some type of firearm in the home, and 202 (19.7%) reported having a handgun in the home. Patients with suicidal ideation or high levels of depression or psychological distress were not significantly more or less likely to have a gun in the home than those without these emotional stressors. The strongest predictors of firearm availability were being male and being married. CONCLUSIONS: These preliminary data suggest that a significant proportion of elderly people have firearms available to them in their homes. Those patients with emotional distress did not differ from those without distress with respect to having firearms available to them. These data strongly suggest the need for screening for firearm availability and education about the safe storage of firearms as a potential means of prevention of suicide among elderly patients suffering from emotional distress or suicidal ideation.

Aged↗
PubMed1992

Effects of chlorination of chill water on the bacteriologic profile of raw chicken carcasses and giblets.

In March 1989, the USDA Food Safety and Inspection Service sampled raw chicken carcasses and giblets at a federally inspected slaughter establishment in Puerto Rico to determine the effects of adding chlorine to carcass and giblet chill water on bacterial contents of raw poultry products. Over four 8-hour workdays, 200 carcass rinse samples were collected at 3 sites in the establishment; 39 giblet rinse samples were collected at 1 site. Analyses of the carcass rinse samples indicated that carcasses had average aerobe plate counts of log10 3.20 before chilling and 2.51 after chilling; Enterobacteriaceae counts of log10 2.57 before chilling and 1.75 after chilling; and Escherichia coli counts of log10 2.04 before chilling and 1.20 after chilling. Salmonellae were found on 43% of the carcasses before chilling and on 46% after chilling. Analyses of the giblet and neck rinse samples indicated that raw giblets and necks after chilling had average aerobe plate count of log10 3.49, Enterobacteriaceae count of log10 2.57, and E coli count of log10 1.06. Salmonellae were found on 12% of the giblets and necks sampled. Results compared favorably with giblet and neck rinse sample results obtained during a baseline sampling study in November and December 1987. The baseline results indicated aerobe plate count of log10 3.72; Enterobacteriaceae count of log10 2.90; E coli count of log10 1.14; and salmonellae on 69% of the giblets and necks sampled. Placing raw chicken carcasses in chlorinated chill water reduced aerobe, Enterobacteriaceae, and E coli plate counts. Prevalence of carcasses with salmonellae remained nearly the same.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed2004

Loss of heterozygosity at BRCA1, TP53, nm-23 and other loci on chromosome 17q in human breast carcinoma.

BACKGROUND: In Egypt, breast cancer ranks number one among the female malignancies. Activation of oncogenes and inactivation of tumor suppressor genes are thought to play an important role in the development and progression of breast cancer. PURPOSE: The present study is a trial to investigate the role of chromosome 17 in sporadic invasive ductal carcinoma of the breast through detection of LOH for 6 highly polymorphic microsatellite loci, two of which are located at BRCA1 gene (D17S855 and D17S856), one at TP53 gene, one at nm-23 gene and finally two at 17q12-12.3 (D17S183 and D17S250). MATERIAL AND METHODS: Tissue samples and their corresponding safety margin normal tissues were collected from 25 patients with invasive ductal carcinoma of the breast of grades 2 and 3. LOH was detected for the 6 highly polymorphic microsatellite markers mentioned previously using PCR assay. RESULTS: The percentage of overall LOH recorded was 68% of the cases examined. The highest LOH recorded in D17S855 and D17S856 (43% and 32% respectively), both markers are located at BRCA1 gene, followed by 32% LOH in nm-23 gene. D17S183 and D17S250, which are localised telomeric and centromeric to BRCA1 gene, showed 24% and 28% LOH, respectively. The lowest percentage of LOH was observed in the TP53 gene (14%). No significant correlation was found between each of the six markers used and lymph node status, grade, or menopausal status. LOH at the nm-23 marker exhibited a significant association with lymph node involvement. CONCLUSION: It can be concluded from the present study that BRCA1 gene may be involved in carcinogenesis of some sporadic breast cancer cases. Deletion in nm-23 gene is associated with advanced stage of the disease. Finally, another gene located at 17q12-12.3 region may be involved in some sporadic breast cancer cases.

Journal Article↗
PubMed1990

[Spontaneous abortion and advanced maternal age].

A retrospective analysis of pregnancy outcome after demonstration of a live fetus in the first trimester was carried out in 387 patients to establish a background loss rate and evaluate the safety of chorionic villus sampling. The present study proves an increased risk of spontaneous abortion with increasing maternal age, and a miscarriage rate (9.81%) higher than chorionic biopsy (4.4), probably because the therapeutic abortions and the sonograms were performed after bleeding.

Abortion, Spontaneous↗
PubMed1988

Fine needle biopsy diagnosis of thyroid nodules. Perspective.

Needle biopsy is the most cost-effective and reliable method for selecting thyroid nodules for observation or excision. Fine needle biopsy (FNB) is the preferred method because of safety and simplicity. FNB samples should be taken circumferentially at the periphery of the nodule to avoid the common central degeneration. The following criteria for adequate sampling reduce the potential for false negative diagnoses: e.g. a minimum of 6 aspirates, and at least 6 clusters of benign cells on each of at least 2 of the aspirates, and no malignant cells. A small rate of false positive errors is unavoidable if cancers are not to be overlooked. Study of published didactic and illustrative material permits trained and motivated cytopathologists to develop skills in FNB diagnosis quickly. FNB data may be accurate enough to supplant frozen section data for surgical planning. Patients with FNB diagnoses of benign should be followed, usually with thyroxine therapy. Nodules that do not regress after treatment for one year should be biopsied again, and observation may be safely continued if consistently benign findings are obtained. More reliable FNB diagnoses on cellular and Hurthle cell adenomas would be desirable, but it is unlikely that this will be possible in the near future.

Biopsy, Needle↗