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PubMed2005

Efficacy and tolerability of 0.2% brimonidine tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION): a 3-month, double-masked, randomised, placebo-controlled trial.

INTRODUCTION: Neuroprotection may be an option in ischemic optic nerve disease. There have been promising reports about the neuroprotective ability of topical brimonidine in animal studies. Therefore, we tested whether 0.2% brimonidine tartrate could improve the outcome of patients with non-arteritic anterior ischemic optic neuropathy (NAION). The study was stopped after an interim analysis, having not proven its feasibility within practicable time frame. METHODS: A 3-month, double-masked, placebo-controlled, randomised European multicenter trial conducted according to good clinical practice rules. Thirty-six patients (22 m, 14 f), older than 40 years with first eye involvement and typical signs of NAION were included in the study within the 1st week after visual loss (VA 0.05-1.0) and were randomized to treatment with either brimonidine 0.2% (Alphagan) or placebo. Visual acuity (VA, primary endpoint), visual field (VF, Humphrey 30-2 and Goldmann, quantified by a modified Esterman grid) and automated swinging flashlight test (SWIFT) were performed at baseline, 2 weeks, 4 weeks and 12 weeks after first visit. Primary analysis aimed at intention-to-treat group (ITT, n=29), secondary analysis to the per protocol population (PP, n=25). Tolerability and safety were tested in the safety group (n=36). A two-sample two-sided t-test was used for statistical analysis (alpha level at 0.05). RESULTS: VA did not show statistically significant difference by treatment. There were non-significant trends for better visual field results in the brimonidine group. Adverse events consisting of local irritation were observed six times in the verum and three times in the placebo group. No serious adverse events occurred. CONCLUSION: In contradiction to an open-labeled, retrospective study published by Fazzone et al., the results of this trial did not indicate any harmful effect of brimonidine in patients suffering from NAION. However, a statistically significant advantage for the patients receiving brimonidine tartrate could not be shown.

Acute Disease↗

PubMed1994

Octamethylcyclotetrasiloxane in aquatic sediments: toxicity and risk assessment.

The toxicity of octamethylcyclotetrasiloxane (OMCTS) to the midge Chironomus tentans was examined in a series of aqueous and sediment exposures. Midge larvae were exposed for 14 days to five concentrations of radiolabeled [14C]OMCTS in each of three sediments (low, medium, and high organic carbon content). Additional tests were conducted with a water-only exposure. Results indicate the lowest 14-day no observed effect concentrations (NOEC) to be 65, 120, and 54 mg/kg for the low, medium, and high organic carbon sediments, respectively. For the water-only exposure, the 14-day NOEC was > 15 micrograms/liter. These results were used in the preparation of a risk assessment for OMCTS which took into consideration the physicochemical and environmental fate properties of the compound, as well as actual field monitoring and worst-case modeling results for assessment of exposure. Available evidence suggests that sediment concentrations of OMCTS do not present a risk to sediment-associated organisms. For 95% of sediment samples, data indicate that the margins of safety would be greater than 400 and potentially over 1000. Worst-case margins of safety were greater than 150.

Animals↗

PubMed2004

Effectiveness and safety of cholinesterase inhibitors in elderly subjects with Alzheimer's disease: a "real world" study.

Clinical trials have demonstrated the efficacy of cholinesterase inhibitors (ChEI) in improving cognitive status and disability in subjects with mild to moderate Alzheimer's disease (AD). However, little is known about the effectiveness of ChEI in clinical practice, and no large clinical trials comparing different ChEI are available at present. Aim of this study was to evaluate safety and effectiveness of ChEI in a sample of elderly outpatients diagnosed with mild to moderate AD. We selected 407 subjects for ChEI treatment (donepezil,rivastigmine or galantamine). Their cognitive function was evaluated by means of the mini mental state examination (MMSE), and the global functional status was estimated by using the activities of daily living (ADL) and the instrumental activities of daily living (IADL) scales at baseline (To), then after 1 (T1), 3 (T2) and 9 months (T3), respectively. T3 follow-up was completed by 212 subjects. The patients were considered as responders (R), if the MMSEscore at T2 was unchanged or improved, if compared to that of T0. In 35 patients (8.6 %)treatment was withdrawn because of mostly gastrointestinal adverse events. Compared to the other drugs, donepezil was associated with a lower incidence of withdrawals due to adverse events. Subjects who completed T3 follow-up (age 78 +/- 6 years, MMSE scores 18.8 +/- 3.9) showed an increase at T2 of 0.7 +/- 2.7 (p = 0.001) and a decrease at T3 of -0.6 +/- 3.4 (p = 0.008) in the MMSE scores, as compared to To . The ADL and IADL scores did not show significant changes at T2; however, both decreased significantly at T3. The patients Rat-T2 showed a better cognitive and functional outcome at T3 , compared to the nonresponders(NR-at-T2), displaying values of MMSE R-at-T2 0.4 +/- 3.1 vs. NR-at-T2 -3.0 +/- 2.5, p = 0.001, and ADL values of -0.3 +/- 1.2 vs. -0.7 +/- 1.3, p = 0.03, respectively. No significant difference was found in the changes of MMSE scores between donepezil and rivastigmine (galantamine was not included in the comparison due to the small number of treated subjects). In conclusion, in this sample of elderly subjects with mild to moderate AD,treated with ChEI, a small but significant decline in cognitive and functional status was observed after 9 months. Subjects who showed a good response to treatment after 3 months, had a better cognitive and functional outcome at 9 months. No significant difference in cognitive outcome was found between drugs, while donepezil was better tolerated.

Aged↗

PubMed2004

Double-blind, randomized comparison of olanzapine versus fluphenazine in the long-term treatment of schizophrenia.

This study was undertaken to evaluate the efficacy and safety of olanzapine compared with fluphenazine in the treatment of patients who met the Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnostic criteria for schizophrenia or schizoaffective disorder. This was a long-term (22-week), randomized, double-blind, parallel clinical trial. Sixty patients (mean age, 35.4 years) were randomly assigned to either olanzapine (n=30) or fluphenazine (n=30). They received treatment at three centers in Croatia during a 22-week study period and were assessed weekly for the first 6 weeks and monthly thereafter. Efficacy was measured using the Brief Psychiatric Rating Scale (BPRS), the Positive and Negative Syndrome Rating Scale (PANSS) and the Clinical Global Impression (CGI) Severity and Improvement scores. The Hillside Akathisia Scale (HAS), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), vital signs, laboratory tests, and treatment-emergent adverse events were assessed to evaluate safety. The olanzapine group showed significantly greater mean decreases from baseline to endpoint for BPRS total (-25.8 vs. -16.5, P=.035), PANSS total (-45.7 vs. -29.5, P=.037), PANSS positive (-13.0 vs. -7.9, P=.034), and CGI Severity (-2.2 vs. -1.3, P=.031) scores. The olanzapine group showed greater mean decreases on all measures of extrapyramidal symptoms, significantly so for the SAS (-2.1 vs. 1.9, P=.004) and HAS (-3.4 vs. 2.6, P=.028). Patients in the fluphenazine group experienced a higher incidence of treatment-emergent adverse events (76.7% vs. 50.0%, P=.032). Weight gain was the most frequently reported adverse event in the olanzapine group (16.7% vs. 0.0%, P=.020). Akathisia (30.0% vs. 10.0%, P=.053) and insomnia (20.0% vs. 0.0%, P=.010) appeared most frequent in the fluphenazine group. Daily use of anticholinergics and benzodiazepines were both significantly greater for the fluphenazine group (P=.003 and.04, respectively). No significant changes were observed in vital signs, ECG, or clinical chemistry. The study indicates that olanzapine has advantages in both efficacy and safety compared to fluphenazine; however, the small sample size limits our ability to draw definitive conclusions.

Adolescent↗

PubMed2001

Multiple state hazard models and workers' compensation claims: an examination of workers compensation data from Ontario.

The recurrent nature of some workplace injuries has led some researchers to conclude that the first absence from work does not provide an accurate picture of an individual's claim, or employment history, after a workplace injury. In this paper I estimate a multiple state hazard which estimates the transitions between spells where the individual receives workers' compensation benefits and spells where the individual does not receive any workers' compensation benefits. I apply this model to a sample of claims from Ontario's Workplace Safety and Insurance Board.

Accidents, Occupational↗

PubMed2003

Analgesic efficacy of flupirtine in primary care of patients with osteoporosis related pain. A multivariate analysis.

OBJECTIVE: Although chronic pain in elderly patients with osteoporosis is extremely common it has rarely been addressed in pharmacotherapy studies. The efficacy and tolerability of flupirtine (CAS 56995-20-1, Trancopal Dolo) up to 600 mg/day was investigated under daily practice conditions. DESIGN: This was an open-label, multicentre, prospective, observational phase IV study on 869 patients performed in 290 practices (mainly orthopedists) throughout Germany. MAIN OUTCOME MEASURE: Decrease in pain scores on a visual analogue scale (VAS, from 0 = none to 10 = maximum) after an average 3-week therapy, and evaluation of adverse events. Multivariate analyses were performed to identify factors associated with the efficacy of pain reduction. RESULTS: 81% of patients were female; the mean age of all patients was 67 years, and the mean body mass index was 25.7 kg/m2. 81% of patients had reduced bone density, 30% had a family history of osteoporosis, and 32% had previous bone fractures. The mean daily flupirtine dose was 270 +/- 12 mg. The mean baseline pain VAS scores were 7.1 (low back pain), 5.8 (neck pain), 5.6 (shoulder-arm pain), and 6.6 (other pain). Mean pain reduction at the end of flupirtine treatment was 43% for low back pain, 44% for neck pain, 40% for shoulder-arm pain, and 40% for other pain (all reductions p < 0.05 vs. baseline). Rates of pain reduction at the various sites were closely correlated, and the efficacy of pain reduction was independent of age. The pain reduction was more pronounced in patients with recent onset of pain and with higher pain intensity at entry. Tolerability of treatment was excellent with only 2.4% of patients reporting adverse events and only 12 patients (1.4%) withdrawing from the trial. CONCLUSION: This trial performed under daily practice conditions in a large unselected sample of patients confirms the efficacy and safety of flupirtine in the treatment of chronic pain in patients with osteoporosis, independent of the age of the patient.

Aged↗

PubMed1990

Road safety and drink-driving: the knowledge and opinions of male and female adolescents.

This paper reports on a structured questionnaire survey of high school students from years 8, 9 and 10 and their knowledge and opinions on issues relating to general road safety and drink-driving. A representative sample of this larger group was then interviewed in more depth. The results are discussed in terms of previous surveys of adolescents' attitudes and knowledge on these issues and the educational questions that arise in the light of reported sex differences.

Journal Article↗

PubMed2002

Fiber release during the removal of asbestos-containing gaskets: a work practice simulation.

Work practice studies were conducted involving the removal of asbestos-containing sheet gaskets from steam flanges. These studies were performed to determine potential exposure levels to individuals who have worked with these types of materials in the past and may still work with these products today. The work practices were conducted inside an exposure characterization laboratory (ECL) and were performed by scraping and wire brushing, chrysotile-containing (65% to 85%) sheet gaskets from a number of used steam flanges. Airborne asbestos levels were measured by phase contrast microscopy (PCM) and transmission electron microscopy (TEM) for the personnel and area air samples collected during the study. These workplace simulations showed substantial asbestos fiber release using scraping, hand wire brushing, and power wire brushing techniques during the gasket removal process. The range of concentration was 2.1 to 31.0 fibers/cc greater than 5 micrometers when measured by PCM. These results contrasted with the few reported results in the published literature where lower airborne asbestos levels were reported. In these studies the airborne asbestos fiber levels measured in many of the samples exceeded all current and historical Occupational Safety and Health Administration (OSHA) excursion limits (15-30 minutes) and some previous permissible exposure limits (PEL) based on eight-hour time-weighted average (TWA) standards. Also, individuals who performed this type of work in the past may have had exposures higher than previously suspected. The results demonstrated that employees who remove dry asbestos-containing gaskets with no localized ventilation should wear a full face supplied air respirator with a HEPA escape canister and the work area should be designated a regulated area.

Air Pollution, Indoor↗

PubMedDate not supplied

Precision and accuracy of asbestos fiber counting by phase contrast microscopy.

A new method was developed to prepare permanent asbestos slides with relocatable fields of view by imprinting these fields directly on the cleared wedges of filters containing asbestos fibers. The image quality of the fibers is comparable with that of the fibers prepared by the acetone/triacetin and the dimethyl formamide/Euparal method. The slides are suitable for evaluating the intercounter precision and accuracy of fiber counts by phase contrast microscopy. Seventeen chrysotile and 16 amosite slides, prepared from American Industrial Hygiene Association/National Institute for Occupational Safety and Health Proficiency Analytical Testing program samples, were evaluated by 58 analysts of 38 government and private laboratories in Canada. By asking the analysts to examine the same fields of view of the slides, the present study found that when examined at 400x, an average of 59.2 fiber counting errors were made for every 100 chrysotile fibers reported and 24.4 errors for 100 amosite fibers reported. The chrysotile fibers were underestimated by 25.0%, but there was no bias in counting amosite fibers. Remedial steps have been proposed to control the major source of errors, which is the subjective ability of the analyst to observe and size fibers. The slides may also be used to harmonize various phase contrast optical microscopy methods and proficiency testing programs.

Asbestos, Amosite↗

PubMed1989

Occupational exposure and analysis of microcrystalline cristobalite in mullite operations.

Three analytical methods currently used for crystalline free silica determination in occupational exposure samples were evaluated for their applicability to ceramic materials containing synthetic mullite. X-ray powder diffraction is the only method that can be used with sufficient precision and potentially adequate accuracy for occupational exposure monitoring. Personal respirable dust exposure samples were collected in two foundries. The results of exposure evaluations in Plant A showed overexposure to the dust, particularly in the shakeout area. The cristobalite concentration in the respirable dust exceeded that in the original material for this particular area. This may be related to the preheating of molds to more than 1100 degrees C for the pouring of stainless steel castings, causing conversion of some of the colloidal silica binder to cristobalite, and related to high vibration fracture of the material during removal of castings from molds. In Plant B, quartz was sometimes present along with cristobalite in personal samples. Respirable dust levels exceeded the Occupational Safety and Health Administration's (OSHA) permissible exposure limit (PEL) and the National Institute for Occupational Safety and Health's (NIOSH) recommended time-weighted average (TWA) for crystalline free silica, indicating a need for better engineering controls to reduce dust levels. The inadequacy of reference standards currently available for cristobalite analysis in these types of materials is cited. The need for more toxicological research is emphasized.

Aluminum Silicates↗

PubMed1992

Silica exposure in hand grinding steel castings.

Exposure to silica dust was studied in the grinding of castings in a steel foundry that used conventional personal sampling methods and new real-time sampling techniques developed for the identification of high-exposure tasks and tools. Approximately one-third of the personal samples exceeded the National Institute for Occupational Safety and Health recommended exposure limit for crystalline silica, a fraction similar to that identified in other studies of casting cleaning. Of five tools used to clean the castings, the tools with the largest wheels, a 6-in. grinder and a 4-in. cutoff wheel, were shown to be the major sources of dust exposure. Existing dust control consisted of the use of downdraft grinding benches. The size of the casting precluded working at a distance close enough to the grates of the downdraft benches for efficient capture of the grinding dust. In addition, measurements of air recirculated from the downdraft benches indicated that less than one-half of the respirable particles were removed from the contaminated airstream. Previous studies have shown that silica exposures in the cleaning of castings can be reduced or eliminated through the use of mold coatings, which minimize sand burn-in on the casting surface; by application of high-velocity, low-volume exhaust hoods; and by the use of a nonsilica molding aggregate such as olivine. This study concluded that all these methods would be appropriate control options.

Air Pollutants, Occupational↗

PubMed2004

Evaluation of meat products from cloned cattle: biological and biochemical properties.

Agricultural utilization of cloned livestock produced by nuclear transfer and their products for food will require public and governmental acceptance. A series of studies of properties of meat derived from cloned cattle was carried out to collect data for the safety assessment of cloned cattle products. Meat samples obtained from embryonic cloned, somatic cloned and non-cloned cattle were analyzed for chemical composition, as well as amino acids and fatty acids. Digestibility, allergenicity, and mutagenicity of meat were also examined. There were no significant differences in these properties among embryonic cloned, somatic cloned and non-cloned cattle. The analyses and tests revealed that there were no significant biological differences in meat from a non-cloned, an embryonic cloned, or a somatic cloned animal. A 14-week feeding trial in rats showed there were no abnormalities in body growth, general condition, locomotor activity, reflexes, sexual cycle, urinalysis, hematology, blood biochemistry, and histology. This study showed for the first time that the biological/biochemical properties of meat of cloned cattle are similar to those of non-cloned cattle.

Amino Acids↗

PubMed1989

Inhalation anaesthetics--exposure and control: a statistical comparison of personal exposures in operating theatres with and without anaesthetic gas scavenging.

Results are reported for air sampling surveys undertaken by the Health and Safety Executive (HSE) from 1980 to 1984 using diffusive samplers in 40 operating theatres and 18 recovery areas at 27 hospitals. For all personnel the geometric mean time-weighted average exposure to nitrous oxide in unscavenged theatres was 94 ppm and in scavenged theatres 32 ppm; the corresponding means for halothane were 1.7 and 0.7 ppm, respectively. Intermittent use of scavenging led to mean exposures between those found in scavenged and unscavenged conditions. Anaesthetists showed higher mean exposures than other staff in all conditions. Statistical analysis of the data demonstrates that mean exposures of operating theatre staff were significantly lower in scavenged than in unscavenged theatres. For most staff, exposure was also significantly lower in theatres using active scavenging systems compared with those using passive systems. The literature on the hazards of chronic exposure to inhalation anaesthetics and previous studies of exposure is also briefly reviewed.

Air Pollutants↗

PubMed2026

Insulin, Semaglutide and Dapagliflozin in Adults With Type 1 Diabetes: Design and Methods of Triple Therapy for Type 1 Diabetes (TTT1)-An International Phase 3 Clinical Trial.

AIMS: Attaining target glycaemia can be a challenge in Type 1 Diabetes (T1D) due to insulin-induced weight gain. Adjunct therapy with modern glucose-lowering agents developed for type 2 diabetes (T2D) has great potential but may be insufficiently efficacious and carries risks of hypoglycaemia and ketosis. We designed the first Phase 3 clinical trial to assess the efficacy and safety of adding a Glucagon-Like Peptide 1 receptor agonist (GLP-1RA) and a Sodium-Glucose Co-transporter (SGLT2) Inhibitor to insulin therapy in overweight and obese adults with T1D and glycaemia above target (HbA1c 7.5%-11.0% inclusive) (NCT03899402). MATERIALS AND METHODS: In Period 1, participants are randomized 2:1 (open label) for 26 weeks to semaglutide and insulin (uptitrated to 1.0 mg weekly) or standard insulin therapy. In Period 2, those randomized to semaglutide and insulin in Period 1 are further randomized (double-blind) for 26 weeks to dapagliflozin (10 mg daily) or placebo, in addition to semaglutide. The primary objective is to compare change in HbA1c on 'triple therapy' (dapagliflozin, semaglutide and insulin) with 'dual therapy' (placebo, semaglutide and insulin). Secondary objectives include comparisons of triple therapy with standard insulin therapy and dual therapy (semaglutide and insulin) with standard insulin therapy. Safety outcomes include hypoglycaemia and ketosis. A sample size recalculation during the trial based on analysis of masked data revised the original recruitment target from 114 to 82 participants. CONCLUSION: The TTT1 trial will provide clinically useful information on combination adjunct therapy in the treatment of T1D.

Humans↗

PubMed1996

The capacity of children's services in New South Wales to meet their responsibilities under the Public Health (Amendment) Act 1992.

From 1 January 1994 the New South Wales government has required directors of licensed children's services to ask parents for proof of their children's immunisation status, to record and update this information and notify public health units of outbreaks of vaccine-preventable disease. Before introduction of the legislation, we studied the health and safety policies and practices of a random sample of 77 long-day-care centres caring for children under two years of age. All but one recorded immunisation in some way; however, of the 73 centres for which adequate information was available, only 22 per cent (95 per cent confidence interval (CI) 14 to 33) recorded immunisation according to the National Health and Medical Research Council schedule. A review of the records of one in four children enrolled in the centres showed that triple antigen (TA) was recorded in some way on 94 per cent (CI 92 to 95) of records, and measles-mumps-rubella (MMR) on 80 per cent (CI 78 to 83) of records. These entries were independently verified for only 31 per cent of TA and 26 per cent of MMR records, and 38 per cent of TA and 41 per cent of MMR records had not been updated when necessary. Only 53 per cent of directors thought that the school-entry legislation would affect children's services. Directors were generally unaware of the role of the public health units and would have had difficulty in managing an outbreak of a vaccine-preventable disease. Without technical and administrative support, the directors will not be able to meet their responsibilities under the legislation.

Child Day Care Centers↗

PubMed1999

A four-shock Bayesian up-down estimator of the 80% effective defibrillation dose.

INTRODUCTION: New defibrillation techniques are often compared to standard approaches using the defibrillation threshold. However, inference from thresholding data necessitates extrapolation from reactions to relatively ineffective shocks, an error prone procedure requiring large sample sizes for hypothesis testing and large safety margins for defibrillator implantation. In contrast, this article presents a clinically validated statistical model of a minimum error, four-shock defibrillation testing protocol for estimating the 80% effective defibrillation strength for a given patient (ED80). METHODS AND RESULTS: A Bayesian statistical model was constructed assuming that the defibrillation dose-response curve is sigmoidal, and the ED80 is between 150 and 750 V. The model was used to design a minimum predicted error testing protocol and estimates. To prospectively validate the testing protocol and estimates, 170 patients received voltage-programmed biphasic testing. Four fibrillation episodes were induced and terminated in each patient according to the Bayesian up-down protocol. In addition, a validation attempt was made at the estimated ED80 rounded up to the nearest 50 V. In order to estimate the safety margin, in 136 patients, a defibrillation attempt was made at the rounded ED80 + 100 V. Of the 170 attempts at the rounded ED80, 143 (84%) attempts terminated fibrillation. Of the 136 attempts at the rounded ED80 + 100 V, 133 (98%) were effective. CONCLUSIONS: The four-shock Bayesian up-down protocol is the first clinical protocol to accurately predict an ED80 voltage. A 100 V increment above the ED80 provides an adequate safety margin. This simple and accurate method for estimating a highly effective defibrillation dose may be a valuable tool for population-based clinical hypothesis testing, as well as defibrillator implantation.

Adult↗

PubMed1987

Pharmacokinetics of the novel cephalosporin cefepime (BMY-28142) in rats and monkeys.

The disposition of the novel cephalosporin cefepime (BMY-28142) was characterized for intravenous administration of single doses to rats and cynomolgus monkeys, the species used most extensively for safety evaluation of the compound. Serial blood samples were collected from individual animals, and plasma was analyzed for intact cefepime by a high-pressure liquid chromatography-UV method. Assay results were evaluated by compartmental and noncompartmental methods to characterize pharmacokinetics for each species and dosage regimen. For intravenous (i.v.) bolus administration of 28 to 386 mg/kg (body weight) to rats, total body clearance (CL; 11.0 ml/min per kg) was essentially invariant with the dose; however, the terminal half-life (t1/2) and the steady-state distribution volume (Vss) increased with increasing dose level. After administration of 87 to 1,502 mg/kg by i.v. infusion, CL (12.5 ml/min per kg) was again similar for all dose groups. Mean t1/2 values (1.3 to 4.6 h) appeared unusually long for a cephalosporin in rats, and inordinately variable. No consistent differences among dose group mean Vss values were found. The maximal concentration of drug in plasma at the end of infusion was not a linear function of dose. For the cynomolgus monkey, kinetic parameters for 5-min i.v. infusions were linearly related to dose over the range of 10 to 600 mg/kg. Mean parameter values were t1/2 = 1.7 h, CL = 1.6 ml/min per kg, and Vss = 0.21 liters/kg. The pharmacokinetic results indicate substantive differences between the two species with respect to their response to toxicologic doses of cefepime.

Analysis of Variance↗

PubMed1994

Masses in breasts with implants: diagnosis with US-guided fine-needle aspiration biopsy.

PURPOSE: To evaluate retrospectively the findings at ultrasound (US)-guided fine-needle aspiration biopsy (FNAB) of masses in breasts that contain a prosthesis. MATERIALS AND METHODS: Real-time US-guided FNAB was performed in 22 lesions in 17 patients with breast implants. Pneumocystography was performed in seven of eight cysts. The final diagnosis was based on either histologic findings after surgical excision or a combination of cytologic, imaging, and clinical findings. RESULTS: The lesions had a mean diameter of 15 mm +/- 9 (standard deviation). Fifteen lesions (68%) were not identified on mammograms. In all cases, FNAB was completed without complication. Pneumocystography was successful in seven of seven cysts. Cytologic diagnosis was correct in 21 of 22 lesions (95%). There was one case of inadequate specimen (5%). In 16 cases (73%), the diagnosis was established with a single pass. CONCLUSION: Real-time US allowed continuous visualization of the needle during insertion and sampling, which resulted in pinpoint accuracy and safety. US-guided FNAB is recommended for needle biopsy in breasts with implants.

Adult↗