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Reported medication use in the neonatal intensive care unit: data from a large national data set.

OBJECTIVES: The objectives were (1) to identify the drugs reported most commonly during NICU care, (2) to examine how different methods of documenting drug use could influence prioritization of drugs for future research aimed at evaluating safety and efficacy, (3) to describe the demographic differences in the population samples for some specific medications, (4) to identify which reported medications are used for patient populations with >20% mortality rates, and (5) to examine how reports of drug use change over time. METHODS: A retrospective review of a large national data set was performed. RESULTS: The 10 medications reported most commonly for the NICU were ampicillin, gentamicin, ferrous sulfate, multivitamins, cefotaxime, caffeine citrate, furosemide, vancomycin, surfactant, and metoclopramide. Medications used for patient populations with >20% mortality rates included amphotericin, clonazepam, dobutamine, epinephrine, ethacrynic acid, insulin, lidocaine, metolazone, milrinone, inhaled nitric oxide, nitroglycerin, octreotide, pancuronium, phenytoin, sodium nitroprusside, sodium polystyrene sulfonate (Kayexalate), tris-hydroxymethylaminomethane acetate buffer, and tolazoline. Several of these drugs (eg, amphotericin B and bumetanide) were used primarily for extremely premature neonates, and this usage might explain the high mortality rates for the population of neonates treated with these medications. Other medications (clonazepam, milrinone, inhaled nitric oxide, and phenytoin) were used primarily for near-term and term infants. The explanation for the high mortality rates for these neonates is less clear and may be related primarily to the severity of illness for which the medications are used. Utilization rates for several different medications (eg, cisapride, metoclopramide, and dexamethasone) changed by >50% during the past 5 years. CONCLUSIONS: Data reported here are the first from a large national data set on the use of different medications for neonates admitted for intensive care and should be helpful in establishing priority agendas for future drug studies in this population.

Drug Utilization↗

Lead exposure and radiator repair work.

In 1986, the ambient air for lead in radiator repair shops in the Minneapolis-St. Paul metropolitan area exceeded the Occupational Safety and Health Administration (OSHA) action level in nine of 12 shops sampled by Minnesota OSHA. We therefore sought to determine the prevalence of lead exposure/toxicity in this industry. Thirty-five radiator shops were identified, 30 were visited, and 53 workers were studied. The mean blood lead level was 1.53 (range 0.24-2.80). Seventeen individuals had blood lead levels greater than or equal to 1.93 mumol/L (40 micrograms/dl). The mean zinc protoporphyrin level (ZPP) was 0.55 mumol/L (range 0.16-1.43). No single worksite or personal characteristic was a strong determinant of either blood lead or ZPP level.

Adult↗

[The present studies of the development of HCV vaccine].

After isolation of a hepatitis C virus genome in 1989, all donated blood samples have been analyzed by a sensitive screening system, which brought us 'safety transfusion' (free from HCV). However it is likely that about 170 million people around the world, more than 2 million people in Japan have already infected with HCV. Despite the numerous efforts, the lack of efficient cell culture system makes it difficult to develop HCV vaccine. Some novel strategies are engineered day by day that might be useful tools. Hereafter we must clarify the mechanisms of replication and infection in depth, to develop a vaccine that clear HCV from carrier.

Animals↗

Evaluation of clinician response to wireless technology.

The purpose of this study was to investigate the safety, use and response of clinical staff to wireless technology. A convenience sample of clinical staff was surveyed using a variety of assessment tools. The environmental assessment determined there was no interference between the wireless devices and the biomedical equipment on the patient care units. Survey results indicated a high level of acceptance for the wireless technology related to perceived usefulness, perceived ease of use, impact, adoption, advantage and future need. Results indicated a strong, significant relationship between adoption and perceived usefulness (r(s)=.71 p<.01; r(2)(s)=.50).

Attitude of Health Personnel↗

[Once weekly fluoxetine, tolerability and safety according to use patterns in the psychiatric clinical practice].

INTRODUCTION: Treatment with selective serotonin reuptake inhibitors (SSRI) has become generalized in all the medical setting although its efficacy and good tolerability may be affected by long term non-compliance. Once weekly fluoxetine could improve compliance due to the comfort of its use. The objective is to evaluate the safety, tolerability and efficacy of once weekly fluoxetine (90 mg) in a sample of out-patients, following naturalistic criteria in the usual clinical practice. METHOD: A total of 46 patients (age: 41.89 +/- 1.85) who received once weekly fluoxetine for at least 3 months (mean time: 135.24 days) were analyzed retrospectively. Clinical Global Impression of Severity (CGI-S) at the onset and end of the period evaluated, presence of adverse events, drop-out index and impression of patient's satisfaction with the treatment and use pattern were used. RESULTS: The mean of the final CGI-S was 2.09, compared with the onset 3.09 (p < 0.02), indicating significant improvement in the efficacy with once weekly fluoxetine. The most frequent adverse effects were: anxiety (10.87 %), headache (8.69 %) and restlessness (8.69 %) related with once weekly fluoxetine. Compliance was very high at the onset (99 %) and at the end (96 %). Ten patients dropped-out of the treatment (27.74 %), 6 due to appearance of undesirable effects (anxiety, headache and insomnia), three due to voluntary wish and only one due to lack of efficacy. The CGI of satisfaction of clinical global efficacy on the final visit was 1.43 (satisfied-very satisfied) and the CGI of satisfaction for the treatment pattern was 1.17 (very satisfied). CONCLUSION: Change to once weekly fluoxetine generally improves satisfaction of treatment efficacy and its use pattern, although some patients return to the initial regime after adverse effects appear.

Adult↗

Bone contamination and blood culture in tissue donors.

INTRODUCTION: Swab cultures are the most usual method to detect graft contamination; nevertheless it has been confirmed his limited sensibility. We have studied the relationship between blood cultures, swab surface cultures and cultures of entirely samples of cancellous bone. MATERIAL AND METHODS: We have evaluated 5 donors with positive blood culture, from 70 multiorganic donors during 2002. Blood samples were obtained prior the heart arrest. The bone procurement was done just after the organ recovery under aseptic conditions, and surface cultures were performed of each bone. After storage at -80 degrees C, cancellous samples were obtained by trephine and were completely cultured. RESULTS: In one case, the same microorganism grown in blood culture, in 2 of 9 surface cultures, and in 15 of 26 samples of cancellous bone. CONCLUSION: We conclude that to guarantee allograft's safety it is recommended to add donor's blood culture to the habitual surface swab culture if secondary sterilisation is not performed.

Adult↗

Granular cell tumor: report of 8 intraoral cases.

Granular cell tumor (GCT) is an uncommon neoplasm of controversial origin that can appear in any corporal localization, including the orofacial region. Although aggressive and malignant variants of this neoplasm have been described, most of GCTs are benign. In spite of the amount of research, the etiology of this neoplasm remains unclear and its histogenesis and its possible muscular, connective or neural origin has been broadly debated. In this paper 8 oral cases are presented, corresponding to 5 women and 3 men, with a mean age of 36.1 years old and a mean time of evolution of the lesions of 8.3 months. The most common localization was the tongue (75%). In all the cases a resection with safety margins of the lesions was carried out under local anesthesia. The samples were fixed and processed for histopathological study. The main clinicopathologic and diagnostic features of this neoplasm are reviewed and discussed.

Adolescent↗

Acyclovir in pregnancy registry: six years' experience. The Acyclovir in Pregnancy Registry Advisory Committee.

The Acyclovir in Pregnancy Registry was established to gather data on prenatal exposure to acyclovir. Exposed pregnancies are tracked prospectively to ascertain exposure, risk factors, and pregnancy outcome. Through June 30, 1990, 312 acyclovir-exposed pregnancies had been reported and followed. Of these, 239 were exposed during the first trimester; outcomes included 24 spontaneous fetal losses, 47 induced abortions, 159 live births of infants without congenital abnormalities, and nine outcomes with congenital abnormalities. Among the 73 second- and third-trimester exposures, one infant was born with an abnormality. Exposures are also reported to the registry retrospectively, ie, after the outcome of pregnancy is known. Registry findings to date do not show an increase in the number of birth defects among the prospective reports when compared with that expected in the general population, and there is no consistent pattern of abnormalities among retrospective or prospective reports. These findings should provide some reassurance in counseling women following inadvertent prenatal exposure. The cases accumulated to date represent a sample of insufficient size for reaching reliable and definitive conclusions about the safety of acyclovir for pregnant women and their developing fetuses. Therefore, until further information is available, the Acyclovir in Pregnancy Registry Advisory Committee recommends following the 1989 Centers for Disease Control Sexually Transmitted Diseases Treatment Guidelines for the use of acyclovir in pregnancy, and encourages reporting of all prenatal exposures to the registry (1-800-722-9292, ext. 8465).

Acyclovir↗

Municipal occupational health services for small workplaces. Background and general methodology of the study.

This paper deals with the new Occupational Health Service Act of Finland, as well as the background, scope and general methodology of a walk-through survey. The study comprised 163 small places of work within two municipal health center areas, and the primary objective was to determine their need for actual occupational health services. The workplaces were surveyed for a comprehensive picture of their physical and chemical hazards, as well as for knowledge of first-aid preparedness, need for job-related health counseling, personnel facilities, personal protection, and the required ergonomic and safety activities at the workplaces within the community. This ad-hoc information was considered essential for the planning of a nationwide occupational health program, and, more specifically, an assessment could be made of the utility of health personnel in reducing and preventing occupational health and safety risks at small places of work. More specific details of the sample and methodology are reported in other communications.

Absenteeism↗

Impedance monitoring in the stereotactic localization of intracranial structures.

Measurement of tissue impedance is a simple objective method for the localization of intracranial structures. Continuous bipolar impedance monitoring was performed during various CT-guided stereotactic procedures in 36 patients with brain pathology. The obtained values of the impedance profile along the trajectory were compared with the tissue density on CT scans or angled coronal and sagital CT reconstructions intraoperatively. The main goal was the selection of optimal biopsy targets and safe probe trajectory. Histologic findings of serial transtumoral biopsy were retrospectively correlated with both CT (or MRI) transposed data and patterns of tissue impedance. Intraoperative impedance monitoring enhanced the accuracy and safety of CT-guided procedures. The histologic examination of representative tissue samples avoids the risks of "blind" surgical or radiation management. This technique is reported with 6 illustrative cases.

Adult↗

The 1990 Comprehensive Blood Bank Surveys of the College of American Pathologists.

The performance of participants on the 1990 Comprehensive Blood Bank Surveys of the College of American Pathologists was consistent with the high quality of past surveys. The surveys include challenges in ABO and Rh typing, crossmatching, transfusion decisions, unexpected antibody detection and identification, and supplemental questions to assess contemporary practices. As in previous years, a recurrent serologic problem has been the reporting of antibodies not present in serum (anti-E in Set J-B, and anti-K in Set J-D). Such overidentification of antibodies has little implication for transfusion safety and may, in fact, represent an artifact of the survey's samples and reporting practices.

Blood Banks↗

[Evaluation of the nutritional status through determination of anthropometric parameters: new charts for the working population of Catalonia. Group for the Evaluation of body composition in the population of Catalonia].

BACKGROUND: Body composition measure by anthropometric parameters permits the detection of populations at risk of developing diseases with greater impact in public health and provides standard values of normality of nutritional state. METHODS: A prospective transversal study was carried out with a randomly selected sample of 6,445 individuals taken from 25,279 workers evaluated in Safety and Hygiene Centers during 1990. Chronically ill patients were excluded with 5,019 healthy individuals between 16 and 65 years of age being selected. The following data were obtained: height, weight, skin fold of the biceps and triceps, subscapular and abdominal and arm perimeter. Calculation of the weight/height, weight/height, weight/height, sum of two and four folds, mid-arm muscle circunference, area fo the arm, muscle area of the arm, adipose area of the arm and muscle adipose index was performed. RESULTS: The tables of the percentiles 1, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 95, and 99 of the anthropometric parameters according to sex and age are presented. Significant differences were found among the age groups for the fat parameters which were greater from the third decade for the fold of the fat of the trunk in males and from the fourth decade of the fat parameters of the trunk and extremities of females. The muscle parameters successively increased in both sexes and for each age group up to the fourth decade and thereafter remained stable. CONCLUSIONS: The values of the anthropometric parameters may be used as standard patterns of the working population in Catalonia. The differences between sexes and age groups, such as with the values of the Catalan population previously referred and those of the American population, indicate that the anthropometric measurements of body composition must be periodically determined to ensure adequate standards of each population.

Adolescent↗

A feasibility study evaluating rhBMP-2/absorbable collagen sponge device for local alveolar ridge preservation or augmentation.

This two-center human clinical trial evaluated recombinant human bone morphogenetic protein-2 delivered in an absorbable collagen sponge (rhBMP-2/ACS) for either alveolar ridge preservation after tooth extraction or augmentation of localized osseous defects. This 24-month study comprised two parts: a 4-month acute safety and bone induction period (Part I) followed by a 20-month, osseointegration, functional restoration, and long-term safety evaluation (Part II). The primary objective of Part I, discussed in this article, was to evaluate the short-term safety and technical feasibility of the rhBMP-2 device implantation. Twelve patients (six preservation and six augmentation) were enrolled in the investigation. Patient safety was monitored by oral examinations, radiographs, and the collection of blood samples to measure serum chemistries, hematology, and potential antibody formation. Technical feasibility was evaluated by collecting information relating to the handling properties of the rhBMP-2/ACS device. The ability of various evaluative tools to measure the bone-inducing activity of the rhBMP-2/ACS device was also assessed. The clinical results suggested that rhBMP-2/ACS was well tolerated locally and systemically, with no serious adverse events. The device was found to be easily handled and adapted to the ridge and extraction socket. Using direct measurements, all sites demonstrated firmness and fullness to palpation at 4 weeks; however, a loss of volume was noted in some treatment areas between 4 and 8 weeks. Augmentation of the alveolar ridge was not observed in the patients as assessed by the evaluation techniques. This trial indicated that the use of rhBMP-2/ACS to preserve alveolar ridge after tooth extraction or augmentation of localized defects is safe and feasible. Bone fill was observed in all alveolar sockets filled with the rhBMP-2 device.

Absorption↗

Experience with early amniocentesis.

Literature concerning early genetic amniocentesis, obtained before 14-15 weeks of gestation, has been examined and compared. Key figures of post-procedural spontaneous fetal losses have been compared as well as cytogenetic data from the published series. Cytogenetically more samples fail to grow in the early weeks, but the diagnostic accuracy seems to be comparable with that of amniocentesis obtained in the later weeks. A sampling method, improving the cell yield by means of filtration, has been developed in order to lower the risk of culture failure and reduce the reporting time in the gestational weeks 11 to 13. The filter technique is under evaluation in a randomized trial. Detection of neural tube defects with early amniotic fluid sampling is possible, but whether the detection rate is comparable to that of standard amniocentesis remains to be seen. Although the safety of early amniocentesis has not yet been evaluated in a randomised study, data from almost 5,000 cases suggest that the procedure related loss rate is approximately 1%, and thus the same as for standard amniocentesis and chorionic villus sampling.

Amniocentesis↗

Safety assessment of food-contact paper and board using a battery of short-term toxicity tests: European union BIOSAFEPAPER project.

An European Union (EU)-funded project QLK1-CT-2001-00930 (BIOSAFEPAPER) involves the development, validation and intercalibration of a short-term battery of toxicological tests for the safety assessment of food-contact paper and board. Dissemination of the results to industry, legislators (e.g. DG Consumer Protection, DG Enterprises, DG Research), standardization bodies such as CEN, and consumers will create an agreed risk evaluation procedure. The project involves pre-normative research in order to establish a set of in-vitro cytotoxicity and genotoxicity tests that will be easily adaptable to food-contact fibre-based materials and have endpoints relevant to consumer safety, including sub-lethal cellular events. These tests will be performed on samples representing actual migration conditions from food-contact paper and board with respect to different foodstuffs, and should form an experimental basis for scientifically sound recommendations for a harmonized system of risk evaluation and product testing.

Animals↗

The risk of childhood injury on Boston's playground equipment and surfaces.

The Childhood Injury Prevention Program of the Boston Department of Health and Hospitals conducted a survey of injury risk in Boston's playgrounds. A standardized checklist was used to assess a 25% sample of public playgrounds for hazards. Climbers accounted for 34% of the hazards observed and had the greatest proportion of significant hazards. The surfacing material in 100% of the playgrounds observed was unsafe. Urban children risk exposure to hazardous playground equipment frequently situated above unsafe surfacing material.

Boston↗

[Determination of a significant cell count for positive diagnosis in gynecologic suspension preparations and possible consequences for the analysis of automated preparations].

Monolayer preparations used in automated cytology are generated from gynecologic cell suspensions. The suspension-derived preparations (s.p.) show some peculiarities compared with conventional cytologic smears. One important feature of the s.p. is a distribution of cells mainly by chance. Therefore it seems to be possible to determine a cell sample size in minimum needed for cytologic diagnosis. In a blind test the needed cell sample size was determined by counting the cells in the microscopic fields of vision (ocular 12,5 x, objective 10 x, phi of the field of vision 2 mm) step by step until it was possible to classify the specimen (diagnosis 1). To be on the safe side (personal safety requirement) some further cells were assessed (diagnosis 2). We used s.p. from 50 non-suspicious women and 50 women with invasive squamous cell carcinoma of the uterine cervix and its precursors. To recognize strong positive cases (severe dysplasia to invasive carcinoma) only about 600 cells are needed (mean: 150/147 cells). The most cells (about 1200 cells) are required in negative cases and cases of mild to moderate dysplasia (mean: 293/236 cells). The highest personal safety requirement was found in cases of mild to moderate dysplasia (311% compared with a mean sample size of 236 or 100%). The results support such approaches in automated cytology which analyze only some hundreds or about 1000 cells with high resolution.

Autoanalysis↗