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  • 1
    Language: English
    In: Archives of Pediatrics & Adolescent Medicine, 11/01/1985, Vol.139(11), p.1101
    Description: To document passive smoke exposure, the authors measured concentrations of serum cotinine, a major metabolite of nicotine, in 38 young children and compared the results with the smoking histories of home residents. Cotinine was detected in 26 children (68%), of which ten had no household exposure according to a questionnaire. The serum cotinine concentration was significantly elevated in blacks compared with whites after controlling for the number of smokers in the home. After stratifying by race, there was a significant direct correlation between the serum cotinine concentration and the number of smokers in the home, the amount smoked by the mother, and the amount smoked by others in the home. We conclude that the serum cotinine concentration is a useful indicator of the actual exposure of young children to tobacco smoke and that unexplained racial differences in cotinine levels exist.
    Keywords: Radiation, Thermal, And Other Environ. Pollutant Effects On Living Orgs. And Biol. Mat ; Nicotine ; Blood Chemistry ; Metabolites ; Tobacco Smokes ; Health Hazards ; Black Americans ; Children ; Environmental Exposure ; Human Populations ; Aerosols ; Age Groups ; Alkaloids ; Amines ; Autonomic Nervous System Agents ; Azines ; Azoles ; Colloids ; Dispersions ; Drugs ; Hazards ; Heterocyclic Compounds ; Minority Groups ; Organic Compounds ; Organic Nitrogen Compounds ; Parasympatholytics ; Parasympathomimetics ; Populations ; Pyridines ; Pyrroles ; Pyrrolidines ; Residues ; Smokes ; Sols ; 560306 - Chemicals Metabolism & Toxicology- Man- (-1987);
    ISSN: 1072-4710
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  • 2
    Language: English
    In: Pharmacoepidemiology and Drug Safety, June 2010, Vol.19(6), pp.610-617
    Description: Purpose The availability of large databases with person time information and appropriate statistical methods allow for relatively rapid pharmacovigilance analyses. A semi-automated method was used to investigate the effect of fluoroquinolones on the incidence of C. difficile associated diarrhea (CDAD). Methods Two US databases, an electronic medical record (EMR) and a large medical claims database for the period 2006-2007 were evaluated using a semi-automated methodology. The raw EMR and claims datasets were subject to a normalization procedure that aligns the drug exposures and conditions using ontologies; Snowmed for medications and MedDRA for conditions. A retrospective cohort design was used together with matching by means of the propensity score. The association between exposure and outcome was evaluated using a Poisson regression model after taking into account potential confounders. Results A comparison between quinolones as the target cohort and macrolides as the comparison cohort produced a total of 564797 subjects exposed to a quinolone in the claims data and 233090 subjects in the EMR. They were matched with replacement within six strata of the propensity score. Among the matched cohorts there were a total of 488 and 158 outcomes in the claims and the EMR respectively. Quinolones were found to be twice more likely to be significantly associated with CDAD than macrolides adjusting for risk factors (IRR 2.75, 95%CI 2.18-3.48). Conclusions Use of a semi-automated method was successfully applied to two observational databases and was able to rapidly identify a potential for increased risk of developing CDAD with quinolones.
    Keywords: Epidemiology ; Antibiotics ; Quinolones
    ISSN: 1053-8569
    E-ISSN: 1099-1557
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  • 3
    In: Pediatrics, August, 1992, Vol.90(2), p.228(5)
    Description: One hundred thirty-two children who attended a research day-care center were studied to determine whether passive tobacco smoke exposure was associated with an increased rate of otitis media with effusion or with an increased number of days with otitis media with effusion during the first 3 years of life. Based on preliminary studies, a serum cotinine concentration of greater than or equal to 2.5 ng/mL was considered indicative of exposure to tobacco smoke. Otitis media with effusion was diagnosed using pneumatic otoscopy by nurse practitioners and pediatricians who reviewed the children's health status each weekday. The 87 children with serum cotinine concentrations greater than or equal to 2.5 ng/mL had a 38% higher rate of new episodes of otitis media with effusion during the first 3 years of life than the 45 children with lower or undetectable serum cotinine concentrations (incidence density ratio = 1.38, 95% confidence interval 1.21 to 1.56). The average duration of an episode of otitis media with effusion was 28 days in the children with elevated cotinine concentrations and 19 days in the children with lower cotinine concentrations (P less than .01). It is estimated that 8% of the cases of otitis media with effusion in this population and 17.6% of the days with otitis media with effusion may be attributable to exposure to tobacco smoke.
    Keywords: Passive Smoking -- Health Aspects ; Otitis Media -- Risk Factors ; Otitis Media With Effusion -- Causes Of
    ISSN: 0031-4005
    E-ISSN: 10984275
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  • 4
    In: Critical Care Medicine, 1996, Vol.24(2), pp.247-251
    Description: OBJECTIVES: To determine the use of commonly used diagnostic criteria for adult/acute respiratory distress syndrome (ARDS), evaluate physiologic variables of most value in diagnosing ARDS, and assess the frequency of newly diagnosed ARDS. DESIGN: Self-administered questionnaire by mail. SETTING: Hospital intensive care units (ICUs). SUBJECTS: Intensive care physicians (n equals 923) in the United States listed as ICU directors in the Society of Critical Care Medicine Membership Directory. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 448 (48.5%) physicians responded, with 301 questionnaires completed. Bilateral infiltrates on chest radiograph, the PaO2/FIO2 ratio, and pulmonary artery occlusion pressure were the most commonly used diagnostic criteria. However, the actual values used to diagnose ARDS were highly variable. The most important clinical physiologic variable used in determining the respiratory status of the ARDS patient was the PaO2/FIO2 ratio, followed by shunt fraction, alveolar-arterial oxygen tension gradient, FIO2, PaO2, respiratory system compliance, and minute ventilation. Respondents indicated that 9% of ICU beds at their institutions were occupied by a patient diagnosed with ARDS within the previous 7 days and 18.6% of all mechanically ventilated patients had ARDS by their own criteria. Based on the total number of ICU beds, the predicted incidence of ARDS would be approximate 275,000 patients per year in the United States. CONCLUSION: A wide range of diagnostic criteria are utilized by clinicians in the diagnosis of ARDS.(Crit Care Med 1996; 24:247-251)
    Keywords: Respiratory Distress Syndrome, Adult -- Diagnosis;
    ISSN: 0090-3493
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  • 5
    In: The New England Journal of Medicine, 1998, Vol.338(6), pp.341-346
    Description: Background In patients with the acute respiratory distress syndrome, pneumothorax and other air leaks — any extrusion of air outside the tracheobronchial tree — have been attributed to high ventilatory pressures or volumes and linked to increased mortality. Methods We analyzed data from a prospective trial of aerosolized synthetic surfactant in 725 patients with the acute respiratory distress syndrome induced by sepsis. We compared the ventilatory pressures and volumes in the patients without any air leaks (the highest values during the five-day study) with the pressures and volumes in those with pneumothorax or with any air leaks (the highest values during the 16- and 24-hour periods before the complication developed). Results Fifty patients (6.9 percent) had pneumothorax, and 77 (10.6 percent) had pneumothorax or other air leaks. There were no significant differences between patients with air leaks and those without air leaks in any pressure or volume examined. Overall mortality at 30 days was 40.0 percent (95 percent confidence interval, 36.4 to 43.6); among the patients with pneumothorax, it was 46.0 percent (95 percent confidence interval, 32.2 to 59.8), and among those without pneumothorax, it was 39.3 percent (95 percent confidence interval, 35.6 to 43.0; P = 0.35). The mortality rate was 45.5 percent (95 percent confidence interval, 34.4 to 56.6) in the group with any air leaks and 39.0 percent (95 percent confidence interval, 35.3 to 42.8) in the group without air leaks (P = 0.28). Conclusions In patients with sepsis-induced acute respiratory distress syndrome who were receiving mechanical ventilation with conventional pressures and volumes, there were no significant correlations between high ventilatory pressures or volumes and the development of pneumothorax or other air leaks. Pneumothorax or other air leaks were not associated with a significantly increased mortality rate. Over the past 20 years, laboratory investigations have led to the belief that high ventilatory pressures result in barotrauma, or more appropriately, air leaks. Air leaks are defined as any extrusion of air outside the tracheobronchial tree, including pneumothorax, pneumomediastinum, pneumopericardium, pulmonary interstitial edema, and subcutaneous emphysema. Air leaks have been associated with acute lung injury and increased mortality in animal models of the acute respiratory distress syndrome.1–6 These findings have been linked with computed tomographic (CT) evidence that the acute respiratory distress syndrome has a nonuniform distribution throughout the lungs.7,8 The CT findings and concomitant physiologic studies . . .
    Keywords: Pneumothorax -- Etiology ; Positive-Pressure Respiration -- Adverse Effects ; Respiratory Distress Syndrome, Adult -- Mortality;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 6
    In: Journal of the American Medical Informatics Association, 2010, Vol. 17(6), pp.652-662
    Description: Objective Active drug safety surveillance may be enhanced by analysis of multiple observational healthcare databases, including administrative claims and electronic health records. The objective of this study was to develop and evaluate a common data model (CDM) enabling rapid, comparable, systematic analyses across disparate observational data sources to identify and evaluate the effects of medicines. Design The CDM uses a person-centric design, with attributes for demographics, drug exposures, and condition occurrence. Drug eras, constructed to represent periods of persistent drug use, are derived from available elements from pharmacy dispensings, prescriptions written, and other medication history. Condition eras aggregate diagnoses that occur within a single episode of care. Drugs and conditions from source data are mapped to biomedical ontologies to standardize terminologies and enable analyses of higher-order effects. Measurements The CDM was applied to two source types: an administrative claims and an electronic medical record database. Descriptive statistics were used to evaluate transformation rules. Two case studies demonstrate the ability of the CDM to enable standard analyses across disparate sources: analyses of persons exposed to rofecoxib and persons with an acute myocardial infarction. Results Over 43 million persons, with nearly 1 billion drug exposures and 3.7 billion condition occurrences from both databases were successfully transformed into the CDM. An analysis routine applied to transformed data from each database produced consistent, comparable results. Conclusion A CDM can normalize the structure and content of disparate observational data, enabling standardized analyses that are meaningfully comparable when assessing the effects of medicines.
    Keywords: Pharmacoepidemiology ; Product Surveillance, Postmarketing ; Drug Safety, Medical Records Systems, Computerized ; Epidemiologic Methods ; Drug Toxicity ; Databases, Factual ; Medical Informatics Computing
    ISSN: 1067-5027
    E-ISSN: 1527-974X
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  • 7
    Language: English
    In: Clinical Pediatrics, August 1993, Vol.32(8), pp.504-506
    Description: Ciprofloxacin is a quinolone antibiotic that is effective against stains of Pseudomonas aeruginosa. It has also been found to be helpful in the treatment of pulmonary exacerbations in patients with cystic fibrosis, despite fears that it might cause possible joint toxicity in children. The safety of ciprofloxacin was studied in a long-term follow-up of a large group of children with cystic fibrosis who were taking part in a study of the possible role of rifampin in the emergence of ciprofloxacin-resistant Pseudomonas organisms during therapy with ciprofloxacin 25 to 30 mg/kg/day. Thirty-nine patients received 66 courses of ciprofloxacin over a 32-month period. There were no adverse effects observed during the study, and patients were followed for a period of 1 to 3 years after ciprofloxacin was discontinued.
    Keywords: Medicine
    ISSN: 0009-9228
    E-ISSN: 1938-2707
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  • 8
    In: The New England Journal of Medicine, 1996, Vol.334(22), pp.1417-1422
    Description: Background Patients with acute respiratory distress syndrome (ARDS) have a deficiency of surfactant. Surfactant replacement improves physiologic function in such patients, and preliminary data suggest that it may improve survival. Methods We conducted a prospective, multicenter, double-blind, randomized, placebo-controlled trial involving 725 patients with sepsis-induced ARDS. Patients were stratified according to the risk of death at base line (indicated by their score on the Acute Physiologic and Chronic Health Evaluation [APACHE III] index) and randomly assigned to receive either continuously administered synthetic surfactant (13.5 mg of dipalmitoylphosphatidylcholine per milliliter; 364 patients) or placebo (0.45 percent saline; 361 patients) in aerosolized form for up to five days. Results The demographic and physiologic characteristics of the two treatment groups were similar at base line. The mean (±SD) age was 50±17 years in the surfactant group and 53±18 years in the placebo group, and the mean APACHE III scores at randomization were 70.4±25 and 70.5±25, respectively. Hemodynamic measures, measures of oxygenation, duration of mechanical ventilation, and length of stay in the intensive care unit did not differ significantly in the two groups. Survival at 30 days was 60 percent for both groups. Survival was similar in the groups when analyzed according to APACHE III score, cause of death, time of onset and severity of ARDS, presence or absence of documented sepsis, underlying disease, whether or not there was a do-not-resuscitate order, and medical center. Increased secretions were significantly more frequent in the surfactant group; the rates of other complications were similar in the two groups. Conclusions The continuous administration of aerosolized synthetic surfactant to patients with sepsis-induced ARDS had no significant effect on 30-day survival, length of stay in the intensive care unit, duration of mechanical ventilation, or physiologic function. When Ashbaugh et al.1 described the acute respiratory distress syndrome (ARDS) in 1967, they suggested that the clinical and pathological findings in patients with this condition were in part due to abnormalities in the alveolar wall. Petty et al.2,3 later reported both qualitative and quantitative abnormalities in lung surfactant in patients with ARDS. Hallman et al.4 confirmed that surfactant not only is decreased in quantity but also is functionally abnormal in patients with ARDS. These studies offer evidence that ARDS is a condition of surfactant deficiency.5 Recent data suggest that mechanical ventilation may induce lung damage. Dreyfuss et al. . . .
    Keywords: Administration, Inhalation–Adverse Effects ; Aerosols–Therapeutic Use ; Double-Blind Method–Adverse Effects ; Drug Combinations–Therapeutic Use ; Fatty Alcohols–Adverse Effects ; Female–Therapeutic Use ; Humans–Drug Therapy ; Male–Etiology ; Middle Aged–Mortality ; Phosphorylcholine–Complications ; Polyethylene Glycols–Complications ; Prospective Studies–Complications ; Pulmonary Surfactants–Complications ; Respiratory Distress Syndrome, Adult–Complications ; Sepsis–Complications ; Survival Rate–Complications ; Treatment Failure–Complications ; Abridged ; Aerosols ; Drug Combinations ; Fatty Alcohols ; Pulmonary Surfactants ; Phosphorylcholine ; Polyethylene Glycols ; Dipalmitoylphosphatidylcholine, Hexadecanol, Tyloxapol Drug Combination;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 9
    Language: English
    In: Pediatric Pulmonology, 1990, Vol.9(2), pp.80-85
    Description: Previous studies have found that between 0 and 95% of patients with cystic fibrosis (CF) have a significant response to bronchodilators. These studies have been limited by small numbers and the measurement of response at one point in time. We analyzed the response to bronchodilators of patients with CF in a longitudinal and cross‐sectional manner using pulmonary function data from 1980 to 1988. Overall, the proportion of patients with a positive response to bronchodilators was relatively large but not consistent over time. Of 573 tests in 127 persons, a positive response occurred in 68 tests of 51 patients. A negative response occurred in 19 tests of 17 patients. Only nine patients had a positive response in more than one third of their tests. The cross‐sectional analysis showed variability similar to previous cross‐sectional studies. Although a large proportion of patients with CF had a response to bronchodilators, the response was not consistent and may have been related to the number of tests performed. Continued longitudinal testing is necessary for valid decisions for bronchodilator use and for documenting the length, variability, and clinical significance of these responses. .
    Keywords: Forced Expiratory Flows ; Isoproterenol Hci Aerosol ; Eight Consecutive Yearly Studies ; Response Variability Vs Baseline Function ; Season ; Year
    ISSN: 8755-6863
    E-ISSN: 1099-0496
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  • 10
    In: JAMA, The Journal of the American Medical Association, Nov 9, 1994, Vol.272(18), p.1433(6)
    Description: Objective.--To evaluate the safety and potential efficacy of aerosolized surfactant in intubated patients with adult respiratory distress syndrome (ARDS). Design.--A prospective, double-blind, placebo-controlled, randomized, parallel, mutlicenter pilot clinical trial. Patients.--A total of 51 patients with sepsis-induced ARDS were entered into the study within 18 hours of developing sepsis or sepsis syndrome. Intervention.--Patients were randomized into four treatment groups in a 2:1:2:1 ratio, as follows: 12 hours of surfactant per day, 12 hours of 0.6% saline per day, 24 hours of surfactant per day, and 24 hours of 0.6% saline per day. Surfactant or saline was aerosolized continuously for up to 5 days using an in-line nebulizer that aerosolized only during inspiration. Main Outcome Measures.--Ventilatory data, arterial blood gases, and hemodynamic parameters were measured at baseline, every 4 or 8 hours during the 5 days of treatment, 24 hours after treatment, and 30 days after treatment, at which time mortality was also assessed. Safety was evaluated throughout the 30 days of the study. Results.--Surfactant was administered safely in ventilated patients when given continuously throughout the 5 days using the nebulizer system. Although there were no differences in any physiological parameter between the treatment groups, there was a dose-dependent trend in reduction of mortality from 47% in the combined placebo group to 41% and 35% in the groups treated with 12 hours and 24 hours of surfactant per day, respectively. Conclusions.--Aerosolized surfactant was well tolerated when administered on a continuous basis for up to 5 days; however, at the doses given, it did not result in significant improvements in patients with sepsis-induced ARDS.
    Keywords: Synthetic Lung Surfactants -- Evaluation ; Bacterial Infections -- Complications ; Adult Respiratory Distress Syndrome -- Care And Treatment
    ISSN: 0098-7484
    E-ISSN: 15383598
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