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Eighteen patients with acne vulgaris used a hydroalcoholic solution of clindamycin hydrochloride topically. Serum samples were obtained and assayed for clindamycin; no evidence for systemic absorption was found. The clindamycin capsules used in this preparation contained insoluble fillers that may be removed by filtration without loss of in vitro antibacterial activity. This solution is stable for at least six months.
BACKGROUND: The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination. Safe and immunologic vaccines have been developed based on purified Vi polysaccharide. OBJECTIVE: To compare the immune response elicited by two different brands of Salmonella Vi capsular polysaccharide vaccine (ViCPS). SETTING AND DESIGN: Double blind, randomized (3:1), controlled, parallel, phase III study was conducted at two centres in India to compare the safety and immunogenicity of Typbar, the investigational vaccine with an already marketed vaccine "X", in healthy subjects aged between 12 -25 years. MATERIAL AND METHODS: A sample size of 184 subjects was calculated. Subjects were randomly distributed in two groups, immunized with single dose of Typbar or Vaccine "X". Serum samples were taken before 7 days and 4 weeks after immunization for the determination of antibodies to Vi polysaccharide, by ELISA method. Safety was assessed by physical examination, laboratory parameters before and after vaccination and by monitoring adverse events. STATISTICS: The geometric mean antibody titre (GMT) 4 weeks after vaccination was compared from respective pre-vaccination values by Wilcoxon signed rank test. Geometric mean of antibody levels before and after immunization and the ratio between them (Mann-Whitney test), the Seroconversion rates (Z test of proportions) and the adverse events (Fisher's exact test and Chi square test), were compared between two groups. P value < 0.05 was considered statistically significant. P values and 95% confidence intervals were estimated in two-tailed fashion. RESULTS: 153 subjects (Typbar =116 and Vaccine "X" =37) were studied. 71.6% (95% CI=63.4%-79.8%) and 75.7% (95% CI=64.9% - 89.5%) were the seroconversion rates with Typbar and vaccine "X" respectively. The GMT values for Vi antibodies induced after Typbar and vaccine "X" were 10.23 Typbar and 13.46 mg/mL respectively and these values showed high significance when compared to their respective pre-immunization GMT values (P<0.0001) at 95% CI (-10.49 to -7.19 mg/mL for Typbar and -14.69 to -8.86 mg/mL for Vaccine "X"). The induction of antibody response appeared to be slightly stronger (P=0.032) with vaccine "X" when compared to that of Typbar. This is justifiable as the same group also had high pre-immunization GMT values (P=0.021). CONCLUSION: The immunogenicity and safety of the investigational vaccine Typbar was found to be similar to that of already marketed brand of Vi CPS, Vaccine "X". The availability of a single dose of vaccine that is safe and effective enhances the prospective for control of typhoid fever.
The Hazard Communications Standard, commonly known as the Worker Right to Know law, requires that a chemical information sheet, known as a material safety data sheet (MSDS), be produced for all hazardous chemicals. This study examines the comprehensibility of a sample of MSDSs to a group of about 100 unionized workers in manufacturing industries located in the state of Maryland. Workers were given several MSDSs and performed the equivalent of an open-book test answering questions regarding health and safety information that was provided on the MSDS. On average, the information on the MSDSs was found to be about one-third incomprehensible. This result raises concerns regarding policies and practices for hazard communication. There is a clear indication that MSDSs need to be improved if workers must rely on them for health and safety information.
OBJECTIVES: This study examines the concept and measurement of worker's safety behavior. It shows that the traditional concept of safety behavior centered on workers' carefulness or compliance with safety rules is limited and proposes that an additional dimension, namely, workers' safety initiatives, be taken into account. METHODS: Confirmatory factor analyses were carried out for a random sample of 828 workers drawn from 9 manufacturing facilities located in the province of Quebec (Canada). RESULTS: A 2-correlated congeneric factor model gave parameters in the expected direction, but the overall model was unable to reach a good fit. Separate construct analyses showed that compliance with safety rules is not a consistent dimension. The safety-initiatives dimension achieved a good fit with a high composite reliability (p=0.85). CONCLUSIONS: Workers' compliance with safety rules was not structured as a unitary dimension; therefore a selective process of safety-rules compliance by workers is suggested. Each category of safety rules should be considered as 1 single dimension and measured by several specific indicators. Indicators for safety initiatives provide high reliability, and, since this dimension is an important predictor of effectiveness in accident prevention, the items tested provide a better measurement than those previously published.
BACKGROUND: Needlestick injury poses an occupational hazard to health care workers that will increase with the increasing availability of point-of-care testing using capillary blood obtained with a lancet. OBJECTIVES: To demonstrate the safety and efficacy of a portable pulsed erbium:yttrium-aluminum-garnet (Er:YAG) laser in obtaining a blood sample from patients in a clinical setting and to determine whether the laser radiant energy alters the level of various components of blood, resulting in misleading laboratory results. DESIGN: Comparison of laboratory values of blood samples obtained with the laser and conventional lancet and comparison of patient and user preferences by questionnaire. PATIENTS AND METHODS: One hundred patients with diabetes mellitus attending a diabetes clinic were randomized to have capillary blood sampling from the fingertip performed either by the laser or a conventional lancet first, then with the other device. MAIN OUTCOME MEASURES: A comparison of pain, healing, hematocrit, and glycosylated hemoglobin (HbAlc), blood urea nitrogen, sodium, potassium, bicarbonate, and glucose levels. RESULTS: Adequate blood was obtained with both devices 97% of the time. Blood flow was greater with the laser perforation, resulting in higher operator preference. Although patients felt greater pain and experienced slower healing with the laser, these were not serious problems. Modification of the laser energy output led to a reduction in pain. Possibly owing to hemolysis, the potassium level in the blood obtained with the laser was significantly elevated and unsuitable for clinical decision making in many cases. None of the other measurements were similarly affected. CONCLUSIONS: We conclude that the laser device has the potential to obtain a blood sample for routine tests without a needle. This needle-free method will decrease the risk of bloodborne infections caused by needlestick injuries and thus lead to considerable cost savings and public health advantages. Further work is needed to alter the laser energy so that hemolysis can be decreased, thus enabling a more reliable potassium estimation.
A diffusive sampling method with water as absorbent was examined in comparison with 3 conventional methods of diffusive sampling with carbon cloth as absorbent, pumping through National Institute of Occupational Safety and Health (NIOSH) charcoal tubes, and pumping through NIOSH silica gel tubes to measure time-weighted average concentration of dimethylformamide (DMF). DMF vapors of constant concentrations at 3-110 ppm were generated by bubbling air at constant velocities through liquid DMF followed by dilution with fresh air. Both types of diffusive samplers could either absorb or adsorb DMF in proportion to time (0.25-8 h) and concentration (3-58 ppm), except that the DMF adsorbed was below the measurable amount when carbon cloth samplers were exposed at 3 ppm for less than 1 h. When both diffusive samplers were loaded with DMF and kept in fresh air, the DMF in water samplers stayed unchanged for at least for 12 h. The DMF in carbon cloth samplers showed a decay with a half-time of 14.3 h. When the carbon cloth was taken out immediately after termination of DMF exposure, wrapped in aluminum foil, and kept refrigerated, however, there was no measurable decrease in DMF for at least 3 weeks. When the air was drawn at 0.2 l/min, a breakthrough of the silica gel tube took place at about 4,000 ppm.min (as the lower 95% confidence limit), whereas charcoal tubes could tolerate even heavier exposures, suggesting that both tubes are fit to measure the 8-h time-weighted average of DMF at 10 ppm.
Frey's procedure, which is performed for chronic pancreatitis, principally involves coring of the head of the pancreas and pancreaticojejunostomy. The coring of the inflamed and enlarged pancreatic head is the most difficult and time-consuming part of this operation and is often associated with considerable bleeding. We used the harmonic scalpel to perform Frey's procedure in six consecutive patients, which reduced intraoperative bleeding and made the operation technically easier.
Insurance claims data were combined with telephone survey and on-site crash investigation data to create the first large scale, child-focused motor vehicle crash surveillance system in the US. Novel data management and transfer techniques were used to create a nearly real-time data collection system. In the first year of this on-going project, known as Partners for Child Passenger Safety, over 1200 children < or = 15 years of age per week were identified in crashes reported to State Farm Insurance Co. from 15 states and Washington, D.C. Partners for Child Passenger Safety is similar in its design and overall objectives to National Automotive Sampling System (NASS), the only other population-based crash surveillance system currently operating in the US.
Apart from genotypic identification methods, there is a need for reliable conventional phenotypic identification schemes for simple and rapid determination of enterococcal species in food or in the gastro-intestinal tract (GIT). Only a limited number of enterococcal species is of importance for the ecology of the GIT or the food microflora, including E. faecalis, E. faecium, E. durans/hirae, E. gallinarum and E. casseliflavus. After genus identification the differentiation within these species can include, e.g. mannitol and arabinose fermentation and growth at 50 degrees C. Widely used commercial identification systems may fail to precisely identify rare species. Ecological aspects should also be taken into account. In the human GIT E. faecium is the most common species whereas in most animal species E. faecalis is at least present in the same amount. Especially in foods of animal origin (cheese, pork meat, beef, poultry meat) also E. faecalis is very frequent. This is of special interest as glycopeptide resistance is most often found in human clinical E. faecium strains as well as in E. faecium from the environment or animal samples and less frequent in E. faecalis strains. EU experts propose as safety criteria for probiotics in feed additives the exclusion of resistances or the lack of transferability. This proposal can also be applied to enterococci in foods. Specific resistances must be excluded, but transferability or acquisition of resistance (e.g. vancomycin) cannot be excluded per se. However, technologically used strains should differ from clinical strains concerning their resistance patterns and transfer rates.
Since community-acquired pneumonia (CAP) is a common disease with a high morbidity rate, it is important to obtain information concerning its etiology and susceptibility to antibiotics across different geographic areas. This study presents data obtained in 5 Latin American counties in the course of an international clinical trial that evaluated the efficacy and safety of treatment with either moxifloxacin or amoxicillin administered for 10 days to patients suspected of having CAP caused by a pneumococcal infection. Details are given of the pathogens identified, the patterns of sensitivity to antibiotics observed, and the clinical and microbiological results obtained.A total of 84 patients were studied, of whom 70 (83.3%) were evaluated at the end of the trial to determine the efficacy and safety of the treatment received. Gram-positive bacteria were found in samples from 29 patients (80.5%). The pathogen was Streptococcus pneumoniae in 28 of those cases (77.7%). Gram-negative bacteria were found in 7 patients (19.4%), the most common being Haemophilus influenzae in 3 patients (8.3%). The presence of atypical microorganisms was detected in 18 of the 70 patients (25%), mainly Mycobacterium pneumoniae (n=11), and in 6 cases (8.5%) the infection was mixed. Ten strains of S. pneumoniae (35.7%) were shown to be susceptible to penicillin, 2 (7.1%) were highly resistant, and 16 (57.1%) showed moderate resistance. The clinical success rate at the final visit after treatment was 94.1% for moxifloxacin and 91.7% for amoxicillin. The results of this trial demonstrate a high prevalence of S. pneumoniae with reduced susceptibility to penicillin in patients with CAP in Latin America. It also revealed a high incidence of atypical pathogens and mixed infection in 8.6% of patients. This information should be taken into account when establishing protocols for empirical treatment of CAP in Latin America.
INTRODUCTION: The diagnosis of endotracheal tube (ETT) mal-position may be delayed in extreme environments. Several methods are utilized to confirm proper ETT placement, but these methods can be unreliable or unavailable in certain settings. Thoracic sonography, previously utilized to detect pneumothoraces, has not been tested to assess ETT placement. HYPOTHESIS: Thoracic sonography could correlate with pulmonary ventilation, and thereby, help to confirm proper ETT placement. METHODS: Thirteen patients requiring elective intubation under general anesthesia, and data from two trauma patients were evaluated. Using a portable, hand-held, ultrasound (PHHU) machine, sonographic recordings of the chest wall visceral-parietal pleural interface (VPPI) were recorded bilaterally in each patient during all phases of airway management: (1) pre-oxygenation; (2) induction; (3) paralysis; (4) intubation; and (5) ventilation. RESULTS: The VPPI could be well-imaged for all of the patients. In the two trauma patients, right mainstem intubations were noted in which specific pleural signals were not seen in the left chest wall VPPI after tube placement. These signs returned after correct repositioning of the ETT tube. In all of the elective surgery patients, signs correlating with bilateral ventilation in each patient were imaged and correlated with confirmation of ETT placement by anesthesiology. CONCLUSIONS: This report raises the possibility that thoracic sonography may be another tool that could be used to confirm proper ETT placement. This technique may have merit in extreme environments, such as in remote, pre-hospital settings or during aerospace medical transports, in which auscultation is impossible due to noise, or capnography is not available, and thus, requires further scientific evaluation.
An increased diversity of therapeutic targets in the pharmaceutical industry in recent years has led to a greater diversity of toxicological effects. This, and the increased pace of drug discovery, leads to a need for new technologies for the rapid elucidation of toxicological mechanisms. As part of an evaluation of the utility of metabonomics in drug safety assessment, 1H NMR spectra were acquired on urine and liver tissue samples obtained from rats administered vehicle or a development compound (MrkA) previously shown to induce hepatotoxicity in several animal species. Multivariate statistical analysis of the urinary NMR data clearly discriminated drug-treated from control animals, due to a depletion in tricarboxylic acid cycle intermediates, and the appearance of medium chain dicarboxylic acids. High-resolution magic angle spinning NMR data acquired on liver samples exhibited elevated triglyceride levels that were correlated with changes in the urinary NMR data. Urinary dicarboxylic aciduria is associated with defective metabolism of fatty acids; subsequent in vitro experiments confirmed that MrkA impairs fatty acid metabolism. The successful application of metabonomics to characterize an otherwise ill-defined mechanism of drug-induced toxicity supports the practicality of this approach for resolving toxicity issues for drugs in discovery and development.
The safety, tolerance, and pharmacokinetics of transnasal butorphanol were evaluated in a double-blind, multiple-dose phase I study. A total of 18 subjects received either placebo (n = 6) or a single transnasal dose of 2 mg butorphanol tartrate on the first day and 1, 2, and 4 mg doses of butorphanol tartrate every 6 hours on days 2 through 6, 7 through 11, and 12 through 16, respectively. Safety assessment was performed on days 7, 12, and 17. Serial blood samples were collected on days 1, 6, 11, and 16, and the plasma was analyzed for unchanged butorphanol by a validated and specific radioimmunoassay. Butorphanol was rapidly absorbed and peak levels in plasma were generally attained within 1 hour after the nasal administration. The values of maximum concentration, minimum concentration, and area under the concentration versus time curve from time zero to the dosing interval [AUC(0-tau)] increased as the administered dose increased in a dose-proportional manner. The values of AUC from time zero to infinity after a single dose of 2 mg butorphanol tartrate, 10.9 ng.hr/ml, were identical to the values of AUC(0-tau) after a multiple administration of 2 mg dose, 10.4 ng.hr/ml. Mean elimination half-life value was 5.45 hours. Steady state was reached in fewer than eight doses when given every 6 hours. Transnasal butorphanol was well tolerated by all subjects. After repeated administration of transnasal butorphanol, no significant changes were observed in the nasal examination, which included evaluation of color, wetness, and thickness of nostril membrane, air flow, airway patency, and general nasal conditions.(ABSTRACT TRUNCATED AT 250 WORDS)
The implantable cardioverter-defibrillator (ICD) is today widely used for the treatment of sudden cardiac near-death episodes as a result of malignant ventricular dysrhythmia. After examining the literature, only four descriptive studies, all carried out in the USA, with a qualitative analysis based on ICD-patients' own perspectives on their life situation have been found. The aim of this study was to describe how patients living with an ICD-device in south-western Sweden conceive their life situation. As the focus was on patients' conceptions seen from a holistic perspective, an analysis inspired by phenomenography was employed on a strategic sample of 15 ICD-patients. Six categories emerged: a feeling of safety, a feeling of gratitude, a feeling of being, having a network, having a belief in the future, and gaining awareness. Although the findings cannot be generalized because of the descriptive research design, they illuminate the beneficial as well as intrusive effects of such a device, and emphasize the need for support groups for patients and families as well as further education for personnel in hospital and primary health care.
OBJECTIVE: To investigate if high cassava production levels indicate high consumption and high dietary cyanide exposure in three villages situated within the area of Nigeria with higher cassava production than predicted by a geographic model for cassava production in Africa. DESIGN: Exploratory assessment of: cassava production and processing by qualitative research methods and quantification of residual cyanogens in products; cassava consumption by food frequency and weighed food records and dietary cyanide exposure by urinary thiocyanate and linamarin. SETTING: Rural communities of Afuze, Ebue and Ofabo in mid-west Nigeria. SUBJECTS: 110 subjects from 42 households in three villages for food frequency interviews; 118 subjects in nine Ofabo households for weighed food records. RESULTS: Cassava cultivation was reported to have increased in the preceding 20 years. It was consumed daily by 37 (88%) households, but its mean contribution to daily energy intake was only 13% The range of residual cyanogens in cassava foods was 0 to 62 mg HCN equivalent/kg dry weight (dw). Ten samples (19%) had levels above the 10 mg HCN equivalent/kg dw FAO/WHO safety limit. Mean urinary thiocyanate and linamarin were 51 and 20 micromol/L, indicating low cyanogen intake and dietary cyanide exposure. CONCLUSION: High cassava production levels did not result in high consumption and high dietary cyanide exposure levels, therefore cassava production levels cannot be used to predict consumption or cyanide exposure levels in the study area. A large part of the production is explained by intensive sales.
This study was carried out to estimate the daily intakes (EDIs) of artificial sweeteners such as saccharin, stevioside, D-sorbitol and aspartame in order to evaluate the safety of the artificial sweeteners in Korea. A total of 274 food samples were selected from the foods considered to be representative sources of artificial sweeteners in the Korean diet and analysed by using HPLC with evaporative light scattering and ultraviolet detectors. In case of aspartame, the reference values were used without instrumental analysis. The EDIs of saccharin, stevioside, D-sorbitol and aspartame for average consumers were 0.028, 0.008, 4.9 and 0.14 mg kg-1 body weight day-1, respectively, and as a proportion of the acceptable daily intake (ADI) were not higher than 1% of ADI of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). For 90th percentile consumers, the EDIs of saccharin, stevioside, D-sorbitol and aspartame were 2.0, 0.20, 141 and 4.6 mg kg-1 body weight day-1, respectively, and as a proportion of the ADI, the EDIs of saccharin and aspartame were 40.7% and 11.4% of the ADI set by the JECFA, respectively. Because JECFA did not assign ADIs for stevioside and D-sorbitol, the values for these sweeteners were not compared. According to these results, the EDIs of artificial sweeteners such as saccharin and aspartame in Korea are significantly lower than ADI set by the JECFA.
Personal air sampling for fluorides and solvents was done at 35 semiconductor fabrication facilities in the United States. Fluoride compounds were used in etching and cleaning operations, and solvents were used in photoresist and developing operations. All personal solvent and fluoride levels were less than 2 percent of current Occupational Safety and Health Administration (OSHA) standards. Statistical models of the exposure determinants for the target agents found production level, as indicated by number of semiconductor wafer cassettes loaded/unloaded from the target machines or baths, was predictive of fluoride, xylene and 1-methoxy-2-propyl acetate exposures. The percent of fresh air ventilation and the percent of xylene in the photoresist were also significant determinants in the statistical model predicting personal xylene exposure levels.
This study assessed airborne fiber exposures from intact asbestos-containing gaskets and packings while activities representative of historical work practices were performed. The study design eliminated analytical interferences while systematically capturing information related to activity variables. A series of gasket and packing activities was conducted according to traditional methods while sampling was performed to determine the 8-hour time-weighted average (TWA). The fittings used during this study were obtained intact from a decommissioned industrial power plant and U.S. Navy destroyers. The activities tested included flat blade scraping, hand wire brushing, power wire brushing, making gaskets with a ball-peen hammer, and stem packing removal and replacement. All activities were performed dry. Results for every area and personal sample showed the 8-hour TWAs were well below the current Occupational Safety and Health Administration permissible exposure limit of 0.1 f/cc. A database of more than 400 points was developed to analyze information from variable factors related to the tests. These factors included, for example, type of gasket, composition of the gasket, percentage of gasket adhering to a flange surface, gasket surface area, and minutes elapsed for removal. The results demonstrate a very low rate of fiber exposure from routine activities associated with asbestos-containing elastomeric gaskets and impregnated packing.