Actual Conditions Of Use Research Articles

Usefulness of transdermal fentanyl in the management of nonmalignant chronic pain: A prospective, observational, multicenter study

Abstract Objective. Only a few studies have addressed the effectiveness of fentanyl delivered via the transdermal therapeutic system (TTS) on pain relief in patients with chronic nonmalignant pain. Therefore, we evaluated the usefulness of fentanyl TTS in actual conditions of use in a large sample of subjects with non-cancer pain. Design and patients. A total of 236 patients with chronic non-cancer pain suitable to be treated with transdermal fentanyl participated in a prospective, observational, noncomparative, open-label multicenter study. Treatment with fentanyl TTS was started with 25 μg/h and continued for 6 months. The intensity of pain was evaluated by the patient according to a 100-mm visual analogue scale (VAS) and health-related quality of life using a Spanish validated version of the Nottingham Health Profile (NHP). Study assessments were made at baseline, at days 4, 7, and 15 after initiation of fentanyl TTS, and then once a month for 5 months. Results. There were 120 patients with neuropathic...

A critique of assumptions about selecting chemical-resistant gloves: a case for workplace evaluation of glove efficacy.

Wearing chemical-resistant gloves and clothing is the primary method used to prevent skin exposure to toxic chemicals in the workplace. The process for selecting gloves is usually based on manufacturers' laboratory-generated chemical permeation data. However, such data may not reflect conditions in the workplace where many variables are encountered (e.g., elevated temperature, flexing, pressure, and product variation between suppliers). Thus, the reliance on this selection process is questionable. Variables that may influence the performance of chemical-resistant gloves are identified and discussed. Passive dermal monitoring is recommended to evaluate glove performance under actual-use conditions and can bridge the gap between laboratory data and real-world performance.

Avaliação da eficácia, segurança e tolerabilidade de rabeprazol no tratamento de doenças ácido-pépticas

Racional - Rabeprazol sódico é um derivado benzimidazólico com potente ação inibidora da bomba de prótons. Aprovado na maioria dos países do mundo, inclusive no Brasil, a substância tem se mostrado muito eficaz para o tratamento das doenças ácido-pépticas, especialmente a doença por refluxo gastroesofágico. Objetivos - Avaliar a eficácia e tolerabilidade de rabeprazol em pacientes com esofagite por refluxo e/ou úlcera péptica gástrica e/ou duodenal na prática clínica, bem como avaliar o tempo necessário para a obtenção de alívio dos sintomas. Pacientes/Métodos - Foram avaliados 171 pacientes que procuraram consulta com gastroenterologista e que tiveram como diagnóstico a doença por refluxo ou úlcera péptica. Todos os pacientes eram ambulatoriais, de ambos os sexos, com idade superior a 18 anos. O diagnóstico, assim como o controle pós-tratamento foi obtido através do exame endoscópico. Todos os pacientes receberam 20 mg de rabeprazol ao dia por 4 a 8 semanas, dependendo do diagnóstico e a critério do médico. Os pacientes receberam um diário para registro do início do alívio dos sintomas. Os dados obtidos no inicio e ao final do tratamento foram analisados através do teste não-paramétrico de Wilcoxon para amostras pareadas. Resultados - Dos 171 pacientes iniciais 162 completaram o estudo. Destes, 78 (48,1%) tiveram como diagnóstico a doença por refluxo. Onze (6,8%) apresentaram associação desta com úlcera duodenal e 7 (4,3%) associado à úlcera gástrica. Em 39 (24,1%) o diagnóstico foi de úlcera duodenal. A úlcera gástrica isoladamente estava presente em 24 (14,8%) e associada à úlcera duodenal em 3 (1,9%) casos. O tratamento foi de 4 semanas em 94,2% dos pacientes. Apenas 7 necessitaram 6 semanas e 3 foram tratados por 8 semanas. Mais da metade dos pacientes obtiveram alívio dos sintomas após o 1 dia de tratamento e após 7 dias, 89,5% estavam totalmente assintomáticos. O índice de cicatrização das lesões foi de 88,3% dos casos. Vinte e sete pacientes (15,2%) relataram eventos adversos leves que não necessariamente estavam relacionados à medicação, sendo os mais freqüentes: diarréia, cefaléia e tonturas. Conclusões - O rabeprazol mostrou-se altamente eficaz para o alívio dos sintomas de pacientes com doenças ácido-pépticas. Da mesma forma, a droga proporcionou altos índices de cicatrização das lesões. O medicamento mostrou ser seguro, com efeitos colaterais transitórios e sem maiores conseqüências para os pacientes.

Minimizing burn injury: electric-arc hazard assessment and personnel protection

Significant progress has been made in understanding the arc flash hazard and protecting people. Standard tests have been established to determine the incident energy required to cause ignition of non-FR clothing and evaluate the protective characteristics of FR clothing. One process for selecting FR clothing to protect personnel against arc flash injury has been presented. Protective characteristics for classes of FR clothing and rainwear have been summarized. This performance information is based upon test data produced in a laboratory simulation, not in real-life conditions that may vary. The user is responsible for determining appropriate FR clothing and protective equipment based upon the actual conditions of use and exposure. Incident energy levels produced by three-phase arcs with a 1.25 in electrode gap on a 600 V electrical system with varying bolted fault values have been experimentally determined in a laboratory setting. Algorithms have been developed for predicting incident energy as a function of available bolted fault current, arc duration, and distance from the arc electrodes; and constant incident energy boundary distances.

Effectiveness and Tolerability of Rabeprazole 20mg as Once-Daily Monotherapy in Treatment of Erosive or Ulcerative Gastro-Oesophageal Reflux Disease

Rabeprazole, a new proton pump (H+, K+-ATPase) inhibitor, is a consistently effective treatment for patients with gastro-oesophageal reflux disease (GORD). Most of the data, however, has been obtained from controlled trials. The present study was carried out to assess the effectiveness and tolerability of rabeprazole in actual conditions of use in everyday clinical practice. This was a multicentre, observational, noncomparative, open-label, short-term study conducted in the outpatient clinics of 11 hospitals from a single country (Brazil). Male and female patients over 18 years of age with endoscopically confirmed erosive/ulcerative oesophagitis (Savary-Miller classification) and moderate to severe heartburn as the predominant symptom were eligible. Patients received rabeprazole 20mg once daily in the morning for 4 or 8 weeks. Patients with endoscopically documented healing at week 4 exited the study at that point. 92 patients were included in the intention-to-treat (ITT) group and 68 in the per-protocol (PP) group. At the end of the 4-week treatment period, daytime heartburn was present in 16.2% of patients, as compared with 97.1% at baseline (p < 0.001) and night-time heartburn in 10.3%, as compared with 77.9% at baseline (p < 0.001). All other symptoms of GORD (acid regurgitation, dysphagia, eructation, fullness, nausea, vomiting, epigastric pain) improved significantly after 4 weeks of rabeprazole treatment. The healing rate of erosive/ulcerative oesophagitis was 70.6% in the PP analysis and 69.6% in the ITT analysis after 4 weeks of treatment. At 4 or 8 weeks, the healing rate in the PP group was 78.3% for grade I oesophagitis, 91.7% for grade II, 60% for grade III, and 40% for grade IV. According to diary card information, most patients obtained marked relief of heartburn within the first 3 days of treatment and reduction in the need for supplemental antacids within the first 5 days. A total of 18 adverse events occurred in 17 (18.5%) patients, with a ‘possible’ relationship to the use of rabeprazole in only four cases. Withdrawal of the medication because of adverse events was not necessary. In this non-comparative, open-label, short-term study, rabeprazole 20mg once daily has shown clinical effectiveness in healing oesophageal lesions and in reducing the frequency and intensity of heartburn associated with erosive/ ulcerative oesophagitis in patients with GORD. Rabeprazole was also well tolerated.

Ultraviolet light hazards from transilluminators.

Ultraviolet (UV) light boxes ("transilluminators") are commonly used in molecular biology laboratories for visualizing ethidium bromide-intercalated nucleic acids separated under electric current in electrophoretic gels. These devices typically have peak outputs at 254 or 312 nm, well within the UV-C and -B regions that are biologically active and capable of damaging skin. Field evaluations of laboratory transilluminators under actual conditions of use indicate that the UV light emitted from transilluminators is an identifiable and potentially significant occupational hazard for many laboratory workers, as is the high frequency of workstation surface contamination with ethidium bromide, a known mutagen. Fortunately, these hazards can be relatively easily controlled through worker training and the regular use of basic personal protective equipment.

Determination of Organoiodine Antimicrobial Ingredients in Commercially Available Anti microbial/Deodorant Agents.

In order to grasp the actual conditions of use of three kinds of organoiodine compounds, 3-iodo-2propynylbutylcarbamate (IPBC), 1-bromo-3-ethoxycarbonyloxy-1,2-diiodo-1-propene (BECDIP), and 4-chlorophenyl3-iodopropargylformal (CPIP), which are used as household antimicrobial/antifungal agents and wood preservatives, an analytical method using a gas chromatograph equipped with a flame ionization detector (FID-GC) and gas chromatography mass spectrometry (GC/MS) was employed. The calibration curve (peak area) by FID-GC showed good linearity in the range from 20 µg/ml to 100 µg/ml (correlation coefficient R = 0.99 or more). A purification method using a liquid‐liquid partition by n-hexane/water and the cartridge column (florisil or alumina) was established, and the addition recovery exceeded 90% by this method. By employing this method, the analysis was carried out for 18 commercially available samples. As a result, IPBC was detected from 2 samples of aerosol type fungicides, BECDIP from 4 samples of wood preservatives, and CPIP from one sample of an aerosol type antifungal/ insecticidal paint.

Lasing wavelength changes due to degradation in buried heterostructure distributed Bragg reflector lasers

Changes in the wavelength and lamp characteristics due to the degradation of distributed Bragg reflector (DBR) lasers are investigated and the lasers are confirmed to be reliable enough for application as the light sources in WDM systems. The change in wavelength characteristics is due to degradation of the DBR or phase control region and the change in lamp characteristics is due to the degradation of active region. These changes in the characteristics are caused by diminished recombination carrier lifetime. The wavelength stability is strongly correlated with the injected current density. The lamp characteristics is confirmed to be almost as stable as in conventional Fabry-Perot lasers. The applicability of DBR lasers as the light source for wavelength division multiplexing (WDM) systems is demonstrated for actual-use conditions.

Thermally Induced Failure of Low-Voltage Electrical Nonmetallic-Sheathed Cable Insulation

Nonmetallic sheathed cable assemblies are commonplace throughout the electrical construction industry. The maximum current and ambient temperatures to which these cables can be exposed are listed in NFPA 70, National Electrical Code® (NEC)®. Laboratory test data presented here show the effects of exceeding these limits. Properties of the insulation materials in a standard cable assembly are evaluated using simultaneous thermal analysis (thermal gravimetric analysis (TGA) and differential scanning calorimetry (DSC)) coupled with Fourier transform infrared spectroscopy (STA/FTIR). Cable temperature under actual-use conditions is presented as a function of load current. Insulation resistance measurements of heated cable are included.

On the Shear Strength and Mixed-mode Fracture Toughness of a Lead-Tin and a Tin-Silver Solder

ABSTRACTThe increasing demands on solder joints have made it imperative that they perform not only their traditional role of electrical connection but also possess good mechanical integrity. One such key mechanical property is the shear strength of the solder. A number of specimen geometries can be used to evaluate the shear strength of solders, each with its advantages and limitations. This study uses a modified double lap shear geometry to measure the shear strength of the solders as a function of strain rate. It is ahown that the shear strength measured this way is truly reflective of the complex composite formed by the copper, solder and intermetallics and may be more representative of actual conditions of use rather than measurements of the shear strengths of the bulk solder. The study also uses a modified compact tension specimen to measure the fracture of the solder under combined tensile-shear loading conditions. It is shown that the solder fracture under these conditions follows the general principles of a mixed-mode fracture mechanism map.

In vitro percutaneous absorption of the fragrance ingredient musk xylol

The percutaneous absorption of the fragrance fixative musk xylol was measured in vitro in human and hairless guinea pig skin. For comparison, musk xylol was applied to skin in an oil-in-water emulsion or the volatile solvent, methanol. After 24 hr, total absorption of musk xylol in hairless guinea pig skin was 55% from the emulsion vehicle and 45% from the methanol vehicle. With human skin, permeation of musk xylol from both vehicles decreased to 22% of the applied dose. When human studies were continued for an additional 6 days after skin surface washing, only 6% of the applied dose remained in skin. The data suggest that most of the absorbed musk xylol in skin at 24 hr will be systemically absorbed in vivo within 1 wk. Throughout the 24-hr absorption study, absorbed musk xylol was not metabolized. A permeability constant for musk xylol permeation through hairless guinea pig skin was determined by a modified procedure for the lipophilic compound. At each time point, some diffusion cells were terminated so that skin and receptor fluid levels could be determined. Under steady-state absorption the permeability constant was 6.86 × 10 −5cm/hr. The amount of musk xylol penetrating skin from three types of cosmetic products was also calculated on the basis of actual conditions of use. Products that are applied to large areas of the body and remain on the skin for long periods will result in the greatest absorption of musk xylol.

The Actual Conditions of Use and Maintenance of a Village Park

The Actual Conditions of Use and Maintenance of a Village Park

Migration testing of plastics and microwave‐active materials for high‐temperature food‐use applications

Temperatures have been measured using a fluoro-optic probe at the food/container or food/packaging interfaces as appropriate, for a range of foods heated in either a microwave or a conventional oven. Reheating ready-prepared foods packaged in plastics pouches, trays or dishes in the microwave oven, according to the manufacturers' instructions, resulted in temperatures in the range 61-121 degrees C. Microwave-active materials (susceptors) in contact with ready-prepared foods frequently reached local spot temperatures above 200 degrees C. For foods cooked in a microwave oven according to published recipes, temperatures from 91 degrees C to 200 degrees C were recorded, whilst similar temperatures (92-194 degrees C) were attained in a conventional oven, but over longer periods of time. These measurements form the basis for examining compliance with specific and overall migration limits for plastics materials. The testing conditions proposed depend on the intended use of the plastic - for microwave oven use for aqueous foods, for all lidding materials, and for reheating of foods, testing would only be required with aqueous simulants for 1 h at 100 degrees C; for unspecified microwave oven use, testing with olive oil would be required for 30 min at 150 degrees C; and for unspecified use in a conventional oven testing with olive oil would be required for 2 h at 175 degrees C. For microwave-active materials, it is proposed that testing is carried out in the microwave oven using a novel semi-solid simulant comprising olive oil and water absorbed onto an inert support of diatomaceous earth. The testing in this instance is carried out with the simulant instead of food in a package and heating in the microwave oven at 600 W for 4 min for every 100 g of simulant employed. There is an option in every case to test for migration using real foods rather than simulants if it can be demonstrated that results using simulants are unrepresentative of those for foods. The proposed testing conditions were validated as being realistic by measurement of the specific migration of various components from different plastics into foods under actual conditions of use and comparing with migration into simulants. Migration of plasticizers from PVC and VC/VDC copolymer films was monitored for both microwave reheating and cooking of foods. Total oligomer concentrations were measured from poly(ethylene terephthalate) (PET) trays, and volatile aromatics from thermoset polyester trays, using both types of container in microwave and conventional ovens.(ABSTRACT TRUNCATED AT 400 WORDS)

Stability of floxuridine and leucovorin calcium admixtures for intraperitoneal administration

The stability of floxuridine and leucovorin calcium in admixtures of 0.9% sodium chloride injection at various concentrations, temperature conditions, and time points was determined. Admixtures of floxuridine and leucovorin calcium were prepared in 1-L plastic bags containing 0.9% sodium chloride injection. Admixtures containing the following three concentrations were prepared: floxuridine 1 g and leucovorin calcium 30 mg, floxuridine 2 g and leucovorin calcium 240 mg, and floxuridine 4 g and leucovorin calcium 960 mg. The admixtures were stored at refrigerated temperature (4-8 degrees C), ambient room temperature (20 degrees C), and near-physiologic body temperature (40 degrees C). Drug concentrations were measured with a stability-indicating high-performance liquid chromatographic (HPLC) method at 0, 4, 8, 24, and 48 hours (4-8 degrees C) and at 0, 1, 3, 6, 24, and 48 hours (20 degrees C and 40 degrees C). A second set of samples at the same concentrations was prepared and sequentially stored at refrigerated, room, and near-physiologic temperatures to simulate actual-use conditions; these samples were assayed by HPLC at 0, 4, 8, 24, and 48 hours (4-8 degrees C); 49, 51, 54, and 60 hours (20 degrees C); and 61, 63, 66, and 72 hours (40 degrees C). All solutions were protected from light. Floxuridine and leucovorin calcium were stable at each concentration and temperature condition tested for a minimum of 48 hours. However, leucovorin calcium was more subject to decomposition at near-physiologic temperature than at other temperatures, with the most degradation at the lowest concentration.(ABSTRACT TRUNCATED AT 250 WORDS)

Particulate contamination in parenteral type medical devices

Attention drawn in these last few years on particulate contamination in injectable preparations for i.v. use is now broadening to include also the checking of possible particulate contamination sources such as the infusion devices, for which no standards are yet available guaranteeing quality and safety of use. This investigation was aimed at gathering useful information on the degree of foreign particle contamination in tubular sets for arteriovenous use, and at contributing to the development of a method able to measure the contamination released by such apparatus. To that purpose, we analyzed 5 different types of hemodialysis venous lines (6 sets per type) and 10 types of administration sets (5 sets per type), produced in Italy by different manufacturers. The administration sets were submitted to treatment simulating the actual conditions of use of such equipment. The analyses were carried out with instrumental methods (light blockage and electric zone-sensing method) and with a microscope. All the specimens were previously inspected visually. The results of such analyses were compared with the limits of the F.U. IX edn., for L.V. parenteral products. Usually, the particulate contamination detected did not exceed such standards. The value obtained upon microscope examination corresponded to those found with the light blockage apparatus. In the hemodialysis administration devices, the degree of contamination did not seem to be related to the type of administration set, but rather to the treatment to which it has been submitted. The introduction of Good Manufacturing Practices, Guidelines for Producer, directions for users and qualitative standards appears to be highly desirable.

Summary of the Centers for Disease Control human immunodeficiency virus (HIV) performance evaluation surveys for 1985 and 1986.

During 1985 and 1986, the Centers for Disease Control conducted eight surveys to evaluate laboratory performance in testing for antibody to human immunodeficiency virus (HIV). (Other names for this virus include "human T-lymphotropic virus type III" and "lymphadenopathy associated virus.") The first survey was conducted with ten samples and 50 laboratories; the remaining surveys used six samples, but enrollment increased to as many as 475 laboratories. The purpose of these surveys was to measure test performance by the laboratories under the actual conditions of use. The surveys contained duplicate samples to permit measurement of within- and between-survey reproducibility. One survey included positive and negative reference materials as evaluation samples. Results of the Western blot (WB) test were not always positive on samples that were positive by enzyme immunoassay (EIA), and sometimes they were positive on samples that had negative results by EIA. The percentage of positive results reported by laboratories using Electronucleonics tests was lower than that reported by users of Abbott and of Litton tests. positive results on the negative reference material were reported by 13.7% of the Abbott EIA test users. The tests do not seem to be calibrated against an equivalent standard. Within-survey reproducibility was usually above 95% for EIA and WB methods and for the major manufacturers of EIA tests. Between-survey reproducibility was usually above 90%. Reproducibility was below 75% for some combinations of samples, method, and manufacturer. The test performance observed in these surveys may be lower than is actually achieved on patient samples because the samples were selected to measure technical competence and contain a higher frequency of samples with low reactivity than would be encountered with clinical samples. Stratification and weighting of the results in these surveys to estimate performance parameters for a blood bank population indicate that the tests are performing well in this application. If single EIA tests at the performance levels achieved in these surveys were used (no repeat and no confirmation), about 1 sample with positive results in every 50,000 samples tested would be missed and about 2.5% would be false positive results. Because tests are duplicated and confirmed in blood banks, better performance would be expected. Testing for antibody to HIV virus continues to undergo rapid change because of the introduction of new tests, changes in technical aspects of existing tests, and application of testing to changing populations. Such dynamic factors necessitate an ongoing, comprehensive monitoring of test performance.

「院内消毒剤使用マニュアル」の作成をふまえての消毒剤使用実態調査

Many investigations concerning a proper selection and an usage of disinfectants have been actively promoted by Drug Reevaluation of the Welfare Ministry and the Japanese Society of Hospital Pharmacists and the Japanese Society of Environmental Infection, etc. and the importance of radical prevention of hospital infection has been more emphasized. Now we surveyed the actual conditions of use of disinfectants in order to grasp the conditions in our hospital and to prepare “Manual for Use of Disinfectants in Hospital” . The survey used a questionnaire system with the response rate of 85.7% and revealed that in general, chlorhexidine, povidone-iodine and alcohols were frequently used and held important positions as disinfectants, as previously reported. Among them, aldehydes were used in about 90% of disinfection of linen and precision medical appliances.

Impaired HLA capping capacity of peripheral blood lymphocytes in Duchenne muscular dystrophy.

The cap capacity in nine Duchenne muscular dystrophy (DMD) patients and in 23 healthy male subjects (14 adults and nine neonates) has been investigated by inducing capping of HLA molecules. The evaluation of capping percentages ranged in healthy controls from 44 to 61 with a mean value of 53.39 +/- 4.89, while DMD patients displayed cap capacity of percentages varying from 15 to 38 with a mean value of 31.5 +/- 7.42. Statistical significance of the differences between the two groups, assessed by the Mann-Whitney U test, was p less than 0.00003. A correlation was found in DMD patients between cap capacity and age (tau = +0.657, p = 0.012). The results confirm previous reports of Ig capping impairment noted in B cells of the whole lymphocyte population, supporting the hypothesis of a systemic cellular defect in DMD patients. The data obtained suggest that HLA capping could overcome some of the technical difficulties of Ig capping and could be used as a diagnostic aid in antenatal detection of DMD.

Growth of Bacteria in Intravenous Fluids under Stimulated Actual-Use Conditions

The growth of microorganisms in nonnutritive intravenous solutions under simulated actual-use conditions was studied. Small quantities of Pseudomonas aeruginosa, Staphylococcus aureus, and Klebsiella pneumoniae (final concentration 200-400 cells/ml) were injected into 500-ml containers (glass bottles and plastic bags) of 5% dextrose injection, 0.9% sodium chloride injection, and 5% dextrose and 0.9% sodium chloride injection. Additives (ampicillin, vitamin K, lidocaine, and vitamin B complex) were included in some i.v. solutions. Administration sets were attached to the i.v. containers, and the solutions were run into collection bottles; samples were withdrawn at 0, 1, 2, 3, 4, 5, 6, and 8 hours after contamination and plated for viable counts. Staph. aureus and K. pneumoniae remained viable in 5% dextrose injection and in 0.9% sodium chloride injection, but the numbers of these bacteria did not increase. The number of Ps. aeruginosa declined in all three solutions. In 5% dextrose and 0.9% sodium chloride injection, the number of K. pneumoniae declined but Staph. aureus maintained viability. The type of container and the drug additives had no effect on microbial growth, except that ampicillin was bactericidal to Staph. aureus. Low-level contamination of these bacteria in nonnutritive i.v. solutions under actual-use conditions does not result in large numbers of organisms within the time frame in which most solutions are administered.

Contraceptive Product Development in Public-Sector Programs

Product development which involves the translation of basic research into a usable or marketable product is increasingly important to public-sector contraceptive programs. Institutions considering involvement in product development should weight the various stages in the process and the time and money required. The 4 stages -- feasibility assessment product definition product testing and market testing -- are presented graphically including the relative costs and different types of activities at each stage. The 1st stage involves assessment of the products biological feasibility. The next stage answers the questions as to how well the product will work and how it must be adapted to actual conditions of use. Toxicologic and clinical evaluation are involved in product testing. The last stage involves adapting the product to particular cultural and social characteristics of the population for which it will be used. The produce becomes increasingly complex and expensive at each stage. The types of personnel and administration necessary for this type of activity are discussed.