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The New England Journal of Medicine Sep 2017The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain.
METHODS
In this registry-based randomized clinical trial, we used nationwide Swedish registries for patient enrollment and data collection. Patients with suspected myocardial infarction and an oxygen saturation of 90% or higher were randomly assigned to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through an open face mask) or ambient air.
RESULTS
A total of 6629 patients were enrolled. The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99% among patients assigned to oxygen and 97% among patients assigned to ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as compared with 254 patients (7.7%) in the ambient-air group. The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient-air group. The primary end point of death from any cause within 1 year after randomization occurred in 5.0% of patients (166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to 1.21; P=0.80). Rehospitalization with myocardial infarction within 1 year occurred in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P=0.33). The results were consistent across all predefined subgroups.
CONCLUSIONS
Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality. (Funded by the Swedish Heart-Lung Foundation and others; DETO2X-AMI ClinicalTrials.gov number, NCT01787110 .).
Topics: Aged; Female; Follow-Up Studies; Heart Diseases; Hospitalization; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Oxygen Inhalation Therapy; Proportional Hazards Models; Registries; Sweden; Treatment Failure
PubMed: 28844200
DOI: 10.1056/NEJMoa1706222 -
Indian Journal of Plastic Surgery :... Oct 2008Advent of the tumescent technique in 1987 has allowed for safe contouring in ambulatory single session liposuction under regional or general anaesthesia. Safety and...
Advent of the tumescent technique in 1987 has allowed for safe contouring in ambulatory single session liposuction under regional or general anaesthesia. Safety and aesthetic issues define MegaLiposuction to be in Volume in litres of more than 10% of Body weight in Kgs. 870 cases of liposuction were performed between September 2000 and August 2008. In (65%) cases, the total volume of aspirate was greater then 5 liters. (Range: 5 to 25 liters). In 24% cases, the large volume liposuction was combined with a limited or a total block lipectomy. Regional anaesthesia with conscious sedation was preferred except where liposuction was for above the subcostal region (the Upper Trunk, Lateral Chest, Back, Gynaecomastia, Breast, Arms and Face) or when the patient so desired. Tumescent infiltration with Lactated ringer, adrenalin, triamcinalone and hyalase was made in all cases. This approach has clinically shown less tissue edema in the post operative period than when the conventional physiological saline was being used in place of Ringer Lactate. The amount injected varied from 1,000 ml to 12,500 ml depending on the size, site and area. Local anesthetic was included only to the terminal portion of the tumescent mixture while infiltrating the sub-costal regions, or when above costal region was combined with below costal region being anaesthetized with Spinal Anaesthesia. The aspirate was restricted to the unstained white / yellow fat and the amount of fat aspirated did not have any bearing to the amount of solution infiltrated. There was no major complication. Blood transfusion was given only on one occasion when the patient had been on aspirin and had also received Low Molecular weight Heparin intra-operative. The hospital stay ranged from 8 to 24 hours for liposuction as well as for liposuction with a lipectomy. Serous discharge from access sites, sero-sanguinous fluid accumulation requiring drainage were necessitated in less than 10% cases. Minor re-contouring touch ups were requested in 5% cases. Early ambulation was encouraged for mobilization of third space fluid shifts to expedite recovery and to prevent deep vein thrombosis. More than 10% patients were operated on for Liposuction of other areas, after a gap of 7 days to 6 months. Meticulous perioperative monitoring of systemic functions ensures safety in tumescent megaliposuction for the obese and rewarding results can be achieved in a single sitting.
PubMed: 20174540
DOI: No ID Found -
Saudi Journal of Biological Sciences Jan 2021Microbial surfactants are amphipathic molecules that consist of hydrophilic and hydrophobic domains, which allow partition of two fluid phases of varying degree of... (Review)
Review
Microbial surfactants are amphipathic molecules that consist of hydrophilic and hydrophobic domains, which allow partition of two fluid phases of varying degree of polarity. They are classified into two main groups: bioemulsifier and biosurfactant, depending on their molecular weight. Microbial surfactants occur in various categories according to their chemical nature and producing organisms. These biomolecules are produced by diverse groups of microorganisms including fungi, bacteria, and yeasts. Their production is significantly influenced by substrate type, fermentation technology and microbial strains. Owing to inherent multifunctional properties and assorted synthetic aptitude of the microbes, microbial surfactants are mostly preferred than their chemical counterparts for various industrial and biomedical applications including bioremediation, oil recovery; as supplements in laundry formulations and as emulsion-stabilizers in food and cosmetic industries as well as therapeutic agents in medicine. The present review discusses on production of microbial surfactants as promising and alternative broad-functional biomolecules for various biotechnological applications.
PubMed: 33424354
DOI: 10.1016/j.sjbs.2020.10.058 -
Antimicrobial Agents and Chemotherapy Feb 2021Relebactam/imipenem/cilastatin is approved in the United States to treat complicated urinary tract and intra-abdominal infections in patients who have limited or no...
Relebactam/imipenem/cilastatin is approved in the United States to treat complicated urinary tract and intra-abdominal infections in patients who have limited or no alternative treatment options and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). Initial pharmacokinetic, safety, and tolerability studies of relebactam with and without imipenem/cilastatin included mostly Caucasian participants. This study evaluated the pharmacokinetics, safety, and tolerability of relebactam/imipenem/cilastatin in 12 healthy Chinese participants after three single doses of increasing concentrations (relebactam at 125, 250, or 500 mg; cilastatin at 250, 500, or 1,000 mg; and imipenem at 250, 500, or 1,000 mg) and after multiple doses every 6 h of a single concentration (relebactam at 250 mg, cilastatin at 500 mg, and imipenem at 500 mg) for 14 days. After single doses, the area under the concentration-time curve (AUC) extrapolated to infinity (relebactam, 15.0 to 70.7 h · mg/liter; imipenem, 24.1 to 109.8 h · mg/liter; cilastatin, 18.4 to 95.3 h · mg/liter) and the AUC from 0 to 6 h (relebactam, 14.2 to 66.3 h · mg/liter; imipenem, 23.4 to 107.3 h · mg/liter; cilastatin, 18.3 to 94.4 h · mg/liter) increased in a dose-dependent manner; clearance (relebactam, 6.9 to 8.3 liters/h; imipenem, 8.6 to 10.4 liters/h; cilastatin, 10.5 to 13.6 liters/h) and half-life (relebactam, 1.4 to 1.6 h; imipenem, 1.0 to 1.2 h; cilastatin, 0.7 to 1.0 h) were consistent between doses. Pharmacokinetic parameters after multiple doses were similar to parameters after a single dose (geometric mean ratios of 0.8 to 1.0 for all three agents). Relebactam/imipenem/cilastatin was well tolerated; mild adverse events occurred during single dosing, and one participant experienced serious adverse events after multiple doses. Pharmacokinetics and safety data are comparable with data from participants of other ethnicities, supporting the use of relebactam/imipenem/cilastatin at the approved dose and schedule in Chinese patients.
Topics: Anti-Bacterial Agents; Azabicyclo Compounds; China; Cilastatin; Drug Combinations; Humans; Imipenem
PubMed: 33288637
DOI: 10.1128/AAC.01391-20 -
Human Gene Therapy Aug 2011The large amounts of recombinant adeno-associated virus (rAAV) vector needed for clinical trials and eventual commercialization require robust, economical, reproducible,...
The large amounts of recombinant adeno-associated virus (rAAV) vector needed for clinical trials and eventual commercialization require robust, economical, reproducible, and scalable production processes compatible with current good manufacturing practice. rAAV produced using baculovirus and insect cells satisfies these conditions; however, recovering rAAV particles from 200-liter bioreactors is more complicated than bench-scale vector preparations. Using a variety of processing media, we developed a reliable and routine downstream procedure for rAAV production that is scalable from 0.02- to 200-liter cultures. To facilitate the upstream process, we adapted the titerless infected-cell preservation and scale-up process for rAAV production. Single-use aliquots of cryopreserved baculovirus-infected insect cells (BIIC) are thawed and added to the suspension culture to achieve the desired ratio of BIIC to rAAV-producer cells. By using conditions established with small-scale cultures, rAAV was produced in larger volume cultures. Strikingly consistent rAAV yields were attained in cultures ranging from 10 liters to 200 liters. Based on the final yield, each cell produced 18,000 ± 6,800 particles of purified rAAV in 10-, 20-, 100-, and 200-liter cultures. Thus, with an average cell density of 4.32 × 10(6) cells/ml, ≥ 10(16) purified rAAV particles are produced from 100 to 200 liters. The downstream process resulted in about 20% recovery estimated from comparing the quantities of capsid protein antigen in the crude bioreactor material and in the final, purified product. The ease and reproducibility of rAAV production in 200-liter bioreactors suggest that the limit has not been reached, and 500-liter productions are planned.
Topics: Animals; Baculoviridae; Bioreactors; Cell Count; Cell Culture Techniques; Cell Line; Dependovirus; Genetic Vectors; Invertebrates; Reproducibility of Results
PubMed: 21381980
DOI: 10.1089/hum.2010.250 -
Drug and Alcohol Review Mar 2022Market research indicates an increasing interest in low- and no-alcohol drinks in Europe, but there is no systematic overview of their availability and consumption. In...
INTRODUCTION
Market research indicates an increasing interest in low- and no-alcohol drinks in Europe, but there is no systematic overview of their availability and consumption. In this article, we present data on the availability and apparent consumption of non-alcoholic beer in the European Union and the UK.
METHODS
We use Sold production, exports and imports by PRODCOM list (NACE Rev. 2) dataset, available in Eurostat, to extract the available data on sold production, exports and imports of non-alcoholic beer in the EU-27 (total and country-level) and the UK between 2013 and 2019, and additionally calculate the apparent consumption.
RESULTS
Between 2013 and 2019, the sold production volume in the EU increased from 0.59 to 1.38 billion litres, the value from 0.42 to 1.28 billion EUR and value per litre from 0.72 to 0.93 EUR/L. In 2019, the share of non-alcoholic beer represented 3.8% of all beer volume and 4.1% of all beer value produced. Five countries accounted for 80.8% of sold production volume: Germany, the Netherlands, Spain, Poland and Czechia. The Netherlands and Germany were the largest exporters, while importing was distributed more equally. Per capita, average apparent consumption (2017-2019) was highest in Czechia, followed by the Netherlands, Spain, Luxembourg and Germany.
DISCUSSION AND CONCLUSIONS
Our results show the increasing availability of non-alcoholic beer in the EU-27, although overall changes seem to be driven by a small number of countries. More research is needed at the country-level on no- and low-alcohol consumption trends and drivers, and their impact on alcohol-related harm reduction.
Topics: Alcohol Drinking; Beer; Ethanol; European Union; Humans; United Kingdom
PubMed: 34957634
DOI: 10.1111/dar.13429 -
Antimicrobial Agents and Chemotherapy May 2022The effect of heart transplantation (HTx) on the pharmacokinetics (PK) of caspofungin is not well-characterized. The aim of this study was to investigate the population...
The effect of heart transplantation (HTx) on the pharmacokinetics (PK) of caspofungin is not well-characterized. The aim of this study was to investigate the population PK of caspofungin in HTx and non-HTx patients and to identify covariates that may affect the PK of caspofungin. Seven successive blood samples were collected before administration and at 1, 2, 6, 10, 16, and 24 h after the administration of caspofungin for at least 3 days. This study recruited 27 HTx recipients and 31 non-HTx patients with 414 plasma concentrations in total. A nonlinear mixed-effects model was used to describe the population PK of caspofungin. The PK of caspofungin was best described by a two-compartment model. The clearance (CL) and volume of the central compartment () of caspofungin were 0.385 liter/h and 4.27 liters, respectively. The intercompartmental clearance () and the volume of the peripheral compartment () were 2.85 liters/h and 6.01 liters, respectively. In the final model, we found that albumin (ALB) affected the CL of caspofungin with an adjustment factor of -1.01, and no other covariates were identified. In this study, HTx was not found to affect the PK of caspofungin. Based on the simulations, the dose of caspofungin should be proportionately increased in patients with decreased ALB levels.
Topics: Caspofungin; Heart Transplantation; Humans
PubMed: 35389237
DOI: 10.1128/aac.02249-21 -
Lactate- or bicarbonate-buffered solutions in continuous extracorporeal renal replacement therapies.Kidney International. Supplement Nov 1999Continuous renal replacement therapies (CRRTs) are well accepted for critically ill patients with acute renal failure (ARF). Today, daily fluid exchange in CRRT reaches... (Review)
Review
BACKGROUND
Continuous renal replacement therapies (CRRTs) are well accepted for critically ill patients with acute renal failure (ARF). Today, daily fluid exchange in CRRT reaches 30 to 40 liter and more. Therefore, the composition of the substitution/dialysate fluid, often primarily developed either for intermittent treatment or for peritoneal dialysis, becomes more relevant. Lactate (30 to 45 mmol/liter) is frequently used as the buffer because of the high stability of this substance. However, lactate is thought to have negative effects on metabolic and hemodynamic parameters.
METHODS
Published data for different substitution fluids are presented with respect to acidosis and lactate concentration, uremia, and hemodynamic and metabolic alterations.
RESULTS
Only a few studies compare substitution fluids with different buffers. Uremia and acidosis (pH, base excess) were sufficiently controlled during CRRT with an exchange volume of in average 30 liters using either buffer. If patients with severe liver failure and lactic acidosis were excluded, no difference in hemodynamic and metabolic parameters between the solutions occurred. The plasma lactate concentration was elevated during lactate use in some cases, but lactate levels remained within normal limits in patients without liver impairment. The bicarbonate concentration in the solutions should exceed 35 to 40 mmol/liter, as in some cases the buffer capacity of the solutions was inadequate. In patients with severe liver failure or lactic acidosis, solutions with lactate buffer were shown not to be indicated.
CONCLUSION
In patients with reduced lactate metabolism, for example, concomitant severe liver failure, after liver transplantation or in lactic acidosis, bicarbonate-buffered solutions should be used. In nearly all other cases of critically ill patients with ARF, lactate-buffered solutions may be used as well as bicarbonate solutions.
Topics: Acute Kidney Injury; Bicarbonates; Buffers; Critical Illness; Hemodialysis Solutions; Humans; Lactates; Renal Replacement Therapy
PubMed: 10560802
DOI: No ID Found -
Antimicrobial Agents and Chemotherapy Aug 2020Ethionamide (ETA), an isonicotinic acid derivative, is part of the multidrug-resistant tuberculosis (MDR-TB) regimen. The current guidelines have deprioritized ETA...
Ethionamide (ETA), an isonicotinic acid derivative, is part of the multidrug-resistant tuberculosis (MDR-TB) regimen. The current guidelines have deprioritized ETA because it is potentially less effective than other agents. Our aim was to develop a population pharmacokinetic (PK) model and simulate ETA dosing regimens in order to assess target attainment. This study included subjects from four different sites, including healthy volunteers and patients with MDR-TB. The TB centers included were two in the United States and one in Bangladesh. Patients who received ETA and had at least one drug concentration reported were included. The population PK model was developed, regimens with a total of 1,000 to 2,250 mg daily were simulated, and target attainment using published MICs and targets of 1.0-log kill and resistance suppression was assessed with the Pmetrics R package. We included 1,167 ethionamide concentrations from 94 subjects. The final population model was a one-compartment model with first-order elimination and absorption with a lag time. The mean (standard deviation [SD]) final population parameter estimates were as follows: absorption rate constant, 1.02 (1.11) h; elimination rate constant, 0.69 (0.46) h; volume of distribution, 104.16 (59.87) liters; lag time, 0.43 (0.32) h. A total daily dose of 1,500 mg or more was needed for ≥90% attainment of the 1.0-log kill target at a MIC of 1 mg/liter, and 2,250 mg/day led to 80% attainment of the resistance suppression target at a MIC of 0.5 mg/liter. In conclusion, we developed a population PK model and assessed target attainment for different ETA regimens. Patients may not be able to tolerate the doses needed to achieve the predefined targets supporting the current recommendations for ETA deprioritization.
Topics: Anti-Bacterial Agents; Antitubercular Agents; Bangladesh; Ethionamide; Humans; Microbial Sensitivity Tests; Monte Carlo Method; Tuberculosis, Multidrug-Resistant
PubMed: 32631828
DOI: 10.1128/AAC.00713-20 -
Applied and Environmental Microbiology Aug 2021In this study, the adsorption-elution method was modified to concentrate viral particles in water samples and investigate the contamination of groundwater with norovirus...
In this study, the adsorption-elution method was modified to concentrate viral particles in water samples and investigate the contamination of groundwater with norovirus genogroup II (NoV GII), rotavirus A (RVA), and (PMMoV). The mean recovery rate of a murine norovirus strain, which was inoculated into groundwater samples collected from a deep well, was the highest (39%) when the viral RNA was directly extracted from the membrane instead of eluting the adsorbed viral particles. This adsorption-direct extraction method was applied to groundwater samples (20 liters) collected from deep wells used for the public drinking water supply ( = 22) and private wells ( = 9). RVA (85 copies/liter) and NoV GII (35 copies/liter) were detected in water samples from a deep well and a private well, respectively. PMMoV was detected in 95% and 89% of water samples from deep wells and private wells, respectively, at concentrations of up to 990 copies/liter. The modified method was also used to extract bacterial DNA from the membrane (recovery rate of inoculated Escherichia coli K-12 was 22%). The genetic markers specific to ruminants (BacR) and pigs (Pig2Bac) were detected in samples from a deep well and a private well, respectively. The modified virus concentration method has important implications for the management of microbiological safety in the groundwater supply. We investigated the presence of enteric viruses and bacterial genetic markers to determine fecal contamination in groundwater samples from deep wells used for the public drinking water supply and private wells in Japan. Groundwater is often subjected to chlorination; malfunctions in chlorine treatment result in waterborne disease outbreaks. The modified method successfully concentrated both viruses and bacteria in 20-liter groundwater samples. Norovirus genogroup II (GII), rotavirus A, , and genetic markers specific to ruminants and pigs were detected. Frequent flooding caused by increased incidences of extreme rainfall events promotes the infiltration of surface runoff containing livestock wastes and untreated wastewater into wells, possibly increasing groundwater contamination risk. The practical and efficient method developed in this study will enable waterworks and the environmental health departments of municipal/prefectural governments to monitor water quality. Additionally, the modified method will contribute to improving the microbiological safety of groundwater.
Topics: Adsorption; Bacteroidetes; DNA, Bacterial; Drinking Water; Environmental Monitoring; Escherichia coli K12; Feces; Genes, Bacterial; Groundwater; Japan; Norovirus; RNA, Viral; Rotavirus; Tobamovirus; Water Microbiology; Water Wells
PubMed: 34232739
DOI: 10.1128/AEM.00710-21