Controlling bacterial contamination of an enteral formula through the use of a unique closed system: contamination, enteral formulas, closed system

Contamination of enteral diets may play an essential role in formula tolerance and safety for patients. Contaminated enteral formula commonly support microbiological growth. Commercially sterile liquid formulas received from the manufacturer are required by the Food & Drug Administration (FDA) to be shelf-stable and free from enteric pathogens. This study examined the use of large volume, closed system containers in a typical nursing home. Large volume (1500 mL) containers with unique pierceable caps and piercing spikes were studied to determine their ability to reduce the incidence of microbiological contamination due to their design and ability to decrease handling requirements. This study took place in a room of a typical nursing home. In this clinical setting, 211 containers and administration spike sets were evaluated following a 36-h hangtime. Contamination was virtually nondetectable. Nursing staff in a clinical facility can effectively utilize a large volume, prefilled, ready-to-use feeding system to achieve delivery of noncontaminated product for up to 36 h hangtime.     

Age-dependent penetrance of disease in a transgenic mouse model of familial amyotrophic lateral sclerosis

The mutation gly93-->ala of Cu,Zn superoxide dismutase (SOD) is found in patients with familial amyotrophic lateral sclerosis and causes motor neuron disease when expressed in transgenic mice. The progression of clinical and pathological disease was studied in a line of mice designated G1H. Clinical disease started at 91 +/- 14 days of age with fine shaking of the limbs, followed by paralysis and death by 136 +/- 7 days of age. Pathological changes begin by 37 days of age with vacuoles derived from swollen mitochondria accumulating in motor neurons. At the onset of clinical disease (90 days), significant death of somatic motor neurons innervating limb muscles has occurred; mice at end-stage disease (136 days) show up to 50% loss of cervical and lumbar motor neurons. However, neither thoracic nor cranial motor neurons show appreciable loss despite vacuolar changes. Autonomic motor neurons also are not affected. Mice that express wild-type human Cu,Zn SOD remain free of disease, indicating that mutations cause neuron loss by a gain-of-function. Thus, the age-dependent penetrance of motor neuron disease in this transgenic model is due to the gradual accumulation of pathological damage in select populations of cholinergic neurons.     

HIV-1 infection of monocyte-derived macrophages reduces Fc and complement receptor expression

Fc receptor (FcR) and complement receptor (CR) expression on HIV-infected monocyte-derived macrophages may be an important determinant of immune function. We studied the effects of HIV-1 infection of macrophages in vitro on FcR and CR expression. Macrophages were infected with HIV-1DV 7 days following isolation, and the expression of Fc gamma RI-III and CR3 were measured at intervals thereafter by flow cytometry. We found a reduction in receptor expression with the percentage of cells expressing FcRI 14 days post infection declining from 77% to 13%, FcRII fell from 96% to 85%, FcRIII from 45% to 9%, and CR3 from 91% to 67% 14 days following infection. As these receptors are important for macrophage function, their down-modulation may contribute to the pathogenesis of HIV-related disease.     

Developing outcome measures for ambulatory care--an application to asthma and diabetes

Increasing emphasis is now being placed on the assessment of patient outcomes, both in evaluating medical interventions and in quality assurance initiatives. Clinicians, purchasers, managers and researchers need outcome measures that are valid, reliable and responsive. This paper describes the theory and practice underlying the development of outcome measures for two chronic conditions, asthma and diabetes, for application in ambulatory settings. Existing generic and condition-specific health status and health-related quality-of-life measures were administered to almost 1300 patients. The psychometric properties of these measures were examined to identify those that were of adequate validity and reliability in these population groups. Step-wise regression procedures were then used to identify a core set of scales that best predicted patients' general health perceptions, which could be used in measuring general health outcomes for each of these groups. These core sets consist of up to 40 items, spanning physical function, energy and vitality, emotional well-being and condition-specific aspects of health such as symptom control. Further analysis is being carried out to assess the responsiveness to change of these core item sets.     

Molecular analysis of the F plasmid traVR region: traV encodes a lipoprotein

The nucleotide sequences of the conjugative F plasmid transfer region genes, traV and traR, have been determined. The deduced amino acid sequence of TraV indicated that it may be a lipoprotein; this was confirmed by examining the effect of globomycin on traV-encoded polypeptides synthesized in minicells. An open reading frame that may represent a previously undetected transfer gene, now designated trbG, was identified immediately upstream of traV. The deduced product of traR was found to share amino acid similarity with proteins from the bacteriophages 186 and P2 and with the dosage-dependent dnaK suppressor DksA.     

Gas chromatographic/mass spectrometric analyses of unknown analytical response in imported Fava beans: 4-chloro-6-methoxyindole

A halogenated unidentified analytical response (UAR) was encountered in a number of imported Fava bean samples during the Food and Drug Administration's routine pesticide-monitoring program. Gas chromatographic/mass spectrometric (GC/MS) analyses identified the halogenated component as 4-chloro-6-methoxyindole, a naturally occurring promutagen in Fava beans that has been linked to incidents of gastric cancer. Data from electron impact, positive and negative chemical ionization, collision-induced dissociation, and deuteration studies of this compound are presented, along with GC retention time data.     

Kappa-opioids produce significantly greater analgesia in women than in men

Sex differences in human responses to nociceptive stimuli and painful pathological conditions have generally indicated that women report higher pain levels or exhibit less tolerance than men for given stimulus intensities (reviewed in ref. 1 and 2). However, studies have not evaluated sex differences in analgesic responses. We recently reported that the opioid agonist-antagonist pentazocine, which acts predominantly at kappa-receptors, produced significantly better postoperative analgesia in females than in males in patients who underwent surgery for the removal of their third molars (wisdom teeth). In the current study, we evaluated the hypothesis that this sex difference is a characteristic of kappa-opioid agonism. In order to determine whether there are sex differences associated with kappa-opioid agonism, the analgesic efficacy of two other predominantly kappa-opioid analgesics, nalbuphine and butorphanol; was compared in males and females who underwent surgery for the removal of third molar teeth. We found that both nalbuphine and butorphanol produced significantly greater analgesia in females as compared with males. Considering our earlier findings, we conclude that kappa-opioid analgesia is greater in females than in males, probably reflecting a difference in kappa-opioid-activated endogenous pain modulating circuits.