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PubMed1993

Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user. As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol.

Anti-Asthmatic Agents↗
PubMed2000

Biological products: reporting of biological product deviations in manufacturing. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is amending the regulation requiring licensed manufacturers of biological products to report errors and accidents in manufacturing that may affect the safety, purity, or potency of a product. FDA also is amending the current good manufacturing practice (CGMP) regulations for blood and blood components to require establishments involved in the manufacture of blood and blood components, including licensed manufacturers, unlicensed registered establishments and transfusion services, to report biological product deviations in manufacturing. The final rule requires licensed manufacturers, unlicensed registered blood establishments, and transfusion services who had control over the product when a deviation occurred to report to FDA the biological product deviation if the product has been distributed. The final rule also establishes a 45-day reporting period. FDA is issuing the final rule as part of a retrospective review under Executive Order 12866 of significant FDA regulations to improve the effectiveness of FDA's regulatory program.

Biological Products↗
PubMed2006

Increase in production of matrix metalloproteinase 13 by human articular chondrocytes due to stimulation with S100A4: Role of the receptor for advanced glycation end products.

OBJECTIVE: S100 proteins have been implicated in various inflammatory conditions, including arthritis. The aims of this study were to determine whether chondrocytes produce S100A4 and whether S100A4 can stimulate the production of matrix metalloproteinase 13 (MMP-13) by articular chondrocytes via receptor for advanced glycation end products (RAGE)-mediated signaling. METHODS: The expression of chondrocyte S100A4 was analyzed by immunohistochemistry using normal and osteoarthritic (OA) cartilage and by immunoblotting of chondrocyte cell lysates. RAGE signaling was examined by stimulating chondrocytes with S100A4 and monitoring for the activation of MAP kinases and NF-kappaB. Production of MMP-13 was determined in the conditioned medium. A pulldown assay using biotin-labeled S100A4 was used to demonstrate binding to RAGE. RESULTS: S100A4 expression was detected in human articular chondrocytes by immunoblotting and appeared to increase in the cell lysates from OA tissue. Marked positive immunostaining for S100A4 was also noted in sections of human cartilage with changes due to OA. Stimulation of chondrocytes with S100A4 increased the phosphorylation of Pyk-2, MAP kinases, and activated NF-kappaB, followed by increased production of MMP-13 in the conditioned medium. This signaling was inhibited in cells pretreated with soluble RAGE, advanced glycation end product-bovine serum albumin, or the antioxidant Mn(III)tetrakis (4-benzoic acid) porphyrin, or by overexpression of a dominant-negative RAGE construct. A pulldown assay showed that S100A4 binds to RAGE in chondrocytes. CONCLUSION: This is the first study to demonstrate that S100A4 binds to RAGE and stimulates a RAGE-mediated signaling cascade, leading to increased production of MMP-13. Since both S100A4 and RAGE are up-regulated in OA cartilage, this signaling pathway could contribute to cartilage degradation in OA.

Cartilage, Articular↗
PubMed1988

Alkylating activity in food products--especially sauerkraut and sour fermented dairy products--after incubation with nitrite under quasi-gastric conditions.

N-Nitroso compounds may well rank high among the genotoxic carcinogens present in our environment. Small amounts of such compounds may be formed in the human stomach after consumption of high-nitrate vegetables. Volatile nitrosamines can be conveniently determined but reliable methods of analysis for non-volatile N-nitroso compounds are still lacking. In this study we have used the 4-(4-nitrobenzyl)pyridine test to look for the formation of alkylating compounds such as N-nitroso-N-methylurea in a wide range of food products after incubation with nitrite under simulated gastric conditions. Our results indicate that many food products do not form alkylating compounds in appreciable amounts, even though the nitrite concentration used was five to ten times that found in saliva after a high-nitrate meal. Comparatively strong alkylating activity, however, was detected after incubation of samples of sauerkraut, certain dairy products (yoghurt, biogarde, quark, buttermilk and milk), wine and smoked mackerel. Samples of sauerkraut incubated with simulated gastric fluid, but without (added) nitrite, also displayed appreciable alkylating activity. The formation of alkylating substances in non-fat yoghurt was markedly inhibited by addition of ascorbic acid. The identity of the alkylating agents remains unknown. The isolation procedure was optimized for N-nitroso-N-methylurea, but will certainly result in the isolation of other compounds, such as C-nitroso-, C-nitro- or perhaps even C-nitroso-C'-nitro-compounds as well. Biogenic amines, glucosinolates, indole derivatives or other compounds may be involved as precursors. If alkylating agents are formed in vivo after ingestion of high-nitrate vegetables or drinking water, this is likely to occur only when the food products mentioned above are ingested simultaneously with or shortly after the nitrate load and not appreciably (except perhaps in the case of sauerkraut) when they are ingested alone, without a nitrate source. The health implications of these findings cannot yet be established. Many alkylating agents, however, have strong carcinogenic properties and continued investigation of food products (and their interaction products with nitrite) is indicated.

Alkylating Agents↗
PubMed1993

Toxin production by Bacillus cereus in dairy products.

Spores of a known toxigenic and psychrotrophic dairy isolate of Bacillus cereus (HRM 44) were unable to grow and produce diarrhoeagenic toxin at 6 degrees C in creams and dairy-based products. These findings suggest that the production of B. cereus diarrhoeagenic toxin is unlikely to occur in creams and dairy-based products maintained within the cold chain. Growth and toxin production were readily demonstrated in creams and some desserts stored at 21 degrees C. Growth in creams was associated with obvious spoilage. However, in the flavoured desserts, spoilage was not always obvious before significant growth of B. cereus and toxin production had occurred. Dairy desserts with high sugar content and/or low pH did not support toxin production and these findings are discussed.

Bacillus cereus↗
PubMed1998

Prostaglandin-independent stimulation of interleukin-6 production by fibrinogen degradation product D in perfused murine liver.

Bacterial endotoxin (LPS) and fibrinogen degradation product D (FDP-D) are both potent stimulators of interleukin-6 (IL-6) production in liver, however, there are differences in their metabolic effects. The aim of the present study was to compare the role of prostaglandins in the enhancement of IL-6 production by LPS or FDP-D in perfused mouse livers. Indomethacin inhibited the effect of LPS significantly but was ineffective in the case of FDP-D. Accordingly, production of prostaglandins D2 and E2 was not elevated following the addition of FDP-D, while their formation was increased several fold by LPS. At the same time interleukin-1 (IL-1) production in perfused liver rose markedly upon the addition of FDP-D. It is suggested that prostaglandins are not involved in the effects of FDP-D on the liver. The stimulatory effect of FDP-P on IL-6 production might be the consequence of elevated IL-1 levels.

Animals↗
PubMed2002

Consequences of the ban of by-products from terrestrial animals in livestock feeding in Germany and the European Union: alternatives, nutrient and energy cycles, plant production, and economic aspects.

Consequences of the ban of meat and bone meal (MBM) and animal fat with regard to livestock feeding, cropping, ecology and economy where investigated with an inter-disciplinary approach for Germany and the European Union. Calculations were made for different production systems with pigs and poultry on the basis of statistical data for the production and for the feed markets as well as from requirement data for the respective species and production system. (1.) The ban of MBM from feeding caused a need for alternative protein sources. If all the amount of protein from MBM is to be replaced by soybean meal, in Germany and the EU about 0.30 and 2.30 x 10(6) t would be needed each year (supplementary amino acids not considered). Alternatively, doubling the grain legume acreage in Germany to about 420,000 ha would supply a similar amount of protein. A wider application of phase feeding with adjusted dietary amino acid concentrations, however, would allow for saving protein to an extent which is similar to the amount of protein that was contributed by MBM in recent years. Thus, the ban is a minor problem in terms of ensuring amino acid supply. (2.) However, alternative plant ingredients cannot compensate for the gap in P supply that is caused by the ban. An additional demand for inorganic feed phosphates of about 14,000 and 110,000 t per year is given in Germany and the EU, respectively. So far, this gap is filled almost completely by increased mining of rock phosphates. Alternatively, a general application of microbial phytase to all diets would largely fill this gap. Until the ban, MBM contributed to 57% of the supplementation of P that was needed for pigs and poultry. The ban of MBM makes large amounts of P irreversibly disappearing from the food chain. (3.) Energy from slaughter offal and cadavers can be utilized in different technologies, in the course of which the efficiency of energy utilisation depends on the technology applied. It is efficient in the cement work or rotation furnace if heat is the main energy required. In contrast, the energetic efficiency of fermentation is low. (4.) Incineration or co-incineration of MBM and other by-products causes pollution gas emissions amounting to about 1.4 kg CO2 and 0.2 kg NOx per kg. The CO2 production as such is hardly disadvantageous, because heat and electrical energy can be generated by the combustion process. The prevention of dangerous gaseous emissions from MBM burning is current standard in the incineration plants in Germany and does not affect the environment inadmissibly. (5.) The effects of the MBM ban on the price for compound feed is not very significant. Obviously, substitution possibilities between different feed ingredients helped to exchange MBM without large price distortions. However, with each kg MBM not used in pig and poultry feeding economic losses of about 0.14 [symbol: see text] have to considered. In conclusion, the by far highest proportion of raw materials for MBM comes as by-products from the slaughter process. Coming this way, and assuring that further treatment is safe from the hygienic point of view, MBM and animal fat can be regarded as valuable sources of amino acids, minerals and energy in feeding pigs and poultry. Using them as feedstuffs could considerably contribute to the goal of keeping limited nutrients, phosphorus in particular, within the nutrient cycle and dealing responsible with limited resources.

Amino Acids↗
PubMedDate not supplied

Short-term retention of lexical-semantic representations: implications for speech production.

Patients with semantic STM deficits have difficulty comprehending sentences that require the retention of several lexical-semantic representations prior to their integration into higher-level propositions (Martin, 1995: Martin & Romani. 1994). In Experiment 1, patients with a semantic retention deficit had difficulty with the same type of constructions in speech production, namely noun phrases with one or two prenominal adjectives. Their performance improved when they could produce the nouns and adjectives in sentence form, which placed smaller demands on lexical-semantic retention. In Experiment 2 these patients were better able to produce syntactically complex sentences than the prenominal adjective phrases having an equal number of content words, indicating that the findings in Experiment 1 could not be attributed to syntactic complexity. These patients produced more pauses in the sentence constructions in Experiments 1 and 2, suggesting that the timing of such productions is abnormal. In contrast, patient EA, with a phonological retention deficit, performed better than the patients with a semantic retention deficit on the AN phrases despite having a smaller STM span. She showed no significant benefit of producing sentence compared to phrase constructions, and also made fewer and shorter pauses than the other patients. These findings support the multiple capacities view of verbal working memory and suggest that the same semantic retention capacity used in language comprehension is used in speech production.

Aged↗
PubMed2006

Menstrum for culture preservation and medium for seed preparation in a tetanus toxin production process containing no animal or dairy products.

AIMS: To completely eliminate animal and dairy products from the lyophilization menstrum and the seed medium used to produce tetanus toxin with Clostridium tetani. METHODS AND RESULTS: Tetanus toxin production in a recently developed fermentation medium lacking animal and dairy products was studied with different seed media. It was found that soy peptone could completely replace the beef heart infusion plus animal peptone previously used as seed medium. In addition, we found that cells lyophilized in soy milk could replace the usual type of cells lyophilized in cow's milk. CONCLUSIONS: We have now developed a complete tetanus toxin production process containing no animal and dairy products. SIGNIFICANCE AND IMPACT OF THE STUDY: Toxoid preparations made from toxin produced with animal and dairy products can contain undesirable contaminants such as the prion causing bovine spongiform encephalopathy (Mad Cow's Disease) or antigenic peptides that stimulate anaphylactic reactions and other undesirable immune reactions in immunized hosts. The new vegetable-based process described here avoids such unfortunate possibilities.

Animals↗
PubMed2004

Effects of different spices used in production of fermented sausages on growth of and curvacin A production by Lactobacillus curvatus LTH 1174.

Lactobacillus curvatus LTH 1174, a fermented sausage isolate, produces the listericidal bacteriocin curvacin A. The effect of different spices relevant for the production of fermented sausages was investigated in vitro through laboratory fermentations with a meat simulation medium and an imposed pH profile relevant for Belgian-type fermented sausages. The influence on the growth characteristics and especially on the kinetics of curvacin A production with L. curvatus LTH 1174 was evaluated. Pepper, nutmeg, rosemary, mace, and garlic all decreased the maximum specific growth rate, while paprika was the only spice that increased it. The effect on the lag phase was minor except for nutmeg and especially for garlic, which increased it, yet garlic was stimulatory for biomass production. The maximum attainable biomass concentration (X(max)) was severely decreased by the addition of 0.40% (wt/vol) nutmeg, while 0.35% (wt/vol) garlic or 0.80% (wt/vol) white pepper increased X(max). Nutmeg decreased both growth and bacteriocin production considerably. Garlic was the only spice enhancing specific bacteriocin production, resulting in higher bacteriocin activity in the cell-free culture supernatant. Finally, lactic acid production was stimulated by the addition of pepper, and this was not due to the manganese present because an amount of manganese that was not growth limiting was added to the growth medium. Addition of spices to the sausage mixture is clearly a factor that will influence the effectiveness of bacteriocinogenic starter cultures in fermented-sausage manufacturing.

Animals↗
PubMed1998

Risk assessment of low-level chemical exposures from consumer products under the U.S. Consumer Product Safety Commission chronic hazard guidelines.

The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency that was created in 1973. The CPSC has jurisdiction over more the 15,000 types of consumer products used in and around the home or by children, except items such as food, drugs, cosmetics, medical devices, pesticides, certain radioactive materials, products that emit radiation (e.g., microwave ovens), and automobiles. The CPSC has investigated many low-level exposures from consumer products, including formaldehyde emissions from urea-formaldehyde foam insulation and pressed wood products, CO and NO2 emmissions from combustion appliances, and dioxin in paper products. Many chemical hazards are addressed under the Federal Hazardous Substances Act (FHSA), which applies to acute and chronic health effects resulting from high- or low-level exposures. In 1992 the Commission issued guidelines for assessing chronic hazards under the FHSA, including carcinogenicity, neurotoxicity, reproductive/developmental toxicity, exposure, bioavailability, risk assessment, and acceptable risk. The chronic hazard guidelines describe a series of default assumptions, which are used in the absence of evidence to the contrary. However, the guidelines are intended to be sufficiently flexible to incorporate the latest scientific information. The use of alternative procedures is permissible, on a case-by-case basis, provided that the procedures used are scientifically defensible and supported by appropriate data. The application of the chronic hazard guidelines in assessing the risks from low-level exposures is discussed.

Animals↗
PubMedDate not supplied

Review: production, characterization, and testing of banked mammalian cell substrates used to produce biological products.

A critical component in controlling the production of biological products derived from human and animal cell lines is the characterization and testing of banked cell substrates. The objective is to confirm the identity, purity, and suitability of these cells for manufacturing use. Quality concerns for biological products derived from cell lines originate from the presence of cellular and adventitious contaminants. Well-characterized cell banks not only permit a consistent source of production cells throughout the life of a product but also decrease the likelihood of contamination by other cell lines and adventitious agents. An important part of qualifying a cell line is choosing the appropriate testing for the presence of adventitious contaminants. The qualification of cell banks includes tests for cell identity and endogenous and adventitious microbial contaminants (bacteria, fungi, mycoplasmas, and viruses). For cells producing recombinant deoxyribonucleic acid-derived products, analysis of the expression construct at the nucleic acid level (genetic stability) is also a primary concern. The strategy for designing a safety-testing program for banked cells should be based on sound scientific principles and current regulatory guidance.

Animals↗
PubMed2003

Incidence of Clostridium perfringens in commercially produced cured raw meat product mixtures and behavior in cooked products during chilling and refrigerated storage.

A total of 445 whole-muscle and ground or emulsified raw pork, beef, and chicken product mixtures acquired from industry sources were monitored over a 10-month period for vegetative and spore forms of Clostridium perfringens. Black colonies that formed on Shahidi-Ferguson perfringens (SFP) agar after 24 h at 37 degrees C were considered presumptive positive. Samples that were positive after a 15-min heat shock at 75 degrees C were considered presumptive positive for spores. Of 194 cured whole-muscle samples, 1.6% were positive; spores were not detected from those samples. Populations of vegetative cells did not exceed 1.70 log10 CFU/g and averaged 1.56 log10 CFU/g. Of 152 cured ground or emulsified samples, 48.7% were positive, and 5.3% were positive for spores. Populations of vegetative cells did not exceed 2.72 log10 CFU/g and averaged 1.98 log10 CFU/g; spores did not exceed 2.00 log10 CFU/g and averaged 1.56 log10 CFU/g. Raw bologna (70% chicken), chunked ham with emulsion, and whole-muscle ham product mixtures were inoculated with C. perfringens spores (ATCC 12916, ATCC 3624, FD1041, and two product isolates) to ca. 3.0 log10 CFU/g before being subjected either to thermal processes mimicking cooking and chilling regimes determined by in-plant temperature probing or to cooking and extended chilling regimes. Populations of C. perfringens were recovered on SFP from each product at the peak cook temperatures, at 54.4, 26.7, and 7.2 degrees C, and after up to 14 days of storage under vacuum at 4.4 degrees C. In each product, populations remained relatively unchanged during chilling from 54.4 to 7.2 degrees C and declined slightly during refrigerated storage. These findings indicate processed meat products cured with sodium nitrite are not at risk for the growth of C. perfringens during extended chilling and cold storage.

Animals↗
PubMedDate not supplied

The effect of advanced glycation end-products and aminoguanidine on TNFalpha production by rat peritoneal macrophages.

OBJECTIVE: To evaluate the effect of advanced glycation end-products (AGEs) and the inhibitor of their formation, aminoguanidine, on tumor necrosis factor-alpha (TNFalpha) production (as a functional marker) by rat peritoneal macrophages (PMphi). DESIGN: Charles River rats underwent a daily intraperitoneal injection of peritoneal dialysis solution [(PDS), 4.25 g/dL dextrose; Dialine, Travenol, Ashdod, Israel] for a 2-month period (group E). Another group of rats was subjected to the same protocol with the addition of 25 mg/kg aminoguanidine (group A). Three control groups were utilized: (1) rats that were injected daily with aminoguanidine only (group AO), (2) rats that were injected with Dulbecco's phosphate-buffered saline (group D), and (3) rats in which no intervention was carried out (group C). After 2 months, PMphi were isolated from rat peritoneal effluent and their TNFalpha production measured by ELISA in cell-free culture supernatants, in both the basal state and after 24-hour stimulation with lipopolysaccharide (LPS). The concentrations of AGEs in peritoneal effluent were assayed and correlated to TNFalpha levels. PMphi obtained from normal rats were then incubated for 24 hours with (1) the peritoneal effluent of each of the above respective groups, with or without LPS; (2) increasing concentrations of AGEs (0-250 microg/mL); and (3) increasing concentrations of aminoguanidine (0-7.5 mg/mL), and TNFalpha secretion again determined. RESULTS: After 2 months of daily intraperitoneal injection of PDS, in the basal state, TNFalpha production was significantly higher in PMphi isolated from the peritoneal effluent groups (groups E, A, and AO) compared to controls (group C). Following LPS stimulation, a further increase in TNFalpha secretion was seen, with a significantly greater response in group AO versus groups E, A, and D. Effluent AGEs were markedly elevated only in group E. No correlation was found between TNFalpha secretion by these PMphi and the concentration of AGEs. On incubation with the respective peritoneal effluents (groups E, A, and AO), in both the basal and stimulated state, TNFalpha production by PMphi from normal rats was significantly enhanced compared to group C. Incubation with increasing concentrations of AGEs or aminoguanidine resulted in an increase of TNFalpha secretion by these PMphi. CONCLUSIONS: Following intermittent intraperitoneal administration of glucose-based PDS, rat PMphi are chronically activated, as evidenced by increased basal TNFalpha secretion. The peritoneal effluent of such treated animals is capable of stimulating TNFalpha production by normal rat PMphi. These data suggest that glucose-based PDS acts as a primer of PMphi, which retain their ability to further stimulation by LPS. Although, in vitro, AGEs promote TNFalpha secretion by normal rat PMphi, in vivo, their influence is probably modulated by other factors. Aminoguanidine has a specific inducing effect on rat PMphi, independent of glucose-based PDS.

Animals↗
PubMed2002

[Advanced glycation end products inhibit production of nitric oxide by human endothelial cells through activation of the p38 signal pathway].

OBJECTIVE: To study the effect of advanced glycation end products (AGE) modified protein on nitric oxide (NO) production by human endothelial cells and the possible role of signal transduction pathway in this pathological procedure. METHODS: Human umbilical vein endothelial cells (HUVECs) and HUVEC-derived cell line (ECV304) were cultured in vitro with AGE modified human serum albumin (AGE-HSA) or AGE modified bovine serum albumin (AGE-BSA) of the concentrations of 12.5, 25, and 50 micro g/ml for 2, 4, 8, 12, and 24 hours. NO levels in the supernatant at each time point were determined by using Griess reagents. HUVECs and ECV304 cells incubated with HAS or BSA of the same concentrations were used as controls. The phosphorylation activity of cellular p38 mitogen-activated protein kinase (p38-MAPK) was analyzed by Western blot using a phospho-specific antibody after the cells were incubated with AGE-HAS or AGE-BSA of the concentration of 12.5, 25, 50, and 100 micro g/ml for 5, 15, 30, 60, and 120 minutes. HUVECs were incubated with SB 203580, a specific inhibitor of p38, of the concentrations of 0.075, 0.15, and 0.3 micro mol/L for 4 hours, then the culture with SB 203580 was extracted. The endothelial cells were cleansed with RPMI 1640 culture and then were incubated with AGE-HAS or AGE-BSA for 8 hours. The No level in this supernatant was examined after the above-mentioned method. RESULTS: The NO level in the supernatant of culture of HUVECs incubated with AGE-HAS or AGE-HAS for 2 hours were 92.2% +/- 10.1% and 94.1% +/- 12.5% of the controls respectively. The NO levels reached the lowest values, 72.4% +/- 7.14% and 68.3% +/- 10.9% of the values of the controls respectively after 8-hour incubation with AGE-HAS or AGE-HAS. AGE-HSA and AGE-BSA decreased the NO levels in the supernatant in a dose and time-dependant manner. The unmodified HSA and BSA did not influence the NO production by HUVECs or ECV304 cells. There was no difference in inhibition effect on NO production between AGE-HSA and AGE-BSA (P > 0.05). There was no difference in response to AGE-HSA and AGE-BSA between HUVECs and ECV304 cells (P > 0.05). In the culture of HUVECs or of ECV304 cells incubated with AGE-HSA or AGE-BSA, the p38 phosphorylation activity was obviously enhanced 10 minutes after dose-dependently, reached its peak 30 minutes after, and returned to its basic level in 120 minutes. SB203580 of the concentration of 0.3 micro mol/L completely abolished the inhibitive effect of AGE-albumin on NO production by endothelial cells. CONCLUSION: AGE modified protein inhibits the production of NO by human endothelial cells through activation of the p38 signal pathway. This AGE modification-induced pathobiological cascade may be involved in the pathogenesis of atherosclerosis seen in AGE-associated diseases.

Cells, Cultured↗
PubMed1989

Were hospitals selective in their product and productivity changes? The top 50 DRGs after PPS.

Five separate hospital products are identified based on the concept of the amount of disease remission achieved by the hospital. The parameters of this concept are illness level on admission and discharge location. In a cohort of 646 nonfederal, short-term hospitals over the period 1980-1984, changes in the hospital product are examined separately in the 50 diagnosis-related groups (DRGs) with the greatest volume of Medicare discharges. Productivity changes, as defined by the number of certain inputs, are also examined. In both sets of analyses, patient severity level is controlled for by indexing to the base year (1980) case mix. The purpose of this study was to examine whether the dramatic product and productivity changes following implementation of the prospective payment system, as found in our earlier work, were across-the-board changes or the result of selective changes, specific to certain DRGs or products. The results suggest that the changes were an across-the-board phenomenon. Policy implications are discussed.

Adolescent↗
PubMed1987

[Immunoglobulin production of neonate--T lymphocyte subset and production of cytokine].

On the mechanism underlying the repression of antibody production encountered in the new-born, in this study we used the induction of antibody-producing cells on mitogen stimulation of PWM and SAC, identification of T-cell subsets through two-color FACS and the evaluation of cytokine production of IL-1, IL-2 and BCGF with the following results; 1. The cord blood IgG level rose with gestational weeks due to active transport from the mother. The IgM level was low in full term infants. A natural antibody first appeared in the 16th week. 2. Antibody production on mitogen stimulation in infants was remarkably less than in adults. The inability to produce antibodies appears to be closely related to T-cell factors. 3. In examination of the cell surface maker, new-born infants show less suppressor T-cell but significantly more suppressor inducer T-cell than in adults and that its much smaller number of helper T-cells are insufficient for antibody production. 4. Production of IL-1 in full term infants was significantly lower and that in premature subjects was much lower than that in adults. In full term infants, IL-2 was about the same as in adults, and BCGF production was greater than in adults not depressed in full term infants, and were significantly higher in premature infants than that in adults.

Biological Products↗