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PubMed2001

Medicare program; replacement of reasonable charge methodology by fee schedules for parenteral and enteral nutrients, equipment, and supplies. Final rule.

This final rule implements fee schedules for payment of parenteral and enteral nutrition (PEN) items and services furnished under the prosthetic device benefit, defined in section 1861(s)(8) of the Social Security Act. The authority for establishing these fee schedules is provided by the Balanced Budget Act of 1997, which amended the Social Security Act at section 1842(s). Section 1842(s) of the Social Security Act specifies that statewide or other area wide fee schedules may be implemented for the following items and services still subject to the reasonable charge payment methodology: medical supplies; home dialysis supplies and equipment; therapeutic shoes; parenteral and enteral nutrients, equipment, and supplies; electromyogram devices; salivation devices; blood products; and transfusion medicine. This final rule describes changes made to the proposed fee schedule payment methodology for these items and services and provides that the fee schedules for PEN items and services are effective for all covered items and services furnished on or after January 1, 2002. Fee schedules will not be implemented for electromyogram devices and salivation devices at this time since these items are not covered by Medicare. In addition, fee schedules will not be implemented for medical supplies, home dialysis supplies and equipment, therapeutic shoes, blood products, and transfusion medicine at this time since the data required to establish these fee schedules are inadequate.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2000

NTP Toxicity Studies of Benzyltrimethylammonium Chloride (CAS No. 56-93-9) Administered by Gavage to F344/N Rats, Sprague-Dawley Rats, and B6C3F1 Mice.

Benzyltrimethylammonium chloride is widely used as a solvent for cellulose, a gelling inhibitor in polyester resins, a chemical intermediate, a paint dispersant, and an acrylic dyeing agent. It is also used in plant growth regulator compositions and synthetic processes. The National Institute of Environmental Health Sciences nominated benzyltrimethylammonium chloride for study due to its high production volume and the potential for occupational exposure, as well as the limited information on toxicity of this chemical. Male and female F344/N rats and B6C3F1 mice received benzyltrimethylammonium chloride by gavage for 16 days or 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, neurotoxicity, and reproductive toxicity. Genetic toxicology studies were conducted in Salmonella typhimurium and in mouse peripheral blood erythrocytes. In the 16-day studies, groups of five male and five female rats received 0, 16, 32, 63, 125, or 250 mg benzyltrimethylammonium chloride/kg body weight in deionized water by gavage, 5 days per week for 16 days. Groups of five male and five female mice received 0, 63, 125, 250, 500, or 1,000 mg/kg benzyltrimethylammonium chloride in deionized water by gavage, 5 days per week for 16 days. All rats in the 125 and 250 mg/kg groups, all mice in the 250, 500, and 1,000 mg/kg groups, and one 125 mg/kg female mouse died on day 1 of the studies. Clinical findings observed in 125 mg/kg male and female rats included abnormal breathing, ataxia, lethargy (males only), nasal and eye discharge, and tremors. Salivation was slightly increased in male and female rats in the 63 mg/kg groups. Female mice in the 125 mg/kg group had a significantly greater absolute liver weight than that of the vehicle controls. No gross or microscopic changes observed in rats or mice were considered related to chemical administration. In the 13-week studies, groups of 10 male and 10 female rats and mice received benzyltrimethylammonium chloride in deionized water by gavage at doses of 0, 12.5, 25, 50, or 100 mg/kg, 5 days per week for 13 weeks. Benzyltrimethylammonium chloride generally had little effect on the body weights of rats or mice. Final mean body weights of dosed animals were within 8% (rats) or 3% (mice) of the control group body weights. The deaths of two female rats and one male and one female mouse administered 100 mg/kg were the result of pharmacologic effects on the cardiovascular system. Some cholinergic effects including chromodacryorrhea, lacrimation, salivation, pupillary constriction, altered gait, and mild tremors were observed at nonlethal doses in rats; these effects were accompanied by alterations in body position. No significant target organ toxicity was observed in dosed rats or mice. Benzyltrimethylammonium chloride was not mutagenic in S. typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation enzymes. However, significant increases in the frequency of micronucleated normochromatic erythrocytes were found in the peripheral blood of male and female mice administered benzyltrimethylammonium chloride by gavage for 13 weeks. Based on the mortality observed in the 16-day and 13-week studies, rats and mice appeared to be equally sensitive to benzyltrimethylammonium chloride. The minimally toxic dose for rats and mice was estimated to be 50 mg/kg.

Journal Article↗
PubMedDate not supplied

[Treatment of sialorrhea in Parkinson's disease patients with clonidine. Double-blind, comparative study with placebo].

BACKGROUND: sialorrhea is one of the common nonmotor, non-neuropsychiatric symptoms in Parkinson's disease and its pre-sence can cause limitation in the patient's social life. The traditional treatment with anticholinergic medication is capable of triggering important neuropsychiatric complications. OBJECTIVES: this is a prospective, double-blind, placebo compared study, which follow-up Parkinson's disease patients for 3 months. METHODS: we measured the efficacy of clonidine in the management of sialorrhea. The study was performed in 32 patients (20 males and 12 females), with a mean age of 70.75 years and mean duration of the disease of 8.84 years. Randomly, 17 patients received clonidine 0.15 mg/day and the remaining 15 patients received placebo. Both groups were made up of subjects with similar characteristics, age, years of illness, sex, stage of disease (H and Y), disability (S and C) and motor score (UPDRS). Likewise, salivation affected both groups in the same intensity. We used the variable analysis and there was a p < 0.05 significance. RESULTS: the group which received clonidine showed a significant improvement of the salivation symptoms both at one month as well as at 3 months of treatment (p < 0.00001, respectively). There was no evidence of worsening of the stage of the disease, incapacity or motor score. The side effects were found only in the group that received clonidine (4 patients) without showing statistically significant. CONCLUSION: the use of clonidine can be useful in the management and treatment of sialorrhea in patients with Parkinsońs disease.

Aged↗
PubMed2006

[Dry mouth].

Dryness of the mouth (xerostomia) is a serious problem for the affected patients, in particular if it is caused by a reduced salivation. Triggering factors are, e.g., drugs (antihypertensives, neuroleptics), CNS disorders, chronic obstruction of nasal breathing, irradiation therapy of head-neck tumors, Sjögren's syndrome, sarcoidosis, or diabetes mellitus. Patients with xerostomia should be diagnosed and treated on an interdisciplinary basis. Several causal and symptomatic therapeutic options are available, including local stimulation of salivation. In addition, prevention is to be emphasized. In most patients symptomatic improvement and thus an improved quality of life can be achieved.

Humans↗
PubMed1975

[An atypical case of Aujeszky's disease in a dog (author's transl)].

Two cases of Aujeszky's disease in a cat and a dog belonging to the same owner are reported. The two animals each were five months of age. The symptoms shown by the cat were typical of Aujeszky's disease: intense itching, salivation and the head bent to one side. The main symptoms shown by the dog consisted in salivation, ptosis of one eye, a drooping ear, the head bent to one side and ataxia. As itching was not observed in the dog and the animal had spent the first months of its life in wooded surroundings, it could also have been affected with rabies, although it had been inoculated with LEP-Flury vaccine forty days prior to importation. It is of importance to the practitioner to know that itching may be absent in dogs with Aujeszky's disease and that rabies should also be suspected in these cases. Only a laboratory diagnosis will be conclusive. Studies were negative for rabies, the virus of Aujeszky's disease being found to be present in the two cases. The source of infection probably consisted in contaminated pork offal (larynges).

Animals↗
PubMed2006

Cultural, behavioral, social, and psychological perceptions of saliva: relevance to clinical diagnostics.

The search for a resource that can be used to detect a broad range of diseases easily and reliably is akin to a search for the diagnostic Holy Grail. Yet, each of us may have inside our mouths, a key to the pathological and disease biomarker library hidden inside our bodies. Saliva--the source of all this information--is the secretory product of glands located in or around the oral cavity. If one could read the stories of diagnostic information present within saliva, then the abundance of information waiting to be found could be comparable to a vast vault of information, such as the Internet. Upon dissection of this data, it would be seen that the source of this information is from saliva's origin as a filtrate of blood, and that the validity of both mediums should be equal. Although one day this may be the view, most people's hold of saliva, current and past cultures, have fared much more diverse meanings to the secretion. Ivan Pavlov's experiments has shown how closely tied salivation is with the thought of food, one of life's primary indulgences. The relationship between salivation and behaviors within our daily lives is undeniable. Yet most people never appreciate the uniqueness of saliva. Throughout the world, saliva carries definite positive and negative connotations, based upon its social, psychological, behavioral, and cultural settings. The thought of saliva may be viewed as grotesque in one population, yet may be the vehicle of blessing in other cultures. Saliva's double nature brings up some interesting cultural, social, behavioral, and psychological points about how saliva is perceived in the world, some of which are subsequently stated in order to present saliva as the spirited fluid it is.

Ceremonial Behavior↗
PubMed2006

[Bluetongue in The Netherlands; description of the first clinical cases and differential diagnosis. Common symptoms just a little different and in too many herds].

For the first time Bluetongue (BT) has been diagnosed in the Netherlands. The clinical symptoms of BT on five farms during the first outbreak ever in the Netherlands are described. Fever and swollen sensitive coronets leading to reluctance to stand and walk were sometimes the first symptoms. Later lesions in the mouth occurred with foamy salivation and respiratory problems. In other cases a swollen head with swollen lips and foamy salivation were the first clinical signs. Also sudden death occurred. In the first sixteen confirmed cases morbidity and mortality were lower than described in outbreaks in other countries. Good collaboration between practitioners, specialists of the Animal Health Service (GD-Deventer), and specialists of the Food and Consumer Product Safety Authority (VWA) and CIDC-Lelystad (Wageningen UR) led to a rapid notification and ultimately confirmation of the suspected diagnosis BT.

Animals↗
PubMed1987

Reproductive toxicity studies of rentiapril.

(2R,4R)-2-(o-Hydroxyphenyl)-3-(3-mercaptopropionyl)-4- thiazolidinecarboxylic acid (rentiapril, SA 446), an orally active inhibitor of angiotensin converting enzyme, was examined for effects upon general reproductive performance, for embryofoetal toxicity and for peri- and postnatal toxicity in the rat at dosages of 0, 20, 100 and 500 mg/kg/d. Embryofoetal toxicity was also examined in the New Zealand White rabbit at dosages of 0, 1, 2 and 4 mg/kg/d. The compound was administered by gastric intubation. Prolonged treatment at 100 and 500 mg/kg/d during the fertility study was associated with some slight depression of body weight gain of males. Body weight gain of females during gestation was significantly depressed at 500 mg/kg/d. There was salivation in both sexes at 500 mg/kg/d and also in males receiving 100 mg/kg/d. Following this prolonged treatment in the fertility study. Fo male and female kidney weights were increased at all dosages. Although there was no obvious effect upon fertility there was an increased incidence of total litter loss at 500 mg/kg/d and mean pup weights to day 21 post partum were reduced at this dosage and at 100 mg/kg/d with delays in the attainment of some of the developmental landmarks. In the rat treatment at 500 mg/kg/d from day 7 to 17 of pregnancy did not adversely effect embryofoetal development. Subsequent development and reproductive performance of the F1 offspring was also unimpaired. During this treatment period signs of salivation were seen at 500 mg/kg/d. Slight retardation of maternal body weight gain was noted at 500 mg/kg/d and at 100 mg/kg/d but not at 20 mg/kg/d.(ABSTRACT TRUNCATED AT 250 WORDS)

3-Mercaptopropionic Acid↗
PubMed1988

Reproductive studies of NY-198 in rats. III. Perinatal and postnatal study.

Lomefloxacin (NY-198), a new antibacterial agent, was administered daily by gavage to groups of 22 pregnant female rats of the CD strain at dosages of 30, 100 or 300 mg/kg/day from Day 17 of gestation to Day 21 of lactation. Females were allowed to deliver their litters and the offspring were examined for growth and functional development. There was a slight maternal response at the highest dosage (300 mg/kg/day), including increased salivation after dosing, reduced food intake in the treated period of gestation and increased water intake during the lactation period. Gestation length was slightly increased, although remaining within the laboratory background control range; in consequence, body weight of F1 offspring at Day 1 post partum was slightly increased. At 100 mg/kg/day, a few females showed increased salivation after dosing and there was a slight increase in gestation length. Birth weight of F1 offspring was slightly increased at 30 and 100 mg/kg/day but all values were within laboratory background control ranges. The survival, functional responses and fertility of F1 offspring were essentially unaffected by NY-198. On the basis of the above results, 30 mg/kg/day was considered to be the no-effect level for the F0 females treated during late gestation and lactation whilst 300 mg/kg/day administered to the F0 females had no adverse effect upon their offspring.

4-Quinolones↗
PubMed1988

Quantitating histamine in the saliva and salivary glands of two Palaearctic blackfly species (Diptera: Simuliidae).

Saliva was collected from females of Boophthora erythrocephala (Simulium erythrocephalum) and Wilhelmia lineata (S. lineatum) as they were feeding on a saline-ATP solution through an artificial silicone membrane. The histamine content of the saliva was measured by high-performance liquid chromatography (HPLC). The amount of histamine salivated by B. erythrocephala (2.9 ng/individual when feeding to repletion) was more than four times that released by W. lineata (0.7 ng/individual). For both species, the quantity of histamine salivated increased with duration of feeding and partially with the age of females. The proportion of histamine retaines by in vitro fed W. lineata averaged 36.1% W. lineata females engorged on saline-ATP solution, or stimulated for feeding with the same medium, produced significantly more hist-amine than died unstimulated flies.

Animals↗
PubMed1987

Efficacy, safety, and residue evaluation of levamisole gel formulation in sows.

Anthelmintic efficacy, safety, and residue studies were conducted in sows and gilts with a levamisole gel containing 11.5% levamisole HCl. In 12 sows and 12 gilts, 8 mg of levamisole HCl equivalent/kg of body weight orally was 100% (resinate) and 91.1% (gel) effective against 55-day-old Ascaris suum and 100% (gel) and 96.1% (resinate) effective against Oesophagostomum dentatum. In 20 sows given levamisole gel (8 mg of levamisole HCl/kg) orally just before breeding, 4 to 6 weeks after breeding, 4 to 6 weeks before farrowing, and just before farrowing, there were no adverse effects. Transient salivation was noticed in five sows after treatment. In 4 groups of 4 sows each given levamisole gel orally to provide 8, 24, 40, or 80 mg of levamisole HCl/kg, adverse clinical signs were not observed in sows treated with 8 mg/kg. Transient salivation was noticed in one sow given 24 mg/kg, two sows given 40 mg/kg, and four sows given 80 mg/kg. Multiple emesis and chomping occurred in one sow given 80 mg/kg. Levamisole residues in edible tissues from sows given 8 mg of levamisole gel/kg orally were less than 0.1 mg/kg of muscle and fat in sows killed on posttreatment day (PTD) 3 and less than 0.1 mg/kg of kidney in sows killed on PTD 5. Liver residues averaged 0.78 mg/kg in sows killed on PTD 3 and were reduced to 0.31 mg/kg in sows killed on PTD 5. The 99% upper tolerance limit with 95% confidence on the withdrawal time to assure levamisole residues of less than 0.10 mg/kg in liver tissue was 11 days.

Administration, Oral↗
PubMedDate not supplied

[A unique psychopharmacologic profile of adrafinil in mice].

The following psychopharmacological effects of adrafinil have been observed in mice: increase in locomotor activity (64-256 mg.kg-1), antagonism (16-128 mg.kg-1) of the hypnotic effects of barbitone but not of pentobarbitone, reduction of immobility duration in the forced swimming test (16-256 mg.kg-1); slight antagonism (256 mg.kg-1) of electroshock-induced convulsions; no modification of rectal temperature; no stereotyped or climbing behaviour; no increase in lethality in aggregated mice (LD50 isolated = 1022 mg.kg-1, LD50 aggregated = 859 mg.kg-1); lack of effects on the provisional tests for antidepressants: no interaction with reserpine-, oxotremorine-, or apomorphine-induced hypothermia but potentiation of yohimbine-induced toxicity; lack of peripheral sympathetic effects (no mydriasis, no salivation, no contraction of the pilomotor muscles, no antagonism of reserpine-induced ptosis); lack of peripheral anticholinergic effects (no mydriasis, no antagonism of oxotremorine-induced salivation or lacrimation). As compared to no analeptic, anticholinergic or antidepressant drugs, adrafinil shows a unique behavioural profile in mice defined on the one hand by a specific stimulant activity associated with antidepressant-like effects that do no seem related to a beta-adrenergic mechanism and on the other hand by a lack of dopaminergic effects. Most adrafinil-induced effects (increase in locomotor activity, reduction of immobility duration in the forced swimming test) may correspond to a central alpha 1-adrenergic stimulation, but the unexpected lack of peripheral sympathetic effects remains unexplained.

Animals↗
PubMed1978

[Central and peripheral interactions of the antiparkinson agent biperiden and the antihistaminic bamipin on the rat excited by pilocarpine].

Excitatory reactions elicited by pilocarpine HCl (50 mg/kg i.v. in 6 s) are used for demonstrating synergistic effects of the central anticholinergic drug biperiden (Akineton) and the antihistamine bamipine (Soventol). Scratching movements of the hind legs are used as parameter for central activity, salivation for peripheral and death for toxic drug effect, respectively. The results show distinct synergistic (central) activity of drug combinations concerning the inhibition of scratching movements. On the contrary, no intensified inhibition is found with the peripheal symptom salivation bamipine rather induces an attenuation of inhibitory effects seen after hig doses of biperiden. Furthermore, the enhanced toxicity of pilocarpine caused by bamipine in a defined dosage range is antagonized by biperiden in a dose related manner. The results of the animal experiments presented are paralleled with clinical experience.

Animals↗
PubMed1985

Changes in regional cerebral blood flow and glucose metabolism associated with symptoms of pyrethroid toxicity.

Regional rates of blood flow (rCBF) and of glucose metabolism (rCMRG) were measured in rats showing symptoms typical of an early stage of the type-2 syndrome of pyrethroid toxicity ie. salivation, chewing, and repetitive head and forelimb movements induced by deltamethrin. rCBF was significantly increased in the fourteen brain regions examined, while rCMRG was increased in thirteen of them. In many of the regions the rate of blood flow became excessive in relation to the rate of glucose utilization. This was notable in areas of cerebral cortex, caudate putamen and hippocampus. Values for blood flow in the cortical regions were remarkably similar to those found in rats showing symptoms typical of the type-1 syndrome of pyrethroid toxicity ie. tremors and heightened startle response induced with cismethrin. Excessive blood flow in cerebral cortex appears to be intrinsic to pyrethroid intoxication and unrelated to specific motor symptoms. By contrast, in cerebellum increases in both rCMRG and rCBF appear to correlate with motor disturbances. Other than in cerebellum, a significant increase in rCBF was of early onset, occurring in animals showing salivation and chewing as the only symptoms after being given deltamethrin. The very high ratio of rCBF/rCMRG found in many brain regions of rats given synthetic pyrethroid compounds is unusual and unexplained.

Animals↗
PubMed1979

[Measurement by means of 99mTc-pertechnetate of the function of salivary glands before and after stimulation with pilocarpine in cases of sicca-syndrome of the parotidic glands (author's transl)].

Judgement on xerostomia in systemic diseases of the salivary glands and on the sicca-syndrome as a side-effect of radiation therapy or of a treatment with psychopharmaca has been improved by the function test of the parotidic glands for each side individually with 99mTc-pertechnetate, particularly in view of the detection of lateral differences. Measurements of the salivation volume and activity are completive of the function test, yielding knowledge of the total excretory power of all the salivary glands. Functional remainders and reserves can be visualized objectively by additional utilization of the pilocarpine stimulation test (to-day performed with carbachol). The findings will be still more precise if the parotidic salivation is collected and measured for each side separately. This exploration method is appropriate for frequent controls in the course of a disease and for the forming of an opinion upon therapeutic effects of sialagogic agents.

Adult↗
PubMed1983

Pirenzepine and exocrine secretions: a selective agent for gastric glands?

Nineteen healthy volunteers were studied to investigate whether or not muscarinic receptors of different exocrine glands could be distinguished from one another by the use of pirenzepine. A simultaneous evaluation of lacrimation, salivation and gastric secretion was carried out, bethanechol (80 micrograms/kg/hr) being used as a stimulant and pirenzepine (10 or 5 mg i.v.) as an inhibitor. Bethanechol increased salivation significantly and the volume of gastric juice, and non-significantly increased lacrimation and total acid output. Pirenzepine abolished the hypersecretion induced by bethanechol, and decreased the basal level of the exocrine secretions, to approximately the same extent. These experiments seem to demonstrate that if there is a difference among the muscarinic receptors of lacrimal, salivary and gastric oxyntic glands, pirenzepine is unable to discriminate them from one another, at least under the experimental conditions of this investigation.

Adult↗
PubMedDate not supplied

Elevated cerebellar cyclic GMP levels during the deltamethrin-induced motor syndrome.

Adult male Porton albino rats received deltamethrin (0.5--40.0 mg/kg IP) or glycerol formal solvent IP. Their behaviour was observed during the subsequent 110 minutes and the incidence and latency of salivation, tremor and incoordination and spontaneous choreiform episodes were noted. Cyclic GMP levels in the cerebellum were determined by radioimmunoassay at various times after deltamethrin administration. The development of the motor syndrome was dose-dependent and followed a specific time course. The threshold dose for profuse salivation and tremor and incoordination was 2.5 mg/kg IP, and for spontaneous choreiform episodes, 5.0 mg/kg IP. The latency of tremor and incoordination decreased significantly as the deltamethrin dose was increased. The first significant increase in cyclic GMP levels in the cerebellum was at 70 minutes, which was 10 minutes after the mean latency of tremor and incoordination. The levels increased further at 100 minutes which was approximately 20 minutes after the mean latency of spontaneous choreiform episodes. Deltamethrin did not have a dose-dependent effect on cyclic GMP levels. The results suggest that deltamethrin changes cerebellar cyclic GMP levels indirectly.

Animals↗