Fipexide, an effective cognition activator in the elderly: a placebo-controlled, double-blind clinical trial.

Forty geriatric in-patients with severe cognition disorders were randomly allocated to treatment with either 600 mg fipexide daily or placebo over a period of 3 weeks. Before and after treatment, the symptoms of cognitive performance (disorders of memory and attention, asthenia, apathy and disorders of coenaesthesia) were monitored and scored. Similarly, the Thurstone test (symbol matching test) was performed and time to completion, number of errors and exactitude index were recorded. Haemodynamics, haematology and haematochemistry investigations were made before and after treatment, and accessory symptoms of potential side-reactions were monitored by positive questioning. Treatment with fipexide was associated with a significant improvement in each and all monitored symptoms and signs to an average extent of 60%, whereas placebo was not. Similarly, the patients given fipexide experienced a significant improvement in the Thurstone test, in terms of time to completion (-22%), number of errors (-46%) and exactitude index (+60%); again, placebo was not associated with any significant improvement (variations, respectively, of -5%, -14%, and +24%). Overall, 85% of the patients given fipexide experienced clinical improvement to a greater or lesser degree, a significantly greater proportion than that associated with placebo (25%; p less than 0.001). Tolerance, both subjective and objective, was good in both treatment groups.

Pharmacokinetic study on piroxicam at the steady-state in elderly subjects and younger adults after administration of piroxicam beta-cyclodextrin.

The age effect on the kinetics of piroxicam at the steady-state after oral administration of piroxicam beta-cyclodextrin was evaluated. The mean plasma concentration of piroxicam at the steady-state was significantly higher in elderly subjects (9.30 +/- 0.69 micrograms/ml mean +/- s.e.) than in younger adults (6.24 +/- 0.58 micrograms/ml mean +/- s.e.). Even though the distribution volume tended to be lower in elderly subjects (106.37 ml/kg), it did not show substantial differences in the two groups whereas the correlation between clearance and age was significant (p less than 0.05). It is therefore confirmed that piroxicam beta-cyclodextrin has the same pharmacokinetic behaviour at the steady-state in elderly subjects, as the active principle in a non-complexed form.

Anatomoclinical and chronobiological aspects of sudden death in elderly subjects.

Anatomoclinical and chronobiological aspects of sudden death (SD) of 671 subjects observed at the Emergency Room of Ferrara Hospital from January 1983 to December 1991 were prospectively investigated. 3 groups stratified by age were considered: group A with age < 65 years (no. = 251, 37.4%), group B with age between 65 and 74 years (no. = 210, 31.3%), and group C with age > or = 75 years (no. = 210, 31.3%). SD was classified on the basis of either anatomopathological (i.e.: acute myocardial infarction, acute myocardial failure, intracerebral hemorrhage, rupture of aortic aneurysm, pulmonary embolism), and clinical findings (i.e.: arrhythmic death and circulatory failure death). Patients were grouped into six 4-hour periods according to the time of onset of symptoms, and circadian distribution was tested for uniformity by a chi 2 test for goodness of fit. The analysis found in group C an increased frequency of SD due to pulmonary embolism and rupture of aortic aneurysm, and an increment of males/females ratio in deaths from cardiac causes. In group C the mean age of SD, in particular from acute myocardial infarction, pulmonary embolism or arrhythmic death proved higher in females compared to males. Only for group B was a significant circadian periodicity found for SD from acute myocardial infarction and arrhythmic death, with a peak in the morning.

[Hairy cell leukemia and myeloma]. / Haarzell-Leukämie und Myelom.

A woman with morphologically and cytochemically confirmed hairy cell leukemia also showed the typical signs of myeloma (paraproteinemia IgG/k, Bence-Jones-k-paraproteinuria, numerous partly atypical plasma cells in the bone marrow, diffuse osteoporosis of the spine and osteolytic lesions in the skull). This observation strongly supports the hypothesis of a direct relationship between hairy cells and plasma cells.

Hodgkin's and Castleman's disease in a patient with systemic mastocytosis.

Systemic mastocytosis is a rare condition characterized clinically by the local consequences of vasoactive peptides released from infiltrating mast cells in the reticuloendothelial tissues. Mast cells originate from the pluripotent bone marrow stem cells; it is therefore not surprising that myeloproliferative and myelodysplastic disorders commonly coexist or terminate the clinical phase of mastocytosis. We report here, to our knowledge, the first case of Hodgkin's and Castleman's disease occurring in a patient with co-existent systemic mastocytosis, which remained unchanged after combination chemotherapy for Hodgkin's disease.

Glucosamine sulphate: a controlled clinical investigation in arthrosis.

Efficacy and tolerance of a new preparation of pure glucosamine sulphate, in injectable and oral form, were investigated in 30 patients with osteoarthrosis. Two groups of in-patients with chronic degenerative articular disorders received daily for 7 days either 400 mg glucosamine sulphate or a piperazine/chlorbutanol combination by intravenous or intramuscular injection. During the 2 following weeks, the patients receiving glucosamine had oral glucosamine capsules (6 x 250 mg daily); the other group had placebo. Efficacy was tested by semi-quantitative scoring of pain at rest and during active and passive movements, as well as limitation of articular function, before and after 7 and 21 days of treatment. Patients were positively questioned daily for possible intolerance symptoms. Haematology, circulatory data and urine analysis were tested before and after treatment. During both initial parenteral treatments, each symptom significantly improved, but to a faster and greater extent in the group treated with glucosamine. During the maintenance period, a further improvement was recorded in the patients treated with glucosamine, whereas in those on placebo the symptom scores increased almost to the pre-treatment level. This was considered the major difference between basic therapy, such as with glucosamine, as purely symptomatic treatment. Clinical and biological tolerance were excellent with both treatments, and no definitely drug-related complaints were recorded. It is suggested that parenteral and/or oral treatment with pure glucosamine sulphate should be considered as basic therapy for the management of primary or secondary degenerative osteoarthrosis disorders.

[Granulocyte substitution in febrile leukemia patients with bone marrow aplasia. 1. Results of a prospective study]. / Granulozytensubstitution bei febrilen Leukämiepatienten in Knochenmarkaplasie Erste Resultate einer prospektiven Studie.

A prospective, randomized study was performed in aplastic, granulocytopenic, infected patients with acute leukemia during induction therapy. 12 patients received antibiotics alone, and 13 received antibiotics plus 1.7-14.7 X 10(10) (MEAN 6.6 X 10(10) granulocytes by 1-5 (mean 2.7) daily transfusions. In 10 of 12 controls the infection resolved and remission was achieved with granulocyte counts greater than 500/mm3 15 +/- 9 days after randomization. In the transfused patients, infection was brought under control in 10 out of 13 and remission was achieved with granulocyte counts greater than 500/mm3 25+/- 11 days after randomization. Only one death due to infection was observed (6 days after randomization, control).

Delayed alloimmunization using random single donor platelet transfusions: a prospective study in thrombocytopenic patients with acute leukemia.

A randomized study was performed in 54 thrombocytopenic patients with acute leukemia. Alloimmunization of recipients of random multiple-donor platelet concentrates (MD group) was compared to that of patients receiving random single-donor platelets (SD group). In the SD patients, formation of alloantibodies (mostly anti-HLA) occurred less frequently (p less than 0.002), after a longer time period (p less than 0.002), and after a higher number of transfusions (p less than 0.005) as compared to MD patients. SD patients also became refractory to random platelets less frequently (p less than 0.005), after a longer time period, and after a higher number of transfusions (p less than 0.02). In SD patients, the increments after the first and the last transfusion were in the same range, whereas in MD patients, the 1-hr (p less than 0.001) and the 24-hr (p less than 0.025) increments decreased from the first to the last transfusion. Thus, the use of random SD platelet transfusions postponed alloimmunization.