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Biomedical subjects

U Garagiola

Publications and source records attributed to U Garagiola.

14 recordsLinked to original sources

Aspirin does not affect exercise performance.

A single-blind, cross-over study was carried out to evaluate the effects of acetylsalicylic acid (ASA) on cardiorespiratory performance during exercise. Eighteen young men, 9 athletes and 9 untrained but active subjects, performed a progressive maximal exercise test on a cycle ergometer (30 watt, 3 min steps, starting at 60 watt) on three different occasions, after a single administration of plain aspirin (1000mg of ASA), chewable buffered aspirin (1000mg of ASA and 600 mg of calcium carbonate) and placebo. Continuous measurement of breath-by-breath ventilation, oxygen consumption, carbon dioxide output, respiratory frequency and heart rate was carried-out at rest and during the exercise test. Blood lactate concentration was measured just before the start of exercise and at the third minute of each step in order to detect the anaerobic threshold. The pharmacokinetics of aspirin during exercise was also investigated in ten of the eighteen participants. The analysis of all investigated variables did not show any statistically significant difference between treatments, suggesting that a single dose of 1000mg of aspirin does not affect physical performance during submaximal and maximal exercise.

Adolescent

Pharmacokinetic study of a new oral buffered acetylsalicylic acid (ASA) formulation in comparison with plain ASA in healthy volunteers.

A single-blind, randomized, crossover pharmacokinetic study was carried out to investigate the bioavailability of a new oral buffered 325 mg acetylsalicylic acid (ASA) formulation (ASPIRINA 03) in comparison with a 325 mg plain tablet. Twelve healthy volunteers of both sexes, aged between 20 and 37 years, received buffered or plain ASA on two separate occasions with a wash-out interval of at least two weeks. ASA and salicylic acid (SA) plasma levels were determined by a chromatographic method. The results showed no difference between the area under concentration time curve (AUC0-infinity) ASA values of both formulations (p = 0.19), and buffered ASA relative bioavailability was 102.49% (= bioequivalence). A significant difference was found between the AUC0-30 min ASA values: 90.5 micrograms. min/ml with buffered and 67.7 micrograms. min/ml with the plain tablet (p less than 0.05). The buffered ASA time of maximum concentration was shorter (28 +/- 8 min) than the plain one (38 +/- 19 min, p less than 0.05). The plasma concentrations and pharmacokinetic parameters of SA were not significantly different after the administration of the two ASA formulations. The plain ASA tablet had a significantly lower (p less than 0.05) dissolution rate than buffered ASA tablet. Moreover, the buffered ASA tablet significantly (p less than 0.01) increased the pH by 0.5 units. In conclusion, the bioavailability of the new oral buffered ASA was equivalent to that of plain ASA, but the plasma concentration peak was reached in a shorter time.

Administration, Oral

Telethermography and Raynaud's phenomenon.

A Raynaud's Phenomenon reported by a young female athlete in concomitance with a traumatic injury occurred during her gymnastic performance is described. Discussion is carried out taking into account the recent acquisitions about the pathophysiology of this syndrome.

Adolescent

Use of telethermography in the management of sports injuries.

Telethermography can contribute to the diagnostic process in the management of sports injuries by clearly demonstrating thermal alterations in the tissues involved. Although there are no typical images, in general hyperthermic images are found when inflammatory reactions prevail, and hypothermic pictures when compression or degenerative processes are present. Telethermography is not only an aid to diagnosis, it also appears to be an ideal tool in controlling the injury evolution and treatment efficacy. In fact this objective method of evaluation is noninvasive, innocuous and repeatable, and well-related to the clinical and functional status.

Athletic Injuries

Telethermographic evaluation of NSAIDs in the treatment of sports injuries.

In a multicenter double-blind clinical trial, forty-five athletes, 39 males and 6 females, mean age 20.87 yr (SD 4.48), affected by sports injuries were treated with diclofenac, suprofen, or placebo, orally administered for a period of 1 wk. An objective examination like telethermography was performed with the clinical evaluations (pain on movement or at pressure, motility, and swelling) before and after the treatment period, in all patients. Moreover, at the end of the trial both investigator and patient gave their global judgement of efficacy. The statistical analysis showed a significant superiority of diclofenac sodium versus suprofen and placebo both in patients' and in investigators' global evaluations (P less than 0.05--Kruskal-Wallis tests). This superiority appeared particularly clear in the telethermographic evaluation (P less than 0.05), which is more objective than the clinical one, attesting to the usefulness of the early administration of anti-inflammatory drugs in management of sports injuries. Furthermore, a correlation analysis showed that telethermography is a good technique in controlling the recovery process.

Adult

Iontophoretic administration of pirprofen or lysine soluble aspirin in the treatment of rheumatic diseases.

A double-blind study was designed to compare the efficacy and tolerability of pirprofen and lysine soluble aspirin administered by iontophoresis to 80 patients with various painful rheumatic diseases. Treatment lasted two weeks, with five administrations a week, each lasting 20 minutes (direct current; mean intensity, 2.3 mA). After five administrations, patients showed significant improvement in pain at rest and on movement, with no significant differences between pirprofen and aspirin. Final results were excellent or good in about 75% of the patients treated and functional improvement was satisfactory in about 80%. There were no side effects.

Adult

Pirprofen, naproxen and placebo in the treatment of primary dysmenorrhoea.

In a double-blind between-patient clinical trial, 82 patients were admitted to the study and after a preliminary period with placebo administered in single-blindness, they were divided into two groups: "placebo-responders" and "placebo non-responders". Responders were treated with pirprofen capsules (400 mg, b.i.d.) or placebo capsules b.i.d.; non-responders were treated with pirprofen capsules (400 mg, b.i.d.) or naproxen capsules (250 mg, b.i.d.) according to two different randomisation lists, for four menstrual cycles. A complete medical examination, including evaluation of associated symptomatology, menstrual flow entity and global efficacy, was performed after each cycle. In the responders group results were significantly better with pirprofen than with placebo after only the second cycle of treatment (p less than 0.01). In the non-responders group both treatments showed "good" or "excellent" results in more than 80% of patients in all cycles. In all patients there were no significant differences in the evaluation of the menstrual flow entity, of the associated symptomatology and of the number of side-effects.

Adult

Intramuscular treatment of migraine attacks using diclofenac sodium: a crossover clinical trial.

This was a double-blind clinical trial, with a crossover design, to compare the efficacy of a non-steroidal anti-inflammatory drug, diclofenac sodium, intramuscularly administered, and placebo in the treatment of migraine attacks. The drug was administered to 40 patients once a day in three consecutive migraine attacks. If pain still remained after 6 h following administration the patient was given a 100 mg diclofenac sodium suppository, in open condition. Evaluation was by a complete medical examination performed by the physician and by the patient completing a specially designed self-assessment card. A total of eight patients dropped out of the trial (all during placebo administration): three due to poor compliance, four for refusal to continue and one because no further migraine attacks developed. Results were analysed after having checked the absence of both period and carry-over effects. In all cases diclofenac sodium was more effective than placebo (P less than 0.01). This was also confirmed by data obtained from the patient self-assessment cards (P less than 0.001) and by preferences expressed by patients at the end of the trial (P less than 0.001). Tolerance to the drug was similar to that of placebo.

Adolescent

Pirprofen in the treatment of migraine and episodic headache attacks: a placebo-controlled crossover clinical trial.

A double-blind, within patient, randomized study to compare the efficacy and tolerability of acute rectal administration of 600 mg pirprofen capsules with matched placebo was carried out in 40 out-patients. They were divided into two groups of 20 patients each according to diagnosis of episodic headache or common or classic migraine. Treatment was given once during each of two consecutive attacks according to a crossover design. None of the patients was withdrawn after randomization. There was a statistically significant difference in favour of pirprofen as regards the preferences expressed by patients at the end of the trial: 34 patients preferred pirprofen, two preferred placebo and four patients had no preference. Pirprofen significantly reduced the duration of headache attack and associated symptoms, but not the peak of pain intensity. Tolerability of the drug was good.

Adult

Pirprofen in the treatment of sports injuries.

Patients with sports injuries were treated with pirprofen, a non-steroidal anti-inflammatory drug, in two separate studies. In the single centre study, 39 athletes were treated with 1000 mg/day pirprofen for 2 weeks. In the multicentre study, a further 80 athletes were treated with a variable dosage (600-1200 mg/day) until the disappearance of symptoms, but for no longer than 2 weeks. Efficacy was considered excellent or good in 99/119 (83%) of the patients treated. The clinical variables of pain and mobility significantly (P less than 0.05) improved after 1 week of treatment. Tolerability was satisfactory, the main side-effects involving the gastro-intestinal tract.

Acute Disease

Immunological patterns during regular intensive training in athletes: quantification and evaluation of a preventive pharmacological approach.

The effects of regular intensive exercise training on immune system homeostasis and the potential value of treatment with an immunostimulating agent were assessed in this randomized, double-blind, placebo-controlled, parallel-group study. A total of 60 athletes were studied over a 3-month period of regular intensive physical activity. After 1 and 3 months there were significant decreases in the immunoglobulin levels in the whole athlete population compared with baseline values. Specifically there were significant decreases in immunoglobulin M and immunoglobulin G (G1 and G2 subclasses). There was also a significant decrease in natural killer cells and a slight but significant increase in B and T lymphocytes. In the thymomodulin-treated group, unlike the placebo group, there was no significant decrease in the immunoglobulin G2 subclass and there was a significant increase in the T-helper cell subpopulation. The clinical relevance of these immunological findings should be evaluated in larger clinical and epidemiological studies.

Adolescent