[Calcium polycarbophil in clinical practice. The therapy of constipation]. / Il calcio polycarbophil nella pratica clinica. Terapia della stipsi.

The clinical efficacy of polycarbophil calcium was assessed in 57 patients of both sexes aged between 18 and 77 years old affected by chronic non-organic constipation. The multicentre study was performed using a single blind and cross-over protocol for 8 weeks, 4 with placebo and 4 with the drug (2 c.p.s 3 t.i.d). Thirteen patients failed to complete the study, 8 of them for reasons not related to the drug. In comparison to placebo, the drug caused a significant reduction in the consistency of stool and evacuatory force during the first week of stool therapy. Medical judgement was that efficacy was "very good" in 73% and "good" in 18%, whereas the drug was thought to be "non efficacious" in 9% of cases. The statistical analysis of data confirmed the efficacy of the drug. The hematochemical parameters evaluated before, during and after treatment only showed a slight increase in calcemia and calciuria which did not reach statistical significance. The therapeutic efficacy and lack of undesired effects confirm the value of polycarbophyl calcium in the treatment of chronic constipation.

[Clinical evaluation of calcium-polycarbophil in the treatment of non-specific diarrhea]. / Valutazione clinica del calcio-policarbofilico nella terapia delle diarree non specifiche.

We performed a study on 10 patients aged between 26 and 54 males and females, affected by non-specific diarrhea. A single-blind clinical trial has been developed where Calcium-Polycarbophil was administered (2 cps t.i.d.) for a period of 8 weeks, half with placebo and half with drug in cross-over. No drop-out occurred. Number of evaluations, cramps and consistency of stools, have been evaluated before and after treatment. A definite decrease of evacuations per day and of cramps, when present, together with a higher consistency of stools, are reported when Calcium-Polycarbophil is administered, according to the favourable medical judgement. Haematochemical parameters, evaluated before, during and after the treatment didn't show any relevant variation, apart from slight increase (not statistically significant) of calcium both in blood and in urine). No other unwanted event has been detected. Hence, the high therapeutic index of Calcium-Polycarbophil makes it highly desirable in the treatment of diarrhea.

[Piroxicam in analgesia]. / Il piroxicam in analgesia.

Piroxicam, a NSAID with a proved analgesic and antiphlogistic efficacy, largely used in rheumatic-orthopedic pathologies, has an antalgic action also in extra-rheumatic pathologies, such as postoperative and dental pain and primary dysmenorrhea. This is probably due both to a peripheral mechanism, at the injured site level, which is particularly widespread, and goes from prostaglandin inhibition to suppression of the synthesis of different algesiogenic substances (oxygen free radicals, lytic enzymes), and to a direct non endorphin-mediated action at central level. The data base considered in this review, concerning piroxicam in extra-rheumatic analgesia, is of about 2,500 patients, in 26 clinical studies, mostly with an experimental double-blind placebo-controlled design or vs other NSAIDs. The doses ranged from 5 to 40 mg in a single administration: the doses of 20 and 40 mg showed an immediate analgesic effect, with the onset of analgesia within 30 min./1 hour from the administration. Analgesic activity was intense, comparable or superior to that of other drugs (aspirin, codeine, other NSAIDs) and more prolonged, often lasting as long as 24 hours. Tolerability of this data base was very satisfactory and comparable to that of the placebo, incidence of side effects being negligible.

[Evaluation of the efficacy and tolerability of protirelin. Results of a multicenter study in Italy]. / Valutazione dell'efficacia e tollerabilità della protirelina. Risultati di uno studio policentrico in Italia.

Controlled clinical trials demonstrated protireline tartrate (TRH-T) efficacy, with its analeptic, analgesic and arousing effects, in the treatment of neurological and functional impairment due to cerebrovascular accidents and head injuries. While the efficacy profile has been extensively studied, there isn't yet a completely satisfactory evaluation on TRH-T tolerability profile. We decided to perform, in Italy, a phase IV clinical trial on the efficacy-safety ratio of TRH-T, involving more than 170 centers spread in the whole country. The trial was an open study, with no control group, enrolling 2359 patients (M = 1405; F = 930; n.d. = 24), most aged between 50 and 80 years. About 52% of them had stroke sequelae, about 15% head injury, 11% a TIA and another 11% cerebral hemorrhage. The patients received TRH-T (4 mg/die) for a cycle of 14 days, by either intramuscular or intravenous routes (slow infusion). Drug efficacy was declared good in about 45% and excellent in about 18% of the patients with stroke. Two hundred twenty eight adverse events were found in 153 patients (M = 92; F = 61), namely with an incidence of 6.49%; they were more frequently detected in elderly patients and in those affected by cerebral hemorrhage or TIA. The most frequent adverse events concerned mucocutaneous, gastrointestinal, cardiovascular and central nervous systems; they were mostly considered light or moderate, and only one third of them required suspension of treatment. Drug-event causal relationship was judged, referring to the "Lasagna algorithm", as definite in 23.7% of the adverse events.(ABSTRACT TRUNCATED AT 250 WORDS)