Abstract
This randomised, single-blind, placebo-controlled study involved 20 patients with chronic upper motoneuron syndrome due to ischemic cerebrovascular lesions, selected in order to ensure the greatest possible homogeneity in terms of the severity of the syndrome. All of them were treated with protirelin tartrate 4 mg/die i.m. The study included semiquantitative clinical evaluations of neurological examinations, with particular attention being paid to weakness and spasticity. These were accompanied by neurophysiological evaluations (F-waves, magnetic motor evoked potentials). Extended biohumoral investigations of possible side effects were also carried out. The results indicate a slight but statistically significant absolute improvement in spasticity and muscular strength following protirelin tartrate, especially in the lower limbs; at the same time, the drug also proved to be capable as favourably modifying the response of the biceps femoris muscle to transcranial magnetic stimulation (reappearance, increased amplitude and a reduction in the threshold of motor evoked potentials). The drug was generally well tolerated.
Sommario
Abbiamo condotto uno studio in cieco-singolo, randomizzato, controllato con placebo, su 20 pazienti affetti da sindrome cronica del motoneurone superiore, esito di lesione vascolare ischemica cerebrale. Il gruppo di pazienti era selezionato in funzione della massima possibile omogeneità quanto alla gravità della sindrome e trattato per 2 settimane con protirelina tartrato 4 mg IM/die. Lo studio comprendeva valutazioni cliniche semiquantitative dell'esame neurologico, con particolare riguardo all'ipostenia ed alla spasticità. A queste si affiancavano valutazioni neurofisiologiche (studio dell'onda F e dei potenziali evocati motori magnetici). Venivano effettuate estese indagini bioumorali circa i possibili effetti collaterali. I risultati indicano un miglioramento lieve sul piano assoluto, ma statisticamente significativo, della spasticità e della forza muscolare dopo protirelina tartrato, specie per l'arto inferiore. Contemporaneamente, il farmaco si dimostrava capace di modificare in senso favorevole la risposta allo stimolo magnetico transcranico nel muscolo bicipite femorale (ricomparsa, aumento d'ampiezza e diminuzione di soglia del potenziale evocato motore). Esso si dimostrava complessivamente ben tollerato.
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Civardi, C., Naldi, P., Cantello, R. et al. Protirelin tartrate (TRH-T) in upper motoneuron syndrome: a controlled neurophysiological and clinical study. Ital J Neuro Sci 15, 395–406 (1994). https://doi.org/10.1007/BF02339903
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DOI: https://doi.org/10.1007/BF02339903