A randomized trial of pegylated-interferon-alpha2a plus ribavirin with or without amantadine in the re-treatment of patients with chronic hepatitis C not responding to standard interferon and ribavirin.

BACKGROUND: There is yet no established treatment for chronic hepatitis C patients non-responder to standard interferon and ribavirin. AIM: To evaluate efficacy and safety of pegylated-interferon-alpha2a plus ribavirin with or without amantadine in such patients. METHODS: 161 non-responders to standard interferon and ribavirin were randomized into two groups: 81 patients (Group 1) were given weekly Peg-IFN-alpha2a 180 microg plus ribavirin 1,000-1,200 mg/daily for 12 months, 80 patients (Group 2) received weekly Peg-IFN-alpha2a 180 microg plus ribavirin 1,000-1,200 mg/daily and amantadine 200 mg/daily for 12 months. RESULTS: At the end of follow-up, HCV-RNA was negative in 29.6% of Group 1 and in 21.2% of Group 2 patients (P = 0.22). Patients with genotypes 1 and 4 responded better to bi-therapy (21.7%) than to triple therapy (17.3%, P = 0.5) while among patients with genotypes 2 and 3 there was a trend towards a higher sustained virological response rate when retreated with triple treatment (80% vs. 75%, P = 0.82). On multivariate analysis, genotype 1 or 4, high body mass index and >20% reduction of Peg-interferon were associated with the treatment failure. CONCLUSIONS: The addition of amantadine does not improve the overall SVR rate in non-responder patients retreated with Peg-IFN and ribavirin; however, about 30% of non-responders may achieve a sustained response, in particular patients with genotypes 2 and 3 show a high SVR (75%).

Interferon and amantadine in combination as initial treatment for chronic hepatitis C patients.

BACKGROUND/AIMS: To evaluate the efficacy and tolerance of amantadine in combination with interferon in the treatment of chronic hepatitis C. METHODS: Multi-centre trial including 180 chronic hepatitis C patients without cirrhosis, randomly enrolled to receive interferon 6 MU every other day for 6 months followed by 3 MU for further 6 months (group A, 90 patients), or the same schedule plus amantadine 200 mg/day (group B, 90 patients). Primary end-point was a sustained virological and biochemical response, secondary end-points were on-treatment (third month) and end-of-treatment response rates. RESULTS: The two groups had similar demographic, biochemical and virological characteristics. A sustained response after 6 months follow-up was observed in 17% of group A and 24% of group B patients (P not significant), an end-of-treatment response was observed in 37% in group A and 47% in group B (P not significant), an on-treatment response was observed in 46% in group A and 61% in group B patients (P < 0.05). No major side effects due to amantadine administration were observed. CONCLUSIONS: Adding amantadine to interferon did not improve the sustained treatment efficacy. However, the rate of early response at the third month of therapy was significantly higher in the combination therapy group.

Malignant meningeal melanoma.

We report the case of an isolated pigmented lesion of the cerebellar tentorium which was initially interpreted as meningeal melanocytoma. The immunohistochemical study required as a result of a subsequent post-surgical recurrence prompted us to reconsider the early diagnosis in favour of malignant meningeal melanoma. On the basis of data in the literature, the possibility that the lesion may have been a dural melanoma is discussed.

[Agenesis of the left pericardium: report of a case]. / Agenesia del pericardio sinistro: descrizione di un caso.

We report a case of left pericardial agenesia in a 44 year old woman. Clinical picture was not specific on clinical field: atypical chest pain, asthenia, syncope, cystolic murmur 1/6 Levine on the second left interspace were found. ECG showed clockwise deviation of axis in the precordial leads and incomplete right bundle branch block. Chest X-ray showed marked levocardia and dilatation of pulmonary trunk. Levocardia increased with the patient on the left side. Echocardiography (possible only with patient recumbent on his right side) was normal. Magnetic resonance imaging showed absence of the left pericardium. We analyse the diagnostic problems and the prognostic doubts of this rare congenital anomaly.

[A sustained response in chronic hepatitis C treated with interferon]. / La risposta sostenuta nella epatite cronica C trattata con interferone.

We analyzed 27 subjects with long-term response, from a group of 110 interferon treated patients with biopsy-proven chronic hepatitis and serum anti-HCV antibodies. The following variables were assessed as potential predictors: sex, age, ALT level before the therapy was started, liver structure, type of interferon, total amount of interferon. Total amount of administered interferon statistically correlated with long-term response by univariate analysis. Nevertheless upon stepwise logistic multivariate analysis none of them was independently predictive of long-term response. Additional studies would be needed in order to develop a model capable of predicting from pre-treatment features which patients are likely to have long-term response.

Assessing brain function in post-traumatic coma by means of bit-mapped SEPs, BAEPs, CT, SPET and clinical scores. Prognostic implications.

Sixty-eight severely head injured comatose patients were studied. Bit-colour-mapped SEPs to median nerve stimulation, BAEPs, CT and SPET regional values and ICP were assessed in relation to clinical information in evaluating cerebral function. All these variables were related to a 1-year outcome. Statistical tests confirmed the higher predictive reliability of both neurophysiological and perfusive (SPET) functional parameters compared to CT structural findings. Generally, SEPs appeared to be more reliable in predicting outcome than BAEPs. Modifications of frontal components could occur independently of post-central ones, being closely related to underlying cerebral lesions. The parameter showing the greatest correlation with outcome in the first recording session was the P25 latency, whereas this prognostic role was mainly assumed by the amplitude value of the frontal N30-P45 complex in a second recording session carried out during the third week following head trauma.

Visual evoked potentials related to behavioral asymmetries during foveal attention in the two extrapersonal hemispaces.

In a group of male and female subjects we studied the VEPs related to the solution of a lexical decision task presented in the Left and Right Hemispaces with respect to the Central position in order to explore the electrophysiological correlates of the performance asymmetries obtained when overt spatial attention is directed to the Left or Right Hemispace. When stimuli were presented in the Left Hemispace a significant asymmetry was observed between the two hemispheres of the negative activity around 280 msec in the occipital-parietal areas. Moreover a general increase in the Central and Frontal areas of both the hemispheres was observed. In this paper we discuss why these effects can be considered to be the cause of the costs on accuracy observed in the male subjects. The differences obtained with the female group are discussed in relation to the observed modification on the negative activity around 400 msec with stimuli in the Left Hemispace. These findings give some suggestions about the interaction of structural and attentional mechanisms in the brain during the solution of a lateralized cognitive task.

Labio-glosso-pharyngo-laryngeal paralysis caused by two brain lesions: cortical and subcortical.

We report a case of labio-glosso-pharyngo-laryngeal paralysis with some peculiar features. CT and MRI yielded the diagnosis of acute pseudobulbar syndrome by demonstrating the existence of two lesions of the corticobulbar tract: one subcortical (recent) and the other opercular cortical (old) on the opposite side.

Reappearance of brain-stem auditory evoked potentials after surgical treatment of a brain-stem hemorrhage: contributions to the question of wave generation.

We report on a patient suffering a spontaneous hemorrhage primarily located in the right brain-stem; surgical correction of this led to a substantial improvement in clinical deficits. Brain-stem auditory evoked potentials (BAEPs) were recorded on postoperative days 18, 30, 55 and 205. Waves II through V were initially undetectable on stimulation of the damaged side, whereas the absence of peak V was the only abnormality seen on left-side stimulation. With the regression of the right lower mid-pontine deficits, the right waves gradually reappeared and normalized progressively. On the last recording, only a left wave V abnormality persisted. At that time, the patient had a moderate left hemisyndrome due to a circumscribed right upper pontine-midbrain lesion. Therefore, it can be suggested that the first 4 waves of BAEPs mainly originate in the ipsilateral pons, and the Vth in the contralateral higher regions.

[Evaluation of several parameters of coagulation in liver cirrhosis: disseminated intravascular coagulation or pseudo-disseminated intravascular coagulation?]. / Valutazione di alcuni parametri di coagulazione in corso di cirrosi epatica: CID o pseudo-CID?

Reports in the literature on the difficulty of differential diagnosis between Disseminated Intravascular Coagulation (DIC) Pseudo-DIC and Primary Fibrinolysis (PF) in patients with liver disease, stimulated a study of various coagulation parameters (PT, PTT, Platelets, Fibrinogen, FDP) in 28 cirrhotic patients. The study confirmed reports in the literature on the high incidence of circulating FDP among liver disease patients. The vital role these play in maintaining alterations in haemostasis means that cirrhosis cases must be approached with extreme caution, avoiding any therapeutic or instrumental procedure liable to worsen the already disturbed coagulation pattern in such patients.

[Clinical use of IM-PH immuno-columns]. / Application clinique de l'immuno-colonne IM-PH.

The results of plasma perfusion through immunoabsorbent columns were assessed in neuroimmunological conditions. The method is a modified plasmapheresis. The plasma is passed through a column of polyvinyl alcohol gel bound with phenylalanine. Three patients were treated by this method (two with acute polyneuropathies due to the Guillain-Barré syndrome, and the third with a polyneuropathy related to Hepatitis A). Each patient underwent 3 sessions, on alternate days for a six day period, with perfusion of 6-6.5 1 of plasma. No adverse effects were observed during treatment or changes in PAO values. Serum Na+-K+-Cl-Ca++-Gluc-Tot Prot-Alb-RBC-WBC-Hb-Urea and Creatinine were constant. Complete remission of the peripheral symptoms of the patients with the Guillain-Barré syndrome was observed whilst the third patient had a partial remission (in the left arm). These observations suggest that this method may be of therapeutic value in patients with acute polyneuropathy due to the Guillain-Barré syndrome.

[Hepatic cirrhosis caused by alcohol: normalization of the functional parameters after prolonged abstinence]. / Cirrosi epatica da alcool: normalizzazione dei parametri di funzionalità dopo prolungata astensione.

It has often been noted that total abstention from alcohol will lead to the normalisation of modest liver lesions. For this reason the possibility of regression of more severe lesions was studied. To this end five patients with clinically diagnosed cirrhosis of the liver (bioptically confirmed in 2 cases) were followed up for a minimum of 1 and a maximum of 5 years, demonstrating the total reversibility of clinical and laboratory signs after total abstention for an average 15 months.

[Clinico-statistical considerations on the agreement between echographic and biopsy findings in hepatopathies of the diffuse type]. / Considerazioni clinico-statistiche sulla concordanza fra referto ecotomografico e bioptico nelle epatopatie di tipo diffuso.

A comparison between echographic and bioptic findings in diffuse liver disease is reported. The data obtained are compared with those quoted in the literature and found to be very similar. Finally echography is identified as the indispensable examination of choice.

[Clinical considerations on a case of Caroli disease]. / Considerazioni cliniche su un caso di malattia di Caroli.

A case of Caroli's disease is presented. Stress is laid on the importance of transcutaneous cholangiography in the diagnosis of this morbid form, and the usefulness of both echotomography and computed tomography. The latter permits visualisation of the intra- and extrahepatic bile ducts and indicates the extent of the disease. At the same time, it permits evaluation of any alterations of other organs. Attention is also drawn to the importance of careful diagnostic employment of these means of investigation. Emphasis is equally placed on the way complications can be prevented through medical and surgical management.