inosine-pranobex and Multiple-Sclerosis

Isoprinosine was used under double-blind, randomised, and placebo-controlled conditions in 52 patients with relapsing/remitting or progressive multiple sclerosis. All patients received pulsed treatment with methylprednisolone. There was no significant effect of treatment on clinical disability or the accumulation of MRI abnormalities, after correction of results for multiple comparisons. It is concluded that isoprinosine is not effective therapy for multiple sclerosis.

Topics: Administration, Oral; Adult; Analysis of Variance; Double-Blind Method; Female; Humans; Inosine Pranobex; Magnetic Resonance Imaging; Male; Multiple Sclerosis; Recurrence; Treatment Outcome

We studied 30 patients with clinically definite MS according to the Mc Alpine et al. clinical criteria (20 patients received isoprinosine and 10 amantadine for a period of 12 months). In each patient pattern reversal stimulation was presented to each eye successively and potentials were recorded over both occipital lobes. For each condition the average evoked response to 200 pattern reversals was computed on DISA 2000. During the 24 month-lasting observation high clinical improvement and simultaneous shortening of the latency to peak of the first major positive component of the response in visual evoked potentials was observed in 12 cases with relapsing form treated 12 months with isoprinosine. In 3 cases, despite of the treatment with isoprinosine, new relapses were observed; in these patients delayed response in VEP was observed. In cases treated with amantadine no shortening of the latency to the major positive peak of the potential was observed, also no diminish of relapses frequency was observed.

Topics: Adolescent; Adult; Amantadine; Evoked Potentials, Visual; Female; Humans; Inosine Pranobex; Male; Multiple Sclerosis; Time Factors

Immunological and clinical functions were studied over a 2 year period in conjunction with a placebo controlled trial of isoprinosine and chlorambucil in 21 patients with exacerbating remitting multiple sclerosis. Laboratory and clinical evaluations were performed at 3 month intervals and during relapses. In placebo-treated patients, the decrease in circulating T8+ cells was maximum during relapses, T lymphocyte function was impaired, and five of the six patients experienced clinical worsening. Chlorambucil treatment was responsible for a decrease in circulating T4+ and T8+ cells; nevertheless, T lymphocyte function was slightly improved during relapses. The alterations of delayed hypersensitivity responses were not accompanied by improvement in relapse rate or in intensity and major side effects: mainly infections with leukopenia and thrombocytopenia. During isoprinosine therapy, a regulation of circulating T lymphocytes and cell proliferation occurred. The higher level of circulating T cells was related to the increase in T4+ and T8+ cells, which did not decrease during relapses. The absence of Leu 7+ cell modifications suggest that NK were numerically unaffected by isoprinosine therapy and that in vivo regulation of circulating T suppressor cells was performed by this treatment. Four out of seven patients did not experience any relapse during the duration of the trial. In relapsing patients, the frequency and duration of the relapses were significantly different from that of other patients. A reduction of the disease progression was observed without any side effects. While no conclusion can be drawn on the long-term effectiveness, the results of this pilot study are consistent indicators of the immunological and clinical beneficial effects of isoprinosine therapy in patients with exacerbating remitting multiple sclerosis.

Topics: Adult; Chlorambucil; Clinical Trials as Topic; Double-Blind Method; Humans; Hypersensitivity, Delayed; Immunosuppression Therapy; Inosine; Inosine Pranobex; Multiple Sclerosis; Random Allocation; Reference Values; T-Lymphocytes

Topics: Adult; Double-Blind Method; Drug Evaluation; Humans; Inosine; Inosine Pranobex; Middle Aged; Multiple Sclerosis; Random Allocation

Isoprinosine, a drug enhancing the cellular immunity, was administered to 11 patients with multiple sclerosis (MS) for a period of 60 days. Kurtzke's Disability Status Scale was evaluated in all the patients before the starting of the therapy and after 60 days and after 14 months of follow-up. 11 MS patients were taken as a control group and were treated with prednisone for the same period of time. No significant difference in the clinical course of the disease between the two groups of patients after the therapeutical trial was observed. CSF examination showed IgG oligoclonal bands in all the cases; no modification of the CSF IgG profile was found after the therapy in those patients in whom the lumbar puncture was performed after the follow-up period.

Topics: Adult; Antibody Formation; Humans; Immunity, Cellular; Immunoglobulin G; Inosine; Inosine Pranobex; Male; Middle Aged; Multiple Sclerosis; Prednisone

Oligoclonal IgG bands were analyzed in matching pairs of cerebrospinal fluid (CSF) and serum from 12 subacute sclerosing panencephalitis (SSPE) patients, using isoelectric focusing and immunofixation. Each patient was given isoprinosine, and four of the 12 patients were given alpha-interferon in addition. Two to 4 serial CSF and serum samples were collected from each SSPE patient during periods ranging from 1 to 16 months. In 3 SSPE patients a small number of new oligoclonal bands were seen in the follow-up CSF samples. In the other 9 SSPE patients there was no change in CSF band patterns between initial and follow-up specimens. Band patterns in serum remained unchanged between initial and follow-up samples. Although all 12 SSPE cases had higher IgG indices and increased rate of intra blood-brain barrier (BBB) IgG synthesis in comparison to patients with other neurological diseases, the values did not significantly differ between the first and follow-up specimens. We conclude that treatment of SSPE patients with isoprinosine or with isoprinosine and alpha-interferon had no significant effect on the CSF oligoclonal band profiles or IgG synthesis within the central nervous system.

Topics: Adolescent; Adult; Antibody Formation; Blood-Brain Barrier; Cerebrospinal Fluid Proteins; Child; Combined Modality Therapy; Female; Humans; Immunoglobulin G; Immunologic Factors; Inosine Pranobex; Interferon-alpha; Male; Multiple Sclerosis; Nervous System Diseases; Subacute Sclerosing Panencephalitis; Treatment Outcome

Topics: Adult; Female; Humans; Inosine; Inosine Pranobex; Male; Multiple Sclerosis

Twenty-five patients affected by remittent form of multiple sclerosis (MS) were treated with methisoprinol for a period of 2 years. The clinical parameters, recorded during a 2-year observation period preceding onset of therapy, were compared with the analogous measures recorded during treatment. Treatment was associated with significant favourable changes. In fact, there were observed: a reduction in mean annual relapse rate for 22 of 25 patients; an improvement in the clinical status as demonstrated by the reduction of the Kurtzke Disability Status Scale values obtained in 14 of 25 patients; a reduction in the mean period of standard corticosteroid therapy.

Topics: Adult; Female; Humans; Inosine; Inosine Pranobex; Male; Multiple Sclerosis

Thirty subjects affected with multiple sclerosis, of which 22 were female and eight male, with an average of 30 +/- 7, years were studied, for a period of 10-15 months,. clinically using Kurtzkes' report form, neurophysiologically (responses tested: VEP, BAEP, SEP, ESG) and immunologically (Rosette Et, Ea, EAC). Of the 30 cases, 19 showed poussées in the last three years and 11 were in the stabilization phase. The Kurtzke reports and the neurophysiological tests permitted an accurate assessment of lesion levels and their rate of evolution. The immunological tests showed a notable ability to differentiate between subjects with recent poussées and those in the stabilization phase presenting overall values significantly below the norm. In the follow-up, after treatments with methisoprinol, the immunological tests also revealed modifications of notable interest.

Topics: Adult; Evoked Potentials, Auditory; Evoked Potentials, Somatosensory; Evoked Potentials, Visual; Female; Humans; Inosine Pranobex; Italy; Longitudinal Studies; Male; Multiple Sclerosis; Rosette Formation