Trattamento ciclico con megadosi di metilprednisolone in pazienti affetti da sclerosi multipla a decorso recidivante-remittente. Valutazione clinica a tre anni

Large doses of methylprednisolone (MP) in short course of treatment are today frequently used in treating attacks of relapsing-remitting multiple sclerosis (RR-MS). At present no sufficient knowledge is available about the chance for a long term treatment with periocidal 'pulse' administration of high doses of MP in patients suffering from RR-MS. We treated 55 patients periodically (at 120 day intervals) for 3 years with short course of high doses of MP (1 g/day for 5 days). The study aimed at assessing: 1) the number of relapses occurred during the 3-year therapy compared with that observed in the same patients in the 2 years preceding the treatment; 2) the modification of the degree of the disability according to EDSS; 3) the intervals of time between a cycle of therapy and the onset of relapse in order to evaluate a possible preventive effect; 4) the nature and relevance of adverse effects; 5) a predictive pattern for the fourth year of therapy on the grounds of the obtained data. The results showed that the ARR (Acute Relapse Rate) fell from 0.7 in the two years preceding the therapy to 0.34 at the end of the study (p<0.0001). The patients participating in the study presented 78 attacks in the two years preceding treatment and 56 attacks in the 3 years of therapy. The number of patients free from attacks increased from 5 (9.1%) to 32 (58.2%) and the number of relapses decreased in 31 patients (56.4%), remained unchanged in 14 (25.4%) and increased in 10 (18.2%). By evaluating changes of at least one point in EDSS, 12 patients (21.82%) resulted improved, 36 (65.45%) unchanged and 7 (12.73%) worsened. The average interval between a therapeutic cycle and the onset of an attack resulted to be of 88 days; the majority of attacks occurred after 60 days and only 16, in a shorter time. Side effects were always light and roughly confined to the period of treatment. From the above mentioned results we deduced that the distribution of attacks follows a poissonian pattern. By a trial of unsweving regression of such a poissonian pattern for the next fourth year, it results that about 41 patients will be free from attacks, 12 will have only a relapse, 2 will manifest two attacks and no one more than three attacks. If the results of the present pilot study are not the consequences of the great variability in the course of the disease, it is possible to infer that, in RR-MS, periodical short courses of high doses of MP administered even in the absence of clinically evident relapses, could be useful in modifying the evolution of the disease by a reduction in the number of the attacks.