Introduction: The effect of combined treatment (methylprednisolone and cyclophosphamide) of multiple sclerosis relapse within one year was investigated in an open clinical trial study of 70 patients. The sample comprised subjects shown to have clinically proven multiple sclerosis according to the criteria of C Poser and degree of neurological deficit according to EDSS rating from 2.5 to 6.0 points.
Material and methods: Methylprednisolone (200 mg, i.v., every other day, 10 doses, total course dose 2 g) was administered to 35 patients (mean age 31.34 +/- 1.53 years). Methylprednisolone using the same schedule and cyclophosphamide (200 mg, i.v.) given in the methylprednisolone-free day, 10 doses plus 200 mg i.v. once a month in the first three consecutive months (total course dose 2.6 g) were applied in another 35 patients (mean age 33.22 +/- 1.32 years).
Results and discussion: The changes of EDSS ratings at the end of months 1 and 12, of the CD+ T-lymphocytes subpopulations and B-lymphocytes from peripheral blood--prior to treatment and between the 5th and 9th week of treatment were compared. The neurological deficit degree according to EDSS dropped significantly (P < 0.01; P < 0.001) after one month of treatment in both groups. At the end of month 12 this indicator reached its baseline value in the group treated only with methylprednisolone while remaining significantly lower in the combined therapy group (P < 0.01). After methylprednisolone and cyclophosphamide application the suppressor/inducer CD8+ T-cells increased significantly in percentage (P < 0.05), while the values of B-lymphocytes decrease significantly (P < 0.05), in contrast to the results from the methylprednisolone-only treatment.
Conclusions: The results clearly indicate the greater efficaciousness of treatment by combining two immunosuppressive drugs.