| 摘要 |
<p>In previous studies, Copolymer 1 given at a dose of 20 mg daily has been shown in a controlled study to decrease the relapse rate in multiple sclerosis (MS) by about 30 % over placebo. In our clinical studies, daily subcutaneous (SC) administration has decreased the relapse rate by 73.4 % from baseline. In the present study, relapsing MS patients were treated with 20 mg Copolymer 1 on alternate days. Sixty eight patients were recruited: 51 and 40 patients completed one and two years respectively. The relapse rate during the two years of treatment decreased by 80.8 % compared to the two years prior to treatment (means 0.56±1.02 vs 2.91±1.10, respectively, P<0.0001). The Expanded Disability Status Scale (EDSS) did not differ from baseline following the first year of treatment, but increased somewhat at the end of the second year (baseline=2.72±1.55, one year 2.71±1.59, two years 2.97±1.80, P<0.008). The drug was very well tolerated. This study suggests that alternate day therapy has beneficial effects and is well tolerated in relapsing Multiple Sclerosis, comparing favourably with the effects of daily injections of Copolymer 1.</p> |
