A Prospective Controlled Opening-Trial on Additive Treatment of Rebif in Chines Multiple Sclerosis
|School||Huazhong University of Science and Technology|
|Keywords||multiple sclerosis additive therapy of Rebif corticosteroid hormone therapy therapeutic effect|
Objectives—To evaluate the therapeutic efficacy and the safety of Rebif?( recombinant interferon-beta-1a) in the patients with relapsing remitting multiple sclerosis(RRMS).Methods—In the total 162 multiple sclerosis (MS) patients, diagnosed with McDonald criteria (2005) , hospitalized and followed-up in our Multiple Sclerosis Clinic, 96 cases were enrolled in the trial, and respectively divided into two groups: 1)Rebif? group ; 2)corticosteroid hormone group , based on the simillar disease course and simillar EDSS (The expanded disability status scale).The patients in Rebif? group were treated with Rebif?22μg or 44μg, injected subcutaneously three times weekly and followed-up 6 months to 2 years. In the patients of corticosteroid hormone therapy group, most patients were received the treatment of dexamethasone and prednisone, the others were treated with methylprednisolone and Medrol(oral methylprednisolone). The medical history collection , physical and laboratory examination,MRI(magnetic resonance imaging) and EDSS were recorded in 96 MS patients before the medications. All the patients were regularly followed-up and recorded adverse effects of Rebif? ,such as injecting site reactions, flu-like symptoms, transient GPT(glutamate-pyruvate transaminase) increasing and depressive symptoms,also corticosteroid hormone’s side effects,such as stomachache, obesity ,and so on. The end-points of the trial were respectively chosen at 6th, 12nd and 24th moon. Four observation parameters,as annual relapsing times , relapsing interval duration, and the changes of EDSS and the cerebrospinal MRI were evaluated. Paired t-test was applied to clinical data analysis.Results—At end-points of 6th ,12nd and 24th moon,the average increase of EDSS in Rebif? group was respectively -0.03±0.08, 0.10±0.06, and 0.27±0.10, and respectively 0.04±0.09, 0.27±0.08 and 0.58±0.12 in corticosteroid hormone group. The statistics difference is significant (P<0.01) in the two groups. The annual relapsing times was 0.51±0.11 in Rebif? group and 1.03±0.20 in corticosteroid hormone one; There was obvious statistically significant (P<0.01). The relapsing interval duration was 464.7±20.8days in Rebif? group , and 275.4±16.4days in corticosteroid hormone one(P<0.01). There were 4 patients occuring injection site reactions(8.3%),4 cases(8.3%) with flu-like symptoms, 2 cases(4.2%) with transient GPT increasing,and 2 cases(4.2%) with depression symptoms in Rebif? group. Compared with Rebif? group, there were more common adverse effects in the most patients of corticosteroid hormone group , such as stomachache, body-weight increasing , and so on.Conclusions—It is suggested that there are more advantages to the patients injected subcutaneously Rebif? 22μg or 44μg three times weekly, Compared to the patients with corticosteroid hormone therapy. Rebif? is therapeutically effective in reducing MS relapsing times , lengthening relapsing interval duration , and delaying the accumulation of physical disability . Rebif is very safe and effective in treatment of RRMS patients.