干扰素β在日常临床环境中治疗多发性硬化症：一项上市后3年的研究。

Interferon beta treatment of MS in the daily clinical setting: a 3-year post-marketing study.

作者信息

Onesti E, Bagnato F, Tomassini V, Volante G, Denaro F, Frontoni M, Millefiorini E, Pozzilli C, Fieschi C

机构信息

Department of Neurological Sciences, La Sapienza University of Rome, Viale dell'Università 30, I-00185 Rome, Italy.

出版信息

Neurol Sci. 2003 Dec;24(5):340-5. doi: 10.1007/s10072-003-0186-z.

DOI:10.1007/s10072-003-0186-z

PMID:14716530

Abstract

We performed a post-marketing study of patients with multiple sclerosis (MS) attending the outpatient service to evaluate the impact of interferon beta-1b (IFNbeta-1b) in the daily clinical setting. The absolute changes in relapse frequency and in the mean EDSS score over a three-year period were compared between 83 patients with relapsing remitting MS treated with IFNbeta-1b and 83 RRMS patients who did not take the drug. Annualized relapse frequency significantly decreased in patients undergoing therapy while no statistically significant changes in EDSS score were observed. These findings point out the role of post-marketing studies in evaluating the impact of approved drugs in the daily clinical setting in terms of safety and tolerability. Furthermore, our results confirm the positive effect of immunomodulatory treatment in decreasing the occurrence of inflammatory events.

摘要

我们对在门诊就诊的多发性硬化症（MS）患者进行了一项上市后研究，以评估β-1b干扰素（IFNβ-1b）在日常临床环境中的影响。比较了83例接受IFNβ-1b治疗的复发缓解型MS患者和83例未服用该药物的复发缓解型MS患者在三年期间复发频率和平均扩展残疾状态量表（EDSS）评分的绝对变化。接受治疗的患者年化复发频率显著降低，而EDSS评分未观察到统计学上的显著变化。这些发现指出了上市后研究在评估获批药物在日常临床环境中的安全性和耐受性方面的作用。此外，我们的结果证实了免疫调节治疗在减少炎症事件发生方面的积极作用。