重组人干扰素α-2a治疗复发缓解型多发性硬化症：挪威一项随机、安慰剂对照、双盲试验的设计

Treatment of relapsing-remittent multiple sclerosis with recombinant human interferon-alfa-2a: design of a randomised, placebo-controlled, double blind trial in Norway.

作者信息

Nyland H, Myhr K M, Lillås F, Smievoll A I, Riise T, Nortvedt M, Nilsen R

机构信息

Department of Neurology, University of Bergen, Norway.

出版信息

Mult Scler. 1996 Jul;1(6):372-5. doi: 10.1177/135245859600100618.

DOI:10.1177/135245859600100618

PMID:9345420

Abstract

A multicentre, randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of 4.5 and 9.0 MIU recombinant human interferon alfa-2a (Roferon-A) given thrice weekly in patients with relapsing-remittent multiple sclerosis is described. The patients are treated for 6 months followed by a 6 months drug-free period. The primary objective is to determine new disease activity analysed by monthly MRI with gadodiamide (GdDTPA-BMA, Omniscan). The study is conducted at eight centers in Norway and is completed in January 1996.

摘要

本文描述了一项多中心、随机、双盲、安慰剂对照研究，旨在评估复发缓解型多发性硬化症患者每周三次注射4.5百万国际单位和9.0百万国际单位重组人干扰素α-2a（罗扰素）的疗效和安全性。患者接受6个月治疗，随后为6个月的无药期。主要目的是通过每月使用钆喷酸葡胺（GdDTPA-BMA，欧乃影）进行MRI检查来确定新的疾病活动情况。该研究在挪威的八个中心进行，并于1996年1月完成。