Intervention Review

Interferon in relapsing-remitting multiple sclerosis

  1. George PA Rice2,
  2. Barbara Incorvaia3,
  3. Luca M. Munari4,
  4. George Ebers5,
  5. Chris Polman6,
  6. Roberto D'Amico7,
  7. Elena Parmelli7,
  8. Graziella Filippini1,*

Editorial Group: Cochrane Multiple Sclerosis Group

Published Online: 23 OCT 2001

Assessed as up-to-date: 29 APR 2007

DOI: 10.1002/14651858.CD002002


How to Cite

Rice GPA, Incorvaia B, Munari LM, Ebers G, Polman C, D'Amico R, Parmelli E, Filippini G. Interferon in relapsing-remitting multiple sclerosis. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD002002. DOI: 10.1002/14651858.CD002002.

Author Information

  1. 1

    Fondazione I.R.C.C.S. - Istituto Neurologico C.Besta, Neuroepidemiology Unit, Milano, Italy

  2. 2

    University of Western Ontario, Clinical Neurological Sciences, London, Ontario, Canada

  3. 3

    Osservatorio Epidemiologico - Regione Umbria, Cochrane Neurological Network, Perugia, Italy

  4. 4

    Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy

  5. 5

    University of Oxford, Clinical Neurology, Oxford, UK

  6. 6

    VU Medical Centre, Neurology, Amsterdam, Netherlands

  7. 7

    University of Modena and Reggio Emilia, Department of Oncology and Hematology, Modena, Italy

*Graziella Filippini, Neuroepidemiology Unit, Fondazione I.R.C.C.S. - Istituto Neurologico C.Besta, via Celoria 11, Milano, 20133, Italy. gfilippini@istituto-besta.it.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 23 OCT 2001

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Recombinant interferons have been shown to suppress both the clinical and magnetic resonance imaging (MRI) measures of disease activity in patients with relapsing remitting multiple sclerosis (RRMS).

Objectives

The objective of this review was to assess the effects of recombinant interferons in adults with RRMS.

Search methods

We searched the Cochrane Multiple Sclerosis Group trials register (April 2007), MEDLINE (January 1966 April 2007), EMBASE (January 1985 to April 2007) and reference lists of articles. We also contacted manufacturers and researchers in the field

Selection criteria

The trials selected were double-blind, placebo-controlled, randomised trials of RRMS patients who were treated with recombinant interferon, given by the subcutaneous or the intramuscular route.

Data collection and analysis

All reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.

Main results

Although eight trials involving 1301 participants were included in this review, only 919 (71%) contributed to the results concerning exacerbations and progression of the disease at two years. Specifically interferon significantly reduced the occurrence of exacerbations (Relative risk [RR] 0.80, 95% confidence interval [CI] 0.73 to 0.88, p < 0.001) and progression of the disease (RR 0.69, 95% CI 0.55 to 0.87, p = 0.002) two years after randomisation. However, the correct assignment of dropouts was essential to the demonstration of efficacy, most conspicuously concerning the effect of the drug on disease progression. If interferon-treated participants who dropped out were deemed to have progressed (worst case scenario) the significance of these effects was lost (RR 1.31, 95% CI 0.60 to 2.89, p = 0.5). The evolution in magnetic resonance imaging (MRI) technology in the decade in which these trials were performed and different reporting of data among trials made it impossible to perform a quantitative analysis of the MRI results. Both clinical and laboratory side effects reported in the trials were more frequent in treated participants than in controls; there was no information after two years of follow-up. The impact of interferon treatment (and its side effects) on the quality of life of patients was not reported in any trial included in this review.

Authors' conclusions

The efficacy of interferon on exacerbations and disease progression in patients with relapsing remitting MS was modest after one and two years of treatment. Interferon administered by the oral route was not effective for prevention of relapses. Longer follow-up and more uniform reporting of clinical and MRI outcomes among these trials might have allowed for a more convincing conclusion.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

The use of interferons for treating people with the relapsing-remitting form of multiple sclerosis

Multiple sclerosis (MS) is a chronic disease of the nervous system which affects young and middle-aged adults. Repeated damage to the myelin sheaths and other parts of the nerves can lead to serious disability. MS may be related to the immune system. Interferons have several effects on the immune system, and act against viruses. Interferons can help to reduce disability and attacks for people with multiple sclerosis, but there is not enough evidence about their usefulness in the long term. The review of trials found that interferons administered intramuscularly or subcutaneously can lead to a moderate reduction in recurrences and disability in people who have MS with remissions. Interferon-1a administered by the oral route was not effective for prevention of relapses. Side effects were usually influenza-like symptoms, injection site-reactions, pains in the joints and muscles, fatigue and headache.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

以干擾素治療復發緩解型多發性硬化症

不管是用臨床或是核磁共振(MRI)來評估,合成干擾素似乎可以抑制復發緩解型多發性硬化症(RRMS)的活性。

目標

這篇評論的目的是要評估合成干擾素對RRMS成年病人的效用。

搜尋策略

我們搜尋了the Cochrane Multiple Sclerosis Group trials register (searched December 2000), MEDLINE (January 1966 to December 2000), EMBASE (January 1985 to December 2000)和文章的參考文獻表。我們也聯絡了製造商和這個領域的研究者。

選擇標準

我們所選擇的試驗是雙盲、以安慰劑為對照組、隨機分配的試驗,研究以皮下或肌肉注射的合成干擾素治療RRMS病人。

資料收集與分析

所有四位評論者都獨立地評估試驗的品質,並從試驗中取出數據。我們也聯絡論文的作者以取得額外的資訊。還從試驗中搜集副作用的資訊。

主要結論

雖然這個評論包含了共七個試驗、1215個參與者,但關於二年後疾病復發和惡化的統計,只有919(76%)個參與者的結果被計算在內。確切地說,干擾素在進行隨機分配二年後的統計時,顯著地減少了再復發(相對危險(RR)0.8, 95%信賴區間(CI)0.73 – 0.88, p<0.001)和疾病惡化(RR 0.69, 95% CI 0.55 – 0.87, p = 0.002)。然而,關於病人於中途離開試驗的部分,將最有可能影響本研究的結果,因此必須正確解析此部分的意義,才有辦法確定它的真正療效。如果把中途離開的干擾素治療組病人視為疾病已經惡化的話(以最壞的角度設想),那試驗結果的顯著性就消失了。(RR 1.31, 95% CI 0.60 – 2.89, p = 0.5) 因為這些試驗執行的數年之中,核磁共振(MRI)不斷地進步,各個試驗報告數據的方式也不同,所以要執行MRI結果的定量分析是不可能的。試驗中所報告的臨床副作用或是檢驗數據所顯示的副作用,都是干擾素治療組比較頻繁,但這方面沒有兩年後追蹤的數據。這篇評論所包含的試驗中,沒有人提到干擾素治療及其副作用帶給生活品質什麼樣的影響。

作者結論

在一到二年的干擾素治療之後,在緩解復發型MS病人之中,干擾素顯示對防止復發和惡化有些許效力。如果有更長的追蹤時間及臨床和MRI結果更一致的報告方式,我們可能可以得到更有說服力的結論。

翻譯人

本摘要由新光醫院葉旭霖翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

干擾素可以減少多發性硬化症病人的失能和復發,但是沒有足夠的證據證明它長期的效果。多發性硬化症(MS)是一個神經系統慢性的疾病,主要影響年輕人和中年人。神經髓鞘及其它部份反覆的損壞會造成嚴重的失能。MS可能和免疫系統有關,而干擾素在免疫系統有多重的作用,而且可以對抗病毒。對這些試驗的回顧發現干擾素可以些微減少緩解病人復發和失能的危險。副作用通常是感冒似的症狀、注射部位的反應、關節和肌肉痛,以及疲憊和頭痛。