Interferon in relapsing-remitting multiple sclerosis
Editorial Group: Cochrane Multiple Sclerosis Group
Published Online: 23 OCT 2001
Assessed as up-to-date: 29 APR 2007
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: Edited (no change to conclusions)
- Published Online: 23 OCT 2001
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).
The objective of this review was to assess the effects of recombinant interferons in adults with RRMS.
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
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.
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.
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
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.
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。
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。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。