Gangliosides for acute spinal cord injury
Editorial Group: Cochrane Injuries Group
Published Online: 20 APR 2005
Assessed as up-to-date: 3 JUN 2008
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
How to Cite
Chinnock P, Roberts I. Gangliosides for acute spinal cord injury. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD004444. DOI: 10.1002/14651858.CD004444.pub2.
- Publication Status: New search for studies and content updated (no change to conclusions)
- Published Online: 20 APR 2005
Spinal cord injury (SCI) results in loss of feeling and movement. The consequences can be devastating for the patient and his or her carers. Global estimates of the number of new cases annually range from 15 to 40 per million. Leading causes of acute SCI are road traffic injury, violence, and injuries sustained in sports and other recreational activities. Care for people with SCI has improved, leading to an increase in survival rates. Attempts to improve patients' feeling and movement have involved the use of a wide range of treatments. Gangliosides are compounds that occur naturally in cell membranes. Laboratory studies have suggested they may have protective effects on nerves and even help them to re-grow. Clinical trials have taken place using gangliosides (usually GM1 ganglioside) for a number of neurological conditions.
To quantify the evidence for the effectiveness and safety of gangliosides when used to treat acute SCI.
We searched the following databases to identify trials for inclusion: Cochrane Injuries Group's Specialised Register (searched 4 June 2008), CENTRAL (The Cochrane Library issue 2, 2008), MEDLINE to May (week 3) 2008, PUBMED (searched on 5 June 2008 (Limit: added to database in last 90 days), EMBASE to June 2008, Current Controlled Trials metaRegister (searched 5 June 2008), Web of Knowledge; Science Citation Index (searched 5 June 2008). We also searched web-based sources using the search engine Google.com. We approached the manufacturers of the most widely used ganglioside and researchers in this field to try to locate any unpublished data.
Randomised controlled trials of any ganglioside versus controls, in patients with SCI. Outcome measures specified were: mortality, recovery of motor function, improvement in sensory measures, measures of functional activity, infections and any other adverse events.
Data collection and analysis
Data were extracted from published studies and authors were contacted for further information. All data found was dichotomous and odds ratios (with 95% CIs) were calculated. A fixed-effects model was assumed.
Two studies met the inclusion criteria. There were no deaths in one (n=37). In the other (n=760), there were slightly more deaths in the treatment group than in the control group; odds ratio 1.07 (0.57, 2.00 95%CI) - a result that can be explained by the play of chance. Methodological weaknesses regarding the collection and presentation of data from the two studies made it impossible to reach any conclusions regarding the effect of gangliosides on the other specified outcomes.
The evidence available does not support the use of ganglioside treatment to reduce the death rate in SCI patients. No evidence has yet emerged that ganglioside treatment improves recovery or quality of life in survivors.
Plain language summary
No evidence that treatment with gangliosides reduces death rate or improves life for survivors after spinal cord injury
Injuries to the spinal cord are often devastating. Worldwide there are up to 40 million such injuries a year. People who survive often have severe disabilities. Gangliosides are substances that occur naturally in nerve cells. They can be manufactured and there have been studies to see whether they can be used to treat various conditions where nerves have been damaged. This review found two studies where a ganglioside had been used to treat people with spinal cord injury. The treatment did not produce a lower death rate and there was no evidence that movement, feeling or quality of life was improved for those who lived.
脊髓受傷(Spinal cord injury (SCI))會造成喪失感覺與行動能力。這種結果對於病患及其照護者具有破壞性。估計每年全球每百萬人口中有15至40名的新病例。急性SCI的主因為道路交通傷害，暴力，與持續運動及其他娛樂活動的傷害。SCI病人的照顧方法有改善使得存活率增加。使用廣泛的治療方法以試圖改善病患的感覺與行動能力。Gangliosides是細胞膜自然產生的化合物。實驗研究認為他們也許對於神經具有保護效果，甚至讓它們重新生長。在一些神經學的狀況下已使用gangliosides (通常為GM1 ganglioside)進行臨床試驗。
我們檢索以下的資料庫以確定納入的試驗：CENTRAL, MEDLINE, EMBASE, and the National Research Register。我們也檢索以網站為基礎的試驗資料庫，如 Current Controlled Trials。我們聯繫廣泛使用ganglioside的製造商與該領域的研究人員以嘗試尋找任何未發表的資料。
摘錄已發表研究的資料並連絡作者以了解進一步資訊。所有發現的資料為類別變項並計算odds ratios (與95% CIs)。假設固定效果模式。
兩篇研究符合納入標準。一篇研究發現沒有人死亡(n = 37)。另一篇研究(n = 760)指出治療組比對照組有較多的死亡人數；odds ratio為1.07 (95%CI為0.57，2.00)－結果也可以被解釋為是因為隨機造成的。資料蒐集與代表性的方法學缺點造成無法完成任何有關gangliosides對於其他特定結果的效果的結論。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。