Intervention Review

Fibrinogen depleting agents for acute ischaemic stroke

  1. Ming Liu1,*,
  2. Carl Counsell2,
  3. Xiaoling Zhao1,
  4. Joanna M Wardlaw3

Editorial Group: Cochrane Stroke Group

Published Online: 21 JAN 2009

Assessed as up-to-date: 15 MAY 2003

DOI: 10.1002/14651858.CD000091

Database Title

Additional Information

How to Cite

Liu M, Counsell C, Zhao X, Wardlaw JM. Fibrinogen depleting agents for acute ischaemic stroke. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD000091. DOI: 10.1002/14651858.CD000091.

Author Information

  1. 1

    West China Hospital, Sichuan University, Department of Neurology, Chengdu, Sichuan Province, China

  2. 2

    University of Aberdeen, Department of Medicine & Therapeutics, Aberdeen, UK

  3. 3

    University of Edinburgh, Division of Clinical Neurosciences, Edinburgh, UK

*Ming Liu, Department of Neurology, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, Sichuan Province, 610041, China. wyplmh@hotmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 JAN 2009

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Abstract

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

Background

Fibrinogen depleting agents reduce fibrinogen in blood plasma, reduce blood viscosity and hence increase blood flow. This may help remove the blood clot blocking the artery and re-establish blood flow to the affected area of the brain after an ischaemic stroke. The risk of haemorrhage may be less than with thrombolytic agents.

Objectives

To assess the effect of fibrinogen depleting agents in patients with acute ischaemic stroke.

Search methods

We searched the Cochrane Stroke Group Trials Register (last searched May 2003). In addition we searched the following electronic databases: EMBASE (1980 to October 2001), China Biological Medicine Database (CBM-disc 1981 to December 2002), Chinese Stroke Trials Register (1996 to December 2002) and Index of Scientific and Technical Proceedings (Web of Science Proceedings 1990 to October 2001). We handsearched relevant journals and contacted Chinese and Japanese researchers and drug companies.

Selection criteria

Randomised and quasi-randomised trials of fibrinogen depleting agents started within 14 days of stroke onset, compared with control in patients with definite or possible ischaemic stroke.

Data collection and analysis

Two reviewers independently applied the inclusion criteria, assessed trial quality and extracted the data.

Main results

Five trials involving 2926 patients were included. A further trial has not yet been published in full. Four trials tested ancrod and one trial tested defibrase. Allocation concealment was adequate in four trials. Fibrinogen depleting agents moderately reduced the proportion of patients who were dead or disabled at the end of follow up (relative risk (RR) 0.90, 95% confidence Interval (CI) 0.82 to 0.98, 2P = 0.02). There was no statistically significant difference in death from all causes during the scheduled treatment period (RR 0.71, 95% CI 0.44 to 1.13) and at the end of follow up (RR 0.98, 95% CI 0.78 to 1.24). There was a non-significant excess of symptomatic intracranial haemorrhages with treatment (RR 2.64, 95% CI 0.96 to 7.30, 2P = 0.06).

Authors' conclusions

Fibrinogen depleting agents are promising. However more data, particularly ESTAT data, are needed before more reliable conclusions can be drawn.

 

Plain language summary

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

Fibrinogen depleting agents for acute ischaemic stroke

Fibrinogen depleting agents are promising but unproven for acute ischaemic stroke. Most strokes are due to a blood clot blocking an artery in the brain. Fibrinogen depleting agents may help remove the blood clot to restore the blood supply to the brain and so improve the chance of making a recovery from the stroke. Fibrinogen depleting agents also reduce blood thickness (or viscosity) which also helps to improve blood flow to the brain. However, these agents can also cause serious bleeding in the brain. The limited trial data available suggest that fibrinogen depleting agents may improve outcome after stroke. However, the data from a recently completed trial and an ongoing trial are not yet available. No firm conclusions about the balance of risk and benefit from the agents can be made until these data are included in the review.

 

摘要

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

背景

使用降纖維蛋白原製劑治療急性缺血性腦中風之研究

降纖維蛋白原製劑可降低血漿中的纖維蛋白原，減少血液的粘稠度進而增加血流的流暢。如此有助於移除附著於動脈壁上的血塊。並重建受缺血性腦中風影響的腦部區域之血流，且其出血的危險性小於血栓溶解劑。

目標

這篇研究的目標是評估使用降纖維蛋白原製劑治療急性缺血性腦中風的病人之成效

搜尋策略

我們搜尋了Cochrane Stroke Group Trials Register資料庫(最後搜尋至2003年5月)。我們還搜尋了以下的電子資料庫 MBASE (1980年到2001年10月)，China Biological Medicine Database(CBMdis 981年到2002年12月)，Chinese Stroke Trials Register(1996年到2002年12月)及Index of Scientific and Technical Proceedings(Web of Science Proceedings[1990年到2001年10月])。另外我們也以手工檢索相關的期刊及與相關的中國和日本的研究者及藥廠接觸

選擇標準

收集中風發生14日內使用降纖維蛋白原製劑的隨機及半隨機試驗，與真正或疑似缺血性中風的對照組比較

資料收集與分析

本文2位作者獨立使用納入標準作文獻取捨的判斷，評估試驗的品質及萃取資料

主要結論

我們收納了包含2926位病人的5個試驗，其中一個試驗(ESTAT)還未完全發表，有4個試驗是探討ancrod，而1份是探討defibrase。4個試驗有足夠的遮盲設計(allocation concealment)。在追蹤完成後發現使用降纖維蛋白原製劑可中度減少死亡及殘廢的比例(Relative risk [RR] 0.90, 95% Confidence Interval [CI] 0.82 to 0.98, 2P = 0.02)。使用降纖維蛋白原製劑與所有死亡原因並無統計顯著差異，無論是在約定治療期間(RR 0.71, 95% C .44 – 1.13)或追蹤完成後(RR 2.64, 95% CI 0.78 – 1.24)。在治療後，症狀性顱內出血的比例有增加但未達統計顯著意義(RR 2.64, 95% C .96 – 7.30, 2P = 0.06)。

作者結論

降纖維蛋白原製劑為一有前景的製劑，不過在有更可靠的結論提出之前，還需要更多的資料，尤其是ESTAT試驗結果予以佐證。

翻譯人

本摘要由奇美醫院林志遠翻譯。

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

總結

降纖維蛋白原製劑為一有前景，但還未有足夠證據證實用於急性缺血性中風之成效。大多數中風乃因腦部血管受血塊阻塞. 降纖維蛋白原製劑可幫助移除血塊，重新建立腦部血流供應，因此可增加中風復原的機會。降纖維蛋白原製劑也可減少血液的厚度(或粘稠度)，如此也可改善腦部的血流。然而這些降纖維蛋白原製劑卻可能會造成嚴重的腦部出血。只有有限的試驗結果顯示降纖維蛋白原製劑可改善中風後的結果。然而有一最近完成之試驗(ESTAT)及一正在進行之試驗尚無法取得。在這些試驗結果被納入之前，降纖維蛋白原製劑使用上之利弊尚無一確實的結論。

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