Intervention Review

Piracetam for acute ischaemic stroke

  1. Stefano Ricci1,*,
  2. Maria Grazia Celani2,
  3. Teresa Anna Cantisani3,
  4. Enrico Righetti2

Editorial Group: Cochrane Stroke Group

Published Online: 8 JUL 2009

Assessed as up-to-date: 23 OCT 2008

DOI: 10.1002/14651858.CD000419.pub2

Database Title

Additional Information

How to Cite

Ricci S, Celani MG, Cantisani TA, Righetti E. Piracetam for acute ischaemic stroke. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD000419. DOI: 10.1002/14651858.CD000419.pub2.

Author Information

  1. 1

    ASL 1 dell' Umbria, UO Neurologia, Città di Castello, Italy

  2. 2

    Ospedale di Città della Pieve, A USL 2 dell'Umbria, Città della Pieve, Italy

  3. 3

    Azienda Ospedaliera Perugia, Neurofisiopatologia, Perugia, UMBRIA, Italy

*Stefano Ricci, UO Neurologia, ASL 1 dell' Umbria, Ospedale, Via Engels, Città di Castello, 06012, Italy. istitaly@unipg.it.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 8 JUL 2009

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Abstract

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

Background

Piracetam has neuroprotective and antithrombotic effects that may help to reduce death and disability in people with acute stroke. This is an update of a Cochrane Review first published in 1999, and previously updated in 2006.

Objectives

To assess the effects of piracetam in acute, presumed ischaemic stroke.

Search methods

We searched the Cochrane Stroke Group Trials Register (last searched 24 October 2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2008), MEDLINE (1966 to October 2008), EMBASE (1980 to October 2008), and ISI Science Citation Index (1981 to October 2008). We also contacted the manufacturer of piracetam to identify further published and unpublished studies.

Selection criteria

Randomised trials comparing piracetam with control, with at least mortality reported and entry to the trial within approximately 48 hours of stroke onset.

Data collection and analysis

Two review authors extracted data and assessed trial quality and this was checked by the other two review authors. We contacted study authors for missing information.

Main results

We included three trials involving 1002 patients, with one trial contributing 93% of the data. Participants' ages ranged from 40 to 85, and both sexes were equally represented. Piracetam was associated with a statistically non-significant increase in death at one month (approximately 31% increase, 95% confidence interval 81% increase to 5% reduction). This trend was no longer apparent in the large trial after correction for imbalance in stroke severity. Limited data showed no difference between the treatment and control groups for functional outcome, dependency or proportion of patients dead or dependent. Adverse effects were not reported.

Authors' conclusions

There is some suggestion (but no statistically significant result) of an unfavourable effect of piracetam on early death, but this may have been caused by baseline differences in stroke severity in the trials. There is not enough evidence to assess the effect of piracetam on dependency.

 

Plain language summary

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

Piracetam for acute ischaemic stroke

Ischaemic stroke is the third leading cause of death in developed countries, and the first leading cause of long-term disability in survivors. Piracetam is a drug which has been marketed by drug companies in several countries for many years as a 'nootropic' agent: a drug which has metabolic activity in the human brain. The efficacy and safety of piracetam in patients with acute stroke have not yet been proven. Experiments in animals suggest that piracetam could have beneficial effects in patients with acute stroke. There have been a number of randomised controlled trials of piracetam given to patients within 48 hours of the onset of their stroke. Data from three trials, involving 1002 patients, were available for this review, but almost all came from a single study. The data reviewed did not provide conclusive evidence about the effects of piracetam for acute stroke. One additional, large study has been conducted and interrupted by the manufacturer after some preliminary analyses were carried out, but the results have not been made available to the scientific community.

 

摘要

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

背景

Piracetam 對急性缺血性中風的治療效果

Piracetam 有神經保護作用及抗血栓凝集作用. 可能對減少急性中風患者的死亡及殘障率有幫助.

目標

本文是評估piracetam 用於急性缺血性中風的效果

搜尋策略

作者由2005年6月20日以前的Cochrane Stroke Group Trials Register 搜尋資料. 另外也同時搜尋 Cochrane Central Register of Controlled Trials(The Cochrane Library Issue 2,2005年), MEDLINE (1966 到2005年4月), EMBASE (1980到 2005年4月), 及 ISI Science Citation Index (1981到2005年4月). 我們也和piracetam的藥廠接觸,來確認是否有更進一步已發表或未發表的研究.

選擇標準

隨機試驗，比較piracetam 與安慰劑治療中風發作48小時內的病人，並至少有報告死亡率

資料收集與分析

有兩名作者來摘錄資料及評估實驗資料的品質. 另外有兩名作者再次檢驗資料. 聯絡研究作者詢問缺失的資料.

主要結論

有三個試驗共包含了1002名病患，其中一個試驗人數佔了93％). 參與實驗病患年齡在40到85歲之間,男女各佔一半. Piracetamc會增加一個月內死亡率,但無統計學上意義(31% 增加, 95%信賴區間為81%增加到5%減少). 在這個大型的實驗中,就算經過校正中風嚴重度,死亡率的增加的趨勢也不明顯. 以目前有限的資料,治療組跟對照組在肢體功能,殘障,及死亡或殘障的比例,這幾個方面比較並無顯著差異. 藥物副作用並無實驗報告.

作者結論

在使用piracetam可能會增加早期的死亡,但是這個結論無統計學上的意義. 這可能是試驗中病人中風嚴重度不同所導致. 沒有足夠證據來評估piracetam對依賴程度的效果.

翻譯人

本摘要由奇美醫院張峻賓翻譯。

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

總結

piracetam 在急性中風病患的效果及安全性仍未證實. 動物實驗暗示piracetam可能對急性中風的病人有好處. 有一些使用piracetam治療發生中風48小時內病人的隨機對照試驗. 我們收集到1000多個病人資料. 這1000多個病人幾乎都由同一的試驗而來. 所以piracetam 在急性中風病患的效果並無決定性的證據. 另外有一個大型試驗在做過一些初步分析就由藥廠停止了,其結果並沒有發表.

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