Ricci Stefano, Celani Maria Grazia, Cantisani Teresa Anna, Righetti Enrico
UO Neurologia, ASL 1 dell’ Umbria, Città di Castello, Italy.
Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD000419. doi: 10.1002/14651858.CD000419.pub3.
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 and 2009.
To assess the effects of piracetam in acute, presumed ischaemic stroke.
We searched the Cochrane Stroke Group Trials Register (last searched 15 May 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), MEDLINE (1966 to May 2011), EMBASE (1980 to May 2011), and ISI Science Citation Index (1981 to May 2011). We also contacted the manufacturer of piracetam to identify further published and unpublished studies.
Randomised trials comparing piracetam with control, with at least mortality reported and entry to the trial within three days of stroke onset.
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.
We included three trials involving 1002 patients, with one trial contributing 93% of the data. Participants' ages ranged from 40 to 85 years, 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, dependence 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 dependence.
吡拉西坦具有神经保护和抗血栓形成作用,可能有助于降低急性中风患者的死亡率和残疾率。这是Cochrane系统评价的更新版,该评价首次发表于1999年,此前于2006年和2009年进行过更新。
评估吡拉西坦对急性缺血性中风的疗效。
我们检索了Cochrane中风小组试验注册库(最后检索时间为2011年5月15日)、Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2011年第2期)、MEDLINE(1966年至2011年5月)、EMBASE(1980年至2011年5月)以及ISI科学引文索引(1981年至2011年5月)。我们还联系了吡拉西坦的制造商以确定更多已发表和未发表的研究。
将吡拉西坦与对照组进行比较的随机试验,至少报告了死亡率且在中风发作三天内纳入试验。
两位综述作者提取数据并评估试验质量,另外两位综述作者进行核查。我们联系研究作者获取缺失信息。
我们纳入了三项试验,共1002名患者,其中一项试验贡献了93%的数据。参与者年龄在40至85岁之间,男女比例均衡。吡拉西坦与1个月时死亡率的统计学上无显著增加相关(约增加31%,95%置信区间为增加81%至降低5%)。在对中风严重程度的不平衡进行校正后,这一趋势在大型试验中不再明显。有限的数据显示治疗组和对照组在功能结局、依赖程度或死亡或依赖患者比例方面无差异。未报告不良反应。
有一些迹象表明(但无统计学显著结果)吡拉西坦对早期死亡有不利影响,但这可能是由试验中中风严重程度的基线差异所致。没有足够证据评估吡拉西坦对依赖程度的影响。