Bereczki D, Fekete I, Prado G F, Liu M
University of Debrecen, Department of Neurology, Nagyerdei krt. 98, Debrecen, Hungary, H-4012.
Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD001153. doi: 10.1002/14651858.CD001153.pub2.
Mannitol is an osmotic agent and a free radical scavenger which might decrease oedema and tissue damage in stroke.
To test whether treatment with mannitol reduces short and long-term case fatality and dependency after acute ischaemic stroke or intracerebral haemorrhage (ICH).
We searched the Cochrane Stroke Group Trials Register (searched December 2006), MEDLINE (1966 to January 2007), the Chinese Stroke Trials Register (searched November 2006), the China Biological Medicine Database (searched December 2006) and the Latin-American database LILACS (1982 to December 2006). We also searched the database of Masters and PhD degree theses at Sao Paulo University (searched January 2007), and neurology and neurosurgery conference proceedings in Brazil from 1965 to 2006. In an effort to identify further published, ongoing and unpublished studies we searched reference lists and contacted authors of published trials.
We included randomised controlled trials comparing mannitol with placebo or open control in patients with acute ischaemic stroke or non-traumatic intracerebral haemorrhage.
Two review authors independently selected trials, assessed quality, extracted data, and performed the data analysis.
Three small trials, involving 226 participants, were included. One trial included patients with presumed ischaemic stroke without computerised tomography (CT) verification, and the other two trials included patients with CT-verified ICH. Data on the primary outcome measure (death and dependency) were not available in any of the trials. Death and disability could be calculated in the larger ICH trial without differences between the mannitol and control groups. Case fatality was not reported in the trial of ischaemic stroke. Case fatality did not differ between the mannitol and control groups in the ICH trials. Adverse events were either not found or not reported. The change in clinical condition was reported in two trials, and the proportion of those with worsening or not improving condition did not differ significantly between mannitol-treated patients and controls. Based on these three trials neither beneficial nor harmful effects of mannitol could be proved. Although no statistically significant differences were found between the mannitol-treated and control groups, the confidence intervals for the treatment effect estimates were wide and included both clinically significant benefits and clinically significant harms as possibilities.
AUTHORS' CONCLUSIONS: There is currently not enough evidence to support the routine use of mannitol in acute stroke patients. Further trials are needed to confirm or refute whether mannitol is beneficial in acute stroke.
甘露醇是一种渗透性药物和自由基清除剂,可能会减轻中风时的水肿和组织损伤。
测试甘露醇治疗能否降低急性缺血性中风或脑出血(ICH)后的短期和长期病死率及致残率。
我们检索了Cochrane中风组试验注册库(2006年12月检索)、MEDLINE(1966年至2007年1月)、中国中风试验注册库(2006年11月检索)、中国生物医学数据库(2006年12月检索)以及拉丁美洲数据库LILACS(1982年至2006年12月)。我们还检索了圣保罗大学硕士和博士学位论文数据库(2007年1月检索),以及1965年至2006年巴西神经病学和神经外科学术会议论文集。为了识别更多已发表、正在进行和未发表的研究,我们检索了参考文献列表并联系了已发表试验的作者。
我们纳入了比较甘露醇与安慰剂或开放对照治疗急性缺血性中风或非创伤性脑出血患者的随机对照试验。
两位综述作者独立选择试验、评估质量、提取数据并进行数据分析。
纳入了三项小型试验,共226名参与者。一项试验纳入了未经计算机断层扫描(CT)证实的疑似缺血性中风患者,另外两项试验纳入了经CT证实的ICH患者。所有试验均未提供关于主要结局指标(死亡和致残)的数据。在规模较大的ICH试验中可以计算死亡和残疾情况,甘露醇组与对照组之间无差异。缺血性中风试验未报告病死率。ICH试验中甘露醇组与对照组的病死率无差异。未发现或未报告不良事件。两项试验报告了临床状况的变化,甘露醇治疗患者与对照组中病情恶化或未改善的比例无显著差异。基于这三项试验,无法证明甘露醇有益或有害。虽然甘露醇治疗组与对照组之间未发现统计学上的显著差异,但治疗效果估计值的置信区间很宽,包括临床上显著有益和临床上显著有害两种可能性。
目前没有足够的证据支持在急性中风患者中常规使用甘露醇。需要进一步的试验来证实或反驳甘露醇对急性中风是否有益。