Bereczki D, Liu M, do Prado G F, Fekete I
Department of Neurology, University of Debrecen, Health Science and Medical Center, Nagyerdei krt. 98., Debrecen, Hungary, H-4012.
Cochrane Database Syst Rev. 2001(1):CD001153. doi: 10.1002/14651858.CD001153.
Mannitol is an osmotic agent and a free radical scavenger so it 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 cerebral parenchymal haemorrhage.
We searched the Cochrane Stroke Group Specialised Trials Register. In addition to this, supplementary MEDLINE searches were performed. The Chinese Stroke Trials Register was checked and the Latin-American databank LILACS was searched with the search term MANNITOL and its variations in the Portuguese and Spanish languages. A search was performed of Masters and Ph.D. degree theses in the databank of Sao Paulo University, and in abstracts of medical congresses on neurology and neurosurgery from 1965 to 1997 in Brazil.
Truly randomised unconfounded clinical trials comparing the effect of mannitol with placebo or open control in patients with acute ischaemic stroke or parenchymal haemorrhage were eligible for inclusion.
Two reviewers independently selected the trials to be included in the review. After reaching an agreement on which trials to include, two of the reviewers extracted data from the trials and performed the data analysis. Accuracy of data extraction was checked by comparing the results. Included trials were tabulated for methodological quality including the method of randomisation and blinding, and stating if CT was performed, if patients were lost to follow-up and if intention-to-treat analysis was performed. Data synthesis and analysis was performed using the Cochrane Review Manager software.
Only one trial fulfilled the inclusion criteria. The number of included patients was small (36 treated and 41 controls) and the follow up was short. Neither beneficial nor harmful effects of mannitol could be proved. Case fatality, the proportion of dependent patients at the end of the follow up and side effects were not reported and were not available from the investigators. The planned outcome analyses and sensitivity analyses could not be performed due to lack of appropriate trials.
REVIEWER'S CONCLUSIONS: There is currently not enough evidence to decide whether the routine use of mannitol in acute stroke would result in any beneficial or harmful effect. The routine use of mannitol in all patients with acute stroke is not supported by any evidence from randomised controlled clinical trials. Further trials are needed to confirm or refute the routine use of mannitol in acute stroke.
甘露醇是一种渗透性药物和自由基清除剂，因此它可能会减轻中风时的水肿和组织损伤。
检验甘露醇治疗能否降低急性缺血性中风或脑实质出血后的短期和长期病死率及致残率。
我们检索了Cochrane中风小组专业试验注册库。除此之外，还进行了MEDLINE补充检索。检索了中国中风试验注册库，并使用搜索词“甘露醇”及其葡萄牙语和西班牙语变体在拉丁美洲数据库LILACS中进行了检索。在圣保罗大学数据库中检索了硕士和博士学位论文，并在1965年至1997年巴西神经病学和神经外科学术会议摘要中进行了检索。
真正随机且无混杂因素的临床试验，比较甘露醇与安慰剂或开放对照对急性缺血性中风或实质出血患者的疗效，符合纳入标准。
两名评价员独立选择纳入综述的试验。在就纳入哪些试验达成一致后，两名评价员从试验中提取数据并进行数据分析。通过比较结果来检查数据提取的准确性。将纳入试验列表列出，以说明方法学质量，包括随机化和盲法的方法，并说明是否进行了CT检查、患者是否失访以及是否进行了意向性分析。使用Cochrane综述管理器软件进行数据合成和分析。
只有一项试验符合纳入标准。纳入患者数量较少（36例治疗组和41例对照组）且随访时间较短。无法证明甘露醇有有益或有害作用。未报告病死率、随访结束时致残患者比例及副作用，研究者处也未获取相关信息。由于缺乏合适的试验，无法进行计划的结局分析和敏感性分析。
目前没有足够证据来确定急性中风常规使用甘露醇是否会产生有益或有害影响。随机对照临床试验的任何证据均不支持对所有急性中风患者常规使用甘露醇。需要进一步试验来证实或反驳急性中风常规使用甘露醇的做法。
