Efficacy And Safety Of Fasudil In Ischemic Stroke:a Systematic Review

Objective To assess the effectiveness and safety of fasudil for patients with ischemicstroke.Methods We searched The Cochrane Central Register of Controlled Trials(Issue 4,2011),Medline(1950 to November 2011),Embase（1980 to November 2011）,CBM（1978 to November2011）,CNKI（1979 to November 2011）,VIP（1989 to November 2011）,Wanfang Database（1982 to November 2011）by electronic database and relevant journals such as Chinese Journalof Neurology, Journal of Apoplexy and Nervous, Journal of Clinical Neurology etc.by manualsearching to collect all randomized controlled trials(RCT) of fasudil for patients with ischemicstroke.Two reviewers independently selected studies,assessed quality of studies and extracteddata according to the methods recommended by the Cochrane Handbook for Systematic Reviewsof Interventions.The RevMan 5.0 software was used for statistical analysis.Results Eighty-three studies involving 8102 patients were included,of which 3 wereplacebo-controlled,38 were negative controlled and 42 were positive controlled. The resultsshowed that:①Mortality: compared with the control group, mortality difference in fasudilgroups followed for 3 month had no statistical significance.②Disability: Meta analysis of 6studies using MRS score in the evaluation of disabilities improve efficiency, 17 studies using BIscore in the evaluation of activities of daily living , respectively suggested that fasudil cansignificantly improve patients with MRS and BI score, compared with the control group, and thedifference was statistically significant.③Neurologic deficits changes: Meta analysis of 57 studiesusing CSS score, 10 studies using NIHSS score, 10 studies using ESS score, 5 studies using SSSscore,1 study using by JSS score, according to the use of the scale respectively,suggested thatNeurological deficits improved of fasudil was better than the control group and the differencewas statistically significant, in addition to the 4 CSS score of negative case-control study, 3NIHSS score of positive control studies, 4 ESS score of positive control study did not reachstatistical significance.④Adverse events: Adverse events were reported in 57 studies. headache,dizziness, facial flushing, hypotension were the major adverse events of fasudil. Adverse eventsrates of fasudil were higher than the control group, but the extent of minor, adverse events didnot influence the treatment.⑤Quality of live was not assessed in any of the studies.Conclusion Fasudil can effectively improve the neurological function after ischemic stroke, reduce functional disability status, improve the patients’ activities of daily living and appears tobe safe. This included most of the quality is low,and there may be selection bias, measurementbias and performance bias, affecting the reliability of the conclusion. the methodological qualityof research needs to be further improved.We look forward to developing a large sample,multi-center, high quality randomized controlled trials (RCT) , long-term follow-up index,fully and standardize the reporting of adverse reactions, in order to obtain more reliablescientific evidence.