| Objective To assess the safety and efficacy of fasudil for patients with vasospasm after subarachnoid hemorrhage.Methods We searched The Cochrane Library (Issue 4,2010), Medline (1950 to 2010), Embase (1980 to 2010), CBMdisc (1978 to 2010), CNKI (1979 to 2010), VIP (1989 to 2010), Wan fang Database (1978 to 2010), CMCA (1994 to 2010) by electronic database and relevant journals such as Chinese Journal of Neurology, Journal of Clinical Neurology, Journal of Apoplexy and Nervous Diseases, Chinese Journal of Neuroimmunology and Neurology, Chinese Journal of Clinical Neurosciences etc. by manual searching to collect all randomized controlled trials (RCTs ) and quasi-randomized controlled trials (quasi- RCTs ) of fasudil for patients with vasospasm after subarachnoid hemorrhage. The quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions and data were extracted by two reviewers independently. We made funnel plot analysis, quantitative comprehensive analysis (meta-analysis), qualitative comprehensive analysis for the study results.In the quantitative comprehensive evaluation, fixed or random potency model was chosen according to the heterogeneity between the studies.Meta analysis was conducted by The Cochrane Collaboration's RevMan 5.0 software. Estimated the comprehensive evaluation index by 95% confidence interval, and made a =0.05 for the size of test.Results Twenty-six studies involving 1762 SAH patients were included. The results of Meta-analysis showed that: (1) The incidence of CVS in the FSD group was lower than that in the control group (RR=0.66, 95%CI 0.52 to 0.82, P=0.0003); (2) The incidence of mortality in the FSD group was lower than that in the control group (RR=0.58, 95%CI 0.35 to 0.96, P=0.03); (3) The relieved degree from the average flow velocity with cerebral middle cerebral artery (MCA) in FSD group was more obvious than control group (WMD=-2.90, 95%CI -5.53 to -0.26, P=0.03). (4) The incidence of low-area on computed tomography (CT) in the FSD group was lower than that in the control group (RR=0.67, 95%CI 0.52 to 0.86, P=0.002). (5) The total effective rate:â—‹1 Measured by 14 day Chinese scale for clinical neurological deficit: The total effective rate in FSD group was higher than that in the control group, but did not reach statistical significance (RR=1.12, 95%CI 0.98 to 1.28, P=0.09);â—‹2 Measured by Standard of curative effect: The total effective rate in FSD group was higher than that in the control group, but did not reach statistical significance (RR=1.19, 95%CI 0.98 to 1.43, P=0.08). (6) Safety evaluation: Adverse reactions mainly include headache,fever,cardiopalmus,flushing of the face,hypotension.â—‹1 Headache: The incidence of headache in two groups had no statistically significant (RR=0.68, 95%CI 0.31 to 1.48, P=0.33);â—‹2 Fever: The incidence of fever in two groups had no statistical significance (RR=0.82, 95%CI 0.24 to 2.78, P=0.75);â—‹3 Cardiopalmus: The incidence of cardiopalmus in the FSD group was lower than that in the control group (RR=0.34, 95%CI 0.13 to 0.91, P=0.03);â—‹4 Flushing of the face: The incidence of flushing of the face in two groups had no statistical significance (RR=0.61, 95%CI 0.25 to 1.49, P=0.28);â—‹5 Hypotension: The incidence of hypotension in two groups had no statistical significance (RR=0.80, 95%CI 0.29 to 2.17, P=0.66).Conclusion FSD shows an effective reduction in the incidence of CVS, mortality, it can relieve average flow velocity with MCA and reduce the incidence of low-area on CT, it shows a good total effectiveness. The adverse reactions mainly include headache,fever,cardiopalmus,flushing of the face,hypotension. Among them, the incidence of cardiopalmus is lower than control group, others have no statistically significant, so it has better safety. As the evidence obtained is not strong enough owing to the sample size is smaller and the average quality is lower, so the above conclusions still need high quality of randomized controlled trials to confirm.
|
PDF Full Text Request