摘要
BACKGROUND Brain tissue injury in stroke patients involves inflammation around the infarction lesion or hematoma,which is an important reason for disease deterioration and can result in a poor prognosis.The meta-analysis of animal experiments has concluded that fingolimod could treat stroke in animal models by effectively reducing lymphocyte infiltration.However,no evidence-based efficacy and safety evaluation of fingolimod in stroke patients is currently available.AIM To determine whether fingolimod could promote reduction of infarction lesion or hematoma and improve neurological prognosis in stroke patients.METHODS Data extracted for treatment effect included count of T-lymphocytes with cluster of differentiation 8 expression(CD8^(+)T cells,×106/mL),lesion volume(infarction or hematoma,mL),and modified Barthel indexes.Data extracted for safety was risk ratio(RR).Overall standard mean difference(SMD)with its 95%confidence interval(95%CI)and pooled effect with its 95%CI were calculated with a fixedeffects model.I-square(I^(2))was used to test the heterogeneity.Funnel plot symmetry and Egger's regression were used to evaluate publication bias.RESULTS Four high-quality randomized controlled trials were included.There was a significant difference in CD8^(+)T cell count(I^(2)=0,overall SMD=-3.59,95%CI:-4.37-2.80,P=0.737)and modified Barthel index(I^(2)=0,overall SMD=2.42,95%CI:1.63-3.21,P=0.290)between the fingolimod and control groups.However,there was no significant difference in lesion volume(I^(2)=10.6%,overall SMD=-0.17,95%CI:-0.75-0.42,P=0.917),fever(pooled RR=0.93,95%CI:0.97-2.32,P=0.864),suspected lung infection(pooled RR=0.90,95%CI:0.33-2.43,P=0.876),or any adverse events occurring at least once(pooled RR=0.82,95%CI:0.36-1.87,P=0.995)between the fingolimod and control groups.There was no publication bias.All of the results were stable as revealed by sensitivity analysis.CONCLUSION Fingolimod improves neurological function in stroke patients without promotion of lesion absorption.Taking fingolimod orally(0.5 mg/d,3 consecutive days)is safe except for patients with rare severe adverse events.
