The efficacy and safety of fingolimod plus standardized treatment versus standardized treatment alone for acute ischemic stroke: A systematic review and meta-analysis.

ABSTRACT

Acute ischemic stroke (AIS) is the most common type of stroke. Fingolimod is a sphingosine analog that acts on sphingosine-1-phosphate receptors (S1PR). Recently, the safety and efficacy of fingolimod in both patients with intracerebral hemorrhage and patients with AIS have been investigated in proof-of-concept trials. In this review, we performed a meta-analysis to evaluate the efficacy and safety of fingolimod for AIS. This study was conducted according to the PRISMA (Preferred Reporting Items for Systemic review and Meta-Analysis) statement. We searched for publications on the PubMed, Embase, Cochrane Central Register of Controlled Trials, Clinical trials, CNKI, Wanfang Data, VIP, CBM up to August 2021. We compiled five studies; a main meta-analysis forest plots were conducted for the values of the proportion of patients whose modified Rankin scale (MRS) score was 0-1 at day 90. There were heterogeneities in each study; the method of sensitivity analysis was performed. A sensitivity analysis was performed with a mean difference (MD) of the efficacy of fingolimod plus standardized treatment versus standardized treatment alone. Random effect model is used for meta-analysis regardless of the I2 index. The analysis was carried out for categorical variables using the risk ratio (RR), LogRR, and its 95% CI. The methodological quality of each randomized controlled trial (RCTs) was assessed according to the Cochrane Collaboration tool to assess the risk of bias (ROB). A meta-analysis of five studies with 228 participants was conducted. The risk ratio of patients whose MRS score was 0-1 at day 90 between fingolimod plus standardized treatment and standardized treatment alone was 2.59 (95%CI, 1.48-4.56). The Fingolimod plus standard treatment group decreased infarct growth and improved clinical function than the standard treatment.