ObjectiveTo systematically review the efficacy and safety of lumbrokinase capsule for patients with acute ischemic stroke (AIS).MethodsPubMed, EMbase, The Cochrane Library, CNKI, VIP, CBM and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on lumbrokinase capsule for patients with AIS from inception to 1st December, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 33 RCTs involving 4 751 patients were included. The results of meta-analysis indicated that compared with control group, lumbrokinase capsule could improve the treatment efficiency (RR=3.51, 95%CI 2.29 to 5.39, P<0.001), enhance neurological function (SMD=−0.55, 95%CI −0.72 to −0.38, P<0.001) and reduce fibrinogen after treatment (SMD=−0.93, 95%CI −1.41 to −0.44, P<0.001). Reported adverse reactions included dizziness, nausea and gastric discomfort, and no mortality was reported.ConclusionsCurrent evidence shows that lumbrokinase capsule can improve the neurological deficit in patients with AIS. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.