Efficacy And Safety Of Sequential Therapy With Butylphthalide Within 24h After Intravenous Thrombolysis In Patients With Cerebral Infarction And Meta Analysis

Objective: In Acute Cerebral Infarction(ACI),the ischemic area is composed of the central necrosis area and the ISCHEMIC Penumbra.evidence-based medicine has proved that ultra-early thrombolytic therapy has a definite effect on saving the nerve cells in the ISCHEMIC Penumbra.The aim of this study was to evaluate the clinical efficacy and safety of butylphthalide injection in sequential therapy for ischemic stroke within 24 hours after intravenous thrombolysis.In addition,the effect of butylphthalide injection combined with alteplase intravenous thrombolysis on neurological function and safety in patients with acute cerebral infarction was systematically evaluated by meta-analysis.Methods:1.The subjects were divided into thrombolytic therapy group and butylphthalide sequential therapy group with 100 stroke patients who met inclusion and exclusion criteria.Butylphthalide injection was applied within 24 hours after thrombolysis for 14 days and followed up for 90 days.Nihss scores before treatment,1,3,7,14 days after treatment,Mrs and Bl scores before treatment,30 days after treatment and 90 days after treatment were observed.2.Search PubMed,Embase,Ovids,CNKI,Wanfang,and wip databases by computer,a clinical controlled trial(RCT)of intravenous thrombolytic therapy with alteplase combined with butylphthalide injection in the treatment of acute cerebral infarction.The literature quality was evaluated by the Case-control study of the NOS Scale(Newcastle-Ottawa Scale).The key data included NIHSS score,Mrs Score and Barthel Index.Meta-statistical analysis using RevMan 5.3 software.Results:1.There was no significant difference between the two groups before Treatment(P>0.05).2.Compared with thrombolytic therapy group,the NIHSS score of butylphthalide sequential therapy group decreased slightly at 1 and 3 days after treatment,but there was no significant difference(P>0.05).The NIHSS scores of patients in butylphthalide sequential therapy group were significantly better than those in thrombolytic therapy group at 7 and 14 days after Treatment(P<0.05).3.Compared with thrombolytic therapy group,the effective rate of sequential treatment group was significantly higher than that of thrombolytic therapy group(P<0.05).4.After treatment,mRS Scores(30 days)and Bl scores(30 days)of the two groups were compared.The scores of patients in the butylphthalide sequential therapy group were improved more than those in the thrombolytic therapy group,but there was no significant difference(P>0.05).After treatment,mRS Score(90 days)and Bl score(90 days)were significantly better than that of thrombolytic therapy(P<0.05).5.There was no significant difference in the incidence of adverse events between the two groups(P>0.05).6.Meta analysis results:(1)Fifteen studies(1326 participants)evaluated the improvement of neurological deficits in patients with NIHSS,the analysis showed that the mean difference of NHISS score between the experimental group(rt-PA intravenous thrombolytic therapy combined with butylphthalide injection)and the control group((rt-PA intravenous thrombolytic therapy)after 14 days of acute cerebral infarction was combined(P<0.00001,MD-2.27,95% CI[-2.60,-1.94]),the differences were statistically significant.(2)Six studies(562 patients)used Barthel index to evaluate the improvement of daily living ability.The analysis showed that the mean difference of Barthel index between the experimental group and the Control Group after 14 days of treatment of acute cerebral infarction was combined(P< 0.00001,MD 11.21,95% CI[ 8.85,13.56]),the differences were statistically significant.(3)The incidence of adverse events was reported in 6 studies(655 patients).The analysis showed that there was no significant difference between the experimental group and the Control Group(P=0.09,OR 0.69,95% CI[0.44,1.07]).Conclusions:1.The sequential treatment of butylphthalide was better than that of thrombolytic therapy in the improvement of neurological function defect and daily life ability in patients,indicating that sequential treatment of butylphthalide was more effective and could better alleviate neurological function defect and improve prognosis in patients with cerebral infarction.2.The sequential application of butylphthalide injection after thrombolysis is safe.3.The results of a meta-analysis showed that patients with acute cerebral infarction treated with intravenous thrombolytic therapy of alteplase combined with butylphthalide injection had a better recovery of neurological function than patients treated with intravenous thrombolytic therapy of alteplase,the ability of daily living improved significantly,and the incidence of adverse reactions did not increase significantly.