Study On The Effect Of Honey-fried Astragalus And Leech On Acute Ischemic Stroke With Qi Deficiency And Blood Stasis After Intravenous Thrombolysis

Objective: To evaluate the clinical effect and safety of honey-fried Astragalus and Leech granules on patients who have acute ischemic stroke(AIS)with Qi deficiency and blood stasis syndrome after intravenous thrombolysis(IVT)by alteplase.Methods: From 2019.01.01 to 2020.09.31,in the Shandong University of Traditional Chinese Medicine Affiliated Hospital,Shandong University of Traditional Chinese Medicine No.2 Affiliated Hospital,and Penglai Traditional Chinese Medicine Hospital,the inpatients who had AIS and met the alteplase IVT criteria were selected in this clinical trial,finally 64 cases with Qi deficiency and blood syndrome were included.Then these patients were divided into two groups randomly,including the control group and the treatment group,with32 cases in each group.The control group received routine treatments such as IVT,lipid regulation,and collateral circulation drugs.And the treatment group took the honey-fried Astragalus and Leech granules orally based on the control group.The whole course of treatment was 14-day.We recorded the patients’ general information,blood test,blood biochemical items and other blood indicators.Additionally,the NIHSS,m RS and Barthel scores were evaluated and recorded before the IVT and at instant,24 hours,14 days,and 90 days after IVT respectively,and the TCM syndrome score were recorded before and after the whole treatment.Finally we analyzed the clinical data statistically,and recorded the incidence of adverse reactions within the 90 days.Results: There were 2 cases lost follow-up and removed,with 30 cases in the control group and 32 cases in the treatment group left.At 90 days after the IVT,the rate of neural function and recovery in the treatment group was better than that of the control group(P<0.01),and the TCM symptom recovery rate in the treatment group was also better than that of the control group.Compared with the control group,the NIHSS score was much lower in the treatment group at 14 days and 90 days after IVT(P<0.05),and it decreased with time significantly in both groups(P<0.01).The Barthel score was much higher in the treatment group at 14 days and 90 days after IVT(P<0.05),and it grown with time significantly in both groups(P<0.01).The m RS score was much lower in the treatment group at 90 days after IVT(P<0.05),and it decreased with time significantly in both groups(P<0.01),it was much lower in the treatment group at 14 days and 90 days after IVT(P<0.05),and the number of patients from 0-2 was more than that of the other group.TCM syndrome score was lower in both groups after using granule for 14 days(P<0.01),and the treatment group owns much lower score compared with the control group(P<0.01).During the entire observation process,there was no report of liver or kidney dysfunction,coagulation abnormalities or early neurological deterioration in the two groups.In the control group,and there were 1 case of gum bleeding and 1 case of re-infarction during the follow-up.Conclusion: Honey-fried Astragalus and Leech granules can assist alteplase IVT to improve the neural function,self-care ability,prognosis and TCM symptoms of AIS patients with Qi deficiency and blood stasis syndrome,and there was no safety difference of using this granule in this way.