| Objective: To evaluate the clinical efficacy and safety of Tiaoqi Tongmai Prescription No.1 combined with intravenous thrombolysis(IVT)in the treatment of acute ischemic stroke(AIS).Methods: Patients were recruited from the third Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine from October 2021 to October 2020.Using the random number table method,68 patients with AIS who met the inclusion criteria were divided into treatment group(34 cases)and control group(34 cases).Control group:according to the specification of IVT for AIS,alteplase was given 0.9mg/kg(the maximum dose was 90 mg),of which 10% of them were injected intravenously within 1 min at the initial stage,and the rest were continuously injected within 1 h.Pay close attention to the patient’s condition within 24 hours of medication,and regularly check blood pressure and nerve function.During the thrombolytic process,atorvastatin 40 mg was given to enhance lipid reduction.After 24 hours of thrombolysis,CT was used to rule out bleeding and aspirin or aspirin combined with plavil was used.Treatment group: On the basis of control group,thrombolysis was also given Tiaoqi Tongmai Prescription No.1 to treatment.Two groups of patients were treated with a course of 2 weeks.During the treatment period,observe the scores of the National Institutes of Health Stroke Scale(NIHSS)and the Modified Rankin Scale(m RS)of the two groups at each time point,and the Barthel index(BI)and TCM syndrome score before and after treatment were observed.At the same time,the safety was evaluated.Finally,the experimental data were statistically analyzed using SPSS26.0 and plotted using Prism.Results: No patients were dropped out during the observation.1.The comparison of the neurological outcome 90 days after thrombolysis between the two groups,the treatment group was better than the control group,the difference was statistically significant(P=0.021<0.05).2.The curative effect of the two groups was significantly higher in the treatment group than in the control group(P=0.003<0.01).(1)There was no significant difference in NIHSS scores between the two groups before thrombolysis(P=0.812>0.05).(2)There was no significant difference in NIHSS scores between the two groups at 24 hours after thrombolysis(P=0.054> 0.05).(3)The NIHSS scores of the treatment group were significantly better than those of the control group at 14 days after thrombolysis(P=0.000<0.05).(4)At 90 days after thrombolysis,NIHSS scores in the treatment group were significantly better than those in the control group(P=0.000<0.05).(5)The comparison between two groups showed that the NIHSS score of the two groups at each time point was better than that before thrombolysis(P<0.05).(6)At 90 days after thrombolysis,the 14 days NIHSS score was superior to that at 24 hours after thrombolysis(P<0.05).(7)The NIHSS score at 90 days after thrombolysis was better than that at 14 days after thrombolysis(P<0.05).4.The m RS scores of the two groups at each time node were decreased compared with the previous,and the difference was statistically significant(P<0.001).The m RS scores obtained before thrombolysis were compared with those obtained 24 hours after thrombolysis,14 days after thrombolysis,and 90 days after thrombolysis in both groups,and the m RS scores improved compared with those obtained before(P<0.05).The percentage of patients with good outcome at 90 days(proportion of patients with m RS of 0-2 points)was compared between the control and treatment groups(P=0.04<0.05).5.Barthel scores were not significantly different between the two groups before treatment(P=0.880>0.05).After treatment,the score of the treatment group was higher than that of the control group,and there was a significant difference in the Barthel score between the two groups(P=0.029<0.05).6.(1)There was no statistical difference between the two groups before treatment(P=0.591>0.05).After treatment,the score of TCM syndrome in the treatment group was significantly lower than that in the control group,and the difference was statistically significant(P=0.003<0.01).(2)Compare the main TCM symptoms of the two groups before and after treatment(except for stroke),there was no significant difference between the two groups before treatment(P>0.05).After treatment,there were significant differences in the symptoms of bad mouth,restlessness,constipation,and tongue coating pulse between the two groups(P<0.05),but there were no significant differences in nasal snoring sputum and abdominal distension symptoms(P>0.05).There were no liver and kidney work or coagulation abnormalities in both groups throughout the observation.In the control group,early neurological deterioration occurred in 2 patients,gingival bleeding in 3 patients,subcutaneous bleeding in 2 patients,and reinfarction(at day 47 after onset)in 1 patient,gingival bleeding in 2 patients in the treatment group,and hematuria in 1 patient.Conclusion: Tiaoqi Tongmai Prescription No.1 combined with alteplase intravenous thrombolysis is superior to alteplase intravenous thrombolysis alone.In addition,the safety of the application of the traditional Chinese medicine is better than that of alteplase alone,which may reduce the incidence of reperfusion,bleeding and re-infarction,and reduce the incidence of adverse events. |
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