Objective: To evaluate the efficacy and safety of Huatan Tongluo Decoction by comparing the changes of TCM score,National Institutes of Health Stroke Scale(NIHSS)and thromboelastography before and after treatment in patients with acute ischemic stroke of wind-phlegm and blood stasis type.METHODS: Patients with acute ischemic stroke of wind-phlegm and blood stasis type who visited the Encephalopathy Ward of Xiamen Hospital of Traditional Chinese Medicine from January 2021 to December 2021 and met the criteria of this study were selected.A total of 88 subjects who met the access criteria were included in the study by randomized controlled method and randomly divided into observation group(n =44)and control group(n = 44).Among them,the observation group was given Huatan Tongluo Decoction with conventional medical treatment,and the control group was given conventional medical treatment,with a treatment cycle of 2 weeks.The efficacy and safety of Huatan Tongluo Decoction were evaluated by observing and comparing the changes of TCM score,NIHSS score and thromboelastogram before and after treatment in patients with acute ischemic stroke between the two groups,combined with blood routine,liver function,renal function,coagulation function and electrocardiogram as safety indicators.Results:1.A total of 88 eligible subjects were included in this study,82 of whom completed clinical observation.6 cases dropped out,4 cases in the observation group and 2 cases in the control group.The overall drop rate was 6.8%2.There was no significant difference in sex,age,stroke risk factors,laboratory examination index,NIHSS score,TCM score and distribution of main symptoms between the two groups before treatment(P>0.05).3.TCM score:(1)On the 7th day of treatment,the TCM score of the two groups were significantly lower than that before treatment(P<0.01).The decrease of TCM score in the observation group was not better than that in the control group,and there was no statistical difference between the two groups(P>0.05).(2)On the 14 th day of treatment,the TCM scores of the two groups were significantly lower than those before treatment(P<0.01).The decrease of TCM score in the observation group was better than that in the control group,and there was significant difference between the two groups(P<0.05).In terms of individual symptoms,after 14 days of treatment,,there were significant differences between the observation group and the control group in the treatment of numbness,hemiplegia and speech astringency(P<0.01).4.NIHSS score:(1)On the 7th day of treatment,NIHSS score in both groups was significantly lower than that before treatment(P <0.01).The reduction of NIHSS score in the observation group was better than that in the control group,and there was significant difference between the two groups(P<0.05).(2)After 14 days of treatment,the NIHSS score of the two groups was significantly lower than that before treatment(P<0.01).The decrease of NIHSS score in the observation group was also higher than that in the control group,and the difference between the two groups was significant(P<0.05).5.Changes of thromboelastography: There was no significant difference in thromboelastography before treatment between the two groups(P>0.05),while in the comparison between the two groups after two weeks of treatment,the change of αangle in the control group was statistically significant(P<0.05),and there was no significant difference in the other items(R,K,MA,CI,LY30)before and after treatment(P> 0.05).6.Safety analysis: Before and after treatment,no significant abnormal changes were observed in liver and kidney function,coagulation function,blood lipid and other related examinations in the two groups,and no abnormal changes were observed in ECG examination.There was no significant difference between the two groups(P>0.05).Conclusion:1.Huatan Tongluo Decoction can improve the TCM syndrome score and NHISS score of patients with acute ischemic stroke with rheumatic sputum stasis,and in terms of improving the clinical symptoms of TCM,the effect of limb numbness,hemiplegia and speech astringency is remarkable.2.Huatan Tongluo Decoction has a certain effect on improving the α angle of thrombelastography in patients.3.No obvious adverse reactions were found during the treatment of Huatan Tongluo Decoction,with good safety. |