| BackgroundIschemic stroke is a common cerebrovascular disorder that is usually caused by a decrease in blood supply to an area of the brain due to blockage of blood vessels.The clinical manifestations are motor function and sensory disorders,and in severe cases,consciousness is affected,and coma occurs.The recovery period(2 weeks to 6 months)is a stage of its occurrence and development,which is a critical period for the patient’s recovery and an important part of clinical treatment.Many patients still have residual dysfunction during the recovery period,which seriously affects daily life.Actively improving the treatment effect of ischemic stroke recovery is of great significance to improve the quality of life of patients and reduce the burden on families and society.In recent years,traditional Chinese medicine has shown good results in ischemic stroke during the recovery period.ObjectiveTo evaluate the effectiveness and safety of Huatuo Zaizao Pill in the treatment of motor function in patients recovering from ischemic stroke(sputum stasis obstruction),and to explore the theoretical basis of Huatuo Zaizao Pill in the treatment of ischemic stroke.MethodThis study is a prospective,randomized controlled trial study,and patients convalescent from ischemic stroke(sputum stasis)were included according to the inclusion criteria,and they were divided into experimental and control groups by random number table method.The experimental group was given Huatuo Zaizao Pill orally on the basis of basic treatment of Western medicine,and the control group was treated with basic treatment of Western medicine.The duration of the trial was 12 weeks.Subjects were visited at 0 weeks,6 weeks,and 12 weeks,and general conditions,important signs,and scale scores were recorded,and adverse reactions were monitored.This study was evaluated using the Neurological Deficit Rating Scale(NIHSS),the Basel Index of Daily Living(Barthel),the Modified Ashworth SPasticity Scale,the Fugl-Meyer Score,and the TCM Syndrome Score.The Primary efficacy indexes were the changes in the scores of NIHSS and Barthel after 12 weeks of treatment,and the secondary efficacy indexes were Fugl-Meyer motor function score,modified Ashworth spasticity scale,and stroke TCM syndrome grading score.SPSS 26.0 software was used to analyze the test data.Measurements that are continuous and normally distributed are described by mean ± standard deviation,and measurements and counts that do not conform to normal are described by median and quartile.P<0.05 was considered statistically significant for the difference tested.When comparing between groups,the data distribution is tested for normality.To follow the normal distribution,the two-independent sample T-test is used,and vice versa,the Mann-Whitney U test is used.When comparing within groups,the data distribution is tested for normality,the paired-sample t-test is used to follow the normal distribution,and the Mann-Whitney U test is used instead.The grade data is tested using 2.Multi-time data types,such as TCM syndrome score in the data measured three times in a row,using repeated measured ANOVA to compare the data trends of treatment group and control group.ResultsA total of 51 subjects were included in this study,including 25 in the experimental group and 26 in the control group.Statistical analysis was performed between the pretreatment test group and the control group,and there was good comparison between the two groups(P>0.05).The main efficacy indexes:NIHSS score:the effective rate of the experimental group was higher than that of the control group,and there was a statistical difference between the groups(P<0.05);Barthel:After 12 weeks of treatment,there was a difference between the exPerimental and control groups,and the difference was statistically significant(P<0.05),and the effect of the experimental group was better than that of the control group.Secondary efficacy indicators:(1)FMA score:comparison between groups:at 12 weeks,there was no significant difference between the experimental group and the control group(P>0.05);Intra-group comparison:After 6 weeks and 12 weeks of treatment,the FMA scores of the two groups were significantly higher than before,and the difference was statistically significant(P<0.05).(2)Modified Ashworth Spasticity Scale:between-group comparison:no statistically significant comparison between experimental group and control group at 12 weeks(P>0.05);Intra-group comparison:at 12 weeks,the difference between the experimental group and 0 weeks was statistically significant(P<0.05);at 12 weeks,the difference between the control group and 0 weeks was no statistically significant(P>0.05);(3)TCM syndrome score:After 6 weeks of treatment,the TCM syndrome of both groups improved,but there was no significant difference between the groups(P>0.05).After 12 weeks of treatment,there was a statistically significant difference between the two groups(P<0.05).The differences are mainly reflected in the crooked tongue,astringent sPeech,chest tightness,shortness of breath,strong limbs,and white and thick moss.Safety analysis:The incidence of adverse events between the two grous was similar,and no statistical difference was found(P>0.05).Conclusion(1)Huatuo Zaizao Pill is used for the treatment of patients recovering from ischemic stroke(sputum stasis obstruction),with precise efficacy and clinical application value.(2)Huatuo Zaizao Pill can promote the recovery of motor function in patients recovering from ischemic stroke(sputum stasis obstruction),and has a significant effect in improving the quality of life of patients and TCM syndrome.(3)Huatuo Zaizao Pill is relatively safe for the treatment of ischemic stroke. |
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