The Clinical Efficacy Observation Of Huatan Jieyu Prescription In Treating Post-stroke Depression With Liver Depression And Phlegm Stagnation Type

Objective:Evaluate the effectiveness and safety of Huatan Jieyu Prescription in treating post-stroke depression with liver depression and phlegm stagnation type by observing the changes of TCM Syndrome score,Hamilton Depression scale(HAMD-24)score,National Institutes of Health Stroke scale(NIHSS),Barthel Index(BI)rating scale,and laboratory examination index of patients.Methods:A randomized controlled method was used in this research.A total of 84 PSD patients who met the inclusion criteria were randomly divided into observation group and control group(42 each case).Both groups received individualized treatment and rehabilitation training for anti-platelet aggregation,blood pressure reduction,lipid-lowering,and hypoglycemic treatment.On this basis,the control group was treated with western medicine“sertraline hydrochloride”,and the observation group was treated with “sertraline hydrochloride” combined with traditional Chinese medicine “Huatan Jieyu Prescription”.The course of treatment was 8 weeks.The changes of HAMD,BI,NIHSS and TCM syndrome scores were observed in the two groups of PSD patients before and after treatment.At the same time,liver function,renal function,blood coagulation function and electrocardiogram examination were taken as safety observation indexes to evaluate the efficacy and safety of“Huatan Jieyu Prescription”.Results:1.A total of 84 patients were included in this clinical study,77 patients completed clinical observation,4 patients in the observation group and 3 patients in the control group,the total shedding rate was 8.33%.2.There was no significant difference in gender,age,blood pressure,basic diseases,focus distribution,laboratory indexes,TCM syndrome score HAMD score,NIHSS score,and BI score between the two groups before treatment(P>0.05).3.Total clinical efficacy: After treatment,the total efficiency was 92.11% in the observation group and 79.49% in the control group,and there was significant difference between the two groups(P<0.05).4.TCM symptom score:(1)After 4 weeks of treatment,the TCM symptom scores in both groups were lower than those before treatment(P<0.05).and the difference between the two groups was statistically significant(P<0.05),and the efficacy of the observation group was better than that of the control group.(2)After 8 weeks of treatment,the scores of TCM symptoms in the two groups were lower than that before treatment(P<0.05),and the efficacy of the observation group was better than that of the control group(P<0.05).5.HAMD score:(1)After 4 weeks of treatment,HAMD scores in both groups were lower than those before treatment(P<0.05).and the difference between the two groups was statistically significant(P<0.05),and the efficacy of the observation group was better than that of the control group.(2)After 8 weeks of treatment,the scores of HAMD in the two groups were lower than that before treatment(P<0.05),and the efficacy of the observation group was better than that of the control group(P<0.05).6.NIHSS score:(1)After 4 weeks of treatment,NIHSS scores in both groups were lower than those before treatment(P<0.05).However,there was no significant difference in the degree of reduction of NIHSS scores between the groups(P> 0.05).(2)After 8 weeks of treatment,the scores of NIHSS in the two groups were lower than that before treatment(P<0.05),and there was significant difference in the degree of reduction of NIHSS scores between the groups(P<0.05).7.BI score:(1)After 4 weeks of treatment,BI scores in both groups were higher than those before treatment(P<0.05).However,there was no significant difference in the degree of increase of BI scores between the groups(P>0.05).(2)After 8 weeks of treatment,the scores of NIHSS in the two groups were higher than that before treatment(P<0.05),and there was significant difference in the degree of increase of BI scores between the groups(P<0.05).8.Safety analysis: During the whole process of observation,in the first week of treatment,there were 2 cases of dizziness and 1 case of diarrhea in the observation group,3cases of xerostomia and 2 cases of nausea in the control group.The clinical symptoms were mild,without any treatment,and disappeared after 2 weeks,which was considered as the known adverse reaction of sertraline hydrochloride.The above 8 subjects continued to complete the clinical observation.There was no significant difference in the rate of adverse reactions between the two groups(P>0.05).There was no significant difference in liver and kidney function,blood coagulation and other indexes between the two groups before treatment(P>0.05),and electrocardiogram examination showed no change of clinical value.The blood lipid value of the two groups after treatment was significantly lower than that before treatment(P<0.05),but there was no significant difference in the same period after treatment(P>0.05).Conclusion:1.Huatan Jieyu Prescription combined with sertraline hydrochloride is effective in the treatment of post-stroke depression of liver depression and phlegm stagnation.It has more advantages in reducing TCM syndrome score,HAMD score,NIHSS score and BI score than sertraline hydrochloride alone,and can better improve the symptoms of "chest distension,good breathing,epigastric distension,frequent belching and dizziness".2.No obvious adverse reactions were found during the treatment of Huatan Jieyu Prescription,which demonstrated its safety.