| Objective To observe the clinical efficacy and safety of Dachaihu Decoction combined with Guizhi Fuling Pill in the Treatment of post-stroke depression with qiyuhuahuo type,so as to provide an objective basis for clinical application and a solid foundation for the tandardization and modernization of traditional prescriptions.Methods A total of 78 patients with PSD who met the inclusion criteria were randomly divided into two groups:treatment group(n=39)and control group(n=39).The control group was given basic treatment for stroke,including anti-platelet,lipid regulating,blood pressure lowering,risk factors control,and oral sertraline tablets 50mg qd;On the basis of the control group,the treatment group was given Dachaihu decoction combined with Guizhi Fuling pill granule for 4 weeks.Before and after treatment,the TCM syndrome efficacy evaluation,NIHSS score,health status survey short form(SF-36),Hamilton Depression Scale were observed(HAMD-24).Serum levels of 5-HT,NE and BDNF were measured.Liver and kidney function,blood routine and electrocardiogram were measured.The differences in these indexes between the two groups after treatment were compared,and the clinical efficacy and safety of Dachaihu decoction combined with Guizhi Fuling pill were evaluated.Results l.A total of 78 patients were included in this study,of which 73 patients completed clinical observation,2 cases fell off in the treatment group and 3 cases in the control group,with a total rate of 6.41%.2.Comparison of TCM syndrome score and efficacy:After 4 weeks of treatment,the TCM syndrome score of the treatment group was 8.16±4.83,and that of the control group was 11.67±6.23,and the difference between the two groups was statistically significant(P<0.05).The total effective rate of the treatment group was 91.89%,which was better than that of the control group(72.22%),and the difference was statistically significant(P<0.05).3.HAMD scale score and efficacy comparison:After 4 weeks of treatment,the HAMD scale score of the treatment group was 7.76±3.85,and that of the control group was 9.69±4.19,and the difference between the two groups was statistically significant(P<0.05).The total effective rate of the treatment group was 94.59%,which was better than that of the control group(77.78%),and the difference was statistically significant(P<0.05).4.NIHSS scale score comparison:After 4 weeks of treatment,the NIHSS scale score of the treatment group was 6.65±3.93,and that of the control group was 8.47±3.72.The treatment group was better than the control group,and the difference between the two groups was statistically significant(P<0.05).5.SF-36 score comparison:After 4 weeks of treatment,the SF-36 score of the treatment group was 86.14±9.01,and that of the control group was 72.08±10.78,the treatment group was better than the control group,and the difference between the two groups was statistically significant(P<0.05).6.Comparison of serum 5-HT level:After 4 weeks of treatment,the serum 5-HT level of the treatment group was 40.15±4.18ng/mL,and that of the control group was 36.30±3.83ng/mL.The treatment group was higher than the control group,and the difference between the two groups was statistically significant(P<0.05).7.Comparison of serum NE level:After 4 weeks of treatment,the serum NE level of the treatment group was 73.79±5.89ng/mL,and that of the control group was 59.89±6.07ng/mL.The treatment group was higher than the control group,and the difference between the two groups was statistically significant(P<0.05).8.Comparison of serum BDNF level:After 4 weeks of treatment,the serum BDNF level of the treatment group was 42.68±4.20ng/mL,and that of the control group was 39.59±3.70ng/mL,which was higher than that of the control group,and the difference between the two groups was statistically significant(P<0.05).9.Safety analysis:During the treatment and observation,2 patients in the observation group had stool deterioration,and the adverse symptoms disappeared after adjusting the dosage of rhubarb.No adverse reactions or other adverse events occurred in the other patients.After 4 weeks of treatment,73 patients in the two groups were reexamined and the results of blood routine examination,liver and kidney function examination,electrocardiogram examination showed no special changes compared with those before treatment,suggesting that Dachaihu decoction combined with Guizhi Fuling pill and sertraline were safe and reliable in the treatment of PSD.Conclusion 1.Dachaihu decoction combined with Guizhi Fuling pill is effective in the treatment of patients with post-stroke depression of qi yu hua huo type.It is superior to the control group in terms of improving depressive symptoms,neurological function,quality of life and serum 5-HT,NE,BDNF levels,which is worthy of further clinical verification and promotion.2.Dachaihu decoction combined with Guizhi Fuling pill has no obvious adverse reactions during the treatment,and has good safety. |
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