醒脾解郁方治疗抑郁症相关性失眠的临床研究OA

Objective To investigate the clinical efficacy of Xingpi Jieyu Formula(Spleen-Awakening and Constraint-Relieving Formula)in the treatment of depression-related insomnia(DRI)and its effects on serum melatonin(MT),glutamate(Glu),and γ-aminobutyric acid(GABA)levels.Methods Randomized double-blind double-dummy parallel positive-controlled study.90 DRI patients were randomly divided into the Western medicine group(n=45)and the TCM group(n=45).The patients in the Western medicine group were given esiciprom oxalate tablets and Xingpi Jieyu Formula Granule placebo,and those in the TCM group were given Xingpi Jieyu Formula Granules and escitalopram oxalate tablet placebo.Both groups were treated for 8 weeks.The changes of Hamilton Depression(HAMD)score,Pittsburgh Sleep Index(PSQI)score,TCM pattern score,and serum MT,Glu,GABA levels were recorded before and after treatment of the two groups,and and the Glu/GABA ratio was calculated.Results After treatment,the total effective rate was 84.44%in the TCM group and 71.11%in the Western medicine group.The differences between the groups were not statistically significant(P>0.05).After treatment,the scores of HAMD,PSQI and TCM pattern scale were significantly lower than before treatment(P<0.05),but there was no statistical difference between the groups(P>0.05).After treatment,the sleep quality,sleep time and daytime dysfunction of the two groups were significantly improved(P<0.05),sleep disorders and the use of hypnotic drugs were also improved(P<0.05),while the improvement in sleep time and sleep efficiency was not obvious(P>0.05);the factors of sleep between the groups were compared and there is no difference(P>0.05).In terms of serum indicators,the serum MT level increased significantly after treatment in the TCM group(P<0.05),and the Glu/GABA ratio decreased significantly(P<0.05);only the Glu/GABA ratio in the Western medicine group decreased significantly(P<0.05);There was no significant change in the average serum Glu and GABA after treatment of the two groups(P>0.05);there was no statistical difference between the comparison of MT,Glu,GABA and Glu/GABA groups after treatment(P>0.05).Conclusion Xingpi Jieyu Formula demonstrates efficacy equivalent to Escitalopram Oxalate Tablets in treating DRI.It significantly improves sleep quality and alleviates depressive mood in DRI patients.The therapeutic mechanism involves elevating serum MT levels and reducing the Glu/GABA ratio,thereby restoring excitation/inhibition balance in the central nervous system.