Abstract:Objective:To observe the clinical efficacy of Tongfu Jieyu Prescription as adjuvant therapy for poststroke depression (PSD) of phlegm-heat disturbing the spirit type. Methods:A total of 106 PSD patients of phlegmheat disturbing the spirit type treated at Wenzhou Traditional Chinese Medicine Hospital of Zhejiang Chinese Medical University from January to September 2024 were randomly divided into a traditional Chinese medicine group (n=53, treated with Tongfu Jieyu Prescription) and a western medicine group (n=53, treated with Fluoxetine Hydrochloride Tablets). After eight weeks of treatment, clinical efficacy, incidence of adverse reactions, as well as depression scores [Hamilton Depression Scale (HAMD) and Self-Rating Depression Scale (SDS)], traditional Chinese medicine syndrome scores, Pittsburgh Sleep Quality Index (PSQI) scores, and neurotransmitter levels [5- hydroxytryptamine (5-HT), norepinephrine (NE), dopamine (DA)] before and after treatment were compared between the two groups. Results: After treatment, the total effective rate was 84.91% (45/53) in the traditional Chinese medicine group and 79.25% (42/53) in the western medicine group,with no significant difference (P>0.05). HAMD and SDS scores decreased in both groups( P<0.05),with no significant difference between the two groups( P> 0.05). The traditional Chinese medicine syndrome scores (primary symptoms,secondary symptoms,and total scores) decreased in both groups (P<0.05), with lower scores in the traditional Chinese medicine group (P<0.05). PSQI scores decreased in both groups (P<0.05), with lower scores in the traditional Chinese medicine group (P<0.05). Levels of 5-HT,NE,and DA increased in both groups (P<0.05),with higher NE and DA levels in the traditional Chinese medicine group (P<0.05); no significant difference was found in 5-HT levels between groups (P>0.05). During treatment,the incidence of adverse reactions was 3.77% (2/53) in the traditional Chinese medicine group and 20.75% (11/53) in the western medicine group, showing a significant difference (P<0.05). Conclusion: Tongfu Jieyu Prescription can regulate serum neurotransmitter levels, alleviate depressive symptoms, improve traditional Chinese medicine syndrome manifestations and sleep quality,and enhance clinical efficacy in PSD patients of phlegmheat disturbing the spirit type,and has relatively fewer adverse reactions.