Objective

2

To observe the clinical efficacy and safety of

Tongluo Fuzheng Decoction

（通络扶正汤， TFD） in the treatment of patients with acute ischemic stroke characterized by wind-phlegm and blood stasis syndrome.

Method

2

A total of 150 patients diagnosed with acute ischemic stroke and wind-phlegm and blood stasis syndrome were randomly divided into a study group and a control group， with 75 cases in each. The control group received conventional western medical treatment， including intravenous thrombolysis， vasodilation， anticoagulation， and neurotrophic support. On the basis of the control treatment， the study group was additionally given TFD orally 24 hours after the condition stabilizes. Both groups were treated for three weeks. Clinical efficacy was evaluated after treatment. Before and after treatment， changes in traditional Chinese medicine （TCM） syndrome scores， including primary and secondary symptoms， National Institutes of Health Stroke Scale （NIHSS） scores， and Montreal Cognitive Assessment （MoCA） scores were assessed. Coagulation function indices including tissue-type plasminogen activator （t-PA）， fibrinogen （FIB）， and D-dimer （D-D）， as well as vascular endothelial function indices including endothelin-1 （ET-1）， nitric oxide （NO）， and reactive hyperemia index （RHI）， were measured.

Results

2

The total effective rate in the study group was 93.33% （70/75）， significantly higher than 81.33% （61/75） in the control group （

P

＜0.05）. Both groups showed improvements in MoCA scores， t-PA， RHI， and NO levels， while showing decreases in NIHSS scores， TCM primary and secondary symptom scores， D-D， FIB， and ET-1 levels （

P

＜0.05）. Moreover， improvements in all these parameters were significantly greater in the study group than in the control group （

P

＜0.05 or

P

＜0.01）. During treatment， no significant abnormalities in liver or kidney function or electrocardiograms were observed in either group， and no serious adverse reactions occurred. The incidence of adverse events was 9.33% （7/75） in the study group and 5.33% （4/75） in the control group， with no statistically significant difference （

P

＞0.05）.

Conclusion

2

TFD as an adjunctive therapy demonstrates a definite clinical efficacy in patients with acute ischemic stroke of wind-phlegm and blood stasis syndrome. It can effectively alleviate clinical symptoms， improve neurological and cognitive functions， regulate vascular endothelial function， and ameliorate coagulation status， with good safety and tolerability.