| Objective:To explore the efficacy and safety of Zhenlong Xingnao Capsule in treating patients with early recovery stage of ischemic stroke(IS)who suffered from limb movement disorders and were diagnosed with phlegm and blood stasis syndromes in traditional Chinese Medicine,and to investigate the central effect mechanism of Zhenlong Xingnao Capsule based on diffusion tensor imaging and graph theory.Methods:A total of 47 eligible patients were included.All patients were treated with conventional treatment and rehabilitation,while the experimental group was given the Tibetan medicine Zhenlong Xingnao Capsule additionally for 4 weeks.The primary outcome indicators were the Stroke Symptom Assessment Scale and the Fugl-Meyer Assessment(FMA).The secondary efficacy indicators were the National Institute of Health stroke scale(NIHSS),the Fugl-Meyer Sensory Functioning Scale,the Montreal Cognitive Assessment(MoCA),the Barthel Index,and the modified Rankin Scale(mRS).The safety indicators were laboratory tests and adverse events.A whole brain structural network was constructed using diffusion tensor imaging technology(DTI)and graph theory,and the topological properties of network nodes in specific brain regions were compared before and after treatment.Results:31 patients in the experimental group and 10 patients in the control group made it through the clinical study.The age,gender,vital signs,and medical history of the two groups were comparable at the time of enrollment.As for the Stroke Symptom Assessment Scale,the points of phlegm syndrome and blood stasis syndrome in the experimental group after 4 weeks of treatment were higher than those in the control group,and the subtraction value of the points of phlegm syndrome at 90 days of onset was bigger than those in the control group.The difference was statistically significant(P<0.05).As for the FMA scale,the total scores of the FMA scale in the experimental group after 4 weeks of treatment and at 90 days of onset were higher than that in the control group and the difference was statistically significant(P<0.05).The change in the total score of the FMA scale after 4 weeks of treatment was bigger than that of the control group with a statistically significant difference(P<0.05).In terms of the neurological deficits,the change in the NIHSS and Fugl-Meyer Sensory Functioning Scale after 4 weeks of treatment and 90 days of onset was larger than that of the control group,and the change in the MoCA scale after 90 days of onset was greater than that of the control group with a statistical difference(P<0.05).The percentage of mRS scores less than 2 was higher than that in the control group,and the difference was statistically significant(P<0.05).In terms of the ability of daily living,the percentage of Barthel index scores greater than or equal to 75 was higher in the experimental group at 90 days of onset,and the difference was statistically significant(P<0.05).Two serious adverse events occurred in two subjects in the experimental group,and no adverse events appeared in the control group.No significant changes in laboratory tests were found in both groups before and after treatment.The topology properties of network nodes in the experimental group were compared before and after the treatment.The results showed that the betweenness centrality of the left superior frontal gyrus,the vertical branch of the left lateral fissure,and the right inferior frontal gyrus were significantly higher after treatment.In terms of degree centrality,the left intermediary sulcus of Jensen,the left superior temporal gyrus,and the right parahippocampal gyrus were significantly elevated in the experimental group after treatment.Regarding the nodal network efficiency,the left precuneus,the left intermediary sulcus of Jensen,the left inferior parietal sulcus,and the left superior temporal gyrus were significantly improved in the experimental group after treatment.There was a significant negative correlation between the phlegm symptom and the betweenness centrality of the vertical branch of the left lateral fissure but a significant positive correlation with the nodal network efficiency of the left precuneus in the experimental group before treatment.Age was negatively correlated with the betweenness centrality of the vertical branch of the left lateral fissure and the nodal network efficiency of the left intermediary sulcus of Jensen after treatment.MoCA score was positively correlated with the betweenness centrality of the right inferior frontal gyrus and the degree centrality of the right parahippocampal gyrus after treatment.There was a significant positive correlation between change in the nodal network efficiency of the left intermediary sulcus of Jensen and improvement in the MoCA score before and after treatment in the test group.Conclusion:Zhenlong Xingnao Capsule was effective and safe for IS patients in the early stage of recovery with phlegm and blood stasis syndromes,which could improve traditional Chinese medical syndromes and limb movement disorders,reduce the degree of disability and neurological deficits,and improve the ability of daily living.Zhenlong Xingnao Capsule also could lead to an increase in the importance of brain regions related to cognitive,motor,and sensory functions in the brain network and enhance the efficiency of information transmission.This may be the mechanism of action by which Zhenlong Xingnao Capsule promotes the compensation and reorganization of brain networks in patients with IS. |
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