| Research objectives:1.To observe the effects of Gandouling tablets on digital muscle tension assessment scale,daily living ability and TCM syndrome of phlegm-stasis type WD with dystonia,and evaluate its clinical efficacy and safety.2.To explore the neural imaging mechanism of Gandouling tablets in the treatment of phlegm-stasis type WD with dystonia by resting-state functional magnetic resonance(rs-f MRI)functional connectivity(FC)technology,and to provide objective scientific basis for its clinical application.Research Objects and methods:Sixty phlegm-stasis type WD with dystonia who were admitted to the Brain Disease Center of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine from October 2021 to October 2022 were selected,and 30 healthy persons matched in age and sex were recruited as healthy control group.Sixty patients were randomly divided into the conventional treatment group(control group)and the conventional treatment and Gandouling tablet treatment group(treatment group),with30 cases in each group according to the method of numerical randomization.The control group was given conventional drug treatment according to the latest western medicine guidelines,and the treatment group was given Gandouling tablet orally on the basis of the guidance-based conventional treatment.Digital muscle tension F(muscle oscillation frequency,which can represent muscle tension)value detection,clinical scale detection and rs-f MRI scanning were respectively given to patients in the two groups before treatment and 40 days after treatment.The healthy control group received no drugs and only one rs-MRI scan at the time of enrollment.Select bilateral lenticular nucleus(including globus pallidus and putamen)as ROI,and each globus pallidus was divided into two subregions: anterior globus pallidus(a GP)and posterior globus pallidus(p GP),and each putamen is divided into four subregions: ventroanterior putamen(PUT-VA),dorsoanterior putamen(PUT-DA),ventroposterior putamen(PUT-VP)and dorsoposterior putamen(PUT-DP)were extracted and compared before and after treatment,and the FC values of the lenticular nucleus and the whole brain of the two groups were compared after 40 days of treatment.Results:1.The intra-group comparison before and after treatment found that F values of bilateral biceps and right lateral gastrocnemius of the two groups and left medial gastrocnemius of the treatment group were significantly decreased compared with before treatment(P<0.01).The F values of the left gastrocnemius in the two groups,the left gastrocnemius in the control group and the medial right gastrocnemius in the treatment group were lower than those before treatment(P<0.05),.In the control group,the F value of the medial gastrocnemius muscle was not significantly decreased compared with that before treatment(P>0.05).The comparison between the two groups after treatment showed that the reduction degree of F value in bilateral biceps humeral muscle in the treatment group was significantly greater than that in the control group(P<0.01),the reduction degree of F value in the right medial gastrocnemius muscle in the treatment group was greater than that in the control group(P<0.05),and the reduction degree of F value in the left gastrocnemius muscle inside and outside and the right lateral gastrocnemius muscle was not significantly different between the two groups after treatment(P>0.05).2.Intra-group comparison after treatment showed that the score of united dystonia rating scale(UDRS)and Burke-Farn-Marsden dystonia scale(BFMDRS)of the two groups after treatment was significantly decreased(P<0.01),while the modified Babbitt index(MBI)score was significantly increased(P<0.01).The score of TCM syndrome score scale after treatment was decreased in control group compared with before treatment(P<0.05),and significantly decreased in treatment group compared with before treatment(P<0.01).After treatment,the decrease of UDRS score and TCM syndrome score scale score in the treatment group was significantly greater than that in the treatment group(P<0.01),and the decrease of BFMDRS score and increase of MBI score in the treatment group was greater than that in the control group(P<0.05).3.Compared with the healthy group,the FC from all subareas of lenticular nucleus to cerebellum in patients decreased(P<0.001),FC in the putamen subregion except for the right PUT-VP and FC in the right globus pallidus to the middle cingulate cortex(MCC)(P<0.001).4.Before and after treatment,it was found that bilateral PUT-VP,right PUT-DA and right p GP in the two groups after treatment,and left PUT-DA,left PUT-DP and right PUT-VA to cerebellar FC in the treatment group were significantly increased compared with before treatment(P<0.01).In control group,the left PUT-DA and right PUT-VA to cerebellar FC were increased compared with before treatment(P<0.05),and the left PUT-DP to cerebellar FC was not significantly changed compared with before treatment(P>0.05).Comparison between groups showed that after treatment,the FC enhancement degree of the other brain regions in the treatment group was greater than that in the control group(P<0.05),except that there was no significant difference between the left PUT-DA and right PUT-VP to the cerebellar FC group(P>0.05).Conclusion:1.WD patients with dystonia have abnormal functional connectivity from the lenticular nucleus to the cerebellum and the middle cingulate cortex.2.On the basis of standardized internal medicine treatment based on western medicine,the clinical effect of Gandouling Tablet oral combination of traditional Chinese and western medicine in the treatment of phlegm-stasis type WD with dystonia is better,which can better improve the dystonia and TCM syndromes of patients,improve the quality of life of patients and have better safety and clinical effect.3.Gandouling tablet can enhance the FC level between lenticular nucleus and cerebellum,and improve the functional connectivity network of the damaged lenticular nucleus to cerebellum pathway,which may be one of the neurofunctional imaging mechanisms of Gandouling tablet to improve the phlegm-stasis type WD with dystonia. |
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