Clinical Study Of Gandouling Combined With Botox Injection In The Treatment Of Phlegm-stasis Interjunction Syndrome Of Dystonia Of Cerebral Hepatolenticular Degeneration(HLD)

Objective:A randomized controlled clinical trial was conducted to observe and evaluate the clinical efficacy and safety of Gandou Ling tablet combined with botulinum toxin injection in the treatment of cerebral type hepatolenticular degeneration(HLD)dystonia with phlegm and blood stasis.Methods:1.Grouping: A total of 54 patients with cerebral HLD and phlegm and blood stasis type who were hospitalized in the First Department of Divinity and Internal Medicine of Anhui Provincial Hospital of Traditional Chinese Medicine from October 2020 to October 2022 were admitted and voluntarily received botulinumtoxin injection.The inclusion and exclusion criteria were strictly implemented,and they were randomly divided into treatment group(27 cases)and control group(27 cases).2.Treatment: both groups were given basic copper excretion treatment and local injection of botulinum toxin type A at the time of admission and the second week,2weeks as a course of treatment,and the total course of treatment was 4 weeks.The treatment group was given Gandouling tablets on the basis of the control group.3.The scores of Unified Dystonia Rating Scale(UDRS),Unified Wilson Rating Scale(UWDRS),Numerical Rating Scale(NRS)and activities of daily living(ADL)were recorded at the time of enrollment,the second week and the fourth week.Results:1.Comparison of UDRS scores: There was no significant difference in scores between the two groups before treatment(P > 0.05).After 2 weeks of treatment,the difference between the UDRS score of the treatment group and the UDRS score before treatment was-6.63±2.604,which was significantly lower than the difference between the UDRS score after treatment and the UDRS score before treatment of the control group was-1.22±1.251.The two groups of data did not conform to the normal distribution,and the non-parametric test was used to obtain Z=-6.148.P=0.000(P <0.01),the difference was statistically significant.After 4 weeks of treatment,the difference between the UDRS score of the treatment group and the UDRS score before treatment was-6.37±2.404,which was significantly lower than the difference between the UDRS score after treatment and the UDRS score before treatment of the control group was-1.00±1.468.The two groups of data did not conform to the normal distribution,and the non-parametric test was used to obtain Z=-6.046.P=0.000(P <0.01),the difference was statistically significant.2.Comparison of UWDRS scores: There was no significant difference between the two groups before treatment(P > 0.05);After 2 weeks of treatment,the difference between the UWDRS score of the treatment group and the UWDRS score before treatment was-8.48±3.984,significantly lower than the difference between the UWDRS score after treatment and the UWDRS score before treatment of the control group was-3.04±1.605.The two groups of data did not conform to the normal distribution,and the non-parametric test was used to obtain Z=-4.940.P=0.000(P < 0.01),the difference was statistically significant.After 4 weeks of treatment,the difference between the UWDRS score of the treatment group and the UWDRS score before treatment was-8.74±4.266,significantly lower than the difference between the UWDRS score after treatment and the UWDRS score before treatment of the control group was-2.96±1.605.The two groups of data did not conform to the normal distribution,and the non-parametric test was used to obtain Z=-5.108.P=0.000(P < 0.01),the difference was statistically significant.3.Comparison of NRS scores:There was no significant difference in scores between the two groups before treatment(P > 0.05).After 2 weeks of treatment,the difference between the NRS score of the treatment group and the NRS score before treatment was-3.19±1.210,significantly lower than the difference between the NRS score after treatment and the NRS score before treatment of the control group was-1.11±1.086.The data of the two groups were in line with normal distribution,and the independent sample t test was used to obtain t=6.628.P=0.000(P < 0.01),the difference was statistically significant.After 4 weeks of treatment,the difference between the NRS score of the treatment group and the NRS score before treatment was-2.81±1.469,which was significantly lower than the difference between the NRS score after treatment and the NRS score before treatment of the control group was-1.00±0.961.The data of the two groups were in line with normal distribution,and the independent sample t test was used to obtain t=-5.373.P=0.000(P < 0.01),the difference was statistically significant.4.Comparison of ADL scores:There was no significant difference in scores between the two groups before treatment(P > 0.05).After 2 weeks of treatment,the difference between the ADL score of the treatment group and the ADL score before treatment was 4.81±1.688,which was significantly higher than the difference between the ADL score after treatment and the ADL score before treatment of the control group was 1.67±2.402.The data of the two groups did not conform to the normal distribution,and the non-parametric test showed that Z=4.492,P=0.000(P < 0.01).The difference was statistically significant.After 4 weeks of treatment,the difference between the ADL score of the treatment group and the ADL score before treatment was 5.00±1.387,which was significantly higher than the difference between the ADL score after treatment and the ADL score before treatment of the control group,which was 3.33±2.774.The two groups of data did not conform to the normal distribution,and the non-parametric test showed that Z=4.947,P=0.007(P < 0.01).The difference was statistically significant.Conclusion:1.The therapeutic effect of Gandouling tablet combined with Botox injection on dystonia of phlegm-stasis interjunction syndrome of cerebral HLD is better than that of Botox injection alone.2.Gandouling tablet combined with Botox injection in the treatment of dystonia with phlegm-stasis interjunction syndrome of cerebral HLD has more significant reduction in UDRS score,UWDRS score and NRS score,and more significant improvement in ADL score than Botox injection alone.3.There was no significant difference in adverse reactions between the treatment group and the control group(P > 0.05).