| Objective:Dingxian Pill combined with perampanel was used to treat adult patients with refractory epilepsy in the syndrome of wind-phlegm stasis.The frequency and duration of seizures,video EEG,self-rating anxiety Scale,self-rating depression Scale,Pittsburgh sleep Index scale and serum inflammatory factor levels were observed before and after treatment.To evaluate the clinical efficacy of Dingxian Pill combined with perampanel in the treatment of RE,and its effects on anxiety,depression and sleep in RE patients,and to explore the mechanism of anticonvulsant action of Dingxian Pill from the inflammatory mechanism.Method:The study selected 138 cases of RE patients with the syndrome of wind-phlegm stasis who were admitted to the Department of Neurology of Hubei Provincial Hospital of Integrated Traditional Chinese and Western Hospital from January 2020 to December 2021.Using random number assignment,the included cases were divided into three groups,namely the observation group（Dingxian Pill group,Dingxian Pill + perampanel group）and the control group.Add Dingxian Pill and perampanel for treatment,Dingxian Pill is 6g（about 1 bottle cap）twice a day,and the oral dose of perampanel is adjusted to 2-6mg in the early stage,once a night,the course of treatment is 3 months.The frequency of seizures,seizure duration,video EEG,SAS（self-rating anxiety scale）,SDS（self-rating depression scale）,PSQI（Pittsburgh Sleep Index）and inflammatory factor IL-1β（interleukin-1β）,IL-6（interleukin-6）,IL-8（interleukin-8）,TNF-α（tumor necrosis factor-α）levels.Result:A total of 138 subjects were included in this study,and a total of 13 cases were excluded or dropped out during the process.In the Dingxian Pill group,2 cases were excluded,and 2 cases dropped out;in the Dingxian Pill+perampanel group,2 cases were excluded,and1 case dropped out;in the control group,2 cases were excluded,and 4 cases dropped out.Finally,125 cases were included,including42 cases in Dingxian Pill group,43 cases in Dingxian Pill+perampanel group,and 40 cases in control group.Efficacy analysis:（1）Comparison of clinical efficacy: There was no significant difference in the frequency and duration of epileptic seizures between the three groups before treatment（P>0.05）.The duration of seizures was significantly reduced（P<0.01）;compared with the Dingxian Pill group,the frequency of seizures in the Dingxian Pill+perampanel group was significantly reduced（P<0.01）.（2）Comparison of SAS,SDS and PSQI scores: before treatment,there was no significant difference in SAS,SDS and PSQI scores between the three groups（P>0.05）;Compared with Dingxian Pill group,the PSQI score of Dingxian Pill + perampanel group decreased significantly（P<0.01）;SAS between the two observation groups after treatment Compared with SDS score,there was no significant difference（P>0.05）.（3）Comparison of serum inflammatory factor levels: There was no significant difference in the levels of IL-1β,IL-6 and TNF-α between the three groups before treatment（P>0.05）;compared with the control group,after treatment for 3 months The serum IL-1β,IL-6 and TNF-α in the observation group of the latter two groups decreased significantly（P<0.01）;after three months of treatment,the serum IL-1β,IL-6 and TNF-α of the observation group There was no significant difference in the α level（P>0.05）.（4）Comparison of EEG abnormality,epileptiform discharge and epileptogenic index: before treatment,there was no significant difference in EEG abnormality,epileptiform discharge and epileptogenic index among the three groups（P>0.05）;After 3months of treatment,the number of cases with mild abnormal EEG in the two observation groups increased（P<0.05）;the number of cases without epileptiform discharge increased（P<0.05）;the level of epileptogenic index decreased（P<0.05）.Compared with Dingxian Pill group,the number of cases with mild abnormal EEG in Dingxian Pill + perampanel group increased（P<0.05）;the number of cases without epileptiform discharge increased significantly（P<0.01）;the level of epileptogenic index decreased（P<0.05）.（5）Safety evaluation: There were no serious adverse reactions in the three groups of patients in the study,which proves that Dingxian Pill and perampanel are safe in the clinical application of RE treatment.Conclusion:1.The addition of Dingxian Pill combined with perampanel can effectively reduce the frequency and duration of epileptic seizures in RE patients with the syndrome of wind-phlegm stasis,relieve anxiety and depression,and improve sleep.2.Dingxian Pill can reduce the level of serum inflammatory factors in patients with RE patients in the syndrome of wind-phlegm stasis,and reduce the degree of inflammatory response in the brain.3.Dingxian Pill combined with perampanel in the treatment of RE patients with the syndrome of wind-phlegm stasis had no serious adverse reactions,and the clinical efficacy was good,which is worthy of popularization and application. |
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