| Background:Epilepsy is one of the most common chronic diseases of the central nervous system,which is caused by the excessive discharge of brain neurons,and is characterized by recurrent,transient chronic brain diseases with the dysfunction of the central nervous system.The treatment of epilepsy is mainly symptomatic treatment,aimed at reducing the risk of epilepsy recurrence,medical therapy is the most basic and important treatment and is the preferred treatment for epilepsy.The majority of patients can achieve clinical remission with anti-seizure medications therapy,but a significant number of patients are currently not effectively controlled based on current medications,and seizures that are not effectively controlled often leads to disability,psychological and social dysfunction,reduced educational and employment prospects,impaired quality of life and the risk of premature death.Focal seizures are the most common type of seizure and can pose a significant risk to an individual’s health and impair quality of life,especially when they are associated with disturbance of consciousness.Although more than ten new anti-seizure medications have been introduced in China in the past 20 years,the results remain unchanged,so it is particularly important to develop and apply novel ASMs with new mechanisms of action.As the third generation of new ASMs,lacosamide(LCM)is currently the only ASMs known to selectively affect slow inactivating sodium channels,and it was marketed in the United States in 2008.It was approved in China in 2018 for patients aged≥16 years with refractory focal seizures.Purpose:This study aims to evaluate the efficacy and safety of lacosamide add-on treatment by collecting clinical data and outcome variables in patients with focal seizures(with or without secondary generalized seizures)and conducting statistical analysis,and then explore the factors affecting the efficacy of lacosamide add-on treatment.Methods:106 patients’ data were collected from patients aged≥16 years with focal seizures(with or without secondary generalized seizures)from October 2020 to April 2022 in qilu hospital,the Department of Neurology,Shandong University,and all patients were unable to achieve seizure control based on the current clinical medications,then they added lacosamide as add-on treatment on the basis of the current clinical medications.Collect the basic clinical data of patients,number and mechanism of action of accompanying medications,frequency of seizures 3 months before administration of lacosamide,frequency of seizures 3 months and 6 months after lacosamide add-on treatment,treatment-emergent adverse events,and compare the changes in seizure frequency after and before lacosamide add-on treatment.According to the change in seizure frequency 6 months after lacosamide add-on,the patients were divided into valid and invalid groups.The clinical data of the two groups were compared,and then explored factors affecting the efficacy of lacosamide add-on treatment,and the data were analyzed by SPSS 26.0 statistical software.Result:106 patients with focal seizures were 16-71 years,with an average of 31.49±12.50 years;age of first onset of epilepsy 1-70 years,with an average of 23.96±12.43 years;and the minimum duration of epilepsy history was 1 year,a maximum of 52 years and a median of 4 years.The overall response rates were 54.72%and 66.35%after 3 and 6 months,and the percentage of patients who were seizure-free at the same time point was 18.87%and 25.00%respectively.The retention rates were 99.1%at the 3-month and 93.3%at the 6-month.For the valid group and invalid group,the difference of age,sex,age at the onset of epilepsy,seizure etiology,seizure type were not statistically significant(all P>0.05).The valid group epilepsy history duration was shorter than invalid group,the mean frequency of seizures over 28 days was less than invalid group,the number of anti-seizure medications and number of previous anti-seizure medications applied were less than invalid group,these difference were statistically significant(all P<0.05).The difference in effective rate was statistically significant between patients with enzyme-induced ASMs and non-enzyme-induced ASMs(P<0.001),but the difference in effective rate was not statistically significant between patients with sodium channel blockers and patients with non-sodium channel blockers(P=0.103).In the combination regimen of ASMs in the valid group,the combination VP A and LCM treatment regimen has the highest percentage(43.48%,30/69),the second highest was the combination of LEV and LCM treatment regimen(20.29%,14/69).In 106 patients,the effective rate in patients with a two anti-seizure medications treatment regimen was better than those patients with a triple or more anti-seizure medications treatment regimen,and it was statistically significant(P<0.001).The overall incidence of adverse events was 37.74%.The leading AEs were dizziness(16.98%)and somnolence(8.5%).There was no statistical difference regardless of the application of enzyme-induced ASMs or sodium channel blockers and the occurrence of adverse events(all P>0.05).Conclusions:1.Patients with focal-onset seizures(with or without secondary generalized seizures)who were treated with add-on lacosamide had good curative effect,and the early effective rate could reach 66.35%.2.The efficacy of lacosamide is affected by the duration of epilepsy history,frequency of seizures before lacosamide add-on treatment,the number of concomitant anti-seizure medications,the number of previous anti-seizure medications applied,the combination of enzyme-induced anti-seizure medications.Among them,the number of concomitant anti-seizure medications was an independent factor affecting the efficacy of lacosamide add-on.3.The most common combination ASMs regimen in this study was VPA+LCM,followed by LEV+ LCM.4.The overall incidence of adverse events related to lacosamide add-on was 37.74%the leading AEs were dizziness(16.98%)and somnolence(8.5%),symptoms were mild and patients were more tolerant. |
PDF Full Text Request