A Randomized Clinical Trial Of Lamotrigine Prevention The Late Post-traumatic Epilepsy

ObjectiveTo analyze and evaluate the influence of Lamotrigine on the incidence of late epilepsy and cognitive function recovery within one year for acute traumatic brain injury patients,by comparing to Carbamazepine group.Methods:using the Cohort study program, we collect 175 acute traumatic brain injury patients who meet the inclusion criteria in Neurosurgery at First Hospital of Shanxi Medical University from January 2008 to December 2008. we randomly divided the patients into three groups:LTG 1 group:taking LTG for 6 months, (n= 60); LTG 2 group:taking LTG for 1 month(n=58); CBZ group taking CBZ a week(n=56). Medication all started within 24 hours after trauma.Follow-up period was 12 months.We mainly recorded the number of Early posttraumatic epilepsy,(EPTS) and late posttraumatic epilepsy(LPTE), as well as the Montreal Cognitive Assessment (MoCA) Scale ratings at 12 month and 1 month for the conscious patients.we Statistic EPTE incidence byχ2 test. Since all of the early seizures occurred in 1 month, so the calculation of EPTE we take LTG two sub-groups as a group to compare with the CBZ group. Comparing the time of late traumatic seizures,we used Kapland-Meier curve and Log-rank test. Comparison of risk factors used Cox proportional hazards regression. Since LTG only lower the seizures during medication but not after treatment.So in order to avoid the impact of that and the interference of other confounding factors such as lost follow-up, so a 12-month cumulative incidence and its standard error were compared. Three groups patients with early stage MoCA score comparison, between the two groups using Kruskal-Wallis test score, each group using paired data, before and after the sign W test. All data in statistical work in SPSS 13.0, and therefore P<0.05 statistically significant.ResutsOf the 175 cases,there were 14 patients lost during follow-up due to awareness has not yet fully recovered at one month,7 cases can not accept MoCA) Scale. Results:incidence of EPTS are all low:LTG group was 7.6%, CBZ group,5.3%.There is no significant difference between the two groups (χ2= 0.068, P> 0.05); LPTE 12-month cumulative incidence is 8.6%,7.2%,20%, Kapland-Meier curve showed that there is no significant difference between the two groups, and both significantly lower than the CBZ group (Log-rank test p= 0.049 Table 2). In this study, Cox proportional hazards regression analysis showed that LPTE incidence and severity of brain injury have a significant correlation ([RR]= 3.657,95% confidence intervalCI 1.7-7.9). Initial MoCA score among the three groups there was no significant difference .in final score there is no significant difference between the two LTG groups (25.5±1.82,25.0±1.72, p> 0.05) and higher than the CBZ group (24.3±1.82) statistically significant (p<0.05). It shows that LTG contributes to cognitive function recovery after traumatic brain injury.As to adverse effects ,in LTG6 group 2 cases have skin rash,but disappear after treatment. Patients of three groups all do not have any obvious adverse drug reactions, including blood count and liver function, ALT within normal limits, shows security of LTG. ConclusionThis study explore a new type of drugs to prevent late post-traumatic epilepsy .We found that low-dose LTG early intervention, to a certain extent, is able to combat the formation of late post-traumatic epilepsy, and the more favorable to post-traumatic cognitive recovery compared with the CBZ. For clinical prevention we provide a new basis. It was found that application of lamotrigine prevent post-traumatic epilepsy is relatively safe, Except individual patients in the remaining outer skin rash other side effects are rare.