The Clinical Study Of Levetiracetam Treatment In The Middle And Old Aged Patients With Partial Seizures And Generalized Tonic-clonic Seizures

Objective To analyse the effective rate,adverse effect and retention rate of only levetiracetam(LEV) versus LEV plus other drugs in the treatment of middle and aged patients with partial seizures and generalized tonic-clonic seizure.Methods125cases of PS and GTCS were allocated into the monotherapy group(n=31) and the add-on therapy group(n=94), respectively. The clinical data including age, gender, history, cause of disease, symptom, imaging scanning and the frequency of the seizures were recorded. All patients entered the baseline period followed by a titration interval and a maintenance period. Patients initially received LEV0.25g twice daily (0.5g/d),1week later changed to0.5g twice daily (1.0g/d), and after another4-weeks increased to0.75g or1.Og twice daily (1.5g/d or2.0g/d) if the curative effect was not satisfactory. The main outcome measures:To observed the efficacy of LEV monotherapy and LEV add-on therapy in the treatment of middle and aged patients with partial seizures and generalized tonic-clonic seizure. To observed the efficacy of the various types of epileptic seizures and the combined medication in the treatment of middle and aged patients; The efficacy was assessed according to the percentage of responders (decreased seizure frequency≥50%) every3months up to24months after LEV treatment. The effective rate, the side effects and the retention rate of LEV were observed and compared between LEV singled and plus drug or between the patients with only epilepsy versus epilepsy plus other diseases, respectively. Multivariate regression analyses were performed to investigate associations among covariates. The influence on the retention rate of LEV was evaluated with the COX proportional hazards model.Results The percentage of responders was high and stable in each3months assessment interval. The effective ratios at the end of3、6、9、12、15、18、21and24months after LEV single treatment were83.9%、81.5%、77.3%、75.0%、75.0%、77.8%、75.0%and60.0%. The effective ratios at the end of3、6、9、12、15、18、21and24months after LEV add-on therapy were72.3%、68.3%、69.8%、69.9%、63.9%、61.5%、61.2%和57.7%. A chi-square test showed that the differences in effective ratios were not statistically significant(P＞0.05) between monotherapy group and add-on therapy group. The effective ratios at the above time points after taking AEDs only were78.1%、75.0%、72.7%、73.7%、68.7%、63.6%、66.7%and60.0%, and the effective ratios at the above time points after taking LEV with other disease combined were74.2%、70.4%、71.0%、70.0%、64.9%、64.0%、62.5%and57.7%, there were no significant different among above time points(P>0.05). The adverse event rate in the monotherapy group and the add-on therapy group was12.8%and13.8%, there was no significant different between two groups(P>0.05). The main adverse event, including drowsiness, weakness, headache, dizziness, irritability and anorexia, which were mild and could be well tolerated. The retention rate at the different observation points(3、6、12、18、24) after LEV single treatment were93.5%、85.2%、81.2%、77.8%、and60.0%, and the retention rate at the above time points after LEV add-on therapy were90.4%、76.8%、71.4%、67.3%、and61.5%. A chi-square test showed that the differences in retention rate were not statistically significant(P>0.05). It was shown that age, gender, seizuretype, current and previous medications and cause have not contact with rentention rate. The retention rate of LEV mainly correspond to the number of reducing seizure frequency (P＜0.01).The main reasons of discontinuation included inadequate efficacy and affordability.Conclusion The curative effects of levetiracetam single or in combination are definite, stable and continuous for PS and GTCS especially in combination with other diseases and in the middle and old aged patients. It proves that LEV has the satisfactory effect with the comfortable safety and higher retention rate. And new ongoing placebo-controlled studies are needed further clarify our results.