Abstract:
OBJECTIVE To study correlation and differential on the concentration of levetiracetam(LEV) with clinical efficacy and safety in Xinjiang Uygur and Han nationality pediatric patients with epilepsy, meanwhile predicted the LEV steady valley concentration(
Css) that can obtain the best curative effect.
METHODS Using UPLC to measure LEV
Css of 300 cases pediatric patients with epilepsy, analysed the influence of race on LEV
Css, and observed its curative effect and adverse reactions. Analysed the relationship between clinical efficacy and plasma concentration by using Logistic regression and subjects operating characteristics(ROC) curve.
RESULTS There was no statistically significant difference between the concentration-dose ratio(CDR) results of LEV in Xinjiang Uygur and Han nationality pediatric patients. There were statistically significant differences in CDR values between the two groups in the age group of 0-4 years(
P<0.05). Correlation of the LEV dosage and plasma concentration in the two groups all showed positive, the correlation of the Uygur pediatric patients group(
r=0.628,
P<0.01) was better than the Han nationality pediatric patients group(
r=0.545,
P<0.01). The effective rate of LEV treatment in the two groups was 78.43% and 81.63%. There were statistically significant differences of the LEV
Css in the effective group and the ineffective group(
P<0.05). There was a positive correlation between the two groups of the LEV
Css in a range of concentrations (3.41-34.56 mg·L
-1) by Logistic regression analysis. The predicted accuracy of
Css for curative effect was exceed than dosage in the two groups. The clinical efficacy could be better assured when the Uygur nationality pediatric patients's
Css was ≥ 13.15 mg·L
-1 and the Han nationality pediatric patients's
Css was ≥ 9.28 mg·L
-1.
CONCLUSION There are both correlations and differential with different degrees between the plasma concentration of LEV with clinical efficacy and safety in Xinjiang Uygur and Han nationality pediatric patients with epilepsy. The clinical efficacy and adverse reactions can be improved by monitoring LEV
Css, and provide the basis for the formulation of individualized drug administration program for the pediatric patients with epilepsy in Xinjiang.