638例次抗癫痫药血清浓度监测结果及其与临床疗效关联性分析

目的:为临床抗癫痫药物(AEDs)的合理使用提供科学参考。方法:对采用荧光偏振免疫(FPIA)法对丙戊酸钠、卡马西平、苯妥英钠、苯巴比妥进行血清浓度监测结果进行回顾性统计分析。结果:共监测638例次,359例次(56.27%)血药浓度位于治疗窗内,202例次(31.66%)低于治疗窗,70例次(10.97%)高于治疗窗,7例次(1.10%)未检出血清浓度;各AEDs血清浓度位于治疗窗的比例分别为卡马西平78.65%、苯巴比妥60.00%、丙戊酸钠57.48%、苯妥英钠23.08%,其中卡马西平、丙戊酸钠、苯妥英钠血清浓度位于治疗窗内癫痫治疗有效率分别为72.86%、90.57%、94.44%,明显高于其他浓度范围(χ2卡马西平=6.324,P卡马西平=0.012;χ2丙戊酸钠=122.782,P丙戊酸钠=0.000;χ2苯妥英钠=19.584,P苯妥英钠=0.000),而苯巴比妥在各浓度范围有效率差异无统计学意义(χ2=3.403,P=0.065);53例次联合用药中,12例次血清浓度在治疗窗内,占联合用药例次的22.64%。结论:对癫痫患者进行血清浓度监测,实施个体化给药,对促进抗癫痫药物安全、有效、合理使用具有重要意义。

Relationship between Serum Concentration of 638 Cases Anti-epileptic Drugs and Clinical Efficacy

OBJECTIVE： To provide scientific reference for the rational use of antiepileptic drugs （AEDs） in the clinic. METHODS： The serum concentrations monitoring resntts of valproic acid sodium, carbamazepine, phenytoin sodium and phenobar bital by fluorescence polarization immunoassay （FPIA） were analyzed retrospectively. RESULTS： Among 638 cases, there were 359 cases （56.27%） whose serum concentration were in therapeutic window, 202 cases （31.66%） were in low range and 70 cases （ 10.97% ） were in high range. Those of 7 cases （ 1.10% ） could not be monitored. The percentage of serum concentrations of carba mazepine, phenobarbital, valproic acid sodium and phenytoin sodium in therapeutic window were 78.65%, 60.00%, 57.48% and 23.08%. The effective rates of carbamazepine, valproic acid sodium and phenytoin sodium in therapeutic window were 72.86% （X2=6.324, P=0.012）, 90.57% （x2= 122.782, P=0.000） and 94.44% （x2 19.584, P=0.000）, desperately, which were distinctly higher than other range of serum concentration （P〈0.05） ; there was no statistical significance in the effective rate of phenobarbital （x2=3.403,P=0.065）. Among 53 cases of drug combination, 12 cases were in therapeutic window （22.64%）. CONCLUSIONS： It is of great importance to monitor the serum concentration of antiepilepsies drugs to provide the individual administration for pa tients and to ensure the safe, effective and rational use of drus.