丙戊酸钠血药浓度与抗癫痫疗效及不良反应关系研究

Association of Blood Concentration of Sodium Valproate with Anti-epileptic Efficacy and Adverse Drug Reactions

目的：研究丙戊酸钠血药浓度与其抗癫痫疗效及不良反应的关系，为临床合理应用抗癫痫药丙戊酸钠提供参考，同时也为制订个体化给药方案提供依据。方法：采用回顾性分析方法，查阅我院2010—-2012年服用丙戊酸钠的癫痫患者的病历，收集整理资料，对丙戊酸钠血药浓度、抗癫痫疗效和各个系统出现的不良反应进行统计和分析。结果：研究共收集114例患者监测结果，丙戊酸钠血药浓度在正常范围内的（50—100μg/ml）有72例，其中显效和有效的有50例（占69．44％），疗效不足或疗效差与无效的有22例（占30．56％）；丙戊酸钠血药浓度〈50μg／ml的有35例，其中显效和有效的有21例（占60．00％），疗效不足或疗效差与无效的有14例（占40．00％）；丙戊酸钠血药浓度〉100μg／ml的有7例。服用丙戊酸钠，出现肝功能异常者4例、肾功能异常者2例、血液系统异常者4例、消化系统不良反应者3例、神经系统不良反应者5例及皮肤不良反应者3例。结论：丙戊酸钠血药浓度在有效浓度范围内有较好的疗效，但存在个体差异。丙戊酸钠在有效浓度范围内，出现了血液系统、消化系统等不良反应，因此在临床上使用时应监测其血药浓度和不良反应。

OBJECTIVE：To investigate the association of blood concentration of sodium valproate （VPA） with anti-epileptic efficacy and adverse reactions, so as to provide reference for clinical rational use of sodium valproate and individualization of the anti-epileptic therapy. METHODS ： A retrospective study was performed on the medical records of the patients with epilepsy treated orally with sodium valproate between 2010 and 2012, with serum concentration of sodium valproate and anti-epileptic efficacy and adverse drug reactions presented in each body system analyzed statistically. RESULTS： A total of 114 cases were collected, of which, 72 showed normal serum drug concentration （50-100μg/ml）, 50 showed excellent efficacy or efficacy （69. 44% ） and 22 （30. 56% ） showed insufficient or poor efficacy or no efficacy; 35 cases showed lower serum drug concentration at 〈 50 μg/ml, of which, 21 cases （60. 00% ） showed excellent efficacy or efficacy and 14 （40. 00% ） showed insufficient or poor efficacy or no efficacy; 7 cases had serum drug concentration of 〉 100μg/ml. During administration of sodium valproate, the patients with epilepsy presented with adverse reactions including dysfunctions of liver （4 cases） and kidney （4 cases） and adverse reactions in hematological system （4 cases ）, digestive system （3 cases ）, nervous system （5 cases ） and skin （3 cases ）. CONCLUSION： Sodium valproate within an effective blood concentration range showed satisfactory therapeutic efficacy yet there is individual difference. Within effective concentration range, sodium valproate resulted in adverse drug reactions in hematological system and digestive system; therefore, it is necessary to monitor blood drug concentrations and adverse reactions in it clinical use.