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丙戊酸钠常规剂型和缓释片临床疗效及血药质量浓度对比研究
Comparison of the valproate plasma levels and clinical efficacy in p atients with epilepsy between conventional preparations and sustained-r elease preparations of sodium valproate
【摘要】 目的 评价丙戊酸钠常规剂型和缓释片治疗癫疒间 的临床疗效、血药质量浓度和药物不良反应。方法 3 3例癫疒间 病人服用丙戊酸钠常规剂型治疗 6月以上 ,换用同等剂量丙戊酸钠缓释片治疗 4周 ,分别于服药 12h和 2 4h清晨服药前测量两种不同剂型丙戊酸质量浓度 ,观察临床疗效和药物不良反应。结果 丙戊酸钠缓释片谷质量浓度明显高于常规剂型 ;服用缓释片癫疒间 控制率 76%明显高于常规剂型 45 % (P <0 0 5 ) ,5例发作显著减少。常规剂型和缓释片治疗中共有 5例出现药物不良反应 ,均与血药质量浓度水平升高和个体对药物耐受量有关。结论 丙戊酸钠缓释片持久平稳升高血药质量浓度水平 ,减少服药间期波动 ,是一种更有效、服用更方便抗癫疒间 药物剂型
【Abstract】 Objectives To evaluate the valproate plasma l ev els,the clinical efficacy and adverse effects in patients with epilepsy treated with the conventional preparations and the sustained-release preparations of sodium valproate (VPA-Na·SR).Methods 33 patients received oral conventional formul ation of sodium valproate for over six months and a similar dosage of VPA-Na·SR for 4 weeks.After 12 or 24 hours,the valproate plasma concentr ations of the two formulations were measured respectively before taking drugs in the early mor ning.The valproate plasma concentrations and the clinical efficacy of the VPA-N a·SR were assessed by comparing with that of conventional valproate.The adverse effects were recorded.Results The average valproate plasma trough concentration was s ignificantly higher in patients receiving VPA-Na·SR than that of those receiving conventional valproate.Seizure free in patients was achi eved by 76%(n=25) with VPA-Na·SR and by 45%(n=15) with conventional valproate resp ectively.There was statistical difference between the two formulations.The seizu re frequency was significantly reduced in 5 patients treated with VPA-Na·SR.A dverse ef fects were observed in 2 patients with conventional valproate,5 patients with V PA-Na·SR whose valproate plasma levels were higher than that of conventional p reparations.Adverse effects were related to increased valproate plasm a levels and individual drugtolerance. Conclusions The advantage of VPA-Na·SR is that serum valproa te con centrations may increase smoothly and minimize fluctuation in serum dr ug concentrations during a dosing interval. It is a more effective and more convenient antiepileptic agent.
- 【文献出处】 中国实用内科杂志 ,Chinese Journal of Practical Internal Medicine , 编辑部邮箱 ,2003年07期
- 【分类号】R96
- 【被引频次】12
- 【下载频次】303