丙戊酸钠缓释片和丙戊酸半钠缓释片致女性月经紊乱6例研究

目的健康受试者空腹口服丙戊酸半钠缓释片与丙戊酸钠缓释片后,测定血浆中丙戊酸的浓度,比较空腹口服丙戊酸半钠缓释片与丙戊酸钠缓释片的药代动力学。方法采用DAS 2.1.1软件随机,依据受试者入组顺序将受试者随机分组,进行3周期自身交叉试验;分别于3个周期空腹口服丙戊酸半钠缓释片、空腹口服丙戊酸钠缓释片、餐后口服丙戊酸半钠缓释片各1次,清洗期为1周。结果 6例女性受试者间断口服丙戊酸钠缓释片或丙戊酸半钠缓释片1~3次,有5例出现月经紊乱。结论女性癫痫患者开始和短期口服丙戊酸钠缓释片或丙戊酸半钠缓释片对月经周期影响值得临床关注。

Objective Healthy subjects respectively fasting and postprandial oral divalproex sodium sustained-release tablets and determinationof the concentration of valproic acid in plasma and fasting serum to medicine and food to pharmacokinetics of divalproex sodium sustained-releasetablets medicine. Methods Using das 2.1.1 software randomly, according to the subjects in order group subjects were randomly divided into twogroups, were 3 cycle crossover trial, respectively in the three cycles of fasting oral valproic acid semi sodium sustained-release tablets, fasting oralsustained-release sodium valproate tablets, postprandial oral divalproex sodium sustained-release tablets 1 times each, wash out period for 1 week.Results 6 cases of female subjects discontinuous semi sodium oral sustained-release sodium valproate tablets or valproate sustained-release tablets 1-3 times, 5 cases of menstrual disorders. Conclusion Women with epilepsy and short-term oral sustained-release sodium valproate tablets or valproicacid semi sodium sustained-release tablets on the menstrual cycle effect is worthy of attention.