奥卡西平单药治疗和辅加治疗对国人癫疗效和副反应的对照研究

The comparison research of therapeutic effect and side reaction of oxcarbazepine(OXC) between the monotherapy group and the auxiliary therapy group

目的评价奥卡西平(OXC)作为辅加药物治疗癫(Ⅰ组)以及单药治疗新诊断癫患者(Ⅱ组)在疗效、毒副作用方面的差异。方法Ⅰ组101例以OXC作为辅助添加剂治疗(OXC150～1200mg/d,中位数600mg/d),Ⅱ组23例以OXC作为单药治疗(OXC150～600mg/d,中位数450mg/d),随访3～25月;对2组患者治疗前后的发作频率、初始目标剂量、退出治疗情况、毒副作用进行对照分析或描述比较。结果Ⅰ、Ⅱ组发作控制率有非常显著性差异(P<0.01),两组总有效率无显著性差异(P>0.05);2组的初始目标剂量无显著性差异(P>0.05);2组因经济原因和毒副作用原因退出治疗的发生率无显著性差异(P>0.05),Ⅱ组的一般副作用发生率高于Ⅰ组(P<0.05)。结论OXC单药治疗国人新诊断的SPS,CPS,SGS的控制率优于作为辅加药物治疗癫,2组总有效率无显著性差异,初始目标剂量和退出治疗的发生率相近;OXC毒副作用相对较少、治疗范围大、用药和换药方便;在辅加治疗组患者对OXC的价格的承受力呈下降的趋势。

Objective To evaluate differents of curative effects and safety of OXC between the monotherapy group （ Ⅰ group） and the auxiliary therapy group （ Ⅱ group） in chinese. Methods The patients of I group （101 cases having had many AEDs （antiepileptic drugs） with poor efficacy） in turn entered into add-on therapy group （OXC 150- 1200 mg/day, median 600 mg/day）, and the patients of Ⅱ group （23 newly diagnosed patients） entered into monotherapy group （OXC 150- 600 mg/day, median 450 nag/day）. All patients were followed and observed for 3 - 25 months. The seizure frequents and side effects of the two groups were contrastted, analysed or described before and after treatment. Results The seizure free rates were respectively 24. 69% in Ⅰ group and 70. 00% in Ⅱ group. The difference betweem the groups was significant （P〈0. 01）. The total effective rates were 65.43% and 85. 00% in the two groups respectively. The difference between the groups was not significant （P〉0. 05）. The difference of initial goal dosage betweem the groups was not significant （P〉0. 05）. The difference of the exiting rates between the groups was not significant （P〉0. 05） for the source of economy or side effects. The side effect includes the central nerve system reaction and the usual reaction, and th4 occuring rates of usual reaction in the Ⅱgroup was higher than in the Ⅰ group （P〈0. 05）. Conclusions The seizure free rates of OXC as a monotherapy treatment in the newly diagnosed chinese epileptic patients was superior to as a auxiliary therapy treatment. The difference of the total effective rates between the groups was not significant. The initial goal dosage and the exiting rate were similar in the tow groups. OXC has less side effects, and it is a safetive and effective drug, its uses and replasement are easy. The tolerant degree of price of OXC showed a declining tendency in the add-on therapy group.