托吡酯添加治疗难治性癫痫Meta分析

The Meta Analysis on Topiramate as Open Add-on Therapy for Refractory Epilepsy

目的综合评价托吡酯(Topiramate TPM)添加治疗难治性癫痫的疗效及耐受性。方法利用中国生物医学文献数据库(CBM disc)检索2001年1月至2002年12月共21项相关研究。选择研究的标准限定在神经科专业期刊的论著性文章。每一研究的样本量大于10。入组病例年龄2岁以上。结果 13项研究(n=1095)符合纳入标准。均系自身对照开放性研究。在资料完整13项研究中,完全缓解率为23.8%,有效率为61.5%,无效率为10.1%。有关的不良反应集中在体重减轻237例(21.6%),嗜睡68例(6.2%),肢体麻木63例(5.7%),厌食72例(6.5%),头痛头晕59例(5.3%),其他103例(9.4%)。去除研究结果描述略为粗糙及样本含量偏小的4项研究后,完全缓解率、有效率、无效率及有关不良反应的比例与上述结果相近(P>0.01;P>0.05)。结论托吡酯添加治疗难治性癫痫疗效确切,不良反应多在可耐受范围,临床上应注意各年龄段、不同发作类型亚组之间有关疗效及不良反应的研究。

Objective To evaluate the antiepileptic efficacy and tolerability of topiramate as open add-on therapy for refractory epilepsy synthetically.Methods:The 21 projects of associated studies from 2001.1 to 2002.12 were refered by Chinese Biology Medical disc(CBM disc) .The studies selected were restricted to the original articles within journal of neurology.The sample size for each study was above 10.The age of patients enrolled the study was above 2.Results:There are 13 projects that were open-label self-control studys(n=1095)eligible for the cri- teria for enrolling.In the 13 studyies with intact dnta,the complete relieving ratio,effective ratio and no effective ratio reported were 23.8%, 61.5% and 10.1% respectively.The adverse reactions focus on weight loss(237 cases)(21.6%),sonmolenec(68 cases)(6.2%),paraes- thesia(63 cases)(5.7%),anorexia 72 cases(6.5%),headache and dizziness(59 cases)(5.3%),others(103 cases)(9.4%) .Except four studies with incomplete data and smaller sample size there was no significant differences on the complete relieving ratio,effective ratio and no effective ratio compared with results mentioned above.Conclusions:The effects of topiramate for adjunctive treatment to refractory epilepsy is certain.The most of adverse reaction of topiramate is well-tolerated.The attention should he paid to on efficacy and adverse event a- mong subgroup as different age period and seizure type,in further study.