Li J N, Chen Y M
Department of Neurology, the Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.
Zhonghua Yi Xue Za Zhi. 2016 Oct 25;96(39):3170-3177. doi: 10.3760/cma.j.issn.0376-2491.2016.39.012.
To systematically review the efficacy, side effects and case-fatality rate of levetiracetam (LEV) versus phenytoin (PHT) for seizure prophylaxis of brain injured patients. Randomized controlled trials of high quality about LEV versus PHT in seizure prophylaxis of brain injured patients from 2000 to 2016 were collected according to the key word PHT, LEV, brain injury in PubMed, Medline, Ovid, Springer, CNKI, Wanfang data and so on. Valid data were extracted to conduct meta-analysis by RevMan 5.3 software according to inclusion and exclusion criteria. A total of 13 English articles were finally included with 2 529 patients in total.Meta-analysis showed that no significant differences were observed in LEV versus PHT at preventing the occurrence of seizures (=0.88, 95%: 0.61-1.27). No superiority of either drug at preventing early seizures (=0.74, 95%: 0.42-1.27). As to the occurrence of late seizures, the differences of the two drugs were not statistically significant (=0.71, 95%: 0.43-1.20). Number of patients with side effect was not statistically significantly different between the two groups (=0.73, 95%: 0.48-1.11). But significant difference was found between LEV and PHT in discontinuation because of side effect (=0.11, 95%: 0.06-0.23); no significant differences were noted in the case-fatality rate of patients received pretreatment between the two drugs (=1.57, 95%: 0.92-2.67). There were no significant differences between the two groups in the length of stay (=-1.03, 95%: -4.97-2.91). LEV and PHT demonstrate equal efficacy in seizure prevention after brain injury. The differences are insignificant in the side effect, the case-fatality rate and the length of stay between LEV and PH treatment, but adverse drug reactions requiring change in therapy occur more in PHT. Phenytoin remains the first choice for seizure prevention after brain injury based on the existing evidence, while levetiracetam seems to be a favorable choice where there is risk of drug-drug interactions and drug toxicity. However, very few randomized controlled trials on this topic were found, and larger prospective trials are warranted.
系统评价左乙拉西坦（LEV）与苯妥英钠（PHT）预防脑损伤患者癫痫发作的疗效、副作用及病死率。根据关键词PHT、LEV、脑损伤，在PubMed、Medline、Ovid、Springer、中国知网、万方数据等数据库中收集2000年至2016年关于LEV与PHT预防脑损伤患者癫痫发作的高质量随机对照试验。按照纳入和排除标准提取有效数据，采用RevMan 5.3软件进行荟萃分析。最终共纳入13篇英文文章，总计2529例患者。荟萃分析显示，在预防癫痫发作方面，LEV与PHT之间未观察到显著差异（比值比=0.88，95%置信区间：0.61 - 1.27）。在预防早期癫痫发作方面，两种药物均无优势（比值比=0.74，95%置信区间：0.42 - 1.27）。至于晚期癫痫发作的发生，两种药物的差异无统计学意义（比值比=0.71，95%置信区间：0.43 - 1.20）。两组间副作用患者数量无统计学显著差异（比值比=0.73，95%置信区间：0.48 - 1.11）。但LEV与PHT在因副作用停药方面存在显著差异（比值比=0.11，95%置信区间：0.06 - 0.23）；两种药物治疗前患者的病死率无显著差异（比值比=1.57，95%置信区间：0.92 - 2.67）。两组住院时间无显著差异（均值差=-1.03，95%置信区间：-4.97 - 2.91）。LEV和PHT在预防脑损伤后癫痫发作方面疗效相当。LEV与PHT治疗在副作用、病死率和住院时间方面差异不显著，但PHT因药物不良反应而需要更改治疗的情况更多。基于现有证据，苯妥英钠仍是脑损伤后预防癫痫发作的首选药物，而左乙拉西坦在存在药物相互作用和药物毒性风险的情况下似乎是一个不错的选择。然而，关于该主题的随机对照试验极少，有必要开展更大规模的前瞻性试验。
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