抗惊厥药治疗足月新生儿围生期窒息临床疗效的Meta分析

Meta-analysis of clinical effectiveness of anticonvulsants for full term newborns with perinatal asphyxia

目的总结国内、外抗惊厥药治疗新生儿围生期窒息文献的研究结果,采用Meta分析方法综合评价抗惊厥药治疗新生儿围生期窒息临床疗效,探讨抗惊厥药治疗新生儿围生期窒息的可能性。方法制定原始文献的纳入标准、排除标准及检索策略,检索PubMed、EMBASE、Ovid、Springer和中国期刊全文数据库等,获得抗惊厥药治疗新生儿围生期窒息的相关文献,使用国际Cochrane中心推荐的方法进行文献质量评价,以病死率、严重神经系统发育障碍发生率、新生儿期惊厥发生率和不良反应发生率等作为观察指标,进行定性和定量综合评估。采用RevMan 4.22软件进行Meta分析。结果依据纳入和排除标准,共纳入5篇RCT文献,其中文献质量评价1篇为B级,4篇为C级。治疗组4篇文献予苯巴比妥治疗,1篇文献予硫喷妥钠治疗;对照组均予常规治疗。Meta分析结果显示:抗惊厥药治疗组与对照组比较,病死率差异无统计学意义(RR=1.13,95%CI:0.59～2.17);严重神经系统发育障碍发生率差异无统计学意义(RR=0.61,95%CI:0.30～1.22);死亡和严重神经系统发育障碍合并发生率差异无统计学意义(RR=0.65,95%CI:0.30～1.41);新生儿期惊厥发生率差异无统计学意义(RR=0.76,95%CI:0.45～1.31)。结论目前,不建议对存在围生期窒息的足月新生儿给予抗惊厥药作为临床常规治疗。远期疗效仍需多中心和大样本RCT研究来检验抗惊厥药治疗新生儿围生期窒息对降低病死率或严重神经系统发育障碍发生率的效用。

Objective The aim of this study was to evaluate the studies of anticonvulsants in the management of neonatal perinatal asphyxia by performing a systematic review of the literature with a meta-analysis method. In order to assess the clinical effectiveness of antieonvulsants for neonatal perinatal asphyxia, discussed the possibility of the antieonvulsants treatment for perinatal asphyxia. Methods PubMed, EMBASE, Ovid, Springer and CNKI databases were searched in two languages （ English and Chinese） by using the anticonvulsants, term infants and perinatal asphyxia for human clinical trials, including unpublished documents from scientific meetings and theses, and the similar documents listed in the reference of above documents were also included. All randomised or quasi-randomised controlled clinical trials that reported data comparing the following outcomes： mortality, neurodevelopmental disability, neonatal seizures and adverse events, following antieonvulsant therapy in term infants compared to controls （with or without placebo） following perinatal asphyxia. Results According to inclusion and exclusion criteria, five randomized or quasi-randomised controlled trials were included, which quality grades were C in 4 RCTs and B in 1 RCT. The results of meta analysis showed there was no significant on mortality compared anticonvulsant therapy group with controls （ RR = 1.13,95 % CI：0.59 - 2.17 ）. There was also no significance on severe neurodevelopmental disability （ RR = 0.61,95 % CI ： 0.30 - 1.22）, death and severe neurodevelopmental disability （ RR = 0.65,95% CI： 0.30 - 1.41 ） and neonatal seizures （ RR = 0.76,95% CI：0.45 - 1.31 ） . Conclusions Anticonvulsant therapy to term infants following perinatal asphyxia cannot be recommended for routine clinical practice now. Any future studies should be of high quality, randomised control trials, sufficient size, with minimal attrition, to have the power to confirm clinically important reductions in mortality and severe neurodevelopmental disability.