Odio C M, Puig J R, Feris J M, Khan W N, Rodriguez W J, McCracken G H, Bradley J S
Children's Hospital and Health Science Center, School of Medicine, Universidad Autónoma de Centro América, San José, Costa Rica.
Pediatr Infect Dis J. 1999 Jul;18(7):581-90. doi: 10.1097/00006454-199907000-00004.
To compare the efficacy and safety of meropenem with cefotaxime for the treatment of infants and children with bacterial meningitis.
Infants and children with strongly suspected or documented bacterial meningitis were randomly assigned in a prospective multicenter study to receive either meropenem or cefotaxime. Patients were assessed at the end of therapy and at 5 to 7 weeks and 5 to 7 months after the end of treatment for the presence of neurologic and sensory neural sequelae.
A total of 258 children were randomized to either treatment group. A further 8 patients with suspected pneumococcal meningitis were treated with meropenem without randomization. Of the randomized patients 154 were fully evaluable, 79 in the meropenem group and 75 in the cefotaxime group. At the end of treatment there were no significant differences in clinical outcome between the two treatment groups. Clinical cure with or without sequelae was achieved in 97 and 96% of the meropenem- and cefotaxime-treated patients, respectively. At the end of treatment and at 5 to 7 weeks, 46 and 54% of meropenem patients were cured with no sequelae, respectively. Corresponding results for cefotaxime patients were 56 and 58%. All pathogens were eradicated. In total 37 patients had seizures during treatment, 15 (12%) in the meropenem and 22 (17%) in the cefotaxime group. None of the seizures was considered to be drug-related.
This trial shows that meropenem is suitable therapy for bacterial meningitis in infants and children and that it offers an efficacy and safety profile similar to that of cefotaxime.
比较美罗培南与头孢噻肟治疗婴幼儿细菌性脑膜炎的疗效和安全性。
在一项前瞻性多中心研究中，将高度怀疑或确诊为细菌性脑膜炎的婴幼儿随机分组，分别接受美罗培南或头孢噻肟治疗。在治疗结束时、治疗结束后5至7周以及5至7个月时，对患者进行评估，以确定是否存在神经和感觉神经后遗症。
共有258名儿童被随机分配至任一治疗组。另有8名疑似肺炎球菌脑膜炎的患者未参与随机分组，接受了美罗培南治疗。在随机分组的患者中，154名可进行全面评估，美罗培南组79名，头孢噻肟组75名。治疗结束时，两个治疗组的临床结局无显著差异。美罗培南组和头孢噻肟组临床治愈（无论有无后遗症）的患者分别为97%和96%。治疗结束时以及5至7周时，美罗培南组分别有46%和54%的患者治愈且无后遗症。头孢噻肟组的相应结果分别为56%和58%。所有病原体均被清除。治疗期间共有37名患者发生癫痫，美罗培南组15名（12%），头孢噻肟组22名（17%）。所有癫痫发作均不被认为与药物相关。
本试验表明，美罗培南是治疗婴幼儿细菌性脑膜炎的合适药物，其疗效和安全性与头孢噻肟相似。
