Tewari Vishal Vishnu, Jain Naveen
Neonatal Unit, Department of Pediatrics, Kerala Institute of Medical Sciences, Trivandrum, India.
J Trop Pediatr. 2014 Aug;60(4):297-302. doi: 10.1093/tropej/fmu017. Epub 2014 Apr 2.
Neonates at risk for early-onset sepsis are started on antibiotics empirically. Antibiotic resistance to conventionally used antibiotics is increasingly being reported. Antenatal maternal antibiotic exposure in this setting contributes to low yield on blood culture drawn at birth, limiting the planning of antibiotics based on culture reports. A head-to-head comparison for selecting the appropriate antibiotic is one strategy.
To compare monotherapy with amikacin against piperacillin-tazobactum as an empirical therapy in neonates at risk for early-onset sepsis.
Randomized open-label controlled trial with stratification and block randomization.
Tertiary care neonatal unit in India
All consecutive inborn neonates delivered between 01 May 2009 and 30 April 2011 who were ≥28 week gestation and/or ≥1000 g birth weight with risk factors for early-onset sepsis.
Randomized to receive either amikacin or piperacillin-tazobactum, after stratifying as asymptomatic or symptomatic within 1 h of birth.
Incidence of treatment failure to the allocated antibiotic defined as blood culture isolate reported resistant to the allocated antibiotic or progression of the illness, necessitating a change of antibiotic.
Of 204 eligible cases, 187 were enrolled. Seventeen babies were excluded. A total of 128 neonates were stratified as asymptomatic and 59 as symptomatic. In all, 64 of the asymptomatic cases received amikacin and 64 received piperacillin-tazobactum, while 29 symptomatic babies received amikacin and 30 received piperacillin-tazobactum. Five babies had blood culture-positive sepsis, and 28 babies had strong suspicion of sepsis. There was no difference in the treatment failure in the amikacin group (3 of 93; 3.2%) compared with piperacillin-tazobactum group (2 of 94; 2.1%) (p > 0.01) and no difference in the incidence of second infection, fungal sepsis and all-cause mortality at day 7 and 28 between the two study groups (p > 0.01).
Monotherapy with amikacin as an empirical antibiotic did not result in a higher incidence of treatment failure in neonates at risk for early-onset sepsis as compared with piperacillin-tazobactum. Both antibiotics were effective in management of babies with early-onset sepsis.
有早发型败血症风险的新生儿开始接受经验性抗生素治疗。对传统使用抗生素的耐药性报告日益增多。在这种情况下，产前母亲使用抗生素会导致出生时血培养阳性率低，限制了根据培养报告制定抗生素治疗方案。进行直接比较以选择合适的抗生素是一种策略。
比较阿米卡星单药治疗与哌拉西林 - 他唑巴坦作为有早发型败血症风险新生儿的经验性治疗。
分层和区组随机化的随机开放标签对照试验。
印度的三级护理新生儿病房
2009年5月1日至2011年4月30日期间出生的所有连续出生的新生儿，孕周≥28周和/或出生体重≥1000克，且有早发型败血症风险因素。
出生后1小时内根据有无症状分层，随机接受阿米卡星或哌拉西林 - 他唑巴坦治疗。
分配抗生素治疗失败的发生率，定义为血培养分离出对分配抗生素耐药或病情进展，需要更换抗生素。
204例符合条件的病例中，187例入组。17例婴儿被排除。共128例无症状新生儿分层，59例有症状。无症状病例中，64例接受阿米卡星，64例接受哌拉西林 - 他唑巴坦，有症状婴儿中，29例接受阿米卡星，30例接受哌拉西林 - 他唑巴坦。5例婴儿血培养确诊败血症，28例婴儿高度怀疑败血症。阿米卡星组治疗失败率（93例中有3例；3.2%）与哌拉西林 - 他唑巴坦组（94例中有2例；2.1%）相比无差异（p>0.01），两组在第7天和第28天的二次感染、真菌败血症和全因死亡率发生率也无差异（p>0.01）。
与哌拉西林 - 他唑巴坦相比，阿米卡星单药作为经验性抗生素治疗有早发型败血症风险的新生儿时，治疗失败率并未更高。两种抗生素对早发型败血症婴儿的治疗均有效。
