Woodgate P, Flenady V, Steer P
Department of Neonatology, Mater Mothers Hospital, Raymond Terrace, South Brisbane, Queensland, Australia, 4101.
Cochrane Database Syst Rev. 2004;2004(3):CD003667. doi: 10.1002/14651858.CD003667.pub2.
Early-onset group B streptococcal disease (EOGBSD) is the most frequent cause of serious infection in the newborn period. Current strategies used to prevent EOGBSD are focused upon maternal antibiotic prophylaxis to reduce transmission of GBS to the infant. Observational studies have suggested that the administration of intramuscular penicillin to the newborn immediately following delivery may be an effective strategy to reduce the incidence of EOGBSD.
To determine if the administration of intramuscular penicillin to newborns at birth is a safe and effective method to prevent morbidity and mortality from EOGBSD.
The standard search strategy of the Neonatal Review Group was used. This included searches of electronic databases: Oxford Database of Perinatal Trials, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2004), and MEDLINE (1966 - Dec 2003); and previous reviews including cross references, expert informants and journal hand searching in the English language as well as conference and symposia proceedings published in Pediatric Research.
Randomised trials in which intramuscular penicillin was administered as prophylaxis for EOGBSD within four hours of birth.Outcomes considered were EOGBSD, neonatal mortality, late-onset GBSD, neonatal sepsis, and other secondary outcomes such as neurodevelopmental status and length of hospital stay.
The search for and assessment of trials for inclusion, quality assessment and data extraction were undertaken independently by the reviewers. Meta-analysis was not undertaken as data from only one trial is included in this review. Data were analysed using relative risk (RR) with 95% confidence intervals (CI).
One randomised controlled trial was included in this review. In this trial of 1187 infants of birthweight 501 to 2000 grams, there were no significant differences found for the outcomes of EOGBSD (RR 0.73; 95%CI 0.32, 1.62), or neonatal mortality (RR 0.78; 95% CI 0.55, 1.11). No other outcomes were able to be assessed.
REVIEWERS' CONCLUSIONS: This review does not support the routine use of intramuscular penicillin to prevent EOGBSD in newborn infants. There is a discrepancy between this finding and the results of a number of larger non-randomised trials. Explanations for this are proposed. There is a need for this intervention to be tested as a component of the existing prevention strategies in widespread use.
早发型B族链球菌病(EOGBSD)是新生儿期严重感染最常见的病因。目前用于预防EOGBSD的策略主要集中在对母亲进行抗生素预防以减少GBS传播给婴儿。观察性研究表明,分娩后立即给新生儿肌内注射青霉素可能是降低EOGBSD发病率的有效策略。
确定出生时给新生儿肌内注射青霉素是否是预防EOGBSD发病和死亡的安全有效方法。
采用了新生儿综述组的标准检索策略。这包括检索电子数据库:牛津围产期试验数据库、Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆2004年第1期)和MEDLINE(1966年至2003年12月);以及以往的综述,包括交叉参考文献、专家提供的信息,并手工检索英文期刊以及发表在《儿科研究》上的会议和研讨会论文集。
在出生后4小时内将肌内注射青霉素作为预防EOGBSD的随机试验。所考虑的结果包括EOGBSD、新生儿死亡率、晚发型GBSD、新生儿败血症以及其他次要结果,如神经发育状况和住院时间。
由评审人员独立进行试验的检索、纳入评估、质量评估和数据提取。由于本综述仅纳入了一项试验的数据,因此未进行荟萃分析。使用相对危险度(RR)及95%置信区间(CI)对数据进行分析。
本综述纳入了一项随机对照试验。在这项针对1187名出生体重为501至2000克婴儿的试验中,EOGBSD(RR 0.73;95%CI 0.32,1.62)或新生儿死亡率(RR 0.78;95%CI 0.55,1.11)的结果未发现显著差异。无法评估其他结果。
本综述不支持常规使用肌内注射青霉素预防新生儿EOGBSD。这一发现与一些较大规模的非随机试验结果存在差异。对此提出了解释。需要将这种干预措施作为广泛使用的现有预防策略的一个组成部分进行测试。