Shah Dharmesh, Sinn John K H
Neonatal Intensive Care Unit, Westmead Hospital, Sydney, Australia.
Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007448. doi: 10.1002/14651858.CD007448.pub2.
Although the exact aetiology of necrotising enterocolitis (NEC) remains unknown, research suggests that it is multifactorial; suspected pathophysiological mechanisms include immaturity, intestinal ischaemia, disruption of intestinal mucosal integrity, formula feeding, hyperosmolar load to the intestine, infection and bacterial translocation. Various antibiotic regimens have been widely used in the treatment of NEC.
To compare the efficacy of different antibiotic regimens on mortality and the need for surgery in neonates with NEC.
Searches were made of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2012), Oxford Database of Perinatal Trials, MEDLINE (1966 to February 2012), EMBASE (1980 to February 2012) and CINAHL (1982 to February 2012).
All randomised and quasi-randomised controlled trials where antibiotic regimens were used for treatment of NEC.
Eligibility of studies for inclusion was assessed independently by each review author. The criteria and standard methods of the Cochrane Neonatal Review Group were used to assess the methodological quality of the included trials.
Two trials met the inclusion criteria. Faix 1988 randomised 42 premature infants with radiological diagnosis of NEC. Infants were randomised to receive either intravenous ampicillin and gentamicin or ampicillin, gentamicin and clindamycin. Hansen 1980 randomised 20 infants with NEC to receive intravenous ampicillin and gentamicin with or without enteral gentamicin.In the study by Faix 1988, there were no statistical differences in mortality (RR 1.10; 95% CI 0.32 to 3.83) or bowel perforation (RR 2.20; 95% CI 0.45 to 10.74) between the two groups although there was a trend towards higher rate of strictures in the group that received clindamycin (RR 7.20; 95% CI 0.97 to 53.36).The Hansen 1980 study showed no statistically significant difference in death, bowel perforation or development of strictures.
AUTHORS' CONCLUSIONS: There was insufficient evidence to recommend a particular antibiotic regimen for the treatment of NEC. There were concerns about adverse effects following the usage of clindamycin, related to the development of strictures. To address this issue a large randomised controlled trial needs to be performed.
尽管坏死性小肠结肠炎(NEC)的确切病因尚不清楚,但研究表明其病因是多因素的;推测的病理生理机制包括不成熟、肠道缺血、肠黏膜完整性破坏、配方奶喂养、肠道高渗负荷、感染及细菌易位。各种抗生素方案已广泛用于NEC的治疗。
比较不同抗生素方案治疗新生儿NEC的死亡率及手术需求的疗效。
检索了Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆,2012年第1期)、牛津围产期试验数据库、MEDLINE(1966年至2012年2月)、EMBASE(1980年至2012年2月)和CINAHL(1982年至2012年2月)。
所有使用抗生素方案治疗NEC的随机和半随机对照试验。
纳入研究的合格性由每位综述作者独立评估。采用Cochrane新生儿综述组的标准和方法评估纳入试验的方法学质量。
两项试验符合纳入标准。Faix 1988年将42例经放射学诊断为NEC的早产儿随机分组。婴儿被随机分配接受静脉氨苄西林和庆大霉素或氨苄西林、庆大霉素和克林霉素治疗。Hansen 1980年将20例NEC婴儿随机分组,接受静脉氨苄西林和庆大霉素治疗,部分加用肠内庆大霉素。在Faix 1988年的研究中,两组之间的死亡率(RR 1.10;95%CI 0.32至3.83)或肠穿孔(RR 2.20;95%CI 0.45至10.74)无统计学差异,尽管接受克林霉素治疗的组中狭窄发生率有升高趋势(RR 7.20;95%CI 0.97至53.36)。Hansen 1980年的研究显示,在死亡、肠穿孔或狭窄形成方面无统计学显著差异。
没有足够证据推荐特定抗生素方案用于NEC的治疗。使用克林霉素后出现与狭窄形成相关的不良反应令人担忧。为解决这一问题,需要进行一项大型随机对照试验。