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口服万古霉素预防早产极低出生体重儿坏死性小肠结肠炎的双盲、随机、安慰剂对照研究

Double blind, randomised, placebo controlled study of oral vancomycin in prevention of necrotising enterocolitis in preterm, very low birthweight infants.

作者信息

Siu Y K, Ng P C, Fung S C, Lee C H, Wong M Y, Fok T F, So K W, Cheung K L, Wong W, Cheng A F

机构信息

Department of Paediatrics, Prince of Wales Hospital, Chinese University of Hong Kong, People's Republic of China.

出版信息

Arch Dis Child Fetal Neonatal Ed. 1998 Sep;79(2):F105-9. doi: 10.1136/fn.79.2.f105.

Abstract

AIMS

To evaluate the effectiveness of oral vancomycin in the prophylaxis of necrotising enterocolitis in preterm, very low birthweight infants.

METHODS

A prospective, double blind, randomised, placebo controlled study in a tertiary referral centre of a university teaching hospital was conducted on 140 very low birthweight infants consecutively admitted to the neonatal unit. The babies were randomly allocated to receive oral vancomycin (15 mg/kg every 8 hours for 7 days) or an equivalent volume of placebo solution. Prophylaxis was started 24 hours before the start of oral feeds. All suspected cases of necrotising enterocolitis were investigated with a full sepsis screen and serial abdominal radiographs. Necrotising enterocolitis was diagnosed and staged according to modified Bell's criteria.

RESULTS

Nine of 71 infants receiving oral vancomycin and 19 of 69 infants receiving the placebo solution developed necrotising enterocolitis (p = 0.035). Infants with necrotising enterocolitis were associated with a significant increase in mortality (p = 0.026) and longer duration of hospital stay (p = 0.002).

CONCLUSIONS

Prophylactic oral vancomycin conferred protection against necrotising enterocolitis in preterm, very low birthweight infants and was associated with a 50% reduction in the incidence. However, widespread implementation of this preventive measure is not recommended, as it would only be effective in necrotising enterocolitis caused by Gram positive organisms and could increase the danger of the emergence of vancomycin resistant or dependent organisms. Its use should be restricted to a high prevalence nursery for a short and well defined period in a selected group of high risk patients.

摘要

目的

评估口服万古霉素对早产、极低出生体重儿坏死性小肠结肠炎的预防效果。

方法

在一所大学教学医院的三级转诊中心,对140名连续入住新生儿病房的极低出生体重儿进行了一项前瞻性、双盲、随机、安慰剂对照研究。将婴儿随机分配接受口服万古霉素(每8小时15毫克/千克,共7天)或等量的安慰剂溶液。在开始经口喂养前24小时开始预防。所有疑似坏死性小肠结肠炎病例均进行全面的败血症筛查和系列腹部X线检查。根据改良的贝尔标准诊断并分期坏死性小肠结肠炎。

结果

接受口服万古霉素的71名婴儿中有9名发生坏死性小肠结肠炎,接受安慰剂溶液的69名婴儿中有19名发生坏死性小肠结肠炎(p = 0.035)。坏死性小肠结肠炎婴儿的死亡率显著增加(p = 0.026),住院时间延长(p = 0.002)。

结论

预防性口服万古霉素可预防早产、极低出生体重儿坏死性小肠结肠炎,发病率降低50%。然而,不建议广泛实施这一预防措施,因为它仅对革兰氏阳性菌引起的坏死性小肠结肠炎有效,且可能增加万古霉素耐药或依赖菌出现的风险。其使用应仅限于高危患者特定组中短时间且明确的高发病率保育室。

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