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随机安慰剂对照试验局部应用莫匹罗星减少新生儿重症监护病房婴儿金黄色葡萄球菌定植。

Randomized Placebo-Controlled Trial of Topical Mupirocin to Reduce Staphylococcus aureus Colonization in Infants in the Neonatal Intensive Care Unit.

机构信息

Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY; Department of Neonatology, Crouse Hospital, Syracuse, NY.

Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY.

出版信息

J Pediatr. 2021 Sep;236:70-77. doi: 10.1016/j.jpeds.2021.05.042. Epub 2021 May 21.

DOI:10.1016/j.jpeds.2021.05.042
PMID:34023342
Abstract

OBJECTIVE

To evaluate the efficacy of topical mupirocin in reducing Staphylococcus aureus colonization in infants in the neonatal intensive care unit (NICU).

STUDY DESIGN

A prospective double-blind randomized controlled trial of mupirocin vs placebo in S aureus-colonized infants was conducted in a tertiary care NICU between October 2016 and December 2019. Weekly universal active surveillance with polymerase chain reaction screening identified colonized infants. Colonized infants received a 5-day course of mupirocin (mupirocin group) or petroleum jelly (control group). Repeat courses were given for additional positive screens.

RESULTS

A total of 216 infants were enrolled; 205 were included in data analyses. Primary decolonization was more successful for mupirocin-treated infants (86 of 104 [83%]) than for controls (20 of 101; 20%) (P < .001). Although recurrent S aureus colonization occurred frequently (59 of 81 [73%] mupirocin-treated and 26 of 33 [79%] controls), subsequent decolonization remained more successful for mupirocin-treated infants than for controls (38 of 49 [78%] vs 2 of 21 [10%]; P < .001). Subgroup analyses of infants of ≤30 weeks' gestational age yielded similar results; decolonization occurred more often in mupirocin-treated infants compared with control infants (63 of 76 [83%] vs 13 of 74 [18%]; P < .001). Bacterial sterile site infections tended to be less frequent in mupirocin-treated infants compared with controls (2 of 104 [2%] vs 8 of 101 [8%]; P = .057). No invasive S aureus infections occurred in mupirocin-treated infants, but 50% of infections in controls were from S aureus, and 1 resulted in death.

CONCLUSIONS

Universal active surveillance and targeted treatment with topical mupirocin is a successful decolonization strategy for NICU infants and may prevent S aureus infection. However, S aureus colonization frequently recurs, necessitating repeat treatment.

TRIAL REGISTRATION

Clinicaltrials.gov: NCT02967432.

摘要

目的

评估局部莫匹罗星在减少新生儿重症监护病房(NICU)中金黄色葡萄球菌定植的疗效。

研究设计

2016 年 10 月至 2019 年 12 月,在一家三级护理 NICU 中进行了一项莫匹罗星与安慰剂治疗金黄色葡萄球菌定植婴儿的前瞻性双盲随机对照试验。每周进行通用主动监测,采用聚合酶链反应(PCR)筛查确定定植的婴儿。定植的婴儿接受为期 5 天的莫匹罗星(莫匹罗星组)或凡士林(对照组)疗程。对额外的阳性筛查进行重复疗程。

结果

共有 216 名婴儿入组;205 名婴儿纳入数据分析。莫匹罗星治疗组(86/104 [83%])的主要去定植效果优于对照组(20/101;20%)(P<0.001)。尽管金黄色葡萄球菌再次定植频繁(莫匹罗星治疗组 59/81 [73%],对照组 26/33 [79%]),但随后的去定植治疗仍对莫匹罗星治疗组婴儿更有效,而对照组则不然(49/81 [78%]对 2/33 [10%];P<0.001)。对≤30 周胎龄婴儿的亚组分析得出了相似的结果;与对照组婴儿相比,莫匹罗星治疗组婴儿去定植更常见(63/76 [83%]对 13/74 [18%];P<0.001)。与对照组相比,莫匹罗星治疗组婴儿的无菌部位感染发生率较低(2/104 [2%]对 8/101 [8%];P=0.057)。莫匹罗星治疗组婴儿未发生侵袭性金黄色葡萄球菌感染,但对照组 50%的感染为金黄色葡萄球菌,其中 1 例导致死亡。

结论

通用主动监测和局部莫匹罗星靶向治疗是 NICU 婴儿成功的去定植策略,可预防金黄色葡萄球菌感染。然而,金黄色葡萄球菌定植经常复发,需要重复治疗。

试验注册

Clinicaltrials.gov:NCT02967432。

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