Kirpal Harita, Gathwala Geeta, Chaudhary Uma, Sharma Deepak
a Department of Paediatrics .
b Department of Microbiology , Pt. B.D. Sharma PGIMS , Rohtak , Haryana , India , and.
J Matern Fetal Neonatal Med. 2016;29(4):624-8. doi: 10.3109/14767058.2015.1013933. Epub 2015 Feb 24.
To evaluate the effect of fluconazole prophylaxis on invasive fungal infection (IFI) in very low birth weight (VLBW) infants in the Neonatal Intensive Care Unit (NICU).
VLBW infants receiving antibiotics for more than 3 days were randomized to receive either fluconazole (6 mg/kg) or placebo, every other day for 7 days followed by everyday till day 28 or discharge whichever was earlier. The primary outcome was IFI, and secondary outcome was fungal attributable mortality and all-cause mortality.
The incidence of IFI was significantly lower (21%) in the fluconazole group compared to the control group (43.2%, 95%CI 0.09-0.37, p < 0.05). The ARR (absolute risk reduction) was 22.2% and the NNT (number needed to treat) was 5. Fungal attributable mortality was also lower in the fluconazole group (2.6% versus 18.9%, 95%CI 0.003-0.52, p < 0.05).
In VLBW neonates on the NICU, use of fluconazole prophylaxis decreases IFI and fungal attributable mortality.
评估氟康唑预防性用药对新生儿重症监护病房（NICU）极低出生体重（VLBW）婴儿侵袭性真菌感染（IFI）的影响。
接受抗生素治疗超过3天的VLBW婴儿被随机分为两组，一组每隔一天接受氟康唑（6mg/kg）治疗，共7天，之后每天治疗直至第28天或更早出院；另一组接受安慰剂治疗。主要结局指标为IFI，次要结局指标为真菌所致死亡率和全因死亡率。
氟康唑组的IFI发生率（21%）显著低于对照组（43.2%，95%CI 0.09 - 0.37，p < 0.05）。绝对风险降低率（ARR）为22.2%，需治疗人数（NNT）为5。氟康唑组的真菌所致死亡率也较低（2.6%对18.9%，95%CI 0.003 - 0.52，p < 0.05）。
在NICU的VLBW新生儿中，预防性使用氟康唑可降低IFI和真菌所致死亡率。
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