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目的评估氟康唑预防新生儿重症监护室极低出生体重儿侵袭性真菌感染的临床疗效。方法采用回顾性对照分析的方法,随机抽取2012年1月至2015年12月于郑州市妇幼保健院新生儿重症监护室住院的极低出生体重儿80例,随机分为预防组40例和对照组40例。所有患儿住院后均给予保暖、心电监护、肠外营养等对症支持治疗。两组患儿分别给予氟康唑(6mg/kg)或安慰剂治疗,第1~2周每72 h1次,第3~4周每48 h1次,4周后停药。持续观察至出院或28 d,研究的主要终点是患儿侵袭性真菌感染,次要终点是患儿真菌感染的归因死亡率或全因死亡率。结果与对照组患儿相比,氟康唑预防组发生侵袭性真菌感染的风险较低(43.2%,95%Cl 0.09~0.37,P<0.05)。其中,绝对危险降低率(ARR)22.2%,需治疗人数(NNT)5。氟康唑预防组的真菌感染死亡率较对照组低(2.6%:18.9%,95%Cl 0.003~0.52,P<0.05)。结论新生儿重症监护室极低出生体重儿氟康唑的预防性应用能够降低真菌感染的风险和死亡率。
Objective To evaluate the clinical efficacy of fluconazole in preventing invasive fungal infections in very low birth weight infants in neonatal intensive care unit. Methods A retrospective analysis of the method of random selection from January 2012 to December 2015 in Zhengzhou Maternal and Child Health Hospital neonatal intensive care unit hospitalized 80 cases of very low birth weight children were randomly divided into prevention group 40 cases and control Group of 40 cases. All children were hospitalized after giving warm, ECG monitoring, parenteral nutrition and other symptomatic and supportive treatment. Two groups of children were given fluconazole (6mg / kg) or placebo treatment, 1 to 2 weeks every 72 h1 times, 3 to 4 weeks every 48 h1 times, 4 weeks after the withdrawal. Continuous observation until discharge or 28 days, the primary endpoint of the study was invasive fungal infection in children, the secondary end point was the attributable or all-cause mortality of fungal infections in children. Results There was a lower risk of invasive fungal infection in the fluconazole prophylaxis group than in the control group (43.2%, 95% Cl 0.09-0.37, P <0.05). Among them, the absolute risk reduction rate (ARR) 22.2%, the number of people to be treated (NNT) 5. The mortality from fungal infection in the fluconazole-treated group was lower than that in the control group (2.6%: 18.9%, 95% Cl 0.003-0.52, P <0.05). Conclusion The prophylactic use of fluconazole in neonates with very low birth weight in intensive care units can reduce the risk and mortality of fungal infections.