Aggressive vs. conservative phototherapy for infants with extremely low birth weight.
Aggressive vs. conservative phototherapy for infants with extremely low birth weight.
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DOI：
10.1056/nejmoa0803024
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发表时间：
2008-10-30
期刊：
影响因子：
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通讯作者：
NICHD Neonatal Research Network
中科院分区：
文献类型：
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作者：
Morris BH;Oh W;Tyson JE;Stevenson DK;Phelps DL;O'Shea TM;McDavid GE;Perritt RL;Van Meurs KP;Vohr BR;Grisby C;Yao Q;Pedroza C;Das A;Poole WK;Carlo WA;Duara S;Laptook AR;Salhab WA;Shankaran S;Poindexter BB;Fanaroff AA;Walsh MC;Rasmussen MR;Stoll BJ;Cotten CM;Donovan EF;Ehrenkranz RA;Guillet R;Higgins RD;NICHD Neonatal Research Network
目前尚不清楚为预防胆红素的神经毒性作用而进行的积极光疗是否有益或有害于极低出生体重（1000 克或以下）的婴儿。我们随机分配 1974 名 12 至 36 小时出生体重极低的婴儿接受积极或保守的光疗。主要结局是由不了解治疗分配的研究人员确定的 91% 婴儿死亡或神经发育障碍的综合结果。与保守光疗相比，积极光疗显着降低了平均血清胆红素峰值水平（7.0 vs. 9.8 mg/dL [120 vs. 168 μmol/L]，P<0.01），但主要结局发生率没有降低（52% vs. 55%；相对风险，0.94；95% 置信区间 [CI]，0.87 至 1.02；P = 0.15）。积极的光疗确实降低了神经发育障碍的发生率（保守光疗为 26%，保守光疗为 30%；相对风险，0.86；95% CI，0.74 至 0.99）。积极光疗组和保守光疗组的死亡率分别为 24% 和 23%（相对风险，1.05；95% CI，0.90 至 1.22）。在预先计划的亚组分析中，出生体重为 751 至 1000 克的婴儿，积极光疗的死亡率为 13%，保守光疗的死亡率为 14%；出生体重为 501 至 750 克的婴儿，死亡率分别为 39% 和 34%（相对风险，1.13；95% CI，0.96 至 1.34）。积极的光疗并没有显着降低死亡率或神经发育障碍的发生率。积极的光疗可显着降低单独神经发育障碍的发生率。这种下降可能会被出生时体重为 501 至 750 克的婴儿死亡率的增加所抵消。 （临床试验。政府编号，NCT00114543。）
It is unclear whether aggressive phototherapy to prevent neurotoxic effects of bilirubin benefits or harms infants with extremely low birth weight (1000 g or less). We randomly assigned 1974 infants with extremely low birth weight at 12 to 36 hours of age to undergo either aggressive or conservative phototherapy. The primary outcome was a composite of death or neurodevelopmental impairment determined for 91% of the infants by investigators who were unaware of the treatment assignments. Aggressive phototherapy, as compared with conservative phototherapy, significantly reduced the mean peak serum bilirubin level (7.0 vs. 9.8 mg per deciliter [120 vs. 168 μmol per liter], P<0.01) but not the rate of the primary outcome (52% vs. 55%; relative risk, 0.94; 95% confidence interval [CI], 0.87 to 1.02; P = 0.15). Aggressive phototherapy did reduce rates of neurodevelopmental impairment (26%, vs. 30% for conservative phototherapy; relative risk, 0.86; 95% CI, 0.74 to 0.99). Rates of death in the aggressive-phototherapy and conservative-phototherapy groups were 24% and 23%, respectively (relative risk, 1.05; 95% CI, 0.90 to 1.22). In preplanned subgroup analyses, the rates of death were 13% with aggressive phototherapy and 14% with conservative phototherapy for infants with a birth weight of 751 to 1000 g and 39% and 34%, respectively (relative risk, 1.13; 95% CI, 0.96 to 1.34), for infants with a birth weight of 501 to 750 g. Aggressive phototherapy did not significantly reduce the rate of death or neurodevelopmental impairment. The rate of neurodevelopmental impairment alone was significantly reduced with aggressive phototherapy. This reduction may be offset by an increase in mortality among infants weighing 501 to 750 g at birth. (ClinicalTrials. gov number, NCT00114543.)