Morris Brenda H, Oh William, Tyson Jon E, Stevenson David K, Phelps Dale L, O'Shea T Michael, McDavid Georgia E, Perritt Rebecca L, Van Meurs Krisa P, Vohr Betty R, Grisby Cathy, Yao Qing, Pedroza Claudia, Das Abhik, Poole W Kenneth, Carlo Waldemar A, Duara Shahnaz, Laptook Abbot R, Salhab Walid A, Shankaran Seetha, Poindexter Brenda B, Fanaroff Avroy A, Walsh Michele C, Rasmussen Maynard R, Stoll Barbara J, Cotten C Michael, Donovan Edward F, Ehrenkranz Richard A, Guillet Ronnie, Higgins Rosemary D
University of Texas Medical School, Houston, TX 77030, USA.
N Engl J Med. 2008 Oct 30;359(18):1885-96. doi: 10.1056/NEJMoa0803024.
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 micromol 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.)
积极光疗预防胆红素神经毒性作用对极低出生体重（1000克或更低）婴儿是有益还是有害尚不清楚。
我们将1974例出生12至36小时的极低出生体重婴儿随机分组，分别接受积极或保守光疗。主要结局是由不知道治疗分组情况的研究者对91%的婴儿判定的死亡或神经发育障碍的复合结局。
与保守光疗相比，积极光疗显著降低了平均血清胆红素峰值水平（7.0比9.8毫克每分升[120比168微摩尔每升]，P<0.01），但未降低主要结局的发生率（52%比55%；相对危险度，0.94；95%置信区间[CI]，0.87至1.02；P=0.15）。积极光疗确实降低了神经发育障碍的发生率（26%，保守光疗为30%；相对危险度，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%（相对危险度，1.05；95%CI，0.90至1.22）。在预先计划的亚组分析中，出生体重751至1000克的婴儿，积极光疗组和保守光疗组的死亡率分别为13%和14%，出生体重501至750克的婴儿，死亡率分别为39%和34%（相对危险度，1.13；95%CI，0.96至1.34）。
积极光疗未显著降低死亡或神经发育障碍的发生率。单独来看，积极光疗显著降低了神经发育障碍的发生率。这种降低可能会被出生体重501至750克婴儿死亡率的增加所抵消。（ClinicalTrials.gov编号，NCT00114543。）
