From the Department of Pediatrics (T.M.S., T.C.L.) and the Biostatistical Design and Analysis Center, Clinical and Translational Science Institute (A.M.B.), University of Minnesota, and Hennepin County Medical Center (T.M.S.) - both in Minneapolis; Center for Healthy Start Initiative (B.O.O.) and Massey Street Children's Hospital (A.A.E.), Lagos, Nigeria; and Department of Pediatrics, Stanford University, Stanford (H.J.V., R.J.W., D.K.S.), and the University of California, San Diego, San Diego (Y.E.V.) - both in California.
N Engl J Med. 2015 Sep 17;373(12):1115-24. doi: 10.1056/NEJMoa1501074.
Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown.
We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn.
We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 μW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion.
Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).
在无法有效实施常规光疗的地区，严重新生儿高胆红素血症的后遗症构成了重大疾病负担。我们之前发现，使用过滤后的阳光进行光疗是一种安全有效的方法，可以降低总胆红素。然而，与常规光疗相比，其安全性和疗效尚不清楚。
我们在尼日利亚一家大型城市妇产医院进行了一项随机、对照非劣效性试验，将过滤后的阳光与常规光疗进行比较，以治疗足月和晚期早产儿的高胆红素血症。主要终点是疗效，定义为对于 72 小时龄内的婴儿，总血清胆红素每小时增加不超过 0.2mg/dL；对于 72 小时龄以上的婴儿，在接受至少 5 小时光疗后总血清胆红素下降；我们预设了两组疗效率差异的非劣效性界值为 10%。换血的需要是次要终点。我们还评估了安全性，定义为由于发热、低体温、脱水或晒伤而需要停止治疗的情况。
我们纳入了 447 名婴儿，并将 224 名随机分配至过滤后的阳光组，223 名随机分配至常规光疗组。在可评估的治疗日中，过滤后的阳光组的疗效为 93%，而常规光疗组为 90%，且平均辐照度更高（40 对 17μW/cm2/nm，P<0.001）。5%接受过滤后的阳光治疗的婴儿体温高于 38.0°C，而 1%接受常规光疗的婴儿体温高于 38.0°C（P<0.001），但没有婴儿因安全性原因退出研究或需要换血。
过滤后的阳光在治疗新生儿高胆红素血症方面与常规光疗非劣效，且不会因安全性原因导致任何研究退出。（由盐湖城 Thrasher 研究基金和美国国立卫生研究院国家转化医学推进中心资助；临床试验.gov 编号，NCT01434810.）
