过滤阳光光疗用于中重度高胆红素血症新生儿：一项随机试验。

Filtered-sunlight phototherapy for newborns with moderate-to-severe hyperbilirubinemia: a randomized trial.

作者信息

Olusanya Bolajoko O, Omololu Olufemi M, Osamebor Folashade B, Olufosoye Anuoluwapo, Alo Temitope, Olaifa Serah M, Emokpae Abieyuwa A, Olusanya Jacob O, Mabogunje Cecilia A

机构信息

Centre for Healthy Start Initiative, Ikoyi, Lagos, Nigeria.

Lagos Island Maternity Hospital, Lagos, Nigeria.

出版信息

Pediatr Res. 2025 Jun 28. doi: 10.1038/s41390-025-04207-6.

DOI:10.1038/s41390-025-04207-6

PMID:40581699

Abstract

BACKGROUND

Filtered-sunlight phototherapy (FSPT) is safe and non-inferior to conventional phototherapy for treating mild-to-moderate hyperbilirubinemia during birth hospitalization. We evaluated the performance of FSPT among newborns with moderate-to-severe hyperbilirubinemia.

METHODS

Newborns were randomized to FSPT or intensive electric phototherapy (IEPT). Primary outcomes were safety, defined as the absence of hyperthermia, hypothermia, dehydration, or sunburn; and efficacy, defined as the rate of increase in total serum or plasma bilirubin (TSB) < 3.4 µmol/L/h for newborns aged ≤72 h or a decrease in TSB for newborns aged >72 h who received ≥4 h of phototherapy. Secondary outcomes were night-time phototherapy, exchange transfusion (ET), and neonatal mortality rates.

RESULTS

Some 104 newborns were assigned to FSPT (n = 52) or IEPT (n = 52). Mean irradiance was 27.7 ± 7.3μW/cm²/nm under FSPT and 36.1 ± 8.3μW/cm²/nm under IEPT. FSPT and IEPT were 93.4% and 93.3% efficacious in all treatment days, respectively. No newborn developed controlled hyperthermia or met the criteria for withdrawal for safety reasons under FSPT. Night-time phototherapy was more frequent under FSPT (52.5%) than IEPT (43.4%). Three neonates (FSPT = 2 and IEPT = 1) had ET. No baby died.

CONCLUSION

Where practicable, FSPT is safe and non-inferior to IEPT for treating neonates with moderate-to-severe hyperbilirubinemia during birth hospitalization when there is no effective IEPT.

GOV NUMBER

NCT02612727 (24/11/2015).

IMPACT

Filtered-sunlight phototherapy (FSPT) is safe and efficacious for treating newborns with moderate-to-severe hyperbilirubinemia during birth hospitalization. Compared to intensive electric phototherapy, FSPT is not associated with higher rates of exchange transfusion or mortality. The incidence of hazardous hyperbilirubinemia with or without acute bilirubin encephalopathy is rare within 72 h of life in a population with high prevalence of G6PD deficiency and ABO incompatibility risk. In settings where intensive electric phototherapy that meets the recommended minimum irradiance threshold of 30 μW/cm²/nm cannot be assured, FSPT should be considered for at least 4 h for newborns with moderate-to-severe hyperbilirubinemia when practicable.

摘要

背景

在出生住院期间，过滤阳光光疗（FSPT）治疗轻度至中度高胆红素血症安全且不劣于传统光疗。我们评估了FSPT在中度至重度高胆红素血症新生儿中的效果。

方法

将新生儿随机分为FSPT组或强化电光疗（IEPT）组。主要结局指标为安全性，定义为无体温过高、体温过低、脱水或晒伤；以及有效性，定义为出生≤72小时的新生儿血清或血浆总胆红素（TSB）每小时升高<3.4 μmol/L，或接受≥4小时光疗的出生>72小时的新生儿TSB下降。次要结局指标为夜间光疗、换血治疗（ET）和新生儿死亡率。

结果

约104名新生儿被分配至FSPT组（n = 52）或IEPT组（n = 52）。FSPT组平均辐照度为27.7±7.3μW/cm²/nm，IEPT组为36.1±8.3μW/cm²/nm。在所有治疗日中，FSPT组和IEPT组的有效率分别为93.4%和93.3%。在FSPT组中，没有新生儿出现可控性体温过高或因安全原因达到退出标准。FSPT组夜间光疗（52.5%）比IEPT组（43.4%）更频繁。3名新生儿（FSPT组2名，IEPT组1名）接受了换血治疗。没有婴儿死亡。

结论

在可行的情况下，对于出生住院期间患有中度至重度高胆红素血症的新生儿，在没有有效的IEPT时，FSPT安全且不劣于IEPT。

政府编号

NCT02612727（2015年11月24日）。

影响

过滤阳光光疗（FSPT）在出生住院期间治疗中度至重度高胆红素血症新生儿时安全且有效。与强化电光疗相比，FSPT与更高的换血治疗率或死亡率无关。在葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症和ABO血型不合风险高的人群中，出生72小时内发生有或无急性胆红素脑病的危险性高胆红素血症的发生率很低。在无法确保达到推荐的最低辐照度阈值30 μW/cm²/nm的强化电光疗的情况下，对于中度至重度高胆红素血症的新生儿，可行时应考虑至少进行4小时的FSPT治疗。