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Randomised controlled trial of single phototherapy with reflecting curtains versus double phototherapy in term newborns with hyperbilirubinaemia

机译:足月新生儿高胆红素血症的单光疗法与反射光幕与双光疗法的随机对照试验

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Aim The use of reflecting curtains with single phototherapy has not yet been directly compared with double phototherapy (DP). The objective of this study is to compare the efficacy of single phototherapy with reflecting curtains (SPRC) and DP in treating neonatal jaundice. Methods This randomised controlled trial involved 160 term newborns with severe neonatal jaundice in the first 2 weeks of life. The subjects were randomised in two groups: the intervention group receiving SPRC (n = 80) and a control group receiving DP (n = 80). Because of post-hoc exclusions, 78 subjects resulted in each group, respectively. The primary outcome was mean decrease in total serum bilirubin (TSB) levels after 4 h of phototherapy. The secondary outcomes were mean decrease in TSB levels after 10 h of phototherapy and duration of phototherapy. Results The mean decrease in TSB after 4 h of phototherapy in the intervention group was similar for the intervention and the control groups (23.46 ± 27.03 vs. 22.43 ± 27.38 μmol/L; P = 0.81). Also, after 10 h, it was similar in both groups (56.06 ± 31.36 vs. 58.17 ± 31.71 μmol/L, respectively; P = 0.67). Cox proportional hazards regression analysis indicated that there was no statistically significant difference in duration of phototherapy in both intervention (SPRC) and control (DP) (x2 change 0.393, P = 0.531; hazard ratio 1.060; 95% confidence interval 0.883-1.273). There were no significant adverse events noted. Conclusions This study suggested that single phototherapy with reflecting curtain is as effective as DP in the treatment of neonatal hyperbilirubinaemia requiring intensive phototherapy.
机译:目的尚未将反射窗帘与单光疗的使用与双光疗(DP)进行直接比较。这项研究的目的是比较单光疗法与反射幕(SPRC)和DP治疗新生儿黄疸的疗效。方法这项随机对照试验涉及160例足月新生儿,出生后2周内患有严重的新生儿黄疸。将受试者随机分为两组:接受SPRC的干预组(n = 80)和接受DP的对照组(n = 80)。由于事后排除,每组分别有78名受试者。主要结果是光疗4 h后平均血清总胆红素(TSB)水平降低。次要结果是光疗10 h后TSB水平平均下降和光疗持续时间。结果干预组光疗4 h后TSB的平均下降与干预组和对照组相似(23.46±27.03 vs. 22.43±27.38μmol/ L; P = 0.81)。同样,在10小时后,两组相似(分别为56.06±31.36和58.17±31.71μmol/ L; P = 0.67)。 Cox比例风险回归分析表明,干预(SPRC)和对照(DP)的光疗时间无统计学差异(x2改变0.393,P = 0.531;危险比1.060; 95%置信区间0.883-1.273)。没有发现明显的不良事件。结论这项研究表明,带反射幕的单光疗法与DP疗法在需要强化光疗法的新生儿高胆红素血症的治疗中一样有效。

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