Shin Young J, Godin Robert, Walters Ryan A, Niu Jianli, Kahn Doron J
Department of Pharmacy (YJS, RG, RAW), Joe DiMaggio Children's Hospital, Hollywood, FL.
Office of Human Research, Memorial Healthcare System (JN), Hollywood, FL.
J Pediatr Pharmacol Ther. 2022;27(6):545-550. doi: 10.5863/1551-6776-27.6.545. Epub 2022 Aug 19.
Few studies have evaluated the effect of phenobarbital (PB) on elevated direct bilirubin (DB) plasma concentrations in neonates and infants, and none have compared its effect with a control group with matched study baseline DB values. The purpose of this study was to quantify changes in elevated DB plasma concentrations (≥2 mg/dL) in neonates and infants between a PB-treated and control group.
A retrospective, observational, matched, cohort study was performed comparing patients between a PB-treated group and a control group with similar study baseline plasma DB values ≥2 mg/dL over an 8-week period. The percent change in DB plasma concentrations from study baseline was compared for each week of the study period.
During the 8-year study period, 310 patients had DB plasma concentrations ≥2 mg/dL, of which 26 remained in each group after exclusions. The PB group had increased DB concentrations and the control group had decreased DB concentrations when compared with their study baseline DB concentrations each week of the study period. By study end, the mean DB concentration increased by 11.2% in the PB group and decreased by 48.5% in the control group (p = 0.02). In multiple regression analysis, only birth weight (standardized coefficient = 0.44, p = 0.02), and gastrointestinal obstruction (standardized coefficient = -0.4, p = 0.03) were associated with significant percent change in DB concentrations.
This study demonstrated PB does not improve cholestasis in neonates and infants.
很少有研究评估苯巴比妥（PB）对新生儿和婴儿血浆直接胆红素（DB）升高的影响，且没有研究将其与具有匹配研究基线DB值的对照组进行效果比较。本研究的目的是量化PB治疗组和对照组之间新生儿和婴儿血浆DB升高浓度（≥2mg/dL）的变化。
进行了一项回顾性、观察性、匹配队列研究，比较了PB治疗组和对照组在8周内基线血浆DB值≥2mg/dL的患者。比较了研究期间每周血浆DB浓度相对于研究基线的变化百分比。
在8年的研究期间，310例患者血浆DB浓度≥2mg/dL，排除后每组各有26例。在研究期间的每周，与各自的研究基线DB浓度相比，PB组的DB浓度升高，而对照组的DB浓度降低。到研究结束时，PB组的平均DB浓度增加了11.2%，而对照组降低了48.5%（p=0.02）。在多元回归分析中，只有出生体重（标准化系数=0.44，p=0.02）和胃肠道梗阻（标准化系数=-0.4，p=0.03）与DB浓度的显著变化百分比相关。
本研究表明PB不能改善新生儿和婴儿的胆汁淤积。
