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氯贝丁酯治疗葡萄糖-6-磷酸脱氢酶缺乏所致重症新生儿黄疸的疗效(一项随机临床试验)

Efficacy of clofibrate on severe neonatal jaundice associated with glucose-6-phosphate dehydrogenase deficiency (a randomized clinical trial).

作者信息

Zahedpasha Yadollah, Ahmadpour-Kacho Mousa, Hajiahmadi Mahmood, Naderi Salma, Kamali Abbas Ali

机构信息

Pediatric Research Center, Amirkola Children Hospital, Department of Pediatric, School of Medicine, Babol University of Medical Sciences, Babol, Iran.

出版信息

Southeast Asian J Trop Med Public Health. 2008 May;39(3):557-61.

PMID:18564698
Abstract

Glucose-6-phosphate dehydrogenase (G6PD) deficiency may cause severe hyperbilirubinemia with bilirubin encephalopathy unless intervention is initiated. The aim of this study was to assess the efficacy of clofibrate in full term G6PD deficient neonates with jaundice. A randomized clinical trial study was performed in two groups of full-term G6PD deficient jaundiced neonates (clofibrate treated group, n = 21; control group, n = 19). Infants in the clofibrate group received a single oral dose of 100 mg/kg clofibrate, whereas control group received nothing. Both groups were treated with phototherapy. Serum total and direct bilirubin levels were measured at the onset of treatments, 16, 24 and 48 hours later. On enrollment, the mean total serum bilirubin (TSB) level in the clofibrate treated group was 18.40 +/- 2.41 and in the control group was 17.49 +/- 1.03 (p = 0.401). At 16, 24 and 48 hours of treatment, the mean TSB in the clofibrate group were 15.2 +/- 1.9, 12.6 +/- 2.4, and 10.1 +/- 2.4 and in the control group were 16.5 +/- 1.2, 13.3 +/- 2.2 and 11.4 +/- 2.4, respectively (p = 0.047). At 48 hours, 7 (33%) cases in the clofibrate group and one (5%) case in the control group were discharged with a TSB < 10 mg/dl (p = 0.031). No side effects were observed on serial examinations during hospitalization, or on the 1st and 7th days after discharge. The results show that clofibrate induces a faster decline in serum total bilirubin level, a shorter duration of phototherapy, and hospitalization with no side effects in full-term G6PD deficient neonates with jaundice.

摘要

葡萄糖-6-磷酸脱氢酶(G6PD)缺乏症可能会导致严重的高胆红素血症并伴有胆红素脑病,除非采取干预措施。本研究的目的是评估氯贝丁酯对足月G6PD缺乏的黄疸新生儿的疗效。对两组足月G6PD缺乏的黄疸新生儿进行了一项随机临床试验研究(氯贝丁酯治疗组,n = 21;对照组,n = 19)。氯贝丁酯组的婴儿口服单次剂量为100 mg/kg的氯贝丁酯,而对照组未接受任何治疗。两组均接受光疗。在治疗开始时、16、24和48小时后测量血清总胆红素和直接胆红素水平。入组时,氯贝丁酯治疗组的平均血清总胆红素(TSB)水平为18.40±2.41,对照组为17.49±1.03(p = 0.401)。在治疗16、24和48小时时,氯贝丁酯组的平均TSB分别为15.2±1.9、12.6±2.4和10.1±2.4,对照组分别为16.5±1.2、13.3±2.2和11.4±2.4(p = 0.047)。在48小时时,氯贝丁酯组有7例(33%)病例和对照组有1例(5%)病例的TSB<10 mg/dl出院(p = 0.031)。住院期间的系列检查以及出院后第1天和第7天均未观察到副作用。结果表明,氯贝丁酯可使足月G6PD缺乏的黄疸新生儿的血清总胆红素水平下降更快,光疗时间缩短,住院时间缩短,且无副作用。

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