Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity: A Randomized Clinical Trial.
Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity: A Randomized Clinical Trial.
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DOI：
10.1001/jamapediatrics.2020.5653
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发表时间：
2021-04-01
期刊：
影响因子：
26.1
通讯作者：
Ley D
中科院分区：
文献类型：
--
作者：
Hellström A;Nilsson AK;Wackernagel D;Pivodic A;Vanpee M;Sjöbom U;Hellgren G;Hallberg B;Domellöf M;Klevebro S;Hellström W;Andersson M;Lund AM;Löfqvist C;Elfvin A;Sävman K;Hansen-Pupp I;Hård AL;Smith LEH;Ley D
从出生到月经后40周补充花生四烯酸（AA）和二十二碳六烯酸（DHA）是否能减少极早产儿严重早产儿视网膜病变（ROP）？
这项随机临床试验发现，肠内补充AA和DHA可使严重ROP的风险降低50%。此外，与对照组相比，接受肠内AA和DHA补充的组血清中AA和DHA水平更高。
对孕周小于27周的最不成熟婴儿的饮食补充含AA:DHA的肠内脂质溶液没有显著不良影响，似乎是一种有前景的干预措施，可预防威胁视力的ROP，从而减少视力损害和失明。
极早产之后缺乏花生四烯酸（AA）和二十二碳六烯酸（DHA）可能导致早产相关疾病，包括早产儿视网膜病变（ROP）。
为了确定从出生到月经后40周肠内补充脂肪酸是否能减少极早产儿的ROP。
Mega Donna Mega试验是一项随机临床试验，是2016年12月15日至2019年12月15日在瑞典3所大学医院进行的多中心研究。筛查的小儿眼科医生对患者分组不知情。共有209名孕周小于28周的婴儿进行了资格测试，其中206名婴儿被纳入研究。对意向性治疗人群的随机分组以及符合方案人群的实际治疗分组进行了疗效分析。统计分析于2020年2月至4月进行。
婴儿在出生后3天内直至月经后40周接受补充提供AA（100mg/kg/d）和DHA（50mg/kg/d）的肠内油（AA:DHA组）或不补充。
主要结局是严重ROP（3期和/或1型）。次要结局是AA和DHA血清水平以及早产的其他并发症发生率。
AA:DHA组共纳入101名婴儿（58名男孩[57.4%]；平均[标准差]孕周为25.5[1.5]周），对照组纳入105名婴儿（59名男孩[56.2%]；平均[标准差]孕周为25.5[1.4]周）。与标准治疗相比，AA和DHA治疗降低了严重ROP的发生率（AA:DHA组101例中有16例[15.8%]，对照组105例中有35例[33.3%]；调整后的相对风险为0.50[95%置信区间，0.28 - 0.91]；P = 0.02）。与对照组相比，AA:DHA组血清磷脂中AA和DHA的比例显著更高（AA:DHA组总体平均差异为0.82mol%[95%置信区间，0.46 - 1.18mol%]；P < 0.001；对照组总体平均差异为0.13mol%[95%置信区间，0.01 - 0.24mol%]；P = 0.03）。AA:DHA组和对照组在支气管肺发育不良发生率（101例中有48例[47.5%]与105例中有48例[45.7%]）以及任何级别的脑室内出血发生率（101例中有43例[42.6%]与105例中有42例[40.0%]）方面没有显著差异。在AA:DHA组和对照组中，分别有101例中的42例（41.6%）和105例中的53例（50.5%）发生败血症，101例中的26例（25.7%）和105例中的26例（24.8%）发生严重不良事件，101例中的16例（15.8%）和106例中的13例（12.3%）死亡。
这项研究发现，与标准治疗相比，肠内补充AA:DHA可使严重ROP的风险降低50%，并且AA和DHA的血清水平总体更高。含AA:DHA的肠内脂质补充是一种减少极早产儿严重ROP的新型预防策略。
ClinicalTrials.gov标识符：NCT03201588
这项随机临床试验研究从出生到月经后40周肠内补充花生四烯酸和二十二碳六烯酸是否能减少极早产儿的早产儿视网膜病变。
Does enteral fatty acid supplementation with arachidonic acid (AA) and docosahexaenoic acid (DHA) from birth to 40 weeks’ postmenstrual age reduce severe retinopathy of prematurity (ROP) in extremely preterm infants? This randomized clinical trial found that enteral AA and DHA supplementation lowered the risk of severe ROP by 50%. In addition, the group that received enteral AA and DHA supplementation showed higher serum levels of both AA and DHA compared with controls. Supplementing the diet of the most immature infants born at less than 27 weeks’ gestational age with an enteral lipid solution with AA:DHA had no significant adverse effects and seems to be a promising intervention to prevent sight-threatening ROP and thereby reduce visual impartment and blindness. Lack of arachidonic acid (AA) and docosahexaenoic acid (DHA) after extremely preterm birth may contribute to preterm morbidity, including retinopathy of prematurity (ROP). To determine whether enteral supplementation with fatty acids from birth to 40 weeks’ postmenstrual age reduces ROP in extremely preterm infants. The Mega Donna Mega trial, a randomized clinical trial, was a multicenter study performed at 3 university hospitals in Sweden from December 15, 2016, to December 15, 2019. The screening pediatric ophthalmologists were masked to patient groupings. A total of 209 infants born at less than 28 weeks’ gestation were tested for eligibility, and 206 infants were included. Efficacy analyses were performed on as-randomized groups on the intention-to-treat population and on the per-protocol population using as-treated groups. Statistical analyses were performed from February to April 2020. Infants received either supplementation with an enteral oil providing AA (100 mg/kg/d) and DHA (50 mg/kg/d) (AA:DHA group) or no supplementation within 3 days after birth until 40 weeks’ postmenstrual age. The primary outcome was severe ROP (stage 3 and/or type 1). The secondary outcomes were AA and DHA serum levels and rates of other complications of preterm birth. A total of 101 infants (58 boys [57.4%]; mean [SD] gestational age, 25.5 [1.5] weeks) were included in the AA:DHA group, and 105 infants (59 boys [56.2%]; mean [SD] gestational age, 25.5 [1.4] weeks) were included in the control group. Treatment with AA and DHA reduced severe ROP compared with the standard of care (16 of 101 [15.8%] in the AA:DHA group vs 35 of 105 [33.3%] in the control group; adjusted relative risk, 0.50 [95% CI, 0.28-0.91]; P = .02). The AA:DHA group had significantly higher fractions of AA and DHA in serum phospholipids compared with controls (overall mean difference in AA:DHA group, 0.82 mol% [95% CI, 0.46-1.18 mol%]; P < .001; overall mean difference in control group, 0.13 mol% [95% CI, 0.01-0.24 mol%]; P = .03). There were no significant differences between the AA:DHA group and the control group in the rates of bronchopulmonary dysplasia (48 of 101 [47.5%] vs 48 of 105 [45.7%]) and of any grade of intraventricular hemorrhage (43 of 101 [42.6%] vs 42 of 105 [40.0%]). In the AA:DHA group and control group, respectively, sepsis occurred in 42 of 101 infants (41.6%) and 53 of 105 infants (50.5%), serious adverse events occurred in 26 of 101 infants (25.7%) and 26 of 105 infants (24.8%), and 16 of 101 infants (15.8%) and 13 of 106 infants (12.3%) died. This study found that, compared with standard of care, enteral AA:DHA supplementation lowered the risk of severe ROP by 50% and showed overall higher serum levels of both AA and DHA. Enteral lipid supplementation with AA:DHA is a novel preventive strategy to decrease severe ROP in extremely preterm infants. ClinicalTrials.gov Identifier: NCT03201588 This randomized clinical trial examines whether enteral supplementation with arachidonic acid and docosahexaenoic acid from birth to 40 weeks’ postmenstrual age reduces retinopathy of prematurity in extremely preterm infants.
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