接受预防性气管内注射重组人铜锌超氧化物歧化酶治疗的早产儿的长期随访
Long-term follow-up of premature infants treated with prophylactic, intratracheal recombinant human CuZn superoxide dismutase.
作者信息
Davis J M, Richter S E, Biswas S, Rosenfeld W N, Parton L, Gewolb I H, Parad R, Carlo W, Couser R J, Baumgart S, Atluru V, Salerno L, Kassem N
机构信息
Department of Pediatrics, Winthrop University Hospital, Mineola, NY 11501, USA.
出版信息
J Perinatol. 2000 Jun;20(4):213-6. doi: 10.1038/sj.jp.7200363.
OBJECTIVE
To examine the long-term effects of treatment with recombinant human CuZn superoxide dismutase (rhSOD) in infants enrolled previously in two placebo-controlled trials.
STUDY DESIGN
Records for 46 (88%) infants were examined, with 19 infants having received either single or multiple intratracheal (i.t.) doses of placebo, 12 having received a single i.t. dose of rhSOD, and 15 having received multiple i.t. doses of rhSOD. Mean age at follow-up was 28 months corrected age. Records were examined for neurologic dysfunction, developmental delay, and any significant medical disorders.
RESULTS
Four placebo infants (21%) had evidence of neurodevelopmental abnormalities and four infants developed asthma. Four single-dose rhSOD infants (33%) had neurodevelopmental abnormalities and two infants developed asthma. One multiple-dose rhSOD infant had evidence of neurodevelopmental abnormalities and one developed asthma. No other differences were found between the placebo and rhSOD groups.
CONCLUSION
Preliminary data suggest that rhSOD is safe and not associated with any long-term adverse effects. Further results will depend on the results of multicenter trials of rhSOD in preterm infants.
目的
研究重组人铜锌超氧化物歧化酶（rhSOD）治疗对先前参与两项安慰剂对照试验的婴儿的长期影响。
研究设计
检查了46名（88%）婴儿的记录，其中19名婴儿接受了单次或多次气管内（i.t.）安慰剂剂量，12名婴儿接受了单次i.t.剂量的rhSOD，15名婴儿接受了多次i.t.剂量的rhSOD。随访时的平均年龄为矫正年龄28个月。检查记录以了解神经功能障碍、发育迟缓及任何重大疾病情况。
结果
4名（21%）接受安慰剂的婴儿有神经发育异常证据，4名婴儿患哮喘。4名单次剂量rhSOD婴儿（33%）有神经发育异常，2名婴儿患哮喘。1名多次剂量rhSOD婴儿有神经发育异常证据，1名患哮喘。安慰剂组和rhSOD组之间未发现其他差异。
结论
初步数据表明rhSOD是安全的，且与任何长期不良反应无关。进一步的结果将取决于rhSOD在早产儿中的多中心试验结果。
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