Long-term follow-up of premature infants treated with prophylactic, intratracheal recombinant human CuZn superoxide dismutase

被引:23
作者
Davis J.M. [1 ,9 ]
Richter S.E. [1 ]
Biswas S. [1 ]
Rosenfeld W.N. [1 ]
Parton L. [2 ]
Gewolb I.H. [3 ]
Parad R. [4 ]
Carlo W. [5 ]
Couser R.J. [6 ]
Baumgart S. [7 ]
Atluru V. [1 ]
Salerno L. [8 ]
Kassem N. [8 ]
机构
[1] Department of Pediatrics, Winthrop University Hospital, Mineola, NY
[2] University Hospital, Stony Brook, NY
[3] University of Maryland, Medical Center, Baltimore, MD
[4] Brigham and Women's Hospital, Boston, MA
[5] University of Alabama, Medical Center, Birmingham, AL
[6] Children's Healthcare, Minneapolis, MN
[7] Thomas Jefferson University, Philadelphia, PA
[8] Bio-Technology General Corporation, Iselin, NJ
[9] Department of Pediatrics, Winthrop University Hospital, Mineola, NY 11501
关键词
D O I
10.1038/sj.jp.7200363
中图分类号
学科分类号
摘要
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.
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页码:213 / 216
页数:3
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