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D-Penicillamine for preventing retinopathy of prematurity in preterm infants
D L Phelps1, L Lakatos, J L Watts
1Pediatrics and Ophthalmology, University of Rochester, Box 651, Pediatrics, 601 Elmwood Ave, Rochester, New York, USA, 14642. dale phelps@urmc.rochester.edu
Insights
Prophylactic d-penicillamine may reduce acute retinopathy of prematurity (ROP) in premature infants. This treatment did not affect survival rates but warrants further investigation for potential side effects.
Area of Science:
- Neonatal medicine
- Ophthalmology
- Pharmacology
Background:
- Retinopathy of prematurity (ROP) is a significant concern in premature infants.
- An observed decrease in ROP incidence in infants treated with d-penicillamine for hyperbilirubinemia prompted this investigation.
Purpose of the Study:
- To evaluate the prophylactic effect of d-penicillamine on acute and severe ROP in very low birth weight infants.
- To assess associated side effects, including mortality.
Main Methods:
- Systematic review of randomized and quasi-randomized controlled trials.
- Inclusion criteria: infants <2000g birth weight, d-penicillamine administration within 24 hours of birth.
- Data extraction and analysis followed Neonatal Cochrane Review Group standards.
Main Results:
- Two trials involving ROP showed a significant reduction in acute ROP incidence with d-penicillamine (RR 0.09, 95% CI [0.01,0.71]).
- Severe ROP stages and mortality rates were not significantly affected (RR 0.99, 95% CI [0.70,1.39]).
- No significant side effects or developmental issues were reported in the ROP trials; however, other studies noted rare rashes and vomiting.
Conclusions:
- D-penicillamine may decrease the incidence of acute ROP in surviving infants.
- The drug's effect on survival appears minimal.
- Further research in a wider infant population is justified, with careful monitoring for adverse events.
Background:
Retinopathy of prematurity remains a common problem. A low rate of this disorder was unexpectedly observed among infants treated with intravenous d-penicillamine to prevent hyperbilirubinemia. This observation led to the investigation of its use to prevent retinopathy of prematurity.
Objectives:
To answer the question: Among very low birth weight infants, what is the effect of prophylactic administration of d-penicillamine on the incidence of acute ROP or severe ROP, and side effects including death?
Search Strategy:
Searches were made of multiple electronic databases, previous reviews including cross references, abstracts, conference/symposia proceedings, and expert informants. The search was updated to November 2000.
Selection Criteria:
Randomized or quasi-randomized controlled trials that administered d-penicillamine to infants less than 2000g birth weight within the day following birth were considered relevant to this review. Additional case series were examined for potential side effects.
Data Collection And Analysis:
Data on clinical outcomes were excerpted by 3 reviewers independently, and consensus reached. Data analysis was conducted according to the standards of the Neonatal Cochrane Review Group.
Main Results:
Two randomized trials on the effects on ROP were identified. When combined, they showed a significantly lower incidence of acute ROP in the treated infants, relative risk of 0.09, 95% CI [0.01,0.71]. Severe stages of ROP could not be analyzed. There was no effect on death rates, relative risk 0.99 95% CI [0.70,1.39]. No side effects were reported, and follow up at one year revealed no significant differences in spasticity or developmental delay, although there were more rehospitalizations among the controls. In other reports of using d-penicillamine in over 140 infants for hyperbilirubinemia, skin rashes were reported in 2 infants and one had vomiting that may have been related.
Reviewer'S Conclusions:
D-penicillamine is unlikely to affect survival, and may reduce the incidence of acute ROP among survivors. Studies to date justify further investigation of this drug in a broader population; careful attention to possible side effects is needed.