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Diagnosis and Management of Infantile Hemangioma

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with prednisolone included endocrine (n=0.18% <strong>of</strong> lesions), gastrointestinal (n=0.14% <strong>of</strong><br />

lesions), growth <strong>and</strong> development (n=0.23% <strong>of</strong> lesions), infection (n=0.09% <strong>of</strong> lesions),<br />

metabolic (n=0.02% <strong>of</strong> lesions), <strong>and</strong> pulmonary/respiratory (n=0.11% <strong>of</strong> lesions). Severe adverse<br />

events occurred more frequently in the prednisolone arm (11 vs. 1 in propranolol arm, p=0.01).<br />

Nine <strong>of</strong> the 11 severe events were related to growth restriction. Fewer children in the<br />

prednisolone arm had pulmonary events (typically upper respiratory tract infection) compared<br />

with children in the propranolol group (5 vs. 14, p70%) in<br />

both arms in this study also experienced blood pressures ≥ the 90 th percentile (>15% in either<br />

arm were ≥ the 95 th percentile) though only one required antihypertensive medication for<br />

persistent elevation, <strong>and</strong> 52 <strong>of</strong> 73 cortisol tests were abnormal (31 in prednisolone arm <strong>and</strong> 21 in<br />

methylprednisolone). Twelve cortisol levels in the prednisolone arm <strong>and</strong> one in the<br />

methylprednisolone arm were in the undetectable range, <strong>and</strong> blood glucose was transiently<br />

elevated in 5 <strong>of</strong> 70 tests. 107 In total, seven <strong>of</strong> 330 participants receiving steroids in comparative<br />

studies discontinued treatment due to adverse events.<br />

Table 8. Harms/adverse effects in comparative studies <strong>of</strong> steroids to treat IH<br />

N Studies Reporting<br />

Intervention<br />

Harm/Adverse Event<br />

Harm (# Participants<br />

With Harm/Total<br />

Participants)<br />

Prednisolone 2-2.6<br />

mg/kg/day<br />

Reported Rates<br />

Across Studies<br />

Irritability 107 1 (3/10) 30%<br />

Crying 107 1 (3/10) 30%<br />

Insomnia 107 1 (3/10) 30%<br />

Hyperactivity 107 1 (2/10) 20%<br />

Vomiting 107 1 (2/10) 20%<br />

Abdominal pain or<br />

2 (5/20) 20%-30%<br />

gastrointestinal distress 100,107<br />

Ulceration or infection 100,108 2 (5/35) 10%-16%<br />

Persistent high blood<br />

1 (1/10) 10%<br />

pressure 107<br />

Respiratory distress 107 1 (1/10) 10%<br />

Chickenpox 107 1 (1/10) 10%<br />

Cushingoid appearance 100 1 (5/10) 50%<br />

Failure to thrive 100 1 (1/10) 10%<br />

30

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