Diagnosis and Management of Infantile Hemangioma

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An additional clinical trial assessing the safety of prednisone extended release was conducted in Germany and included 2676 patients in the safety analysis. 23 Serious adverse events reported included: gastrointestinal disorders (5 events,
thromboembolism, thrombophlebitis, vasculitis, acne, cutaneous and subcutaneous atrophy, dry scalp, edema, hyper or hypopigmentation, sterile abscess, striae, thinning scalp hair, hirsutism, moon faces, hepatomegaly, hiccups, malaise, nausea, charcot-like arthropathy, arachnoiditis, depression, emotional instability, euphoria, insomnia, meningitis, neuritis, neuropathy, paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, and alteration in motility/number of spermatozoa. Warnings for the use of Depo-Medrol® and Solu-Medrol® in pediatric patients due to the presence of benzyl alcohol have been described above (see table 1). 6,7 Adverse events for Depo-Medrol® and Solu-Medrol® were similar to those listed in general for corticosteroids (see above) with the addition of: dry scaly skin, glycosuria, hypertrichosis, negative nitrogen balance due to protein catabolism, injection site infections following nonsterile administration, postinjection flare (following intra-articular use), temporary/permanent visual impairment including blindness associated with periocular injections and decreased resistance to infection. 6,7 Depo-Medrol® has unique adverse events reported in addition to those listed above: calcinosis (following intra-articular or intra-lesional use), seizures, ocular and periocular inflammation including allergic reactions, and residue or slough at injection site. 6 Additional adverse events reported for Solu-Medrol® included: rhinitis and burning or tingling (especially in the perineal area after intravenous injection). 7 Aristospan® (triamcinolone hexacetonide), Kenalog-10® (triamcinolone acetonide) Aristospan® (triamcinolone hexacetonide), Kenalog-10® (triamcinolone acetonide) includes pediatric dosing in the FDA approved labeling. 8,9 FDA review packages were not available for this medication. Warnings for the use of Aristospan® and Kenalog-10® in pediatric patients due to the presence of benzyl alcohol have been described above (see table 1). Adverse events for Aristospan® and Kenalog-10® were similar to those listed in general for corticosteroids (see above) with the addition of: dry scaly skin, glucosuria, hypertrichosis, negative nitrogen balance due to protein catabolism, calcinosis (following intra-articular or intralesional use), postinjection flare (following intra-articular use), rare instances of blindness associated with periocular injections, and decreased resistance to infection. 8,9 FDA medical review packages were not available for these medications. Celestone Soluspan® (betamethasone) Adverse event data for Celestone Soluspan® was gathered from the package insert. 10 FDA approval packages were not available for review. Adverse events for Celestone Soluspan® were similar to those listed in general for corticosteroids (see above) with the addition of: dry scaly skin, glucosuria, hypertrichosis, negative nitrogen balance due to protein catabolism, calcinosis (following intra-articular or intralesional use), postinjection flare (following intra-articular use), rare instances of blindness associated with periocular injections, and decreased resistance to infection. 10 The following adverse events have been reported for general corticosteroids but were NOT included as adverse events for Celestone Soluspan®: manifestations of latent diabetes mellitus and menstrual irregularities. H-19
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Comparative Effectiveness Review Nu
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This report is based on research co
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Acknowledgments The authors gratefu
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Peer Reviewers Prior to publication
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BCI; moderate SOE for effects of pr
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Overview of the Literature ........
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Executive Summary Introduction Infa
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for contextual questions as few eff
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Figure B. Analytic framework for KQ
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Table A. Inclusion criteria (contin
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precision (precise, imprecise), and
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Figure D. Estimates of expected IH
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majority of studies to date have in
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effectiveness outcomes. The evidenc
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changes. We considered the strength
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Table C. Summary of evidence in stu
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Table D. Summary of evidence in stu
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Applicability We set inclusion crit
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quantitative meta-analyses. Researc
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surgically. Lesion characteristics
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References 1. Wassef M, Blei F, Ada
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39. Yu L, Li S, Su B, et al. Treatm
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modalities. The questions of imagin
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KQ2. Among newborns, infants, and c
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of data, and compiling evidence. We
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We only included studies published
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a standardized form (Appendix B) th
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Determining Quality Ratings • We
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Results We present results for Cont
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defects, urogenital anomalies, ulce
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Results of Literature Searches for
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Table 3. Characteristics of include
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scans, had a sensitivity of 20 perc
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of the model fit to all studies, bu
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Detailed Analysis Effectiveness of
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Table 6. Key resolution outcomes in
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with prednisolone included endocrin
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children in 8 studies), skin atroph
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hypopigmentation, impaired wound he
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fair quality for effectiveness outc
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studies of nadolol and atenolol. No
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Table 10. Key resolution outcomes i
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old. 100 Thirty percent of children
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Table 11. Resolution outcomes in st
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Table 15. Key outcomes in studies c
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Table 22. Harms/adverse effects in
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Table 24. Adverse effects in case s
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Table 24. Adverse effects in case s
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• In two RCTs reporting level of
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Nd:YAG Laser With Cooling Compared
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long term follow information was av
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Discussion State of the Literature
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Table 34. Strength of evidence for
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Effectiveness and Harms of Beta-Blo
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older children. One comparative stu
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case series reporting on rarer pres
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agents is critical, especially as u
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References 1. Wassef M, Blei F, Ada
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39. Chen TS, Eichenfield LF, Friedl
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80. Mai HM, Zheng JW, Wang YA, et a
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119. Sharma LK, Dalal SS. Corticost
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162. Snir M, Reich U, Siegel R, et
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198. Chen ZG, Zheng JW, Yuan ML, et
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237. Healy G, McGill T, Friedman EM
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Abbreviations and Acronyms Used in
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Appendix A. Search Strategies Searc
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Searches for Comparative Effectiven
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Appendix B. Screening and Quality A
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Harms Risk of Bias Assessment Form
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QUADAS Diagnostic Accuracy Rating T
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Infantile Hemangioma CER: Risk of B
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20. Grundfest-Broniatowski S, Carey
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65. Dachman AH, Lichtenstein JE, Fr
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111. Yoshida T, Kuratomi K, Mitsuma
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160. Newman SL, Goodwin CD. Colonic
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204. Crockett DM, Healy GB, McGill
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253. Wright GL, Smith RJ, Katz CD,
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301. Paley D, Jackson RW. Synovial
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346. Dombrowski MP, Budev H, Wolfe
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390. Stringel G. Giant hemangioma:
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436. Liu HC, Chang MH, Lue HC, et a
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480. Casale AJ, Menashe DS. Massive
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526. Taylor RS, Joseph DB, Kohaut E
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571. Goldstein MH. The elastic flap
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614. Salloum E, Flamant F, Caillaud
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880. Schulman SR, Jones BR, Slotnic
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968. Thompson DN, Taylor WF, Haywar
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where ΦΦ(xx) is the cumulative di
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Page 379 and 380: Appendix E. Study Design Classifica
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Page 385 and 386: Author, Year Were the harms predefi
Page 397 and 398: 25. Qiu Y, Ma G, Yang J, et al. Imi
Page 399 and 400: 56. Hassan BA, Shreef KS. Propranol
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Page 403 and 404: 120. Pandey A, Gangopadhyay AN, Gop
Page 405 and 406: Appendix G. Applicability Tables Ta
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Page 409 and 410: o Acquired (autoimmune) hemolytic a
Page 411 and 412: o Ankylosing spondylitis o Dermatom
Page 413 and 414: H-7 • Increased dosage of rapidly
Page 415 and 416: Elocon® (mometason e furoate) 11 T
Page 417 and 418: Timoptic® (timolol maleate) 15 Tim
Page 419 and 420: Harms Data for Medications Included
Page 421 and 422: Table H-3: Adverse Events from Flo-
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Page 427 and 428: grades): 103 (48%), erosion/ulcerat
Page 429 and 430: acute myocardial infarction: 3 (Rat
Page 431 and 432: Discontinuations Patients utilizing
Page 433 and 434: ocular irritation including blephar
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Diagnosis and Management of Infantile Hemangioma

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