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The public health threat of smallpox reintroduction requires rapid disseminationof treatment guidelines for smallpox and smallpox (vaccinia) vaccine complications.The timely publication of 2 articles1 - 2 inthe ARCHIVES has introduced treatment options for ocular complications ofsmallpox and smallpox immunization.
Current guidelines for the treatment of vaccinia complications are basedpredominately on expert opinion because there are no controlled clinical studiesof the treatment of ocular vaccinia in humans and only limited controlledclinical studies of the treatment of ocular vaccinia in animal models. Becausethere is a paucity of data regarding the efficacy of treatment options forvaccinia complications, the Centers for Disease Control and Prevention (CDC),in November 2002, convened a panel of infectious disease, ophthalmology, epidemiology,and smallpox eradication experts to review the literature and to offer consultationregarding guidance to clinicians for the treatment of ocular vaccinia. Theserecommendations have been published.3
In Semba's summary of treatment options, he states, "Vaccinia immuneglobulin is recommended for ocular vaccinia4 atdoses of 0.3 to 0.5 mL/kg of body weight and repeated in 48 hours if thereis no improvement.5 Topical vaccinia immuneglobulin (100 mg/mL) may be used every 4 hours but is contraindicated if thecorneal epithelium is not intact."1 (p717) This statement does not accurately reflect currently publishedCDC guidelines for the treatment of ocular vaccinia. Vaccinia immune globulin(VIG) is available from the CDC and Department of Defense only under investigationalnew drug protocols and is indicated for selected adverse events followingsmallpox vaccinia. Of particular importance, the topical application of VIGfor vaccinia ocular complications is not a Federal Drug Administration–approvedroute of use and is no longer a standard of care.
Dr Semba references Dr Pavan-Langston's 1983 article,5 whichmentions the use of topical VIG every 2 hours as one of several options inthe treatment of ocular vaccinia. It is important to note, however, that DrPavan-Langston no longer recommends topical VIG and currently recommends topicalantivirals in the treatment of ocular vaccinia (D. Pavan-Langston, MD, oralcommunication, April 2003).
Current CDC guidelines state that intravenous or intramuscular administrationof VIG
should be considered for use in severe ocular disease when keratitisis not present (eg, severe blepharitis or blepharoconjunctivitis). If keratitisis present with these conditions, consideration of possible VIG use must beweighed against evidence in an animal model for increased risk for cornealscar formation if a substantial dose is administered during multiple days.VIG can be considered if the ocular disease is severe enough to pose a substantialrisk of impaired vision as a long-term outcome.3 (p17)
Pepose et al6 performed a comprehensiveliterature review and have summarized current recommendations. They accuratelyreport that "[n]o controlled clinical trials of antiviral or VIG therapy forocular vaccinia in humans have been published."6 (p349) It is this equipoise and recognition of the public health importanceof the safety and efficacy of VIG for the treatment of ocular vaccinia thatled to the development of a National Eye Institute research protocol to evaluateand treat patients with ocular complications of smallpox vaccination and todetermine the suitability of VIG for sight-threatening conditions in a controlledclinical trial. In the setting of large-scale US vaccinia vaccination programs,this protocol will address this important clinical question with standardizeddata collection and rigorous research methods.
The optimal method to answer these difficult clinical questions is withwell-controlled clinical evaluations that require multicenter collaborationamong many investigators. While evidence-based assessments are pending, treatmentdecisions should be made within published guidelines, with the recognitionthat some of the available data may be vague and contradictory.
We are grateful for this opportunity to clarify the current guidelinesfor the use of VIG and the proper route of administration.
Correspondence: Dr Smith, National Eye Institute, National Institutesof Health, 10 Center Dr, MSC 1863, Bethesda, MD 20892-1863 (smithj@nei.nih.gov).
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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