更昔洛韦预防婴儿巨细胞病毒(Cmv)相关的听力丧失恶化
SAN FRANCISCO (Reuters Health) - Ganciclovir can prevent hearing loss or progression of hearing loss in infants with symptomatic congenital cytomegalovirus (CMV), according to the results of a study presented at the American Academy of Pediatrics 2001 national conference and exhibition.
Since 58% of infants with symptomatic congenital CMV will develop sensory hearing loss, Dr. David W. Kimberlin, of the University of Alabama at Birmingham, said that based on the study findings "ganciclovir should be considered for treatment of symptomatic congenital CMV."
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Dr. Kimberlin and colleagues with the National Institute of Allergy and Immunology Collaborative Antiviral Study Group evaluated 100 infants over a 9-year period. All but two infants were younger than 30 days at enrollment and two were enrolled at 33 days.
Because ganciclovir is a "highly toxic drug," the study enrolled "only the worst of the worst," in terms of CMV complications. Children were randomized to either 6 weeks of IV ganciclovir 12 mg/k per day or no treatment. Both groups were monitored for 12 weeks and followed at 6 months, 1 year and 2 years, he said.
, 百拇医药
The primary endpoint was improved brain stem-evoked response by one gradation, or maintenance of normal hearing. Secondary endpoints were either biologic hearing, measured by hearing in both ears, or functional hearing, measured by "best ear" hearing, he said.
He said that the findings were based on 44 assessable patients. At 6 months, "85% of the 25 ganciclovir-treated children had improved or maintained their hearing. None had worsening hearing," he said. Forty-four percent of the children in the untreated group had improved or maintained hearing at 6 months.
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At 2 years, 52% of the ganciclovir children improved or maintained hearing compared with 25% of the children in the no treatment group, he said. Moreover, at 2 years, 70% of the children in the no-treatment group "had worsening hearing compared [with] 20% in the ganciclovir group," he said.
Ganciclovir improvement was "apparent at 19 days," said Dr. Kimberlin. An interesting finding was that at 6 weeks the ganciclovir children "had greater weight gain and greater gain in head circumference." But he said that change was not sustained at 6 months or after. "It may reflect the really different treatment these children received because they were hospitalized during those 6 weeks," he said.
, 百拇医药
He noted, however, that two thirds of the children treated with ganciclovir "developed grade 3-4 neutropenia compared with just one fifth of the children in the no-treatment group."
Dr. Kimberlin said that in December the NIH would begin a dosing trial of orally available valganciclovir for older CMV-infected children.
He said the NIH estimates that in the US 40,000 children are born with CMV each year. "Of those, about 2800 are symptomatic at birth and 336 have fatal disease. The number who will have sequelae is estimated at 2160."
About 5500 of the asymptomatic children will also develop CNS sequelae, he said, "so the total number of children affected each year is about 8000." The costs associated with caring for those children are about $1.86 billion, he added.
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Since 58% of infants with symptomatic congenital CMV will develop sensory hearing loss, Dr. David W. Kimberlin, of the University of Alabama at Birmingham, said that based on the study findings "ganciclovir should be considered for treatment of symptomatic congenital CMV."
, http://www.100md.com
Dr. Kimberlin and colleagues with the National Institute of Allergy and Immunology Collaborative Antiviral Study Group evaluated 100 infants over a 9-year period. All but two infants were younger than 30 days at enrollment and two were enrolled at 33 days.
Because ganciclovir is a "highly toxic drug," the study enrolled "only the worst of the worst," in terms of CMV complications. Children were randomized to either 6 weeks of IV ganciclovir 12 mg/k per day or no treatment. Both groups were monitored for 12 weeks and followed at 6 months, 1 year and 2 years, he said.
, 百拇医药
The primary endpoint was improved brain stem-evoked response by one gradation, or maintenance of normal hearing. Secondary endpoints were either biologic hearing, measured by hearing in both ears, or functional hearing, measured by "best ear" hearing, he said.
He said that the findings were based on 44 assessable patients. At 6 months, "85% of the 25 ganciclovir-treated children had improved or maintained their hearing. None had worsening hearing," he said. Forty-four percent of the children in the untreated group had improved or maintained hearing at 6 months.
, http://www.100md.com
At 2 years, 52% of the ganciclovir children improved or maintained hearing compared with 25% of the children in the no treatment group, he said. Moreover, at 2 years, 70% of the children in the no-treatment group "had worsening hearing compared [with] 20% in the ganciclovir group," he said.
Ganciclovir improvement was "apparent at 19 days," said Dr. Kimberlin. An interesting finding was that at 6 weeks the ganciclovir children "had greater weight gain and greater gain in head circumference." But he said that change was not sustained at 6 months or after. "It may reflect the really different treatment these children received because they were hospitalized during those 6 weeks," he said.
, 百拇医药
He noted, however, that two thirds of the children treated with ganciclovir "developed grade 3-4 neutropenia compared with just one fifth of the children in the no-treatment group."
Dr. Kimberlin said that in December the NIH would begin a dosing trial of orally available valganciclovir for older CMV-infected children.
He said the NIH estimates that in the US 40,000 children are born with CMV each year. "Of those, about 2800 are symptomatic at birth and 336 have fatal disease. The number who will have sequelae is estimated at 2160."
About 5500 of the asymptomatic children will also develop CNS sequelae, he said, "so the total number of children affected each year is about 8000." The costs associated with caring for those children are about $1.86 billion, he added.
-Westport Newsroom 203 319 2700, http://www.100md.com