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【drug-news】翻译：FDA批准一种用于预防婴幼儿胃
美国食品药品监督管理局（FDA）今天批准第二个口服疫苗——Rotarix，用于预防轮状病毒感染，后者可以引起婴幼儿胃肠炎（主要表现为呕吐和腹泻）。Rotarix是一种液体制剂，从婴儿出生后第六周到二十四周连续服用2剂。
虽然轮状病毒引起的胃肠炎是一种自限性疾病，但它在美国每年仍引起27，000，000例发病，其中55，000到70，000例需要住院治疗，20到60例病人死亡。在没有疫苗的情况下，几乎每一个美国儿童在五岁之前都可能至少收到一次轮状病毒感染。
轮状病毒分许多不同的病毒株。Rotarix主要预防轮状病毒的G1P、G3P和G9P株引起的胃肠炎。
“这种疫苗提供了另一种选择，可打击并减低一种潜在的严重疾病，而这种疾病会影响到许多儿童，” FDA生物制品评价和研究中心Jesse L. Goodman博士说。
在涉及24，000名婴儿的多项临床研究中，Rotarix有效地预防了受试者2岁之前由轮状病毒引起胃肠炎的中重度病例。临床研究中最常报告的不良反应是易激惹、咳嗽、流鼻涕、发热、食欲缺乏，以及呕吐。
1999年，来自于另一家制造者的一种轮状病毒疫苗由于可增加肠套叠的风险而自动撤出美国市场，而肠套叠有导致致命性肠梗阻的潜在可能。其实没有疫苗保护的婴幼儿本身也可能自发的发生肠套叠，但为了确保Rotarix不增加肠套叠发生的几率，Rotarix的生产厂家进行了一项临研究，共纳入超过63，000个婴儿参加。
这项研究显示：接受Rotarix治疗的婴儿（31，673例）对比接受安慰剂治疗的婴儿（31，552例），Rotarix并未增加肠套叠发生的风险。不过在这项关于肠套叠的研究中，婴儿惊厥及肺炎相关性死亡的发生率增加，但这些事件并未在生产厂家主持的其他项研究中观察到。尽管FDA已得出结论：目前以获得的数据并不支持这些事件与疫苗的使用有关。同时为了提供进一步的安全信息，FDA要求制造者进行纳入40，000名婴儿的疫苗上市后安全性研究
Rotarix由比利时葛兰素史克生物制品公司生产制造。
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.
Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year—about 55,000 to 70,000 of those require hospitalization; and between 20 and 60 deaths are attributed to it. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5.
There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.
In 1999, a different rotavirus vaccine from another manufacturer was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage. Intussusception can occur in children spontaneously in the absence of vaccination, but to help ensure that Rotarix does not increase the risk of intussusception, its manufacturer conducted a study of more than 63,000 infants.
In that study, there was no increase in the risk of intussusception in those who received Rotarix (31,673 infants) compared to those who received placebo (31,552 infants). Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study, however these events were not observed in other studies conducted by the manufacturer. Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.
Rotarix is manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. 感谢shihui8091 战友的翻译！～学习了！～
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作者:admin@医学,生命科学 2010-11-30 17:11
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