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首款轮状病毒疫苗获批:真的有必要吗?

First rotavirus vaccine licensed: is there really a need?

作者信息

Glass R I, Bresee J S, Parashar U D, Holman R C, Gentsch J R

机构信息

Viral gastroenteritis Section, Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.

出版信息

Acta Paediatr Suppl. 1999 Jan;88(426):2-8. doi: 10.1111/j.1651-2227.1999.tb14318.x.

DOI:10.1111/j.1651-2227.1999.tb14318.x
PMID:10088904
Abstract

The first rotavirus vaccine was licensed in the United States on 31 August 1998 for the prevention of severe rotavirus diarrhea in children. Despite this landmark in new vaccines, many pediatricians and public health professionals in Europe are uncertain of the need for this vaccine for the routine immunization of infants. In Europe, ample evidence suggests that rotavirus is the most common cause of hospitalizations for severe diarrhea among children, but proper studies documenting the disease burden of rotavirus or the cost-effectiveness of a rotavirus immunization program have only been conducted in the United Kingdom following epidemiologic models used in the United States. All children are infected with rotavirus during their first few years of life, 30-50% of diarrheal hospitalizations among children <5 years are due to this agent, and, by the age of 5 years, between 1 in 40 and 1 in 77 children in Europe and the United States may be hospitalized for rotavirus. The first vaccine is a live, oral preparation combining four different serotypes of rotavirus and administered in three doses with other childhood immunizations. The good efficacy against severe rotavirus diarrhea, the low risk of adverse side effects and the positive cost-effectiveness equation have led the two major immunization advisory groups in the U.S. to recommend this vaccine for routine use in American infants. European physicians and policy-makers should re-examine the epidemiology and disease burden of rotavirus diarrhea now that an effective method of prevention is at hand.

摘要

1998年8月31日,首款轮状病毒疫苗在美国获批上市,用于预防儿童严重轮状病毒腹泻。尽管这是新型疫苗领域的一个里程碑事件,但欧洲的许多儿科医生和公共卫生专业人员对于该疫苗是否有必要纳入婴儿常规免疫计划仍不确定。在欧洲,有充分证据表明,轮状病毒是导致儿童因严重腹泻住院的最常见原因,但仅在英国按照美国使用的流行病学模型开展过相关研究,记录轮状病毒的疾病负担或轮状病毒免疫计划的成本效益。所有儿童在其生命的最初几年都会感染轮状病毒,5岁以下儿童因腹泻住院的病例中,30%至50%是由这种病原体引起的,到5岁时,欧洲和美国每40至77名儿童中就可能有1人因轮状病毒住院。首款疫苗是一种口服活疫苗,它将四种不同血清型的轮状病毒组合在一起,并与其他儿童疫苗同时分三剂接种。该疫苗对严重轮状病毒腹泻疗效良好,副作用风险低,成本效益可观,因此美国两大免疫咨询小组建议将这种疫苗用于美国婴儿的常规接种。鉴于已有预防轮状病毒腹泻的有效方法,欧洲的医生和政策制定者应重新审视轮状病毒腹泻的流行病学情况和疾病负担。

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First rotavirus vaccine licensed: is there really a need?首款轮状病毒疫苗获批:真的有必要吗?
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引用本文的文献

1
The control of rotavirus gastroenteritis in the United States.美国轮状病毒肠胃炎的防控
Trans Am Clin Climatol Assoc. 2012;123:36-52; discussion 53.
2
Rotavirus vaccine for preventing diarrhoea.用于预防腹泻的轮状病毒疫苗。
Cochrane Database Syst Rev. 2004;2004(1):CD002848. doi: 10.1002/14651858.CD002848.pub2.
3
Viruses causing gastroenteritis.引起肠胃炎的病毒。
Clin Microbiol Infect. 2003 Apr;9(4):247-62. doi: 10.1046/j.1469-0691.2003.00560.x.
4
The link between rotavirus vaccination and intussusception: implications for vaccine strategies.轮状病毒疫苗接种与肠套叠之间的关联:对疫苗策略的影响。
Gut. 2002 Jan;50(1):11-2. doi: 10.1136/gut.50.1.11.
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Hospitalizations for rotavirus gastroenteritis in Gipuzkoa (Basque country), Spain.西班牙吉普斯夸省(巴斯克地区)轮状病毒肠胃炎的住院情况。
Emerg Infect Dis. 1999 Nov-Dec;5(6):834-5. doi: 10.3201/eid0506.990619.