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水痘疫苗:新药。在某些情况下风险效益比良好。

Chickenpox vaccines: new drugs. A favourable risk-benefit balance in some situations.

出版信息

Prescrire Int. 2005 Jun;14(77):85-91.

PMID:15977369
Abstract

(1) Chickenpox is generally mild. Most severe cases of chickenpox occur in immunocompromised patients, adults, and pregnant women (and their foetuses). (2) Two live attenuated chickenpox vaccines derived from the same strain of varicella virus (Oka) are marketed in France, under the trade names Varilrix and Varivax. (3) They have not been adequately evaluated in immunocompromised children. (4) The impact of routine vaccination of women of child-bearing age on complications of chickenpox during pregnancy has not been studied. (5) Immunogenicity studies in several thousand immunocompetent children aged from 1 to 12 years show that the vaccine is almost always immunogenic after a single injection. Other comparative studies in adolescents and adults show that two injections are needed, at least two months apart. (6) A double-blind placebo-controlled trial including 513 immunocompetent children showed that Varilrix prevented 88% of cases of chickenpox after a median follow-up of 29 months, but no data on severe chickenpox were reported. A study that followed up 9202 children aged 1 to 12 years for more than 13 years showed that vaccination with Varivax failed to prevent chickenpox in 12.5% of cases and that 1.7% of these cases were severe. (7) Immunocompetent children vaccinated within three days after exposure to the virus are partially protected, according to one study of Varilrix (104 children) and two small studies of Varivax (10 and 42 children). There are no equivalent studies in adults. (8) Local adverse effects such as fever and rash are common in immunocompetent vaccinees. The rash is sometimes varicella-like and is due to infection by the vaccine strain. Pharmacovigilance studies of Varivax have shown no serious adverse effects. (9) Disseminated and/or persistent infection caused by the vaccine strain has been reported in immunocompromised patients. (10) Vaccination of immunocompetent subjects does not appear to result in a risk of chickenpox transmission to subsequent contacts. There seems to be no increase in the risk of herpes zoster in vaccinated children nor is there any firm evidence that chickenpox vaccination increases the incidence of herpes zoster in the general population. (11) Little information is available on vaccination during pregnancy. As a precaution, however, pregnant women should not be vaccinated. (12) Mass vaccination does not appear to be justified: chickenpox is generally mild during childhood, and several questions concerning the effects of the vaccine remain unanswered. (13) Chickenpox vaccination should be restricted to specific groups of non immune immunocompetent adults who are in a position to transmit chickenpox to immunodeficient contacts (e.g. health care personnel and kindergarten staff); adults who have been in contact with a case of chickenpox within the past three days; and children awaiting transplantation. The potential benefits and risks of vaccinating immunocompromised patients should be assessed on a case by case basis.

摘要

(1)水痘一般症状较轻。大多数严重的水痘病例发生在免疫功能低下的患者、成年人和孕妇(及其胎儿)身上。(2)两种源自同一水痘病毒株(Oka)的减毒活水痘疫苗在法国上市,商品名为Varilrix和Varivax。(3)它们在免疫功能低下的儿童中尚未得到充分评估。(4)育龄妇女常规接种疫苗对孕期水痘并发症的影响尚未进行研究。(5)对数千名1至12岁免疫功能正常的儿童进行的免疫原性研究表明,单次注射后疫苗几乎总是具有免疫原性。在青少年和成年人中进行的其他比较研究表明,需要注射两次,间隔至少两个月。(6)一项纳入513名免疫功能正常儿童的双盲安慰剂对照试验表明,在中位随访29个月后,Varilrix预防了88%的水痘病例,但未报告严重水痘的数据。一项对9202名1至12岁儿童进行了13年以上随访的研究表明,接种Varivax未能预防12.5%的水痘病例,其中1.7%的病例为重症。(7)根据一项对Varilrix(104名儿童)的研究以及两项对Varivax(分别为10名和42名儿童)的小型研究,在接触病毒后三天内接种疫苗的免疫功能正常儿童受到部分保护。在成年人中没有类似的研究。(8)在免疫功能正常的接种者中,发热和皮疹等局部不良反应很常见。皮疹有时类似水痘,是由疫苗株感染引起的。对Varivax的药物警戒研究未显示严重不良反应。(9)免疫功能低下的患者中报告了由疫苗株引起的播散性和/或持续性感染。(10)对免疫功能正常的个体进行疫苗接种似乎不会导致水痘传播给后续接触者的风险增加。接种疫苗的儿童中带状疱疹的风险似乎没有增加也没有确凿证据表明水痘疫苗接种会增加普通人群中带状疱疹的发病率。(11)关于孕期接种疫苗的信息很少。然而,作为预防措施,孕妇不应接种疫苗。(12)大规模接种疫苗似乎没有道理:水痘在儿童期一般症状较轻,而且关于疫苗效果的几个问题仍未得到解答。(13)水痘疫苗接种应限于特定的非免疫免疫功能正常的成年人组,这些人有可能将水痘传播给免疫缺陷的接触者(如医护人员和幼儿园工作人员);在过去三天内接触过水痘病例的成年人;以及等待移植的儿童。应逐案评估为免疫功能低下患者接种疫苗的潜在益处和风险。

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