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JID:既往带状疱疹史不影响疫苗的安全性

2013-05-09 JID MedSci原创

带状疱疹预防研究(SPS)是一项大型的随机双盲安慰剂对照的临床试验,涉及了38546名具有免疫力的、年龄大于60岁的成年人。研究发现,活性减毒带状疱疹疫苗(Oka/Merck VZV vaccine)能够减轻61%的带状疱疹相关的疼痛或不适,使带状疱疹后神经痛的发病率降低了67%,使带状疱疹的发病率降低了51%。因此,无论是否有过带状疱疹病史,CDCC和ACIP均推荐大于60岁的成年人接种带状疱疹

带状疱疹预防研究(SPS)是一项大型的随机双盲安慰剂对照的临床试验,涉及了38546名具有免疫力的、年龄大于60岁的成年人。研究发现,活性减毒带状疱疹疫苗(Oka/Merck VZV vaccine)能够减轻61%的带状疱疹相关的疼痛或不适,使带状疱疹后神经痛的发病率降低了67%,使带状疱疹的发病率降低了51%。因此,无论是否有过带状疱疹病史,CDCC和ACIP均推荐大于60岁的成年人接种带状疱疹疫苗。为了比较带状疱疹疫苗在420名有明确带状疱疹感染史的人群中与其他SPS参与者中的安全性,来自于美国明尼阿波利斯市军人退伍医疗中心的Morrison等人做了一项研究,研究结果在线发表于2013年4月30日的Journal of Infectious Diseases上。研究发现,带状疱疹史不影响疫苗的安全性。
在SPS研究中,有13681名参与者接种了带状疱疹疫苗,并跟踪观察严重不良反应(SAE)28天。与SPS相反的是,有带状疱疹病史不是接种带状疱疹疫苗的禁忌症。接种带状疱疹疫苗的参试者中包括了420名有明确带状疱疹感染史的人。
研究结果显示,在420名有带状疱疹史人群中,带状疱疹感染与接种带状疱疹疫苗之间的平均间隔是3.61年(中值:3.77年;范围:3-85个月);间隔少于5年的大约占了80%。在有带状疱疹史的参试者中,有一种或一种以上严重不良反应的比例(0.95%)与在其无带状疱疹史的接种者的比例(0.66%)无显著差异,并且严重不良反应在这两个群体中的分布也是相似的。
研究发现,带状疱疹疫苗在老年人中的安全性不因近期带状疱疹史而改变,证明了CDCC和ACIP的推荐—“所有大于60岁的人(无论是否有过带状疱疹史)可接种带状疱疹疫苗,且无禁忌症”是安全的。
带状疱疹相关的拓展阅读:


Safety of Zoster Vaccine in Elderly Adults Following Documented Herpes Zoster.
Abstract
Background. After completion of the Shingles Prevention Study (SPS; VA Cooperative Studies Program #403), SPS placebo recipients were offered investigational zoster vaccine without charge. This provided an opportunity to determine the relative safety of zoster vaccine in older adults following documented herpes zoster (HZ).Methods. SPS placebo recipients who elected to receive zoster vaccine (13,681) were followed for serious adverse events (SAE) for 28 days post-vaccination. In contrast to the SPS, a prior episode of HZ was not a contraindication to receiving zoster vaccine. The SPS placebo recipients who received zoster vaccine included 420 who had developed documented HZ during the SPS.Results. The mean interval between the onset of HZ and receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median 3.77 years; range 3-85 months); the interval was less than 5 years in approximately 80%. The proportion of vaccinated SPS placebo recipients with prior HZ who developed one or more SAE (0.95%) was not significantly different from that of vaccinated placebo recipients with no prior history of HZ (0.66%), and the distribution of SAE in the two groups was comparable.Conclusions. These results demonstrate that the general safety of zoster vaccine in older persons is not altered by a recent history of documented HZ, supporting the safety aspect of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommendation to administer zoster vaccine to all persons >60 years of age with no contraindications, regardless of a prior history of HZ.

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