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麻疹、腮腺炎和风疹病毒疫苗(M-M-R™II):32 年临床和上市后经验回顾。

Measles, mumps, and rubella virus vaccine (M-M-R™II): a review of 32 years of clinical and postmarketing experience.

机构信息

Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.

出版信息

Vaccine. 2012 Nov 6;30(48):6918-26. doi: 10.1016/j.vaccine.2012.08.057. Epub 2012 Sep 7.

Abstract

M-M-R™II (measles, mumps, and rubella virus vaccine live; Merck, Sharp, & Dohme Corp.) is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals ≥ 12 months of age. Before the vaccine era, these viruses infected most exposed individuals, with subsequent morbidity and mortality. One of the greatest achievements of public health has been to eliminate these 3 diseases in large geographic areas. The safety profile of M-M-R™II is described using data from routine global postmarketing surveillance. Postmarketing surveillance has limitations (including incomplete reporting of case data), but allows collection of real-world information on large numbers of individuals, who may have concurrent medical problems excluding them from clinical trials. It can also identify rare adverse experiences (AEs). Over its 32-year history, ≈ 575 million doses of M-M-R™II have been distributed worldwide, with 17,536 AEs voluntarily reported for an overall rate of 30.5 AEs/1,000,000 doses distributed. This review provides evidence that the vaccine is safe and well-tolerated.

摘要

M-M-R II(麻疹、腮腺炎和风疹病毒活疫苗;默克公司)适用于≥12 个月龄个体同时预防麻疹、腮腺炎和风疹。在疫苗时代之前,这些病毒感染了大多数暴露的个体,随后出现发病率和死亡率。公共卫生的最大成就之一是在大面积地区消除了这 3 种疾病。M-M-R II 的安全性概况是使用来自常规全球上市后监测的数据描述的。上市后监测存在局限性(包括病例数据报告不完整),但可以收集大量个体的真实世界信息,这些个体可能同时存在医学问题,使其无法参加临床试验。它还可以识别罕见的不良事件(AE)。在 32 年的历史中,全球已分发了约 5.75 亿剂 M-M-R II,自愿报告了 17536 例不良事件,总发生率为每 100 万剂 30.5 例。这篇综述提供了证据表明该疫苗是安全且耐受良好的。

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