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首页> 美国卫生研究院文献>Bulletin of the World Health Organization >Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data
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Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data

机译：肺炎球菌结合疫苗的安全性：许可前后数据的系统评价

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A 7-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) was licensed in the United States of America in 2000, but no comprehensive postmarketing review of safety has been carried out. We conducted a systematic review of the safety of PCV7 and other pneumococcal conjugate vaccines. A total of 42 studies were included in the review. Reactogenicity data from some randomized trials suggest that PCV7 may result in more local reactions and fever than certain comparison vaccines. However, the reactions were mild and self-limited, and PCV7 did not carry an increased risk of severe injection-site reactions or high fever. Some, although not all, of the randomized trials in children found that mild local and systemic reactions associated with PCV7 may increase with the number of doses, at least over the three-dose primary series. In addition, PCV7 and other pneumococcal conjugate vaccines were found to have tolerable reactogenicity in Native American and African populations and in medically high-risk groups for which pneumococcal vaccination is recommended. Two of the largest studies of PCVs, one involving PCV7 and the other, PCV9, found a statistically significant increased risk of hospitalization for reactive airway disease, including asthma. Another large trial of PCV9, however, did not find an increased risk of asthma. In conclusion, this review of the evidence did not identify any major safety problems with PCV7 or any other pneumococcal conjugate vaccine, with the possible exception of reactive airway disease, which may bear further scrutiny as additional data become available.
机译：7价肺炎球菌多糖-蛋白质结合疫苗（PCV7）于2000年在美国获得许可，但尚未进行安全性的全面上市后审查。我们对PCV7和其他肺炎球菌结合疫苗的安全性进行了系统评价。该评价共纳入42项研究。来自一些随机试验的反应原性数据表明，与某些比较疫苗相比，PCV7可能导致更多的局部反应和发烧。但是，这些反应是轻度且自限的，并且PCV7不会带来严重的注射部位反应或高烧的风险。一些（尽管不是全部）儿童随机试验发现，与PCV7相关的轻度局部和全身反应可能会随着剂量数量的增加而增加，至少在三剂主要系列中如此。此外，在美洲原住民和非洲人群以及建议接种肺炎球菌疫苗的医学高危人群中，发现PCV7和其他肺炎球菌结合疫苗具有可耐受的反应原性。关于PCV的最大的两项研究中，一项涉及PCV7，另一项涉及PCV9，发现反应性气道疾病（包括哮喘）的住院风险在统计学上显着增加。然而，另一项PCV9大型试验并未发现哮喘风险增加。总之，对证据的审查并未发现PCV7或任何其他肺炎球菌结合疫苗存在任何重大安全性问题，可能的反应性气道疾病除外，随着更多数据的获得，可能需要进一步审查。

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