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麻疹、腮腺炎和风疹联合疫苗(MMR)接种后的意外事件:一项系统评价

Unintended events following immunization with MMR: a systematic review.

作者信息

Jefferson Tom, Price Deirdre, Demicheli Vittorio, Bianco Elvira

机构信息

Reparto Epidemiologia Clinica, Istituto Superiore di Sanità, Viale Regina Elena, 299-00161 Rome, Italy.

出版信息

Vaccine. 2003 Sep 8;21(25-26):3954-60. doi: 10.1016/s0264-410x(03)00271-8.

Abstract

Public debate over the safety of the trivalent measles, mumps and rubella (MMR) vaccine and the drop in vaccination rates in several countries persists despite its almost universal use and accepted effectiveness. We carried out a systematic review to assess the evidence of unintended effects (beneficial or harmful) associated with MMR and the applicability of systematic reviewing methods to the field of safety evaluation. Eligible studies were comparative prospective or retrospective on healthy individuals up to 15 years of age, carried out or published by 2003. We identified 120 articles satisfying our inclusion criteria and included 22. MMR is associated with a lower incidence of upper respiratory tract infections, a higher incidence of irritability, similar incidence of other adverse effects compared to placebo and is likely to be associated with benign thrombocytopenic purpura (TP), parotitis, joint and limb complaints and aseptic meningitis (mumps Urabe strain-containing MMR). Exposure to MMR is unlikely to be associated with Crohn's disease, ulcerative colitis, autism or aseptic meningitis (mumps Jeryl-Lynn strain-containing MMR). The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunization with MMR cannot be separated from its role in preventing the target diseases.

摘要

尽管三价麻疹、腮腺炎和风疹(MMR)疫苗几乎被普遍使用且其有效性已被认可,但关于该疫苗安全性的公众辩论以及几个国家疫苗接种率的下降仍在持续。我们进行了一项系统综述,以评估与MMR相关的意外影响(有益或有害)的证据,以及系统综述方法在安全性评估领域的适用性。符合条件的研究是针对15岁及以下健康个体的比较性前瞻性或回顾性研究,于2003年之前开展或发表。我们识别出120篇符合纳入标准的文章,并纳入了其中22篇。与安慰剂相比,MMR与上呼吸道感染发病率较低、易激惹发病率较高、其他不良反应发病率相似有关,并且可能与良性血小板减少性紫癜(TP)、腮腺炎、关节和肢体不适以及无菌性脑膜炎(含腮腺炎Urabe株的MMR)有关。接触MMR不太可能与克罗恩病、溃疡性结肠炎、自闭症或无菌性脑膜炎(含腮腺炎Jeryl-Lynn株的MMR)有关。MMR疫苗上市前和上市后研究中安全性结果的设计和报告在很大程度上是不充分的。接种MMR后不良事件的证据与其在预防目标疾病中的作用无法分开。

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