上海市2006年预防接种安全性分析

Analysis on Immunization Safety in Shanghai in 2006

目的了解上海市预防接种安全性的现况和影响因素。方法对预防接种安全性监测系统收集的信息进行描述性分析。结果上海市2006年预防接种不良反应报告率为37.1/10万,其中一般反应32.4/10万,异常反应4.7/10万。实施差错报告率为0.2/10万。夏季不良反应报告率较秋冬季低。市区不良反应报告率最高,其次是远郊,近郊最低。病毒类和细菌类疫苗不良反应报告率分别为13.7/10万和66.3/10万。不良反应报告率前5位的制品种类是抗狂犬病血清、肺炎球菌疫苗、白喉-百日咳-破伤风联合疫苗、b型流行性感冒嗜血杆菌疫苗和白喉-破伤风联合疫苗。有1例接种乙型肝炎疫苗后发生急性过敏反应死亡。结论上海市预防接种安全性监测系统准确性高,敏感性仍可提高;病毒类疫苗比细菌类疫苗安全;不良反应存在季节性和地区性差异;同一制品种类不同产品的安全性差别较大;对产品安全性的判断需要考虑偏倚。

Objective To know the status and influencial factors of immunization safety in Shanghai. Methods Descriptive analysis was applied on the data collected by immunization safety monitoring system. Results The reported adverse reactions following immunization（ARFI） was 37.1/100000,including common reaction（32.4/100000）and of abnormal reaction（4. 7/100000） in 2006. The rate of practice error was 0. 2/100000. Reported ARFI rates were higher in summer autumn and winter. ARFI rates viral and bacterial vaccines caused by were 13.7/100000 and 66.3/ 100000respectively. The top five categories on the reported ARFI rates were： Anti-rabies serum, Pneumococcal vaccine,Diphtheria Pertussis Tetanus vaccine, Haemophilus Influenza B vaccine and Diphtheria Tetanus vaccine. One case died caused by acute allergy reaction after receiving Hepatitis B vaccine. Conclusion The immunization safety monitoring system in Shanghai was accurate and could be more sensitive. Seasonal and district difference were influenciat factors to ARFI. Viral vaccines were safer than bacterial vaccines. The safety of different products was significantly difference. Deflection should be taken into account to the product safety evaluation.