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目的分析7价肺炎球菌多糖结合疫苗(7-valent Pneumococcal Polysaccharide Conjugate Vaccine,PCV7)上市后大规模人群应用的被动监测结果,评价PCV7的安全性。方法通过疑似预防接种异常反应(Adverse Event Following Immunization,AEFI)信息管理系统,收集广东省珠江三角洲(珠三角)地区广州、深圳、东莞、中山、佛山5个市2009~2011年接种PCV7报告的AEFI个案,采用描述性流行病学方法分析相关信息。结果 5个市共接种PCV724.86万剂,报告AEFI 196例,报告发生率78.85/10万剂。报告一般反应102例,报告发生率41.04/10万剂;其中发热84例,报告发生率33.79/10万剂;局部红肿10例,报告发生率4.02/10万剂;异常反应73例,报告发生率29.37/10万剂;其中过敏性皮疹70例,报告发生率28.16/10万剂;热性惊厥2例,报告发生率0.80/10万剂;过敏性紫癜1例,报告发生率0.40/10万剂。97.96%的个案发生在接种后≤3d。结论现有的PCV7被动监测数据未发现不同于其他疫苗的不良反应。
Objective To analyze the passive monitoring results of 7-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV7) in large-scale population after its listing, and to evaluate the safety of PCV7. Methods AEFI was collected from 5 cities in Guangzhou, Shenzhen, Dongguan, Zhongshan and Foshan in 2009 ~ 2011 inoculated with PCV7 in the Pearl River Delta (Pearl River Delta) region of Guangdong Province through the AEFI (Information Management System) Cases, using descriptive epidemiological methods to analyze the relevant information. Results Five cities were vaccinated with PCV 7.2486 million and AEFI 196 cases, the reported incidence was 78.85 / 100 000 doses. Reported the general reaction of 102 cases, the report rate of 41.04 / 10 million; of which 84 cases of fever, the report incidence of 33.79 / 10 million; 10 cases of local redness, the report rate of 4.02 / 10 million; 73 cases of abnormal response, the report occurred Rate of 29.37 / 10 million; of which 70 cases of allergic rash, the report rate of 28.16 / 10 million; febrile seizures in 2 cases, the report rate of 0.80 / 10 million; allergic purpura in 1 case, the report rate of 0.40 / 10 Ten thousand doses. 97.96% of cases occurred after inoculation ≤ 3d. Conclusion The existing PCV7 passive monitoring data found no adverse reactions different from other vaccines.