潍坊市疑似预防接种异常反应监测分析

Surveillance and analysis on adverse events following immunization in Weifang City,Shandong Province,China

目的分析山东省潍坊市2011～2012年疑似预防接种异常反应(adverse events following immunization,AEFI)的发生特征,评价AEFI监测系统运转情况及预防接种安全性。方法通过AEFI监测系统,收集全市2011年1月1日至2012年12月31日报告的AEFI个案数据,采用描述性流行病学方法和卡方检验进行数据分析。结果 2011～2012年全市AEFI监测系统共报告AEFI 1 836例,报告发生率为39.75/10万,2012年报告发生率(42.79/10万)高于2011年(36.57/10万),差异有统计学意义(P<0.01)。在1 836例AEFI中,男女性别比为1.34∶1;≤1岁占79.63%;病例报告主要集中在8～11月份,占52.67%;报告疫苗以国家免疫规划疫苗(National Immunization Program,NIP)为主;一般反应占97.50%,报告发生率为38.76/10万,以单纯发热、局部红肿伴有硬结和单纯局部红肿为主,异常反应占2.07%,报告发生率为0.83/10万,以过敏性反应和卡介苗淋巴结炎为主,偶合症占0.33%,报告发生率为0.13/10万,心因性反应和待定分别1例,占0.05%,报告发生率为0.02/10万,大多数病例已痊愈。估算全市NIP不良反应报告发生率为6.45～109.30/10万。2011～2012年全市12个县市区均有AEFI个案报告,报告县覆盖率、48 h及时报告率和48 h及时调查率均达到100%。结论全市AEFI系统的监测灵敏性尚需继续提高,AEFI多发生在低年龄儿童和夏秋季节,疫苗以NIP为主,应重点监测;NIP不良反应报告发生率均在预期发生范围内,安全性良好。

Objective To analyze the occurrence features of adverse events following immunization （AEFIs） in Weifang City, Shandong Province, China in 2011-2012, and to evaluate the implementation of AEFI surveillance system and the safety of immunization with vaccines included in National Immunization Program（NIP）. Methods The data on AEFIs re- ported in Weifang City from January 1st 2011 to December 31st 2012 were collected by AEFI surveillance system, and analyzed by descriptive methodology and chi-square test. Results A total of 1 836 cases of AEFIs were reported by AEFI surveillance system in the city in 2011 - 2012, indicating an incidence of 39. 75 / 100 000. The incidence in 2012 （42. 79/100 000） was significantly higher than that in 2011 （36. 57/100 000） （P 〈 0. 01 ）. The ratio of male to female in the 1836 AEFI cases was 1. 34 ： 1. A portion of 79. 63% of AEFI cases occurred in the infants at ages of not more than one year. Of the cases, 52. 67% were reported between August and November. Most of the cases occurred after im- munization with the vaccines included in NIP. A portion of 97. 50% of the AEFIs were general reaction mainly expressed as simplex fever, local redness and swelling ＋ duration and simplex redness and swelling, with an incidence of 38. 76/ 100 000. However, 2. 07% of the AEFIs were abnormal reactions mainly expressed as anaphylactic reactions and BCG-as- sociated lymphadenitis, with an incidence of O. 83 / 100 000. Concidental symptom accounted for 0. 33% of the AEFIs, with an incidence of O. 13/100 000. One case of psychogenic reaction and one case of undefined reaction were observed, each of which accounted for 0. 05% of the AEPIs, with an incidence of O. 02 / 100 000. Most of the cases were recovered. It was established that the reported incidence of AEFI of NIP vaccines in this city was （6. 45 - 109. 30） / 100 000. AEFIs were reported in all the 12 counties or districts in the whole city in 2011 - 2012. All the county-based coverage rate of AEFI report, report rate within 48 h and investigation rate within 48 h were 100%. Conclusion The sensitivity ofAEFI surveillance system in Weifang City needed to be further improved. Most of AEFIs occurred in young children, in summer and autumn, and after immunization with NIP vaccines. The reported incidence rate of AEFIs after immunization with NIP vaccines was within the range expected, indicating high safety of the vaccines.