吸附无细胞和全细胞百白破联合疫苗上市后预防接种安全性的比较分析

Comparative Study on Post-marketing Immunization Safety of Absorbed Diphtheria,Tetanus and Acellular Pertusis Combined Vaccine,and Absorbed Diphtheria,Tetanus and Whole-cell Pertusis Combined Vaccine in China

目的评价中国(未包括香港、澳门特别行政区和台湾地区,下同)吸附无细胞百白破联合疫苗(Diphtheria Teta-nus and Acellular Pertusis Combined Vaccine,Absorbed;DTaP)和吸附全细胞百白破联合疫苗(Diphtheria,Tetanus and Whole-cell Pertusis Combined Vaccine,Absorbed;DTwP)上市后预防接种的安全性。方法通过全国疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测系统,收集10个试点省2005～2006年DTaP和DTwP严重不良反应监测数据,采用描述性方法对两种疫苗不良反应的发生特征进行比较分析。结果中国DTaP和DTwP上市后,严重不良反应总发生率分别为3.5/10万剂和3.3/10万剂;DTaP以过敏反应为主,且第4剂反应危险性高;DTwP以无菌脓肿为主,高危险性反应剂次因反应的临床损害不同而异;部分疫苗品种和批号的反应存在聚集性,DTwP聚集性反应危险高于DTaP。结论DTaP和DTwP上市后均具有较好的预防接种安全性;聚集性分析显示,DTaP安全性优于DTwP;需进一步加强对每批DTaP或DTwP上市前的质量控制。

Objective This study is to evaluate the post-marketing immunization safety of absorbed diphtheria, tetanus, and acellular pertusis combined vaccine （DTaP）, and absorbed diphtheria,tetanus and whole-cell pertusis combined vaccine （DTwP） in China. Methods Through National Surveillance System for Adverse Events Following Immunization （AEFI）,serious AEFI cases during 2005-2006 were collected in 10 pilot provinces,and the occurrence features of AEFIs were analyzed by using descriptive methodology. Results The overall incidence rates of serious AEFIs for post-marketing DTaP and DTwP were 3.5 and 3.3 per 100 000 doses,respectively. Anaphylaxis dominated DTaP AEFIs, and the high-risk for DTaP AEFIs was the 4th dose. Sterile abscess dominated DTwP AEFIs, and the high-risk dose for DTwP AEFIs varied with AEFI illnesses. AEFI clusters were identified in some vaccine lots of products, with higher risk for AEFI clusters in DTwP than in DTaP. Conclusions Both DTaP and DTwP have good immunization safety. The study on AEFI clusters indicates that the safety of DTaP is better than that of DTwP. Pre-marketing quality control for each vaccine lot of DTaP or DTwP should be strengthened.