The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: A capture-recapture analysis
The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: A capture-recapture analysis
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DOI：
10.1016/j.vaccine.2012.01.013
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发表时间：
2012-03-09
期刊：
影响因子：
5.5
通讯作者：
Chuang, Jen-Hsiang
中科院分区：
文献类型：
--
作者：
Huang, Wan-Ting;Huang, Wei-I;Chuang, Jen-Hsiang
2009年H1N1流感疫苗（“2009 H1N1疫苗”）在台湾发生的不良事件被动报告给国家药品不良反应报告系统。评价自发报告的完整性，2009年11月1日至8月31日期间发生的2009年H1N1疫苗接种后死亡、格林-巴利综合征（GBS）、惊厥、贝尔麻痹和特发性血小板减少性紫癜（ITP）病例，从国家药品不良反应报告系统（NADRRS）数据库中选择2010年，并额外构建了全国大型-链接数据库（LLDB），并在唯一个人标识符、接种日期（+/-7天内）和诊断日期（+/-7天内）上进行匹配。总体而言，两个数据源之间的匹配包括21例死亡，5例GBS，19例惊厥，22例贝尔麻痹和5例ITP。Chapman捕获-再捕获法估计接种后0-42天内的自发报告完整性为：死亡4%，GBS 71%，惊厥3%，贝尔麻痹9%，ITP 15%。对于接种后>= 43天的间隔，死亡报告完整性为0.1%，GBS为14%，惊厥为0.1%，
Adverse events following pandemic (H1N1) 2009 vaccines ("2009 H1N1 vaccines") in Taiwan were passively reported to the National Adverse Drug Reaction Reporting System. To evaluate the completeness of spontaneous reporting, cases of death, Guillain-Barre syndrome (GBS), convulsion, Bell's palsy, and idiopathic thrombocytopenic purpura (ITP) after 2009 H1N1 vaccination that occurred between November 1, 2009 and August 31, 2010 were selected from the National Adverse Drug Reaction Reporting System (NADRRS) database and an additionally constructed nationwide large-linked database (LLDB), and matched on a unique personal identifier, date of vaccination (within +/- 7 days), and date of diagnosis (within +/- 7 days). Overall, matches occurred between the two data sources included 21 for death, 5 for GBS, 19 for convulsion, 22 for Bell's palsy, and 5 for ITP. The Chapman capture-recapture estimated spontaneous reporting completeness within 0-42 days of vaccination was 4% for death, 71% for GBS, 3% for convulsion, 9% for Bell's palsy, and 15% for ITP. For the interval >= 43 days after vaccination, reporting completeness was 0.1% for death, 14% for GBS, 0.1% for convulsion,