2011 年至 2017 年在中国广州进行的五联疫苗（DTaP-IPV/Hib 联合疫苗）上市后监测的安全性。
Safety of pentavalent DTaP-IPV/Hib combination vaccine in post-marketing surveillance in Guangzhou, China, from 2011 to 2017.
机构信息
Guangzhou Center For Disease Control And Prevention, Department of Immunization Planning, No.1, Qide Rd, Jiahe, Baiyun, Guangzhou, Guangdong, China.
出版信息
Int J Infect Dis. 2020 Oct;99:149-155. doi: 10.1016/j.ijid.2020.07.019. Epub 2020 Aug 12.
BACKGROUND
The DTaP-IPV/Hib combination vaccine can replace the acellular tetanus vaccine, polio vaccine, and the Haemophilus influenzae type B vaccine. Data on the safety of DTaP-IPV/Hib vaccines are required. We aimed to evaluate the safety of the vaccination program.
METHODS
Using the National Adverse Events Following Immunization (AEFI) surveillance system (CNAEFIS) in Guangzhou, China, a retrospective study was performed from May 11, 2011, to December 31, 2017. There were 376 cases of adverse events after vaccination with the DTaP IPV/Hib vaccine. The primary analysis indicators were the number of vaccines used, the number of AEFI reports received, and the reporting rate (per 100,000).
RESULTS
From May 1, 2011, to December 31, 2017, 516,000 doses of vaccine were inoculated, and 376 cases of adverse reactions were reported; the reporting rate was 72.8 per 100,000 vaccines. There were eight cases of serious AEFIs (1.5 per 100,000), with four cases of thrombocytopenic purpura (0.8 per 100,000); three cases of cyanosis of the lips, stiffness, and flexion of limbs, and convulsions (0.6 per 100,000); and one case of a high fever (0.2 per 100,000). The highest incidence of AEFIs occurred after the fourth dose (n = 207, 55.0%, 40.1 per 100,000), followed by the first dose (n = 81, 21.5%, 15.7 per 100,000), second dose (n = 48, 12.8%, 9.3 per 100,000) and third dose (n = 40, 10.6%, 7.7 per 100,000). The AEFI incidence was higher after injection of the vaccine into the deltoid muscle of the upper arm (n = 276, 73.4%, 53.5 per 100,000) than after injection of the vaccine into the thigh (n = 100, 26.6%, 19.4 per 100,000). There was a significant difference between AEFIs after injection into the deltoid of the upper arm deltoid and the thigh (x = 164.8, P < 0.05).
CONCLUSIONS
Most of the reported AEFIs after DTaP-IPV/Hib vaccination are not serious. There were four cases of TP in this study; vaccination may be a rare cause of thrombocytopenic purpura.
背景
DTaP-IPV/Hib 联合疫苗可替代无细胞破伤风疫苗、脊髓灰质炎疫苗和流感嗜血杆菌 b 疫苗。需要关于 DTaP-IPV/Hib 疫苗安全性的数据。我们旨在评估接种计划的安全性。
方法
利用中国广州国家疑似预防接种异常反应（AEFI）监测系统（CNAEFIS），对 2011 年 5 月 11 日至 2017 年 12 月 31 日期间接种 DTaP-IPV/Hib 疫苗后的不良事件进行回顾性研究。共报告了 376 例疫苗接种后不良事件。主要分析指标为疫苗使用数、AEFI 报告数和报告率（每 10 万剂）。
结果
2011 年 5 月 1 日至 2017 年 12 月 31 日，接种疫苗 51.6 万剂次，报告 376 例不良事件；报告率为每 10 万剂 72.8 例。8 例严重 AEFI（每 10 万剂 1.5 例），其中血小板减少性紫癜 4 例（每 10 万剂 0.8 例）；嘴唇发绀、四肢僵硬和弯曲、抽搐 3 例（每 10 万剂 0.6 例）；高热 1 例（每 10 万剂 0.2 例）。AEFI 发生率最高的是第四剂（n = 207，55.0%，每 10 万剂 40.1 例），其次是第一剂（n = 81，21.5%，每 10 万剂 15.7 例）、第二剂（n = 48，12.8%，每 10 万剂 9.3 例）和第三剂（n = 40，10.6%，每 10 万剂 7.7 例）。在上臂三角肌接种疫苗的 AEFI 发生率（n = 276，73.4%，每 10 万剂 53.5 例）高于大腿接种疫苗的 AEFI 发生率（n = 100，26.6%，每 10 万剂 19.4 例），差异有统计学意义（x = 164.8，P < 0.05）。
结论
本研究报告的大多数 DTaP-IPV/Hib 疫苗接种后 AEFI 并不严重。该研究中有 4 例 TP；接种疫苗可能是血小板减少性紫癜的罕见病因。
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