佛山市三水区2016—2019年疑似预防接种异常反应监测分析

周开举; 何永辉; 吴碧娇; 邓洁莹; 陈俊虎

doi:10.16766/j.cnki.issn.1674-4152.002606

佛山市三水区2016—2019年疑似预防接种异常反应监测分析

doi: 10.16766/j.cnki.issn.1674-4152.002606

1.
佛山市三水区疾病预防控制中心，广东佛山 528100
2.
广东省生物制品与药物研究所，广东广州 510440

基金项目:

广东省医学科学技术研究基金项目 A2019199

中国肝炎防治基金会项目 YGFK20210046

广东省佛山市科学技术局科研项目 1920001001287

详细信息

通讯作者:
陈俊虎, E-mail: qq99jj@163.com

中图分类号: R186
计量
- 文章访问数: 119
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- 被引次数: 0
出版历程
- 收稿日期: 2021-06-08
- 网络出版日期: 2022-09-26

Analysis of monitoring results of suspected adverse event following immunization in Sanshui District, Foshan City, 2016-2019

1.
Center for Disease Control and prevention of Sanshui District, Foshan, Guangdong 528100, China

摘要

摘要: 目的分析佛山市三水区疑似预防接种异常反应(AEFI)发生率，掌握接种疫苗的安全性，为免疫规划管理提供依据。方法通过中国免疫规划信息系统收集2016—2019年佛山市三水区报告的疑似预防接种异常反应个案，采用Excel和SPSS 17.0统计学软件进行描述性分析。结果 2016—2019年三水区共报告AEFI个案437例，年均报告发生率为30.29/10万剂次，一般反应332例(占73.68%)，异常反应76例(占17.39%)，未报告过疫苗质量事故、接种事故和心因性反应，报告个案的性别比为1.5 9∶ 1，以1岁以下年龄组报告数最多，≥7岁组最少，1岁以下AEFI报告病例中，8月龄儿童占比最高，达22.78%；接种疫苗到发生疑似预防接种异常反应间隔时间以接种后12 h内占比最高(64.76%)；所有报告AEFI共涉及27种疫苗，报告发生率居前3位的疫苗为：23价肺炎疫苗、麻风疫苗、无细胞百白破疫苗；其中异常反应发生率居前3位的疫苗为：麻风疫苗、四价HPV疫苗、23价肺炎疫苗；发生的异常反应前3位分别为过敏反应-荨麻疹26例(34.21%)；过敏性皮疹17例(22.37%)；过敏反应-斑丘疹12例(15.79%)。结论 2016—2019年佛山市三水区AEFI监测各项指标均达到监测方案要求，系统运转正常，AEFI监测结果在一定程度上反映了疫苗的安全性，尤其需关注报告发生率居前的疫苗，有必要持续加强AEFI监测，进一步提高监测系统的敏感性和上报及时性。
- 疑似预防接种异常反应 /
- 监测 /
- 安全性
Abstract: Objective To analyze the incidence of suspected adverse event following immunization (AEFI) in Sanshui District of Foshan City, to master the safety of vaccination, and to provide basis for immunization planning and management. Methods The AEFI cases reported in Sanshui District of Foshan City from 2016 to 2019 were collected through the China immunization planning information system, and descriptive analysis was carried out by using Excel and SPSS 17.0 software. Results A total of 437 cases of AEFI were reported in Sanshui District from 2016 to 2019, with an average annual reporting rate of 30.29/100 000 doses, 332 cases (73.68%) of general reactions and 76 cases (17.39%) of abnormal reactions. No vaccine quality accidents, vaccination accidents nor psychogenic reactions were reported. The sex ratio of the reported cases was 1.5 9∶ 1, with the most reported cases in the group under 1 year old, the least in the group over 7 years old and the most reported cases in the group under 1 year old. Amongst the cases, 8-month-old children accounted for the highest proportion (22.78%). The interval between vaccination and the occurrence of suspected adverse reactions after vaccination accounted for the highest proportion (64.76%). All the reported AEFI involved 27 kinds of vaccines and the top three vaccines with the highest reported incidence were 23 valent pneumonitis vaccine, leprosy vaccine and acellular DPT vaccine. The top three vaccines with abnormal reaction rate were leprosy vaccine, tetravalent HPV vaccine and 23 valent pneumonia vaccine. The top three vaccines with abnormal reaction rate were allergic reaction urticaria in 26 cases (34.21%); allergic rash in 17 cases (22.37%); and allergic reaction macular papule in 12 cases (15.79%). Conclusion From 2016 to 2019, all the AEFI monitoring indicators in Sanshui District of Foshan City met the requirements of the monitoring scheme and the system operated normally. The AEFI monitoring results reflect the safety of vaccines to a certain extent, especially the vaccines with the highest reported incidence. AEFI monitoring must be continuously strengthened and the sensitivity and timeliness of the monitoring system must be further improved.
- Adverse events following immunization /
- Monitoring /
- Safety

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表 1 2016—2019年佛山市三水区AEFI报告发生情况[例(%)]

Table 1. Reported occurrence of AEFI in Sanshui District of Foshan City from 2016 to 2019 [cases (%)]

项目	一般反应	异常反应	偶合症	合计
年份
2016	84(25.30)	16(21.05)	4(13.79)	104(23.80)
2017	74(22.29)	19(25.00)	9(31.03)	102(23.34)
2018	89(26.81)	18(23.68)	6(20.69)	113(25.86)
2019	85(25.60)	23(30.26)	10(34.48)	118(27.00)
性别
男	203(61.14)	44(57.89)	21(72.41)	268(61.33)
女	129(38.86)	32(42.11)	8(27.59)	169(38.67)
年龄(岁)
0~	120(36.14)	46(60.53)	14(48.28)	180(41.19)
1~	109(32.83)	8(10.53)	5(17.24)	122(27.92)
2~	46(13.86)	7(9.21)	7(24.14)	60(13.73)
3~6	51(15.36)	9(11.84)	2(6.90)	62(14.19)
≥7	6(1.81)	6(7.89)	1(3.45)	13(2.97)
反应间隔时间(h)
0~	205(61.75)	60(78.95)	18(62.07)	283(64.76)
12~	48(14.46)	3(3.95)	0	51(11.67)
24~	67(20.18)	4(5.26)	1(3.45)	72(16.48)
36~	5(1.51)	1(1.32)	2(6.90)	8(1.83)
≥48	7(2.11)	8(10.53)	6(20.69)	21(4.81)
转归情况
好转	0	0	1(3.45)	1(0.23)
痊愈	332(100.00)	73(96.05)	28(96.55)	433(99.08)
治疗	0	3(3.95)	0	3 (0.69)
不详	0	0	0	0

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表 2 2016—2019年佛山市三水区各类疫苗AEFI报告发生情况

Table 2. Incidence of AEFI of various vaccines in Sanshui District, Foshan City, 2016-2019

疫苗名称	接种剂次	一般反应		异常反应		偶合症	合计
疫苗名称	接种剂次	例数	报告发生率(/10万)	例数	报告发生率(/10万)	偶合症	例数	报告发生率(/10万)
卡介苗	43 881	0	0	6	13.67	0	6	13.67
乙肝疫苗	173 040	14	8.09	6	3.47	4	24	13.87
脊灰减毒活疫苗	125 271	6	4.79	4	3.19	4	14	11.18
脊灰灭活疫苗	31 752	2	6.30	1	3.15	0	3	9.45
无细胞百白破疫苗	161 919	106	65.46	3	1.85	3	112	69.17
白破疫苗	35 691	19	53.23	1	2.80	0	20	56.04
麻风疫苗	42 859	14	32.67	16	37.33	1	31	72.33
麻腮风疫苗	42 174	7	16.60	8	18.97	1	16	37.94
乙脑减毒活疫苗	83 457	30	35.95	3	3.59	0	33	39.54
流脑A群疫苗	73 866	19	25.72	4	5.42	1	24	32.49
流脑A+C疫苗多糖疫苗	72 868	7	9.61	1	1.37	0	8	10.98
甲肝减毒活疫苗	42 830	2	4.67	3	7.00	2	7	16.34
甲肝灭活疫苗	3 898	0	0	1	25.65	0	1	25.65
DTaP-IPV/Hib五联苗	9 388	5	53.26	0	0	0	5	53.26
百白破-Hib四联苗	1 547	1	64.64	0	0	0	1	64.64
水痘疫苗	66 166	9	13.60	2	3.02	0	11	16.62
轮状病毒疫苗	32 308	7	21.67	0	0	3	10	30.95
流脑ACYW4价疫苗	6 123	4	65.33	0	0	0	4	65.33
流脑A+C-Hib三联苗	8 445	2	23.68	1	11.84	0	3	35.52
HiB疫苗	47 453	8	16.86	0	0	0	8	16.86
23价肺炎疫苗	19 290	26	134.78	5	25.92	5	36	186.63
儿童流感疫苗	48 599	9	18.52	0	0	1	10	20.58
流感疫苗(3岁及以上)	38 015	17	44.72	3	7.89	2	22	57.87
人用狂犬疫苗	147 218	3	2.04	3	2.04	1	7	4.75
肠道病毒71型疫苗	47 238	9	19.05	3	6.35	0	12	25.40
13价肺炎疫苗	8 341	4	47.96	0	0	1	5	59.94
四价HPV疫苗	7 364	2	27.16	2	27.16	0	4	54.32
其他疫苗	21 597	0	0	0	0	0	0	0
合计	1442 598	332	23.01	76	5.27	29	437	30.29

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表 3 2016—2019年佛山市三水区异常反应临床诊断情况

Table 3. Clinical diagnosis of abnormal reactions in Sanshui District of Foshan City from 2016 to 2019

最终临床诊断	例数	构成比(%)
过敏反应-荨麻疹	26	34.21
过敏性皮疹	17	22.36
过敏反应-斑丘疹	12	15.78
卡介苗淋巴结炎	6	7.89
过敏反应-麻疹猩红热样皮疹	3	3.95
过敏反应-血管性水肿	3	3.95
热性惊厥	3	3.95
过敏反应-其他过敏性反应	2	2.63
癫痫	1	1.32
过敏反应-过敏性紫癜	1	1.32
过敏反应-血小板减少性紫癜	1	1.32
急性播散性脑脊髓炎	1	1.32
合计	76	100.00

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