上海市浦东新区2012～2016年含b型流感嗜血杆菌成分疫苗预防接种不良反应特征分析
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摘要
目的分析含b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)成分类疫苗的预防接种不良反应特征。方法通过中国疑似预防接种异常反应信息管理系统收集2012～2016年上海市浦东新区报告的含Hib成分类疫苗预防接种不良事件(Adverse Events Following Immunization,AEFI)数据,通过上海市免疫规划信息系统收集接种数据,采用描述性流行病学方法进行统计分析。结果 2012～2016年共报告接种含Hib类成分疫苗AEFI 1 766例,报告发生率318. 78/10万剂,其中一般反应1 735例,报告发生率313. 36/10万剂,异常反应30例,报告发生率5. 42/10万剂,偶合症1例,报告发生率0. 18/10万剂。Hib、流脑HI、DTaP-Hib、DTaP-IPV-Hib疫苗不良反应报告发生率分别为160. 69/10万剂、203. 28/10万剂、358. 24/10万剂和590. 59/10万剂,差异有统计学意义(P <0. 001)。各疫苗基础免疫(前3剂次之和)共接种473 223剂次,不良反应报告发生率224. 84/10万剂,加强免疫共接种80 457剂次,不良反应报告发生率871. 27/10万剂,基础免疫与加强免疫之间不良反应报告率差异有统计学意义(P <0. 001);Hib、DTaP-Hib、DTaP-IPV-Hib疫苗在加强免疫中的不良反应报告发生率均高于基础免疫(P均<0. 001)。各疫苗在不同接种部位的不良反应报告率差异有统计学意义(P均<0. 001),其中Hib、流脑HI疫苗不良反应发生部位主要在上臂,不良反应报告率分别为118. 71/10万剂和203. 28/10万剂,DTaP-IPV-Hib疫苗不良反应发生部位主要在大腿,不良反应报告率545. 75/10万剂,DTaP-Hib疫苗不良反应发生部位主要在臀部,不良反应报告发生率259. 41/10万剂。各疫苗的不良反应发生时段主要集中在6～24和24～48 h,不良反应报告率255. 92/10万剂,不同时间间隔的不良反应报告发生率差异有统计学意义(P均<0. 001)。结论含Hib成分类疫苗不良反应报告发生率低,安全性较好,建议接种部位为上臂和大腿,同时应做好接种后1～2 d不良反应的监测及处置。
Objective To analyze the characteristics of adverse events following immunization(AEFI)reaction of Haemophilus influenzae b(Hib)containing vaccines. Methods The data on AEFI of Hib containing vaccines reported in Pudong New District,Shanghai were collected through China AEFI Information Management System during 2012 ～ 2016,while that on vaccination through the Shanghai Immunization Program Information System,and subjected to statistical analysis by descriptive epidemiological methods. Results A total of 1 766 cases of AEFI of Hib were reported during 2012 ～2016,indicating an incidence rate of 318. 78/100 000 doses,of which 1 735 cases were general reactions(98. 24%),indicating an incidence rate of 313. 36/100 000 doses,while 30 cases of abnormal reaction were reported,indicating an incidence rate of 5. 42/100 000 doses. One case of coincidence was observed,indicating an incidence rate of 0. 18/100 000 doses. The incidence rates of AEFI of Hib,epidemic encephalitis-HI,DTaP-Hib,DTaP-IPV-Hib were 160. 69/100 000 doses,203. 28/100 000 doses,358. 24/100 000 doses and 590. 59/100 000 doses respectively,which showed significant difference(P < 0. 001). A total of 473 223 doses of various vaccines were inoculated for primary immunization(three doses),of which the incidence rate of AEFI was 224. 84/100 000 doses. However,a total of 80 457 doses were inoculated for booster immunization,of which the incidence rate of AEFI was 871. 27/100 000 doses,indicating a significant difference with that of primary immunization(P < 0. 001). The incidence rates of AEFI of Hib,DTap-Hib and DTaP-IPV-Hib in booster immunization were significantly higher than those in primary immunization(each P < 0. 001). The incidence rates of AEFI of various vaccines in various injection sites showed significant difference(each P < 0. 001). The AEFI of Hib and epidemic encephalitis-HI mainly appeared in upper arm,with incidence rates of118. 71/100 000 doses and 203. 28/100 000 doses respectively. The AEFI of DTaP-IPV-Hib mainly appeared in thigh,with an incidence rate of 545. 75/100 000 doses,while that of DTaP-Hib mainly appeared in buttocks,with an incidence rate of 259. 41/100 000 doses. Most of the AEFI of various vaccines appeared 6 ～ 24 and 24 ～ 48 h after immunization,with an incidence rate of 255. 92/100 000 doses. The incidence rates of AEFI at various time intervals after immunization showed significant difference(each P < 0. 001). Conclusion The incidence of AEFI of Hib containing vaccines was low,indicating a high safety. It is recommended that the vaccines should be vaccinated in upper arm or thigh,and the monitoring and disposal of AEFI should be strengthened 1 ～ 2 d after vaccination.
Objective To analyze the characteristics of adverse events following immunization(AEFI)reaction of Haemophilus influenzae b(Hib)containing vaccines. Methods The data on AEFI of Hib containing vaccines reported in Pudong New District,Shanghai were collected through China AEFI Information Management System during 2012 ～ 2016,while that on vaccination through the Shanghai Immunization Program Information System,and subjected to statistical analysis by descriptive epidemiological methods. Results A total of 1 766 cases of AEFI of Hib were reported during 2012 ～2016,indicating an incidence rate of 318. 78/100 000 doses,of which 1 735 cases were general reactions(98. 24%),indicating an incidence rate of 313. 36/100 000 doses,while 30 cases of abnormal reaction were reported,indicating an incidence rate of 5. 42/100 000 doses. One case of coincidence was observed,indicating an incidence rate of 0. 18/100 000 doses. The incidence rates of AEFI of Hib,epidemic encephalitis-HI,DTaP-Hib,DTaP-IPV-Hib were 160. 69/100 000 doses,203. 28/100 000 doses,358. 24/100 000 doses and 590. 59/100 000 doses respectively,which showed significant difference(P < 0. 001). A total of 473 223 doses of various vaccines were inoculated for primary immunization(three doses),of which the incidence rate of AEFI was 224. 84/100 000 doses. However,a total of 80 457 doses were inoculated for booster immunization,of which the incidence rate of AEFI was 871. 27/100 000 doses,indicating a significant difference with that of primary immunization(P < 0. 001). The incidence rates of AEFI of Hib,DTap-Hib and DTaP-IPV-Hib in booster immunization were significantly higher than those in primary immunization(each P < 0. 001). The incidence rates of AEFI of various vaccines in various injection sites showed significant difference(each P < 0. 001). The AEFI of Hib and epidemic encephalitis-HI mainly appeared in upper arm,with incidence rates of118. 71/100 000 doses and 203. 28/100 000 doses respectively. The AEFI of DTaP-IPV-Hib mainly appeared in thigh,with an incidence rate of 545. 75/100 000 doses,while that of DTaP-Hib mainly appeared in buttocks,with an incidence rate of 259. 41/100 000 doses. Most of the AEFI of various vaccines appeared 6 ～ 24 and 24 ～ 48 h after immunization,with an incidence rate of 255. 92/100 000 doses. The incidence rates of AEFI at various time intervals after immunization showed significant difference(each P < 0. 001). Conclusion The incidence of AEFI of Hib containing vaccines was low,indicating a high safety. It is recommended that the vaccines should be vaccinated in upper arm or thigh,and the monitoring and disposal of AEFI should be strengthened 1 ～ 2 d after vaccination.
引文
[1]刁连东,徐爱强.A、C群脑膜炎球菌-b型流感嗜血杆菌结合疫苗:一种新联合疫苗应用策略的综述[J].中华预防医学杂志,2014,48(12):1118-1122.
[2]SHEN J H,CHEN W H,GU S K,et al.Safety of acellular DTP,inactivated poliovirus and Haemophilus influenzae type b conjugate combined vaccine[J].Chin J Biologicals,2014,27(9):1189-1191.(in Chinese)沈金花,陈文花,顾士康,等.吸附无细胞百白破、灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗的安全性[J].中国生物制品学杂志,2014,27(9):1189-1191.
[3]YANG Y H,LENG Z Q,LU D L,et al.Pediatric Haemophilus influenzae type bmeninngitis in hefei city:an epidemiologic study[J].National Med J China,1998,78(4):11-13.(in Chinese)杨永弘,冷志勤,陆达林,等.合肥市小儿b型流感嗜血杆菌性脑膜炎的发病调查[J].中华医学杂志,1998,78(4):11-13.
[4]SHI L B,LV W Y,WANG Y,et al.Analysis on surveillance of adverse reactions for inoculation of Hib vaccine from 2011to 2016 in Henan province[J].Prog in Microbiol Immunol,2017,45(3):31-35.(in Chinese)史鲁斌,吕宛玉,王燕,等.2011-2016年河南省b型流感嗜血杆菌结合疫苗预防接种不良反应监测分析[J].微生物学免疫学进展,2017,45(3):31-35.
[5]GAO J,ZHANG J L,MA F B.Study on surveillance data of adverse reactions for Haemophilus influenzae type b vaccine in Jiangsu,2008-2014[J].Mod Prev Med,2016,43(4):722-726.(in Chinese)高君,张晋琳,马福宝.2008-2014年江苏省b型流感嗜血杆菌疫苗预防接种不良反应监测分析[J].现代预防医学,2016,43(4):722-726.
[6]潘原勇.b型流感嗜血杆菌结合疫苗的安全性评价[J].吉林医学,2015,36(11):2299-2300.
[7]ZHAO X J,LI C,LIU L Y,et al.Nasopharyngeal carriage of Haemophilus influenzae in 2-5 years old in Huairou district of Beijing and safety of related vaccine[J].Occup and Health,2015,31(20):2859-2861.(in Chinese)赵小娟,李超,刘利英,等.北京市怀柔区2~5岁儿童流感嗜血杆菌携带现况及其相关疫苗安全性研究[J].职业与健康,2015,31(20):2859-2861.
[8]YE J K,LI K L,XU D S,et al.Evaluation of the adverse events following immunization information management system in China,2013[J].Chin J Vac Immun,2015,21(2):121-131.(in Chinese)叶家楷,李克莉,许涤沙,等.中国2013年疑似预防接种异常反应信息管理系统数据分析[J].中国疫苗和免疫,2015,21(2):121-131.
[9]王春霞,李雅梅,冯素荣,等.b型流行性感冒嗜血杆菌感染及疫苗应用的安全性分析[J].现代中西医结合杂志,2008,17(23):3637-3638.
[10]吴昕,黎明强,崔雪莲.国产b型流感嗜血杆菌结合疫苗的安全性观察[J].应用预防医学,2009,15(4):239-242.
[11]REN S S,WANG D F,ZHONG C H.Immunogenicity and safety of the acellular pertusis,diphtheria,tetanus,inactivated poliomyelitis,Haemophilus influenzae type b conjugate vaccine(DTaP-IPV/Hib combined vaccine):a meta-analysis[J].JClin Pediatr,2014,32(3):271-277.(in Chinese)任思思,王栋芳,钟朝晖.吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗的安全性和免疫原性的meta分析[J].临床儿科杂志,2014,32(3):271-277.
[12]李文敏,尹刚,孔玉梅,等.我国儿童b型流感嗜血杆菌(Hib)疫苗接种率的meta分析[J].中国卫生统计,2017,34(1):69-73.
[13]刘红联,刘小祥,吴美华,等.b型流感嗜血杆菌结合疫苗两种不同接种途径的安全性观察[J].中华流行病学杂志,2006,27(9):828.
[14]MA J Q,SUN C Q,LIU X,et al.Haemophilus influenzae type b infection and its vaccine safety[J].Chin J Nosocomiol,2016,26(12):2667-2668,2672.(in Chinese)马建青,孙长青,刘霞,等.b型流感嗜血菌感染与疫苗安全性研究[J].中华医院感染学杂志,2016,26(12):2667-2668,2672.
[2]SHEN J H,CHEN W H,GU S K,et al.Safety of acellular DTP,inactivated poliovirus and Haemophilus influenzae type b conjugate combined vaccine[J].Chin J Biologicals,2014,27(9):1189-1191.(in Chinese)沈金花,陈文花,顾士康,等.吸附无细胞百白破、灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗的安全性[J].中国生物制品学杂志,2014,27(9):1189-1191.
[3]YANG Y H,LENG Z Q,LU D L,et al.Pediatric Haemophilus influenzae type bmeninngitis in hefei city:an epidemiologic study[J].National Med J China,1998,78(4):11-13.(in Chinese)杨永弘,冷志勤,陆达林,等.合肥市小儿b型流感嗜血杆菌性脑膜炎的发病调查[J].中华医学杂志,1998,78(4):11-13.
[4]SHI L B,LV W Y,WANG Y,et al.Analysis on surveillance of adverse reactions for inoculation of Hib vaccine from 2011to 2016 in Henan province[J].Prog in Microbiol Immunol,2017,45(3):31-35.(in Chinese)史鲁斌,吕宛玉,王燕,等.2011-2016年河南省b型流感嗜血杆菌结合疫苗预防接种不良反应监测分析[J].微生物学免疫学进展,2017,45(3):31-35.
[5]GAO J,ZHANG J L,MA F B.Study on surveillance data of adverse reactions for Haemophilus influenzae type b vaccine in Jiangsu,2008-2014[J].Mod Prev Med,2016,43(4):722-726.(in Chinese)高君,张晋琳,马福宝.2008-2014年江苏省b型流感嗜血杆菌疫苗预防接种不良反应监测分析[J].现代预防医学,2016,43(4):722-726.
[6]潘原勇.b型流感嗜血杆菌结合疫苗的安全性评价[J].吉林医学,2015,36(11):2299-2300.
[7]ZHAO X J,LI C,LIU L Y,et al.Nasopharyngeal carriage of Haemophilus influenzae in 2-5 years old in Huairou district of Beijing and safety of related vaccine[J].Occup and Health,2015,31(20):2859-2861.(in Chinese)赵小娟,李超,刘利英,等.北京市怀柔区2~5岁儿童流感嗜血杆菌携带现况及其相关疫苗安全性研究[J].职业与健康,2015,31(20):2859-2861.
[8]YE J K,LI K L,XU D S,et al.Evaluation of the adverse events following immunization information management system in China,2013[J].Chin J Vac Immun,2015,21(2):121-131.(in Chinese)叶家楷,李克莉,许涤沙,等.中国2013年疑似预防接种异常反应信息管理系统数据分析[J].中国疫苗和免疫,2015,21(2):121-131.
[9]王春霞,李雅梅,冯素荣,等.b型流行性感冒嗜血杆菌感染及疫苗应用的安全性分析[J].现代中西医结合杂志,2008,17(23):3637-3638.
[10]吴昕,黎明强,崔雪莲.国产b型流感嗜血杆菌结合疫苗的安全性观察[J].应用预防医学,2009,15(4):239-242.
[11]REN S S,WANG D F,ZHONG C H.Immunogenicity and safety of the acellular pertusis,diphtheria,tetanus,inactivated poliomyelitis,Haemophilus influenzae type b conjugate vaccine(DTaP-IPV/Hib combined vaccine):a meta-analysis[J].JClin Pediatr,2014,32(3):271-277.(in Chinese)任思思,王栋芳,钟朝晖.吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗的安全性和免疫原性的meta分析[J].临床儿科杂志,2014,32(3):271-277.
[12]李文敏,尹刚,孔玉梅,等.我国儿童b型流感嗜血杆菌(Hib)疫苗接种率的meta分析[J].中国卫生统计,2017,34(1):69-73.
[13]刘红联,刘小祥,吴美华,等.b型流感嗜血杆菌结合疫苗两种不同接种途径的安全性观察[J].中华流行病学杂志,2006,27(9):828.
[14]MA J Q,SUN C Q,LIU X,et al.Haemophilus influenzae type b infection and its vaccine safety[J].Chin J Nosocomiol,2016,26(12):2667-2668,2672.(in Chinese)马建青,孙长青,刘霞,等.b型流感嗜血菌感染与疫苗安全性研究[J].中华医院感染学杂志,2016,26(12):2667-2668,2672.