江苏省滨海县3～5月龄婴儿接种吸附无细胞百白破联合疫苗后局部不良反应主动监测分析

张鹏; 梅茂冬; 于佳; 魏明伟; 王小山; 潘红星

doi:10.11847/zgggws1141811

江苏省滨海县3～5月龄婴儿接种吸附无细胞百白破联合疫苗后局部不良反应主动监测分析

Proactive surveillance on DTaP vaccination-induced adverse local reac-tions among infants in a county of Jiangsu province

摘要

摘要:
目的通过对婴儿接种吸附无细胞百白破联合疫苗（diphtheria, tetanus and acellular pertussis combined vaccine, DTaP）后局部不良反应的主动监测，评价婴儿接种DTaP的安全性。
方法于2020 年 7 月— 2021 年 3 月，对在江苏省滨海县东坎镇、陈涛镇、界牌镇、滨海现代农业产业园4个乡镇卫生院接种DTaP的3～5月龄婴儿局部不良反应进行主动监测，并按照《预防用疫苗临床试验研究不良事件分级标准指导原则》（2019 年第102号）对发生的局部不良反应进行分级，用描述流行病学方法进行局部不良反应分析。
结果共有2 490人次纳入至本次DTaP接种后局部不良反应主动监测分析中。DTaP 接种后，局部不良反应1 009例次，总发生率为40.52%，其中局部硬结和红晕发生率最高，分别为14.4%和17.0%。1 级局部不良反应发生率为35.9%（893/2 490），其中硬结和红晕占比最高，分别占38.18%（341/893）和42.89%（383/893）；2 级局部不良反应发生率为4.66%（116/2 490），其中红晕和触痛占比最高，分别占34.48%（40/116）和26.72%（31/116）；未见 3 级及以上局部不良反应。局部不良反应多发生在 DTaP接种后 3d 内，占总发生率的 98.0%（988/1 009）。硬结和红晕的发生率在 3 个不同厂家（A、B、C厂家）DTaP 受种儿间差异有统计学意义（P < 0.05）。不同剂次 DTaP 接种后，硬结、肿胀、红晕和皮疹发生率差异有统计学意义（P < 0.05），其中第 2 剂、第 3 剂 DTaP 接种后硬结、肿胀、红晕发生率明显高于第 1 剂（P < 0.01），第 3 剂 DTaP 接种后皮疹发生率明显高于第1 剂（P < 0.05）。男、女婴儿接种DTaP后局部不良反应发生率分别为 40.71%（517/1270）和40.33%（492/1220），差异无统计学意义（P > 0.05）。
结论硬结、红晕和肿胀为3～5月龄婴儿DTaP 接种后发生的主要局部不良反应。

Abstract:
Objective To examine adverse local reactions (ALRs) among infants after vaccinated with diphtheria, tetanus and acellular pertussis combined vaccine (DTaP) for evaluating the safety of DTaP vaccination in the infants.
Methods We conducted a proactive surveillance local on DTaP vaccination-induced ALRs among 2 494 healthy infants of 3 - 5 months old at four township health centers in a county of Jiangsu province from July 2020 through March 2021. The identification of ALRs was based on the Guidelines for the Classification of Adverse Events in Clinical Trials of Preventive Vaccines (No.102 of 2019) issued by National Medical Products Administration. The collected data were analyzed with descriptive statistics.
Results Among 2 490 infants finally included in the analysis, 1 009 were identified as having DTaP vaccination-induced ALRs, with an overall incidence rate of 40.52%, and there was no significant gender difference in the incidence rate (40.71% for the boys and 40.33% for the girls, P > 0.05); the incidence rate of grade I and II ALRs were 35.9% and 4.66% and no ALRs of grade III and above was observed in all the infants. Local tissue induration and redness were among the most frequent adverse reactions, accounting for 14.4% and 17.0% of all the ALRs, 38.18% and 42.89% of all grade I ALRs; while, the proportion tissue redness and tenderness were 34.48% and 26.72% for all the grade II ALRs; Almost all (98.0%) the ALRs occurred within 3 days after DTaP inoculation. The incidence rate of local tissue induration and redness differed significantly among the infants inoculated with DTaP from various manufactures (P < 0.05); the incidence rate of induration, swelling, redness and rash were significantly higher among the infants with the second and third dose of DTaP than those among the infants with the first dose vaccine (P < 0.01) and the incidence rate of rash was significantly higher in the infants with the third dose DTaP than that of the infants with the first dose vaccine (P < 0.05).
Conclusion Induration and redness are main adverse local tissue reactions after DTaP vaccination among 3 – 5 months old infants .

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