妊娠期接种百白破联合疫苗安全性的Meta分析

Meta-analysis of safety of vaccination with tetanus,diphtheria and pertussis combined vaccine use in pregnancy

目的分析妊娠期接种百白破联合疫苗(tetanus toxoid,reduced diphtheria toxoid,and acellular pertussis combined vaccine,TdaP)的安全性。方法检索中国知网(China National Knowledge Infrastruture,CNKI)、中国生物医学文献数据库(China Biology Medicine Disc,CBM)、万方数据库(WanFang Database,WF)、PubMed、EMbase、Cochrane Library,时间为建库至2020年4月公开发表关于妊娠期接种TdaP疫苗安全性的随机对照试验(random contralled trial,RCT),同时辅以手工检索及追溯纳入文献的参考文献。应用RevMan 5.3统计分析软件进行Meta分析。结果共纳入6篇RCT文献。Meta分析显示,TdaP试验组与对照组相比,发生疼痛、肿胀、红斑、发热、头疼、乏力、肌肉酸疼、早产、严重不良反应、新生儿先天异常和畸形、新生儿严重不良反应的合并风险比(risk ratio,RR)分别为3.74(95%CI:1.43~9.76)、6.69(95%CI:3.92~12.34)、2.20(95%CI:1.60~3.02)、1.55(95%CI:0.45~5.30)、1.09(95%CI:0.84~1.41)、0.93(95%CI:0.52~1.67)、1.11(95%CI:0.20~6.61)、1.48(95%CI:0.74~2.98)、0.98(95%CI:0.71~1.34)、0.74(95%CI:0.37~1.50)、0.83(95%CI:0.51~1.35)。结论妊娠期接种TdaP疫苗后,局部疼痛、红斑、肿胀的发生率略增高,但不会增加其他不良反应的风险。

Objective To analyze the safety of vaccination with tetanus,diphtheria and acellular pertussis combined vaccine(TdaP) use in pregnancy. Methods Databases including China National Knowledge Infrastruture(CNKI),China Biology Medicine Disc(CBM),WanFang Datebase(WF),PubMed,Embase and Cochrane Library were searched for randomized controlled trials(RCTs)on the safety of TdaP in pregnancy from the establishment of the databases to April 2020.Meanwhile,manual search was conducted,and references of included literature were retrieved. Meta-analysis was conducted by using RevMan 5. 3 software. Results A total of six published articles on RCT were included. Meta-analysis showed that,compared with those in control group,the combined RR values for incidences of pain,swelling,redness,fever,headache,fatigue,muscle aches,premature delivery,severe adverse reactions,congenital abnormalities and severe adverse reactions in newborn in trial group were 3. 74(95% CI :1. 43 ~ 9. 76),6. 69(95% CI:3. 92 ~ 12. 34),2. 20(95% CI 1. 60 ~ 3. 02),1. 55(95% CI:0. 45 ~ 5. 30),1. 09(95% CI:0. 84 ~ 1. 41),0. 93(95% CI:0. 52 ~ 1. 67),1. 11(95% CI:0. 20 ~ 6. 61),1. 48(95% CI:0. 74 ~ 2. 98),0. 98(95% CI:0. 71 ~ 1. 34),0. 74(95% CI:0. 37 ~1. 50)and 0. 83(95% CI:0. 51 ~ 1. 35)respectively. Conclusion The vaccination with TdaP in pregnancy does not increase the risk of other adverse reactions except for the slightly higher incidences of local pain,redness and swelling.