新型冠状病毒肺炎疫苗有效性和安全性的系统评价

Efficacy and safety of the COVID-19 vaccine:a systematic review

目的系统评价新型冠状病毒肺炎疫苗的安全性和有效性。方法计算机检索CNKI、VIP、WanFang Data、PubMed、EMbase和Web of Science数据库,搜集有关新型冠状病毒肺炎疫苗安全性和有效性的随机对照试验(RCT),检索时限均为建库至2022年6月30日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3和Stata 12.0软件进行Meta分析。结果共纳入13个RCT,包括139015例受试者。Meta分析结果显示,疫苗组血清抗体转化率[RR=37.883,95%CI(8.086,177.491),P<0.001]及预防率[RR=1.011,95%CI(1.006,1.017),P<0.001]均高于安慰剂组。疫苗组不良反应发生率高于安慰剂组[OR=1.839,95%CI(1.165,2.903),P=0.009],主要包括注射部位疼痛、红肿、发热、头痛、瘙痒、乏力(P<0.05),但疫苗组严重不良反应发生率与安慰剂组差异无统计学意义。结论当前证据显示,新型冠状病毒肺炎疫苗的有效性较高,不良反应主要为轻、中度,严重不良反应与安慰剂无明显差异。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of vaccines for the coronavirus disease2019(COVID-19).Methods The CNKI,VIP,WanFang Data,PubMed,EMbase and Web of Science databases were electronically searched to collect randomized controlled trials(RCTs)on the safety and efficacy of COVID-19 vaccines from their inception to June 30th,2022.Two reviewers independently screened the literature,extracted data and assessed the risk of bias of the included studies.Meta-analysis was then performed using RevMan 5.3 software and Stata 12.0software.Results A total of 13 RCTs involving 139015 subjects were included.The results of meta-analysis showed that the sero-antibody conversion rate(RR=37.883,95%CI 8.086 to 177.491,P<0.001)and infection prevention rate(RR=1.011,95%CI 1.006 to 1.017,P<0.001)of the vaccine group were higher than those of the placebo group.The incidence of adverse reactions in the vaccine group was higher than that in the placebo group(OR=1.839,95%CI 1.165 to2.903,P=0.009),which mainly included pain,redness,swelling,fever,headache and itching(P<0.05).However,the incidence of serious adverse reactions was not significantly different from that of the placebo group.Conclusion The current evidence shows that the efficacy of the COVID-19 vaccines is high.The most prevalent adverse reactions are mild and moderate,and severe adverse reactions are the same as those of the placebo group.Due to the limited quality and quantity of the included studies,more high-quality studies are required to verify the above conclusion.