口服轮状病毒疫苗免疫效果及安全性研究文献综述

Review of the Study Literature of the Immune Effect and Safety of Oral Rotavirus Vaccine

目的评价口服轮状病毒减毒活疫苗(Oral Rotavirus Attenuated Live Vaccine,ORV)的免疫效果及安全性。方法电子检索《中国知网》、《中国期刊全文数据库》、《万方全文数据库》、等数据库,将有关接种口服轮状病毒疫苗的保护效果及安全性的研究进行Meta分析。结果共纳入9篇文献,有5项疫苗保护率研究,4项为疫苗接种对临床表现的研究,4项安全性研究。大多数研究疫苗保护率都在74%以上,最高达86.4%;定性检测结果Ⅰ、Ⅱ、Ⅲ、Ⅳ、LLR型抗体阳转率分别为75.00%、66.67%、63.16%、75.86%、76.47%。定量检测各型抗体4倍增长率分别为60.38%、50.94%、45.28%、52.83%、47.17%。归纳各研究者的报导,轮状病毒口服疫苗的副反应有体温反应和消化道反应两类,无严重不良反应和死亡报告。结论接种口服轮状病毒疫苗可以不同程度地降低轮状病毒感染性腹泻的发病,减少重症病例及缩短病程;接种后反应轻微多为一过性反应,具有良好的保护效果和安全性。

Objective To evaluate the immune effect and safety of Oral Rotavirus Attenuated Live Vaccine （ORV）. Methods Stud- ies about the immune effect and safety of ORV from www.cnki.net, CJFD, www.wanfangdata.eom.cn and other databases were searched electronically for Meta-analysis. Results A total of 9 literatures were included, of which there were 5 vaccine protection rate studies, 4 of vaccination on clinical studies, 4 safety studies. The vaccine protection rate in most studies was above 74%, up to 86.4%. The qualitative detection result of 1 , II, Ill, IV, LLR antibody positive conversion rate was 75.00%, 66.67%, 63.16%, 75.86%, 76.47%, respectively. Quantitative detection of the four times growth rate of antibodies was 60.38%, 50.94%, 45.28%, 52.83%, 47.17%, respectively. According to the reports of the researchers, the side effects of ORV mainly were 2 kinds, tempera- ture response and digestive tract reaction, no serious adverse reactions and death report. Conclusion Vaccinating ORV can reduce the incidence of rotavirus diarrhea to varying degrees, reduce the severe cases and shorten the course of disease; and the reactions after vaccination are mild, mostly transient response, which has good protective effect and safety.