国产水痘减毒活疫苗保护效果的系统评价和证据质量初步分析

发布时间：2018-09-16 19:06

【摘要】：目的对国内上市的水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Var V)的保护效果和证据质量进行评价和分析。方法电子检索科克伦对照试验中心注册库(The Cochrane Central Register of Controlled Trials)、医疗文献分析及在线检索系统(Medline)、中国全文期刊数据库(1915年~)、万方数据库(1988年~),将国产Var V针对1~13岁儿童保护效果的随机对照试验纳入分析,由两名评价员共同提取资料,用Meta分析软件(Review Manager,Rev Man)5.2版本进行研究质量和统计分析,利用证据推荐分级的评估、制订与评价(The Grading of Recommendations Assessment,Development and Evaluation;GRADE)方法对整合证据的质量进行评级。结果共纳入6篇原始研究,无异质性,其干预措施为A公司和B研究所生产的冻干(Freeze-dried)Var V,对照措施为麻疹-流行性腮腺炎减毒活疫苗,干预对象多为3~6岁儿童,研究地点分别为山东、湖南和湖北省。Meta分析发现接种这种Vra V可明显降低水痘发病的概率[相对危险度(Relative Risk,RR)=0.11,95%可信区间(Confidence Interval,CI)=0.07~0.16],此结果与国内其他类型研究及国际研究结果一致。6篇研究报告存在明显缺陷,根据GRADE评价方法,整合的证据质量级别为"极低"。结论本研究结果基于现有发表文献得到的,国内上市Var V的保护效果可能与此估计值存在差异,提示国内Var V及其他此领域评价研究应提高研究质量,并提高文章报告的质量和完整性。
[Abstract]:Objective to evaluate and analyze the protective effect and evidence quality of live attenuated varicella vaccine (Varicella Attenuated Live Vaccine,Var V). Methods (The Cochrane Central Register of Controlled Trials), medical literature analysis and online retrieval system (Medline), (1915 ~) and Wanfang database (1988 ~) were used to search the medical literature of Cochrane controlled experimental center registry. Domestic Var V was targeted at children aged 13 years old. The protective effects of randomized controlled trials were included in the analysis, The data were extracted by two evaluators, the research quality and statistical analysis were carried out by Meta analysis software (Review Manager,Rev Man) version 5.2, and the quality of integrated evidence was rated by using the evaluation of evidence recommendation classification and (The Grading of Recommendations Assessment,Development and Evaluation;GRADE). Results A total of 6 original studies were included without heterogeneity. The intervention measures were freeze-dried (Freeze-dried) Var V, control measures were measles-mumps attenuated live vaccine). Most of them were children aged 3 to 6 years old. The research sites are respectively Shandong, Meta-analysis of Hunan and Hubei Province showed that inoculation with Vra V significantly reduced the probability of chickenpox incidence [relative risk (Relative Risk,RR) 0.1195% confidence interval (Confidence Interval,CI) 0.070.16]. The results were in agreement with other domestic and international studies. According to the GRADE evaluation method, the quality of the integrated evidence was "extremely low". Conclusion the results of this study are based on the published literature. The protective effect of Var V on the market in China may be different from the estimated value, suggesting that the research quality of domestic Var V and other evaluation studies in this field should be improved. And improve the quality and integrity of the article report.
【作者单位】：中国疾病预防控制中心免疫规划中心;北京大学中国卫生发展研究中心;
【分类号】：R186

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