【摘要】：目的對國內(nèi)上市的水痘減毒活疫苗(Varicella Attenuated Live Vaccine,Var V)的保護效果和證據(jù)質(zhì)量進行評價和分析。方法電子檢索科克倫對照試驗中心注冊庫(The Cochrane Central Register of Controlled Trials)、醫(yī)療文獻分析及在線檢索系統(tǒng)(Medline)、中國全文期刊數(shù)據(jù)庫(1915年~)、萬方數(shù)據(jù)庫(1988年~),將國產(chǎn)Var V針對1~13歲兒童保護效果的隨機對照試驗納入分析,由兩名評價員共同提取資料,用Meta分析軟件(Review Manager,Rev Man)5.2版本進行研究質(zhì)量和統(tǒng)計分析,利用證據(jù)推薦分級的評估、制訂與評價(The Grading of Recommendations Assessment,Development and Evaluation;GRADE)方法對整合證據(jù)的質(zhì)量進行評級。結(jié)果共納入6篇原始研究,無異質(zhì)性,其干預(yù)措施為A公司和B研究所生產(chǎn)的凍干(Freeze-dried)Var V,對照措施為麻疹-流行性腮腺炎減毒活疫苗,干預(yù)對象多為3~6歲兒童,研究地點分別為山東、湖南和湖北省。Meta分析發(fā)現(xiàn)接種這種Vra V可明顯降低水痘發(fā)病的概率[相對危險度(Relative Risk,RR)=0.11,95%可信區(qū)間(Confidence Interval,CI)=0.07~0.16],此結(jié)果與國內(nèi)其他類型研究及國際研究結(jié)果一致。6篇研究報告存在明顯缺陷,根據(jù)GRADE評價方法,整合的證據(jù)質(zhì)量級別為"極低"。結(jié)論本研究結(jié)果基于現(xiàn)有發(fā)表文獻得到的,國內(nèi)上市Var V的保護效果可能與此估計值存在差異,提示國內(nèi)Var V及其他此領(lǐng)域評價研究應(yīng)提高研究質(zhì)量,并提高文章報告的質(zhì)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.
【作者單位】： 中國疾病預(yù)防控制中心免疫規(guī)劃中心;北京大學(xué)中國衛(wèi)生發(fā)展研究中心;
【分類號】：R186

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