疫苗安全性评价文献数据仓库建立及应用前景初探

杨羽; 曾雪扬; 刘志科; 李志霞; 赵厚宇; 刘佐相; 李沛; 姚晓莹; 贺冰洁; 李克莉; 李燕; 孙凤; 詹思延

Abstract

杨羽,曾雪扬,刘志科,李志霞,赵厚宇,刘佐相,李沛,姚晓莹,贺冰洁,李克莉,李燕,孙凤,詹思延.疫苗安全性评价文献数据仓库建立及应用前景初探[J].Chinese journal of Epidemiology,2022,43(3):431-435

疫苗安全性评价文献数据仓库建立及应用前景初探

Artificial intelligence-based literature data warehouse for vaccine safety

Received:April 07, 2021

DOI：10.3760/cma.j.cn112338-20210407-00288

KeyWord: 疫苗免疫后不良事件安全性评价文献仓库

English Key Word: Vaccine Adverse events following immunization Safety assessment Literature data warehouse

FundProject:国家重点研发计划（2021YFC2301601）；国家自然科学基金（72074011）

Author Name	Affiliation	E-mail
Yang Yu	National Institute of Health Data Science, Peking University, Beijing 100191, China
Zeng Xueyang	School of Public Health, Peking University, Beijing 100191, China
Liu Zhike	School of Public Health, Peking University, Beijing 100191, China
Li Zhixia	Department of Education, Peking University Health Science Center, Beijing 100191, China
Zhao Houyu	School of Public Health, Peking University, Beijing 100191, China
Liu Zuoxiang	School of Public Health, Peking University, Beijing 100191, China
Li Pei	School of Public Health, Peking University, Beijing 100191, China
Yao Xiaoying	School of Public Health, Peking University, Beijing 100191, China
He Bingjie	School of Public Health, Peking University, Beijing 100191, China
Li Keli	National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing 100050, China
Li Yan	National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing 100050, China
Sun Feng	School of Public Health, Peking University, Beijing 100191, China	sunfeng@bjmu.edu.cn
Zhan Siyan	School of Public Health, Peking University, Beijing 100191, China Research Center of Clinical Epidemiololgy, Peking University Third Hospital, Beijing 100191, China	siyan-zhan@bjmu.edu.cn

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Abstract:

目的建立可持续更新的全球疫苗安全性评价文献数据仓库，为疫苗安全性循证评价提供数据支持。方法通过循证评价的标准操作步骤与人工智能技术的不断整合，实现文献数据仓库的半自动化构建和更新。检索包括英文数据库（OVID、Scopus、Web of Science、Cochrane Library、ClinicalTrails.org）和中文数据库（万方数据知识服务平台、中国知网、维普、SinoMed）中与疫苗安全性评价相关的中英文文献，检索日期截至2020年11月29日。按照纳入排除标准，通过半自动化方式（人工智能文献处理系统和研究人员人工处理）对检出文献进行两阶段筛选。进一步将根据疫苗类型和免疫后不良事件种类对文献进行分组管理；建立更新制度，定期更新文献数据仓库；组织专家优选特定疫苗安全性话题，开展专题示范研究。结果共检索获得文献41万余篇，根据纳入排除标准，经过两轮筛选后最终纳入23 304篇。基于该仓库现已遴选出三个优先话题进行示范研究，已完成“百白破类疫苗与脑病/脑炎”的系统评价，并对过敏性紫癜、臂丛神经炎两种不良事件相关文献进行分类管理。结论持续更新的疫苗安全性文献数据仓库可以为疫苗安全性研究提供高质量的研究数据，包括为免疫接种相关政策制定和调整提供证据支持；为开展疫苗安全性相关方法学研究和临床工具开发提供数据基础。进一步的示范研究还可为及时高效的新方法学框架体系建立提供参考。

English Abstract:

Objective To establish a sustainable updated literature data warehouse for global vaccine safety assessment, and provide data support for evidence-based vaccine safety assessment. Methods Semi-automated construction and updating of a literature data warehouse were achieved through the continuous integration of standard operating steps of evidence-based reviews with artificial intelligence technologies. Following the standard procedure of a systematic literature review, the literatures about vaccine safety assessment published before November 29, 2020 were retrieved from 9 databases including OVID, Scopus, Web of Science, Cochrane Library, and ClinicalTrails.org in English and Wanfang, CNKI, VIP, and SinoMed in Chinese. Literatures were screened for two rounds in a semi-automatic manner (by artificial intelligence literature processing system and manual work) according to the inclusion/exclusion criteria. Furthermore, the literatures were classified according to the types of vaccines and adverse events. The updating strategy was established, and the literature data warehouse was updated regularly. Experts were organized to select specific vaccine safety topics and carry out special demonstration studies. Results More than 0.41 million articles were retrieved. According to the inclusion/exclusion criteria, 23 304 articles were included after two rounds of screening. At present, we have selected and completed three prior topics as demonstration studies, including the systematic review of "DPT (diphtheria, pertussis and tetanus) vaccine and encephalopathy/encephalitis", and the classified management of literatures about allergic purpura and brachial plexus neuritis. Conclusions The sustainable updated literature data warehouse of vaccine safety can provide high-quality research data for vaccine safety research, including evidence support for immunization related policy-making and adjustment and vaccine safety-related methodological research or clinical tool development; and further demonstration studies can provide references for building a new methodological framework system for timely and efficient completion of the evidence-based assessment of vaccine safety.

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