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目的:通过系统综述总结我国2005—2012年发表文献使用的药源性肝损伤(DILI)的诊断标准,了解我国DILI诊断标准的使用情况及其特点。方法:中国期刊全文专题数据库(CNKI)、中国生物医学文献数据库(CBM)、维普中文科技期刊数据库(VIP)、万方数据以关键词“药物性/药源性+肝损害/肝损伤/肝病/肝炎”对2005—2012年文献进行检索,使用Noteexpress软件对检索到的文献进行管理,排除不同数据库间重复的文献,按照纳入和排除标准,对文献进行筛选。用Excel2007建立文献摘录表,进行数据提取和分析。结果:有273篇文献纳入研究,包括199篇病例系列和74篇病例报告。199篇病例系列采用的DILI诊断标准不一,有15个不同的标准,采用最多的是我国通用标准、1997年Maria评分、以及以“病史、临床表现和相关检查等”作为诊断标准。199篇病例系列对这3种标准的使用并没有明显随时间变化的趋势。不同类别杂志的文献对DILI诊断标准的使用也没有明显的趋势。74篇病例报告均是根据病史、临床表现和相关检查等做出诊断。结论:药源性肝损伤(DILI)目前没有统一的标准,在DILI诊断标准的选择上应根据患者年龄、原患疾病、临床症状、各项相关检查等选择合适的诊断标准,尽量避免漏诊和误诊的发生。
OBJECTIVE: To summarize the diagnostic criteria of drug-induced liver injury (DILI) published in our country from 2005 to 2012 through systematic review and to understand the usage and characteristics of DILI diagnostic criteria in our country. Methods: CNKI, CBM, VIP, Wanfang data were analyzed with the key words of “drug / drug-induced liver injury / liver injury / Hepatology / Hepatitis ”searched the 2005-2012 literature, used the Noteexpress software to manage the retrieved literature, excluded duplicates from different databases, and screened the literature for inclusion and exclusion criteria. Using Excel2007 to establish a literature excerpt table, data extraction and analysis. RESULTS: A total of 273 articles were included in the study, including 199 case series and 74 case reports. DILI diagnostic criteria used in 199 case series are different, with 15 different standards, most commonly used by our common standards, 1997 Maria score, and to “medical history, clinical manifestations and related tests ” as a diagnostic criteria. The use of these three criteria in the 199 case series did not show a clear trend over time. There is also no clear trend in the use of DILI diagnostic criteria in the literature of different categories of magazines. 74 case reports are based on history, clinical manifestations and related tests to make a diagnosis. Conclusion: There is no uniform standard for drug-induced liver injury (DILI) at present. The diagnostic criteria of DILI should be based on the patient’s age, original disease, clinical symptoms, various related tests, etc. to choose the appropriate diagnostic criteria, to avoid missed diagnosis and Misdiagnosis occurred.