PDF(Pubmed)
Abstract：
Drug-induced liver injury (DILI) is a type of bizarre adverse drug reaction (ADR) damaging liver (L-ADR) which may lead to substantial hospitalizations and mortality. Due to the general low incidence, detection of L-ADR remains an unsolved public health challenge. Therefore, we used the data of 6.673 million of ADR reports from January 1st, 2012 to December 31st, 2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation. Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from the original heterogeneous system. By cleaning and standardizing the data fields by the dictionary of synonyms and English translation, we resulted 94,593 ADR records reported to liver injury and then created a new database ready for computer mining. The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years. The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men. The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population, despite known underreporting situation in spontaneous ADR reporting system. The percentage of herbal and traditional medicines (H/TM) L-ADR reports in the whole number was 4.5%, while 80.60% of the H/TM reports were new findings. There was great geographical disparity of reported agents, i.e. more cardiovascular and antineoplastic agents were reported in higher socio-demographic index (SDI) regions and more antimicrobials, especially antitubercular agents, were reported in lower SDI regions. In conclusion, this study presented a large-scale, unbiased, unified, and computer-minable L-ADR database for further investigation. Age-, sex- and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.
摘要：
药物性肝损伤（DILI）是一种奇怪的药物不良反应（ADR）损害肝脏（L-ADR），可能导致大量住院和死亡。由于发病率普遍较低，L-ADR的检测仍然是一个尚未解决的公共卫生挑战。因此,我们使用了1月1日起667.3万份ADR报告的数据，2012年12月31日,2016年在中国国家ADR监测系统中建立了新的L-ADR报告数据库，用于未来的调查。结果表明，通过对原始异构系统中肝脏相关损伤的关键词搜索，共检索到114,357份ADR报告。通过同义词词典和英文翻译对数据字段进行清理和标准化，我们收集了94,593份报告为肝损伤的ADR记录,然后创建了一个新的数据库,可用于计算机挖掘.在过去五年中，L-ADR的报告状况持续变化1.62倍。随着年龄的增长，全国人口调整后的L-ADR报告数量呈上升趋势，在男性中更为明显。80岁以上年龄组L-ADR的年报告率显著超过一般人群的年DILI发病率,尽管已知自发性ADR报告系统存在漏报情况。中草药和传统药物(H/TM)L-ADR报告占总数的百分比为4.5%,而80.60%的H/TM报告是新发现。报告的特工有很大的地理差异，即在更高的社会人口统计学指数（SDI）地区和更多的抗微生物药物中报告了更多的心血管和抗肿瘤药物，尤其是抗结核药,在较低的SDI地区报告。总之,这项研究提出了一个大规模的，没有偏见,统一,和计算机可挖掘的L-ADR数据库进行进一步调查。年龄-,与性别和SDI相关的L-ADR发生风险需要强调中国或世界其他地区的精确药物警戒政策。
