Analysis of data elements in case reports of traditional Chinese medicine drug-induced liver injury

doi:10.19803/j.1672-8629.20220209

Abstract

Abstract: Objective To evaluate the reported cases of traditional Chinese medicine (TCM) drug-induced liver injury(DILI) in China and provide reference for the standardization of TCM DILI. Methods Comprehensive collection of the 3 databases of CNKI, Wanfang Data and China Biomedical Text Service System from the establishment of the database to May 31, 2021, set the basic data elements of TCM DILI literature reports and evaluate the reported cases of TCM DILI in China. Results 43 data elements of TCM DILI literature reports were set, and 451 literatures involving 549 cases were included. The information of data elements was extracted, of which the reporting rate of 16 data elements was less than 50%.The reporting rate of data elements related to Roussel Uclaf scoring method (RUCAM) was low, and there were some problems such as fuzzy element reporting and discontinuous description of numerical data. Conclusion Some important information was missing in the literature of TCM DILI, and it is difficult to support the diagnosis and cality evaluation of TCM DILI. It is suggested that a unified standard should be established by developing the basic data set of TCM DILI literature case reports, to improve the quality of case report and promote the in-depth analysis and utilization of literature.

Key words: literature case report, TCM, drug-induced liver injury, data element, data analysis

CLC Number:

R28
R994.11

ZHU Lan, ZHU Yan, YAO Keyu, CHEN Chao, LIU Lihong. Analysis of data elements in case reports of traditional Chinese medicine drug-induced liver injury[J]. Chinese Journal of Pharmacovigilance, 2022, 19(12): 1352-1357.

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